Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives should not be used in women who are over 35 years and smoke.
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be taken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal genital bleeding.
Do not use estrogen-alone therapy for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens 0.625 mg alone, relative to placebo.
Do not use estrogen plus progestin therapy for the prevention of cardiovascular disease. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo.
The WHI estrogen-plus-progestin substudy demonstrated an increased risk of invasive breast cancer.
Do not use estrogen-alone therapy for the prevention of dementia. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg) alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Do not use estrogen plus progestin therapy for the prevention of dementia. The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Only daily oral conjugated estrogens 0.625 mg and medroxyprogesterone acetate 2.5 mg were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower conjugated estrogens plus other medroxyprogesterone acetate doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile. Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Abnormal uterine bleeding, acute (off-label use):
Note: For use in hemodynamically stable patients without high risk for thrombosis (Ref). Use active (hormonal) tablets from monophasic combinations containing at least 30 mcg of ethinyl estradiol; do not use multiphasic combinations or inactive (placebo) tablets (Ref). Concurrent use of an antiemetic may improve tolerability. After resolution of acute bleeding, transition to maintenance therapy (eg, monthly or extended cycle oral contraceptive regimen, levonorgestrel IUD) (Ref).
Oral: Multiple regimens have been described:
One tablet 3 times per day for 7 days, then taper as tolerated to maintain control of bleeding (Ref)
or
One tablet every 6 to 8 hours until cessation of bleeding (24 to 48 hours), then taper as tolerated to maintain control of bleeding (Ref)
or
Five tablets on day 1, then four tablets on day 2, then three tablets on day 3, then two tablets on day 4, then one tablet daily; continue 1 tablet daily for at least 1 week after acute bleeding subsides, then discontinue for 3 to 5 days to allow for a withdrawal bleed. The daily dose may be administered as a single dose or in divided doses to improve tolerability (Ref).
Abnormal uterine bleeding, nonacute (off-label use): Note: Not indicated for management of acute abnormal bleeding (ie, excessively heavy or prolonged bleeding that requires urgent evaluation). Product selection: Preparations with shorter hormone-free intervals (ie, ≤4 hormone-free days per month) may reduce withdrawal bleeding and are preferred by some experts (Ref).
Oral: Refer to dosing for “Contraception” (Ref).
Acne vulgaris, inflammatory, moderate to severe: Estrostep Fe, Tilia Fe, Tri-Legest Fe:
Note: For patients ≥15 years of age who have reached menarche and desire oral contraception (Ref).
Oral: Refer to dosing for "Contraception."
Contraception: Oral: One tablet once daily in the order presented in the blister pack. Note: Not all products are acceptable for effective contraception. Products intended for contraception have larger amounts of ethinyl estradiol (ie, ethinyl estradiol 0.02 to 0.035 mg/norethindrone 0.4 to 1.5 mg) compared to products intended for postmenopausal indications. Do not use Femhrt, Fyavolv, or Jinteli for contraception as the ethinyl estradiol amounts are very small (ie, 0.0025 to 0.005 mg).
Patients not currently using a hormonal contraceptive: Note: If reasonably sure the patient is not pregnant, may be initiated at any time during the menstrual cycle (Ref). Quick start method is preferred by some experts (Ref).
Day 1 start: Start on first day of menstrual cycle. Additional method of contraception is not required (Ref).
Quick start: Start on the day the patient receives the prescription (Ref). If initiated >5 days after the onset of menses, use an additional method of contraception (nonhormonal) until 7 days of consecutive administration(Ref).
Sunday start: Start on first Sunday after onset of menstruation; if the menstrual period starts on Sunday, take first tablet on same day. (This schedule is not preferred for all products [eg, Generess Fe, Layolis Fe, Lo Loestrin Fe]). If initiated >5 days after the onset of menses, use an additional method of contraception (nonhormonal) until 7 days of consecutive administration (Ref).
Current method |
Instructions for switching to ethinyl estradiol/norethindrone
|
Implant |
Start ethinyl estradiol/norethindrone on the day of implant removal. |
Injection |
Start ethinyl estradiol/norethindrone on the day the next injection would have been scheduled. |
Intrauterine system (IUS) |
Start ethinyl estradiol/norethindrone on the day of IUS removal. If ethinyl estradiol/norethindrone is not initiated on the first day of menses or the day of IUS removal, use an additional method of contraception (nonhormonal) for the first 7 days of consecutive administration. |
Oral contraceptive |
Start ethinyl estradiol/norethindrone on the day a new pack of the previous oral contraceptive would be started. |
Transdermal system |
Start ethinyl estradiol/norethindrone on the day when the next application would be scheduled. |
Vaginal insert |
Start ethinyl estradiol/norethindrone on the day when the next insertion would be scheduled. |
a Refer to prescribing information for product-specific information. Additional guidance is also available (see CDC [Curtis 2016a]). |
Use after childbirth (not breastfeeding) |
Do not initiate ethinyl estradiol/norethindrone during the first 4 weeks after delivery due to the increased risk of thromboembolic disease. If postpartum menstrual cycles have returned, follow instructions for patients not currently using a hormonal contraceptive. If menstrual cycles have not returned, consider the possibility of ovulation occurring prior to use. |
Use after first-trimester abortion or miscarriage |
Ethinyl estradiol/norethindrone can be started immediately. If not started within 5 days of a first trimester abortion or miscarriage, use an additional method of contraception (nonhormonal) for the first 7 days of consecutive administration. |
Use after second-trimester abortion or miscarriage |
Do not initiate ethinyl estradiol/norethindrone until 4 weeks after second trimester abortion or miscarriage due to the increased risk of thromboembolic disease. When started, follow instructions for patients not currently using a hormonal contraceptive (Sunday start). |
a Refer to prescribing information for product-specific information. Additional guidance is also available (see CDC [Curtis 2016a]). |
If 1 active tablet is missed in weeks 1, 2 or 3 |
Take the missed dose as soon as possible. Continue taking 1 tablet daily until pack is finished. |
If 2 consecutive active tablets are missed in week 1 or week 2 |
Take the 2 missed doses as soon as possible and take the next 2 active tablets the next day. Continue taking 1 tablet a day until the pack is finished. Use back-up (nonhormonal) contraception until active tablets have been taken for 7 consecutive days after the missed tablets. |
If 2 consecutive active tablets are missed during week 3 or 4, or ≥3 consecutive active tablets are missed at any time |
Day 1 start: • Throw out the rest of the pack and start a new pack that same day. Sunday start: • Continue taking 1 tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use back-up (nonhormonal) contraception until active tablets have been taken for 7 consecutive days after the missed tablets. |
a Refer to prescribing information for product-specific information. Additional guidance is also available (see CDC [Curtis 2016a]). |
Hirsutism (off-label use): Oral: One tablet once daily in the order presented in the blister pack. Note: Use a product intended for contraception and a preparation with the lowest effective dose of ethinyl estradiol (eg, 0.02 mg) in patients at higher risk for venous thromboembolism (Ref). Refer to dosing for “Contraception” for additional dosing instructions if also used for the prevention of pregnancy.
Hyperlactation (off-label use): Oral: One tablet once daily using a preparation containing ethinyl estradiol 0.02 to 0.035 mg. Do not initiate treatment <6 weeks postpartum; discontinue once milk production decreases (may significantly decrease within 7 days) (Ref).
Menstrual suppression (off-label use): Oral: One tablet once daily in the order presented in the blister pack, omitting placebo tablets, and continuing with a new pack of active tablets (using a product intended for contraception). May consider initiating as cyclic therapy for 3 to 6 months, then transitioning to extended cycles. Products containing ethinyl estradiol 0.02 mg generally have more breakthrough bleeding than those with higher doses (Ref).
Osteoporosis, postmenopausal, prevention: Oral (Femhrt, Fyavolv, Jinteli): One tablet daily.
Polycystic ovary syndrome, patients with hyperandrogenism and/or menstrual irregularities (off-label use): Oral: One tablet once daily in the order presented in the blister pack (Ref). Note: Use a product intended for contraception and a preparation with the lowest effective dose of ethinyl estradiol (eg, 0.02 to 0.03 mg) (Ref). Refer to dosing for “Contraception” for additional dosing instructions if also used for the prevention of pregnancy.
Vasomotor symptoms associated with menopause:
Note:For use in symptomatic patients who are <60 years of age or within 10 years of menopause who do not have contraindications to hormone therapy (eg, breast cancer) (Ref). Non-oral estrogen preparations are preferred in patients with hypertriglyceridemia, risk factors for venous thromboembolic disease, active gallbladder disease, and/or migraine headache with aura (Ref). Combination products are only indicated for patients with a uterus; the progestogen (ie, a natural progesterone or synthetic progestin) component prevents estrogen therapy–associated endometrial hyperplasia. Use of a combination product offers less dosing flexibility for initiating and tapering estrogen compared to separate estrogen and progestogen products.
Oral:
Femhrt: Ethinyl estradiol 0.0025 mg/norethindrone acetate 0.5 mg: One tablet daily.
Fyavolv: Ethinyl estradiol 0.0025 mg/norethindrone acetate 0.5 mg or ethinyl estradiol 0.005 mg/norethindrone acetate 1 mg: One tablet daily. Note: Initiate at the lowest dose and increase after approximately 4 weeks as needed to relieve symptoms (Ref).
Jinteli: Ethinyl estradiol 0.005 mg/norethindrone acetate 1 mg: One tablet daily.
Duration of therapy: Not clearly established; continued use may be appropriate in patients ≥60 years of age or >10 years after menopause with a low risk of cardiovascular disease and breast cancer and with persistent vasomotor symptoms after attempted taper/discontinuation of estrogen and trial of alternative therapies. Evaluate routinely for comorbidities and appropriateness of lower doses, nonoral routes of administration (preferred in patients ≥60 years of age), choice of progestogen, and discontinuation of therapy (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Use with caution and monitor blood pressure closely.
Use is contraindicated in patients with hepatic impairment.
Note: The Beers Criteria recommends avoiding systemic estrogen therapy in postmenopausal patients ≥65 years of age (independent of diagnosis or condition). In older postmenopausal patients already taking systemic estrogens, consider deprescribing (Ref). Duration of use is not clearly established; continued use may be appropriate in patients ≥60 years of age or >10 years after menopause with a low risk of cardiovascular disease and breast cancer with persistent vasomotor symptoms after attempted taper/discontinuation of estrogen and trial of alternative therapies. Evaluate routinely for comorbidities and appropriateness of lower doses, nonoral routes of administration (preferred in patients ≥60 years of age), choice of progestogen, and discontinuation of therapy (Ref).
Refer to adult dosing.
(For additional information see "Ethinyl estradiol and norethindrone: Pediatric drug information")
Note: Product-specific approved ages and uses in pediatric patients may vary; consult labeling for specific information.
Acne vulgaris: Postmenarche adolescent patients ≥15 years: Oral (eg, Estrostep Fe, Tilia Fe, Tri-Legest Fe): Refer to "Contraception" dosing. Note: When used for acne, use only in patients who also desire combination hormonal contraceptive therapy, are unresponsive to topical treatments, have no contraindications to combination hormonal contraceptive use, and plan to stay on therapy for ≥6 months.
Contraception:
Note: Not all products are acceptable for effective contraception. Products intended for contraception have larger amounts of ethinyl estradiol (ie, ethinyl estradiol 0.02 to 0.035 mg/norethindrone 0.4 to 1.5 mg) compared to products intended for postmenopausal indications. Do not use Femhrt, Fyavolv, or Jinteli for contraception as the ethinyl estradiol amounts are too small (ie, 0.0025 to 0.005 mg).
Postmenarche adolescent patients: Oral: One tablet once daily.
Schedule option 1 (Sunday starter): Dose begins on first Sunday after onset of menstruation; if the menstrual period starts on Sunday, take first tablet that very same day (this schedule is not preferred for all products [eg, Generess Fe, Lo Loestrin Fe]). With a Sunday start, an additional method of contraception should be used until after the first 7 days of consecutive administration (all products).
Schedule option 2 (Day 1 starter): Dose starts on first day of menstrual cycle taking 1 tablet daily.
Additional contraceptive dosing considerations:
Switching from a different contraceptive:
Oral contraceptive: Start on the same day that a new pack of the previous oral contraceptive would have been taken.
Transdermal patch, vaginal ring, injection: Start on the day the next dose would have been due.
IUD or implant: Start on the day of removal. A back-up method of contraception should be used for the first 7 days if IUD is not removed on the first day of the menstrual cycle.
Missed or late doses (Ref):
If 1 dose is late (<24 hours since dose should have been taken) or if 1 dose is missed (24 to <48 hours since dose should have been taken): Take dose as soon as possible. Continue remaining doses at the usual time (even if that means 2 doses on the same day).
If ≥2 consecutive doses are missed (≥48 hours since dose should have been taken): Take the most recently missed dose as soon as possible, discard any other missed doses. Continue remaining doses at the usual time (even if that means taking 2 doses on the same day); use back-up contraception until hormonal pills have been taken for 7 consecutive days. If doses were missed during the last week of hormonal (active) tablets (eg, days 15 to 21 of a 28-day pack), omit the hormone-free interval by finishing the current pack and starting a new pack. If unable to start a new pack immediately, back-up contraception is needed until hormonal pills from a new pack have been taken for 7 consecutive days. Consider use of emergency contraception in some situations (refer to guidelines for details).
Also refer to prescribing information for product-specific information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Use with caution and monitor blood pressure closely.
Use is contraindicated in patients with hepatic impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
Menopausal vasomotor symptoms and osteoporosis prevention:
>10%: Endocrine & metabolic: Increased sex hormone binding globulin (22%)
1% to 10%:
Cardiovascular: Edema (5%)
Gastrointestinal: Abdominal pain (5% to 7%)
Genitourinary: Endometrial hyperplasia (≤1%), mastalgia (8% to 9%)
Nervous system: Headache (6%)
Contraception and Acne:
>10%:
Endocrine & metabolic: Amenorrhea (8% to 36%), change in menstrual flow (including absence of withdrawal bleeding: 31% to 41%)
Genitourinary: Breakthrough bleeding (≤86%), spotting (≤86%)
1% to 10%:
Dermatologic: Acne vulgaris (3%)
Endocrine & metabolic: Heavy menstrual bleeding (≤5%), weight changes (4%), weight gain (2%)
Gastrointestinal: Abdominal pain (3%), nausea (≤9%), vomiting (≤9%)
Genitourinary: Abnormal cervical or vaginal Papanicolaou smear (3%), abnormal uterine bleeding (≤5%), bacterial vaginosis (3%), breast tenderness (≤4%), dysmenorrhea (4%), irregular menses (≤5%), mastalgia (≤2%), uterine cramps (4%), vaginal hemorrhage (≤5%), vulvovaginal candidiasis (6%)
Nervous system: Anxiety (≤2%), depression (≤4%), emotional lability (≤2%), headache (≤8%), migraine (≤8%), mood changes (≤4%), mood disorder (≤3%)
Frequency not defined: Cardiovascular: Hypertension
Postmarketing (any indication):
Cardiovascular: Acute myocardial infarction, angina pectoris, cerebral artery embolism, cerebral thrombosis, cerebrovascular accident, chest pain, coronary thrombosis, deep vein thrombosis, embolism, irregular pulse, ischemic stroke, palpitations, peripheral edema, pulmonary embolism, retinal thrombosis, superficial venous thrombosis, tachycardia, thrombophlebitis, thrombosis (including ovarian), transient ischemic attacks
Dermatologic: Allergic skin rash, alopecia, burning sensation of skin, chloasma, erythema multiforme, erythema nodosum, erythema of skin, facial swelling, night sweats, pruritus, skin discoloration, skin photosensitivity, skin rash, urticaria
Endocrine & metabolic: Altered serum glucose, breast changes, change in libido (including decreased libido), diabetes mellitus, exacerbation of porphyria, fibrocystic breast changes, galactorrhea not associated with childbirth, hirsutism, hot flash, hyperthyroidism, hypocalcemia, hypoglycemia, hypothyroidism, impaired glucose tolerance/prediabetes, increased serum triglycerides, premenstrual syndrome, weight loss
Gastrointestinal: Abdominal cramps, bloating, change in appetite, cholecystitis, cholelithiasis, constipation, diarrhea, gallbladder disease, pancreatitis, swelling of lips
Genitourinary: Benign breast nodule, breast hypertrophy, breast secretion, cervical carcinoma, change in cervical ectropion, change in cervical secretions, cystitis-like syndrome, dysuria, nipple discharge, ovarian cyst, pelvic pain, pollakiuria, rupture of ovarian cyst, uterine hypertrophy, vaginal dryness, vaginal infection, vaginitis, vulvar dryness, vulvovaginal pruritus
Hematologic & oncologic: Anemia, endometrial carcinoma, hemangioma (hepatic), hemorrhagic eruption, malignant neoplasm of breast, malignant neoplasm of ovary, malignant neoplasm of uterus, uterine fibroid enlargement
Hepatic: Cholestatic jaundice, exacerbation of hepatic hemangioma, hepatic adenoma, hepatitis
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction, nonimmune anaphylaxis
Infection: Fungal infection
Local: Localized edema (pelvic)
Nervous system: Abnormal sensory symptoms, bipolar mood disorder, chorea, dementia, dissociative reaction, dizziness, drowsiness, exacerbation of epilepsy, fatigue, hemiparesis, homicidal ideation, hyperesthesia, hypoesthesia, insomnia, irritability, loss of consciousness, malaise, nervousness, nipple pain, panic attack, paresthesia, suicidal ideation
Neuromuscular & skeletal: Arthralgia, asthenia, back pain, lower limb cramp, muscle spasm, myalgia
Ophthalmic: Blurred vision, change in corneal curvature (steepening), contact lens intolerance, corneal thinning, transient blindness, visual impairment
Respiratory: Dyspnea, exacerbation of asthma
Miscellaneous: Mass (breast)
Combination hormonal contraceptives: Hypersensitivity to ethinyl estradiol, norethindrone, or any component of the formulation; breast cancer (current or a history of; may be hormonal-sensitive), endometrial cancer, or other estrogen- or progestin-sensitive cancer; hepatic tumors (benign or malignant) or hepatic disease; cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use; undiagnosed abnormal uterine bleeding; concomitant use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Use is also contraindicated in patients at high risk of arterial or venous thrombotic diseases, such as those with: cerebrovascular disease; coronary artery disease; patients >35 years of age with diabetes mellitus; diabetes mellitus with hypertension, vascular disease, or end-organ damage; diabetes mellitus for >20 years duration; deep vein thrombosis or pulmonary embolism (current or history of); hypertension (uncontrolled); hypertension with vascular disease; headaches with focal neurological symptoms; migraine headaches with aura or migraine headaches if >35 years of age; patients >35 years of age who smoke; hypercoagulopathies (inherited or acquired); thrombogenic valvular or thrombogenic rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease, atrial fibrillation).
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Angina pectoris or myocardial infarction (current or history of); steroid-dependent jaundice or cholestatic jaundice; any ocular lesion arising from ophthalmic vascular disease (such as partial or complete loss of vision or visual field defect); pancreatitis associated with severe hypertriglyceridemia (current or history of); severe dyslipoproteinemia; persistent BP ≥160 mm Hg systolic or ≥100 mm Hg diastolic.
Products used for postmenopausal indications: Angioedema, anaphylactic reaction, or hypersensitivity to any component of the formulation; undiagnosed abnormal genital bleeding; DVT or PE (current or history of); active or history of arterial thromboembolic disease (eg, stroke, MI); breast cancer (known, suspected or history of); estrogen-dependent tumor (known or suspected); hepatic impairment or disease; known protein C, protein S, antithrombin deficiency or other known thrombophilic disorders.
Canadian labeling: Additional contraindications (not in US labeling): endometrial hyperplasia, classical migraine, lactation.
Concerns related to adverse effects:
• Bleeding irregularities: Amenorrhea, spotting, and unscheduled bleeding may occur, primarily during the first 3 months of oral contraceptive therapy. Evaluate unscheduled or breakthrough bleeding that persists or occurs after previously regular cycles to rule out malignancy or pregnancy. Amenorrhea or oligomenorrhea may occur after discontinuing combination hormonal contraceptives, especially when such a condition was preexistent.
• Cervical cancer: The use of combination hormonal contraceptives has been associated with a slight increased risk of cervical cancer; however, studies are not consistent, and the risk may be related to the specific histologic type of cervical cancer, duration of contraceptive use, and other factors (Asthana 2020; Gadducci 2020). Theoretically, use may affect prognosis of existing disease. Patients awaiting treatment for cervical cancer may use combination hormonal contraceptives (CDC [Curtis 2016b]).
• Chloasma: Combination hormonal contraceptives, menopausal hormone therapy, as well as sun exposure and pregnancy, are triggers for chloasma. Avoid exposure to sun or ultraviolet radiation during therapy in patients with a susceptibility to chloasma or additional risk factors.
• Cholestasis: Risk of cholestasis may be increased with previous cholestasis of pregnancy or cholestasis with prior oral contraceptive use.
• Endometrial cancer: The use of unopposed estrogen in patients with an intact uterus is associated with an increased risk of endometrial cancer. The addition of a progestin to estrogen therapy may decrease the risk of endometrial hyperplasia, a precursor to endometrial cancer. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. The risk of endometrial cancer appears to be dose and duration dependent, greatest with use ≥5 years, and may persist following discontinuation of therapy. The risk of endometrial cancer is decreased in patients using combination hormonal contraceptives. Patients awaiting treatment for endometrial cancer may use combination hormonal contraceptives (CDC [Curtis 2016b]).
• Endometriosis: Estrogens may exacerbate endometriosis. Malignant transformation of residual endometrial implants has been reported posthysterectomy with unopposed estrogen therapy.
• Hepatic adenomas or carcinomas: Use of combination hormonal contraceptives is associated with hepatic adenomas (rare); rupture may cause fatal intra-abdominal hemorrhage. Long-term use may be associated with an increased risk of hepatocellular carcinoma (rare).
• Lipid effects: Combination hormonal contraceptives may adversely affect lipid levels, including serum triglycerides. Patients with hypertriglyceridemia or a family history of hypertriglyceridemia may be at increased risk of pancreatitis when using combination hormonal contraceptives. Consider alternative contraception for patients with uncontrolled dyslipidemia.
• Retinal thrombosis: Discontinue if unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions occur and immediately evaluate for retinal thrombosis.
• Thromboembolic disorders: Discontinue use of combination hormonal contraceptives if an arterial or venous thromboembolic event (VTE) occurs. The increased risk of VTE associated with combination hormonal contraceptives is greatest during first year of use and less than the risk associated with pregnancy; some studies suggest this risk may be higher in preparations with third- or fourth-generation progestins and/or high-dose ethinyl estradiol. Patients with inherited thrombophilias (eg, protein C or S deficiency, factor V Leiden mutation, prothrombin mutation, antithrombin deficiency) may have increased risk of VTE. Age >35 years, hypertension, obesity, and tobacco use also increase the risk of thromboembolic events in patients taking combination hormonal contraceptives (Abou-Ismail 2020; ASRM 2017; CDC [Curtis 2016b]). Combination hormonal contraceptives may also increase the risk of arterial thrombosis (eg, myocardial infarction, stroke); do not use in patients with a history of stroke or ischemic heart disease (CDC [Curtis 2016b]).
Disease-related concerns:
• Asthma: Use caution with asthma; may exacerbate disease.
• Bariatric surgery: Fertility is increased following bariatric surgery. All available forms of contraception can be considered following bariatric surgery, considering the patient's body weight and time since surgery. However, long-acting, reversible non-oral contraceptives (eg, implants, intrauterine devices) may be preferred. Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy both have the potential to expedite transit through the small bowel. RYGB may not significantly alter the absorption of oral estrogen or progestogens (limited evidence following a single dose). However, gastric and small bowel transit is not well studied following chronic oral dosing; therefore, contraceptive efficacy cannot be guaranteed. Oral contraceptives may be used in patients having adjustable gastric banding unless there is diarrhea or vomiting. Reliable contraception using oral contraceptives cannot be guaranteed following jejunoileal (JI) bypass, biliopancreatic diversion (BPD), single anastomosis duodeno-ilial bypass (SADI), or omega-loop gastric bypass. Discontinue estrogens at least 4 weeks prior to bariatric surgery and resume no earlier than 4 weeks after surgery to minimize of VTE (Ciangura 2019; Mechanick 2020; Moreira de Brito 2020; Shawe 2019).
• Breast cancer: Based on data from the Women’s Health Initiative (WHI) studies, an increased risk of invasive breast cancer was observed in postmenopausal patients using conjugated estrogens in combination with medroxyprogesterone acetate. Observational studies noted this risk declines once therapy is discontinued. The WHI study did not observe an increased risk of invasive breast cancer in patients with a hysterectomy using conjugated estrogens alone (studies conducted in patients assigned female at birth). The risk of breast cancer in patients who are postmenopausal receiving hormone therapy may depend upon type of estrogen and/or progestogen, dose, timing of therapy initiation, duration of therapy, route of administration, and individual patient characteristics (AACE/ACE [Cobin 2017]; NAMS 2022). Hormone therapy may be associated with increased breast density (NAMS 2022); an increase in abnormal mammogram findings requiring further evaluation has been reported with estrogen alone or in combination with progestogen therapy. Estrogen use may lead to severe hypercalcemia in patients with breast cancer and bone metastases; discontinue estrogen if hypercalcemia occurs. Available studies have not shown a consistent association with combination hormonal contraceptives and breast cancer risk. Multiple studies have shown no association in current or ever users (current or past); other studies have shown a small increased risk in current users (higher risk in current users with longer durations of use) and recent users (<6 months since last use). In patients at risk for breast cancer due to family history or susceptibility genes (BRCA1, BRCA2), it is unclear if combination hormonal contraceptives increase the risk for breast cancer. However, breast cancer is a hormonal-sensitive tumor and the prognosis for patients with a current or recent history of breast cancer may be worse with combination hormonal contraceptive use (CDC [Curtis 2016b]; SGO/ASRM [Chen 2019]).
• Cardiovascular disease: Estrogens with or without progestin should not be used to prevent cardiovascular disease. Using data from the Women’s Health Initiative (WHI) studies, an increased risk of deep vein thrombosis (DVT) and stroke has been reported with conjugated estrogens and an increased risk of DVT, stroke, pulmonary emboli (PE) and myocardial infarction (MI) has been reported with conjugated estrogens with medroxyprogesterone acetate in postmenopausal patients 50 to 79 years of age. Additional risk factors include diabetes mellitus, hypercholesterolemia, hypertension, SLE, obesity, tobacco use, and/or history of venous thromboembolism (VTE). Manage risk factors appropriately; discontinue use immediately if adverse cardiovascular events occur or are suspected. Due to possible lower risk of thrombotic events, transdermal administration may be preferred for treating vasomotor symptoms of menopause in patients with risk factors for cardiovascular disease (AACE/ACE [Cobin 2017]; ACOG 2013d; ES [Stuenkel 2015]). Use is contraindicated in patients with active DVT, PE, arterial thromboembolic disease (stroke and MI), or a history of these conditions. Use combination hormonal contraceptives with caution in patients with risk factors for cardiovascular disease (eg, hypertension, low HDL, high LDL, high triglycerides, older age, diabetes, patients who smoke); use of combination hormonal contraceptives may increase the risk of cardiovascular disease (CDC [Curtis 2016b]). Prior to therapy for menopausal symptoms, consider age, and cardiovascular and metabolic risk factors in patients previously diagnosed with diabetes (AACE/ACE [Cobin 2017]).
• Dementia: Estrogens with or without progestin should not be used to prevent dementia. In the Women’s Health Initiative Memory Study (WHIMS), an increased incidence of probable dementia was observed in patients ≥65 years of age taking conjugated estrogens alone or in combination with medroxyprogesterone acetate. Because the WHI memory studies were conducted in women ≥65 years of age, it is unknown if these findings apply to patients who do not meet these criteria. Hormone therapy is not recommended to prevent or treat cognitive decline or dementia (NAMS 2022).
• Depression: Use with caution in patients with a history of depression; discontinue if serious depression recurs.
• Diabetes: May impair glucose tolerance; use caution in patients with diabetes or prediabetes. In general, use of combination oral contraceptives has limited effects on daily insulin needs and no long-term effects on diabetes control in patients with nonvascular disease. Evaluate contraceptive use in patients with concomitant nephropathy, neuropathy, retinopathy, other vascular diseases, or diabetes >20 years' duration based on the severity of the condition (CDC [Curtis 2016b]).
• Diseases exacerbated by fluid retention: May adversely affect diseases exacerbated by fluid retention, including cardiac or kidney impairment.
• Epilepsy: May exacerbate epilepsy.
• Gallbladder disease: Combination hormonal contraceptives may have a small increased risk of gallbladder disease or may worsen existing gallbladder disease (CDC [Curtis 2016b]). Use of postmenopausal estrogen may be associated with an increased risk of gallbladder disease requiring surgery.
• Hepatic impairment: Estrogens may be poorly metabolized in patients with hepatic impairment. Discontinue if jaundice develops during therapy or if liver function becomes abnormal. Consider use of combination hormonal contraceptives in patients with mild (compensated) cirrhosis; do not use in patients with severe (decompensated) cirrhosis (CDC [Curtis 2016b]).
• Hepatitis: Initiation of combination hormonal contraceptives is not recommended in patients with acute viral hepatitis or during a flare. Continued use in patients with chronic hepatitis has not been shown to increase the rate or severity of cirrhotic fibrosis or hepatocellular carcinoma. Continued use in patients who are carriers has not been shown to trigger liver failure or severe hepatic dysfunction (CDC [Curtis 2016b]).
• Hepatic hemangiomas: May exacerbate hepatic hemangiomas.
• Hereditary angioedema: Exogenous estrogens may exacerbate angioedema symptoms in patients with hereditary angioedema.
• Hypertension: The risk of hypertension may be increased with age, dose, and duration of use. Do not use combination hormonal contraceptives in patients with hypertension and vascular disease, or persistent blood pressure values ≥160 mm Hg systolic or ≥100 mm Hg diastolic. The risks of contraceptive use may not outweigh the benefits of treatment in patients with less severe hypertension (140 to 159 mm Hg systolic or 90 to 99 mm Hg diastolic) or those with hypertension that is adequately controlled (CDC [Curtis 2016a]). Consider other risk factors for cardiovascular disease (eg, older age, smoking, diabetes) when prescribing contraceptives (CDC [Curtis 2016b]). Monitor BP in patients with well-controlled hypertension; discontinue therapy if BP rises significantly.
• Hypoparathyroidism: Use caution in patients with hypoparathyroidism; estrogen-induced hypocalcemia may occur.
• Migraine: Evaluate new, recurrent, severe, or persistent headaches. Use of combination hormonal contraceptives may be considered in patients who have migraines without aura (including menstrual migraines) (CDC [Curtis 2016b]).
• Ovarian cancer: Available information related to the use of menopausal estrogen or estrogen/progestogen therapy and risk of ovarian cancer is inconsistent. If an association is present, the absolute risk is likely rare and may be influenced by duration of therapy (ES [Stuenkel 2015]; NAMS 2022). The risk of ovarian cancer is decreased in patients using combination hormonal contraceptives (CDC [Curtis 2016b]; SGO/ASRM [Chen 2019]). Oral contraceptives may be used to reduce the risk of ovarian cancer in at-risk patients with BRCA1 and BRCA2 mutations who do not have a personal history of breast cancer (SGO/ASRM [Chen 2019]). Patients awaiting treatment for ovarian cancer may use combination hormonal contraceptives (CDC [Curtis 2016b]).
• Porphyria: May exacerbate porphyria.
• Solid organ transplant: Use of combination hormonal contraceptives is not recommended in patients with complicated organ transplants; although data are limited, serious medical complications have been reported (eg, graft failure, rejection, cardiac allograft vasculopathy) requiring discontinuation of the contraceptive (CDC [Curtis 2016b]).
• Systemic lupus erythematosus: Patients with systemic lupus erythematosus (SLE) are at an increased risk for heart disease, stroke, and VTE. Do not use combination hormonal contraceptives in patients with SLE who have positive (or unknown) antiphospholipid antibodies, due to an increased risk of arterial and venous thrombosis (CDC [Curtis 2016b]).
Concurrent drug therapy issues:
• Testosterone: All available forms of contraception can be considered for patients receiving gender-affirming testosterone therapy after evaluating patient preferences and medical conditions (Bonnington 2020; Krempasky 2020). However, it has been suggested to use contraceptive products containing lower daily doses of ethinyl estradiol (0.01 to 0.02 mg) to decrease the risk of possible adverse reactions when testosterone therapy is used with combination hormonal contraceptives (Bonnington 2020).
Special populations:
• Contact lens wearers: Evaluate any changes with lens tolerance or vision by an ophthalmologist.
• Body weight: The contraceptive efficacy of some products (generally those containing lower concentrations of ethinyl estradiol [eg, Generess Fe, Lo Estrin 24 Fe, Layolis Fe, Lo Loestrin Fe; Minastrin 24 Fe]) have not been established in patients with a BMI >35 kg/m2. Available evidence suggests efficacy of combination hormonal contraceptives may be decreased if BMI is ≥30 kg/m2; however, reductions in effectiveness are considered minimal and information is conflicting. In this population, use of combination hormonal contraceptives may increase the risk of VTE. In general, the benefits of combination hormonal contraceptives may outweigh the risks in patients who otherwise are eligible for this method (CDC [Curtis 2016b]). Consult product labeling.
• Smoking: Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use. This risk increases with age, particularly in patients >35 years of age, and with the number of cigarettes smoked.
• Surgery: Whenever possible, discontinue estrogens at least 4 weeks prior to and through 2 weeks following major surgery or other surgeries known to have an increased risk of thromboembolism or during periods of prolonged immobilization.
Dosage form specific issues:
• Femhrt, Fyavolv, Jinteli: Do not use these products for contraception.
• Lactose: Tablets may contain lactose; avoid use in patients with lactase deficiency, galactose intolerance or glucose-galactose malabsorption.
• Medication errors: Errors have occurred when lower-dose preparations for postmenopausal indications have been prescribed for contraception. Lower-dose preparations (ie, ethinyl estradiol 0.0025 or 0.005 mg/norethindrone 0.5 or 1 mg) are available for postmenopausal indications (ie, osteoporosis prevention or vasomotor symptoms associated with menopause), and higher-dose monophasic, multiphasic, and iron-containing preparations (ie, ethinyl estradiol 0.02 to 0.035 mg/norethindrone 0.4 to 1.5 mg) are available for contraception and other indications (eg, acne). Ensure proper dosage for the indication.
• Tartrazine: Some products may contain tartrazine, which may cause allergic reactions in certain individuals.
Other warnings/precautions:
• Appropriate use: When initiating a combination oral contraceptive, consider initiating with a monthly bleeding monophasic formulation that contains ethinyl estradiol 0.03 to 0.035 mg plus a progestin, and adjusting based on adverse events and patient preference (Ott 2014).
• Duration of use: When used for vasomotor symptoms associated with menopause, the duration of use is not clearly established. Continued use may be appropriate in patients ≥60 years of age or >10 years after menopause with a low risk of cardiovascular disease and breast cancer with persistent vasomotor symptoms after attempted taper/discontinuation of estrogen and trial of alternative therapies. Evaluate routinely for comorbidities and appropriateness of lower doses, non-oral routes of administration (preferred in patients ≥60 years of age), choice of progestogen, and discontinuation of therapy (NAMS 2022).
• HIV infection protection: Combination hormonal contraceptives do not protect against HIV infection or other sexually transmitted diseases (CDC [Curtis 2016a]; CDC [Curtis 2016b]).
• Osteoporosis: In patients with premature menopause, hormone therapy to prevent bone loss may be used unless otherwise contraindicated; reassess therapy when the average age of menopause is reached. It is also an appropriate bone-active therapy for patients who are postmenopausal with vasomotor symptoms who are <60 years of age or within 10 years of menopause onset. Consider use in patients who are postmenopausal at high risk of fractures who are not candidates for other osteoporosis therapies (NAMS 2022).
• Risks vs benefits: When used for the relief of menopausal symptoms or increased risk of bone fracture/loss, the benefit-risk of hormone therapy is most favorable if started in patients who have no contraindications to therapy, are <60 years of age, within 10 years of menopause onset, have a favorable lipid profile, and do not have the factor V Leiden genotype or metabolic syndrome. Consider cardiovascular disease risk factors when evaluating therapy and route of administration (AACE/ACE [Cobin 2017]; NAMS 2022). Estrogens with or without progestin should be used for the shortest duration possible at the lowest effective dose consistent with treatment goals and risks for the individual patient. Reevaluate patients as clinically appropriate to determine if treatment is still necessary. Available data related to treatment risks are from Women’s Health Initiative (WHI) studies, which evaluated oral conjugated estrogens 0.625 mg with or without medroxyprogesterone acetate 2.5 mg relative to placebo in patients who were postmenopausal (studies conducted in patients assigned female at birth). Other combinations and dosage forms of estrogens and progestogens were not studied. Outcomes reported from clinical trials using conjugated estrogens with or without medroxyprogesterone acetate should be assumed to be similar for other doses and other dosage forms of estrogens and progestins until comparable data becomes available.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
Gemmily: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 capsules] and ferrous fumarate 75 mg [4 capsules] [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), sesame oil, soybean oil]
Merzee: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 capsules] and ferrous fumarate 75 mg [4 capsules] [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), sesame oil, soybean oil]
Taysofy: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 capsules] and ferrous fumarate 75 mg [4 capsules] [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), sesame oil, soybean lecithin, soybean oil]
Taytulla: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 capsules] and ferrous fumarate 75 mg [4 capsules] [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), sesame oil, soybean oil]
Generic: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 capsules] and ferrous fumarate 75 mg [4 capsules]
Tablet, Oral:
Alyacen 1/35: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets] [contains fd&c blue #2 (indigotine,indigo carmine), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Alyacen 7/7/7: Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-14: Ethinyl estradiol 0.035 mg and norethindrone 0.75 mg [7 tablets]; Day 15-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [7 tablets]; Day 22-28: 7 inactive tablets [contains fd&c blue #2 (indigotine,indigo carmine), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Aranelle: Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-16: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [9 tablets]; Day 17-21: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [5 tablets]; Day 22-28: 7 inactive tablets [contains fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]
Aurovela 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg
Aurovela 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [contains quinoline (d&c yellow #10) aluminum lake]
Aurovela 24 FE: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains quinoline (d&c yellow #10) aluminum lake]
Aurovela Fe 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets]
Aurovela FE 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains quinoline (d&c yellow #10) aluminum lake]
Balziva: Ethinyl estradiol 0.035 mg and norethindrone 0.4 mg [21 tablets and 7 inactive tablets] [contains corn starch, fd&c yellow #6(sunset yellow)alumin lake]
Blisovi 24 Fe: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains corn starch]
Blisovi Fe 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains corn starch, fd&c red #40 (allura red ac dye)]
Blisovi FE 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains corn starch, quinoline (d&c yellow #10) aluminum lake]
Briellyn: Ethinyl estradiol 0.035 mg and norethindrone 0.4 mg [21 tablets and 7 inactive tablets] [contains fd&c yellow #6(sunset yellow)alumin lake]
Cyclafem 1/35: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets] [DSC] [contains fd&c blue #2 (indigotine,indigo carmine), fd&c red #40(allura red ac)aluminum lake]
Cyclafem 7/7/7: Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-14: Ethinyl estradiol 0.035 mg and norethindrone 0.75 mg [7 tablets]; Day 15-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [7 tablets]; Day 22-28: 7 inactive tablets [DSC] [contains fd&c blue #2 (indigotine,indigo carmine), fd&c red #40(allura red ac)aluminum lake]
Dasetta 1/35: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets] [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake, fd&c yellow #5 (tartrazine)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, soybean lecithin]
Dasetta 7/7/7: Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-14: Ethinyl estradiol 0.035 mg and norethindrone 0.75 mg [7 tablets]; Day 15-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [7 tablets]; Day 22-28: 7 inactive tablets [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake, fd&c yellow #5 (tartrazine)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, soybean lecithin]
Estrostep Fe: Day 1-5: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [5 tablets]; Day 6-12: Ethinyl estradiol 0.03 mg and norethindrone acetate 1 mg [7 tablets]; Day 13-21: Ethinyl estradiol 0.035 mg and norethindrone acetate 1 mg [9 tablets]; Day 22-28: Ferrous fumarate 75 mg [7 tablets] [DSC]
Femhrt: Ethinyl estradiol 0.0025 mg and norethindrone acetate 0.5 mg [DSC]
Fyavolv: Ethinyl estradiol 0.0025 mg and norethindrone acetate 0.5 mg [contains corn starch]
Fyavolv: Ethinyl estradiol 0.005 mg and norethindrone acetate 1 mg [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake]
Hailey 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [contains corn starch, fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Hailey 24 Fe: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains corn starch]
Hailey FE 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains corn starch]
Hailey FE 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains corn starch, fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Jinteli: Ethinyl estradiol 0.005 mg and norethindrone acetate 1 mg
Junel 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [contains fd&c red #40(allura red ac)aluminum lake]
Junel 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [contains quinoline (d&c yellow #10) aluminum lake]
Junel FE 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains corn starch, quinoline (d&c yellow #10) aluminum lake]
Junel FE 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains fd&c red #40(allura red ac)aluminum lake]
Junel Fe 24: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains quinoline (d&c yellow #10) aluminum lake]
Larin 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Larin 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Larin 24 FE: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Larin Fe 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Larin Fe 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Leena: Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-16: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [9 tablets]; Day 17-21: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [5 tablets]; Day 22-28: 7 inactive tablets [contains corn starch, fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Lo Loestrin Fe: Day 1-24: Ethinyl estradiol 0.01 mg and norethindrone acetate 1 mg [24 tablets]; Day 25-26: Ethinyl estradiol 0.01 mg [2 tablets]; Day 27-28: Ferrous fumarate 75 mg [2 tablets] [contains fd&c blue #1 (brill blue) aluminum lake]
Loestrin 1.5/30 (21): Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [contains fd&c red #40(allura red ac)aluminum lake]
Loestrin 1/20 (21): Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [contains quinoline (d&c yellow #10) aluminum lake]
Loestrin Fe 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains fd&c red #40(allura red ac)aluminum lake]
Loestrin Fe 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains quinoline (d&c yellow #10) aluminum lake]
Microgestin 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [DSC] [contains corn starch, fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Microgestin 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Microgestin 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Microgestin 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [DSC] [contains fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Microgestin 24 Fe: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Microgestin FE 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [DSC]
Microgestin FE 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Microgestin FE 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Microgestin FE 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [DSC] [contains fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Necon 0.5/35 (28): Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [21 tablets and 7 inactive tablets] [contains corn starch]
Necon 0.5/35 (28): Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [21 tablets and 7 inactive tablets] [DSC] [contains corn starch, quinoline (d&c yellow #10) aluminum lake]
Nortrel 7/7/7: Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-14: Ethinyl estradiol 0.035 mg and norethindrone 0.75 mg [7 tablets]; Day 15-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [7 tablets]; Day 22-28: 7 inactive tablets [contains corn starch, fd&c blue #1 (brill blue) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]
Nortrel 0.5/35 (28): Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [21 tablets and 7 inactive tablets]
Nortrel 1/35 (21): Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21s]
Nortrel 1/35 (28): Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets]
Nylia 1/35: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets] [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]
Nylia 7/7/7: Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-14: Ethinyl estradiol 0.035 mg and norethindrone 0.75 mg [7 tablets]; Day 15-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [7 tablets]; Day 22-28: 7 inactive tablets [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]
Ortho-Novum 1/35 (28): Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets] [DSC] [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6 (sunset yellow), quinoline (d&c yellow #10) aluminum lake]
Ortho-Novum 7/7/7 (28): Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-14: Ethinyl estradiol 0.035 mg and norethindrone 0.75 mg [7 tablets]; Day 15-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [7 tablets]; Day 22-28: 7 inactive tablets [DSC] [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6 (sunset yellow), quinoline (d&c yellow #10) aluminum lake]
Philith: Ethinyl estradiol 0.035 mg and norethindrone 0.4 mg [21 tablets and 7 inactive tablets] [contains soybean lecithin]
Pirmella 1/35: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets] [DSC] [contains fd&c blue #2 (indigotine,indigo carmine), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Pirmella 7/7/7: Day 1-7: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [7 tablets]; Day 8-14: Ethinyl estradiol 0.035 mg and norethindrone 0.75 mg [7 tablets]; Day 15-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [7 tablets]; Day 22-28: 7 inactive tablets [DSC] [contains fd&c blue #2 (indigotine,indigo carmine), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Tarina 24 Fe: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains quinoline (d&c yellow #10) aluminum lake]
Tarina FE 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [DSC]
Tarina FE 1/20 EQ: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets] [contains quinoline (d&c yellow #10) aluminum lake]
Tilia Fe: Day 1-5: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [5 tablets]; Day 6-12: Ethinyl estradiol 0.03 mg and norethindrone acetate 1 mg [7 tablets]; Day 13-21: Ethinyl estradiol 0.035 mg and norethindrone acetate 1 mg [9 tablets]; Day 22-28: Ferrous fumarate 75 mg [7 tablets] [DSC] [contains corn starch]
Tilia Fe: Day 1-5: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [5 tablets]; Day 6-12: Ethinyl estradiol 0.03 mg and norethindrone acetate 1 mg [7 tablets]; Day 13-21: Ethinyl estradiol 0.035 mg and norethindrone acetate 1 mg [9 tablets]; Day 22-28: Ferrous fumarate 75 mg [7 tablets] [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]
Tri-Legest Fe: Day 1-5: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [5 tablets]; Day 6-12: Ethinyl estradiol 0.03 mg and norethindrone acetate 1 mg [7 tablets]; Day 13-21: Ethinyl estradiol 0.035 mg and norethindrone acetate 1 mg [9 tablets]; Day 22-28: Ferrous fumarate 75 mg [7 tablets] [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake, quinoline (d&c yellow #10) aluminum lake]
Vyfemla: Ethinyl estradiol 0.035 mg and norethindrone 0.4 mg [21 tablets and 7 inactive tablets] [contains fd&c yellow #6(sunset yellow)alumin lake]
Wera: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [21 tablets and 7 inactive tablets]
Generic: Day 1-5: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [5 tablets]; Day 6-12: Ethinyl estradiol 0.03 mg and norethindrone acetate 1 mg [7 tablets]; Day 13-21: Ethinyl estradiol 0.035 mg and norethindrone acetate 1 mg [9 tablets]; Day 22-28: Ferrous fumarate 75 mg [7 tablets], Ethinyl estradiol 0.0025 mg and norethindrone acetate 0.5 mg, Ethinyl estradiol 0.005 mg and norethindrone acetate 1 mg, Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg, Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets], Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [DSC], Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg, Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets]
Tablet Chewable, Oral:
Charlotte 24 Fe: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains corn starch]
Finzala: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains corn starch]
Generess FE: Ethinyl estradiol 0.025 mg and norethindrone 0.8 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [DSC] [contains fd&c blue #1 (brill blue) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]
Kaitlib Fe: Ethinyl estradiol 0.025 mg and norethindrone 0.8 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10)]
Layolis FE: Ethinyl estradiol 0.025 mg and norethindrone 0.8 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains fd&c blue #1 (brill blue) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]
Melodetta 24 Fe: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [DSC]
Mibelas 24 Fe: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [contains corn starch]
Minastrin 24 Fe: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets] [fresh mint flavor]
Wymzya Fe: Ethinyl estradiol 0.035 mg and norethindrone 0.4 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets]
Generic: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets], Ethinyl estradiol 0.025 mg and norethindrone 0.8 mg [24 tablets] and ferrous fumarate 75 mg [4 tablets], Ethinyl estradiol 0.035 mg and norethindrone 0.4 mg [21 tablets] and ferrous fumarate 75 mg [7 tablets]
Yes
Capsules (Gemmily Oral)
1-20 mg-mcg (24) (per each): $7.71
Capsules (Merzee Oral)
1-20 mg-mcg (24) (per each): $7.71
Capsules (Norethin Ace-Eth Estrad-FE Oral)
1-20 mg-mcg (24) (per each): $7.71
Capsules (Taysofy Oral)
1-20 mg-mcg (24) (per each): $7.94
Capsules (Taytulla Oral)
1-20 mg-mcg (24) (per each): $9.74
Chewable (Charlotte 24 Fe Oral)
1-20 mg-mcg (24) (per each): $5.96
Chewable (Finzala Oral)
1-20 mg-mcg (24) (per each): $5.96
Chewable (Kaitlib Fe Oral)
0.8-25 mg-mcg (per each): $4.36
Chewable (Layolis FE Oral)
0.8-25 mg-mcg (per each): $4.36
Chewable (Mibelas 24 Fe Oral)
1-20 mg-mcg (24) (per each): $5.96
Chewable (Minastrin 24 Fe Oral)
1-20 mg-mcg (24) (per each): $7.61
Chewable (Norethin Ace-Eth Estrad-FE Oral)
1-20 mg-mcg (24) (per each): $5.96
Chewable (Norethin-Eth Estradiol-Fe Oral)
0.4-35 mg-mcg (per each): $3.20
0.8-25 mg-mcg (per each): $4.36
Chewable (Wymzya Fe Oral)
0.4-35 mg-mcg (per each): $2.61
Tablets (Aranelle Oral)
0.5/1/0.5-35 mg-mcg (per each): $1.41
Tablets (Aurovela 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.38
Tablets (Aurovela 1/20 Oral)
1-20 mg-mcg (per each): $1.36
Tablets (Aurovela 24 FE Oral)
1-20 mg-mcg (24) (per each): $3.20
Tablets (Aurovela Fe 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.03
Tablets (Aurovela FE 1/20 Oral)
1-20 mg-mcg (per each): $1.02
Tablets (Balziva Oral)
0.4-35 mg-mcg (per each): $1.60
Tablets (Blisovi 24 Fe Oral)
1-20 mg-mcg (24) (per each): $3.20
Tablets (Blisovi Fe 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.03
Tablets (Blisovi FE 1/20 Oral)
1-20 mg-mcg (per each): $1.02
Tablets (Dasetta 1/35 Oral)
1-35 mg-mcg (per each): $1.05
Tablets (Dasetta 7/7/7 Oral)
0.5/0.75/1-35 mg-mcg (per each): $1.15
Tablets (Fyavolv Oral)
0.5-2.5 mg-mcg (per each): $4.22
1-5 mg-mcg (per each): $3.14
Tablets (Hailey 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.38
Tablets (Hailey 24 Fe Oral)
1-20 mg-mcg (24) (per each): $3.20
Tablets (Hailey FE 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.03
Tablets (Hailey FE 1/20 Oral)
1-20 mg-mcg (per each): $1.02
Tablets (Jinteli Oral)
1-5 mg-mcg (per each): $2.93
Tablets (Junel 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.38
Tablets (Junel 1/20 Oral)
1-20 mg-mcg (per each): $1.36
Tablets (Junel FE 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.03
Tablets (Junel FE 1/20 Oral)
1-20 mg-mcg (per each): $1.02
Tablets (Junel Fe 24 Oral)
1-20 mg-mcg (24) (per each): $3.20
Tablets (Larin 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.38
Tablets (Larin 1/20 Oral)
1-20 mg-mcg (per each): $1.36
Tablets (Larin 24 FE Oral)
1-20 mg-mcg (24) (per each): $3.20
Tablets (Larin Fe 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.02
Tablets (Larin Fe 1/20 Oral)
1-20 mg-mcg (per each): $1.02
Tablets (Leena Oral)
0.5/1/0.5-35 mg-mcg (per each): $2.61
Tablets (Lo Loestrin Fe Oral)
1 MG-10 MCG / 10 mcg (per each): $7.70
Tablets (Loestrin 1.5/30 (21) Oral)
1.5-30 mg-mcg (per each): $11.36
Tablets (Loestrin 1/20 (21) Oral)
1-20 mg-mcg (per each): $11.36
Tablets (Loestrin Fe 1.5/30 Oral)
1.5-30 mg-mcg (per each): $8.52
Tablets (Loestrin Fe 1/20 Oral)
1-20 mg-mcg (per each): $8.52
Tablets (Microgestin 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.23
Tablets (Microgestin 1/20 Oral)
1-20 mg-mcg (per each): $1.36
Tablets (Microgestin 24 Fe Oral)
1-20 mg-mcg (per each): $3.20
Tablets (Microgestin FE 1.5/30 Oral)
1.5-30 mg-mcg (per each): $1.03
Tablets (Microgestin FE 1/20 Oral)
1-20 mg-mcg (per each): $1.02
Tablets (Necon 0.5/35 (28) Oral)
0.5-35 mg-mcg (per each): $1.15
Tablets (Norethin Ace-Eth Estrad-FE Oral)
1-20 mg-mcg (per each): $1.02
1.5-30 mg-mcg (per each): $0.95
Tablets (Norethindron-Ethinyl Estrad-Fe Oral)
1-20/1-30/1-35 mg-mcg (per each): $2.04
Tablets (Norethindrone Acet-Ethinyl Est Oral)
1-20 mg-mcg (per each): $1.36
1.5-30 mg-mcg (per each): $1.38
Tablets (Norethindrone-Eth Estradiol Oral)
0.5-2.5 mg-mcg (per each): $3.75 - $3.90
1-5 mg-mcg (per each): $2.39 - $2.93
Tablets (Nortrel 0.5/35 (28) Oral)
0.5-35 mg-mcg (per each): $1.15
Tablets (Nortrel 1/35 (21) Oral)
1-35 mg-mcg (per each): $1.40
Tablets (Nortrel 1/35 (28) Oral)
1-35 mg-mcg (per each): $1.05
Tablets (Nortrel 7/7/7 Oral)
0.5/0.75/1-35 mg-mcg (per each): $1.15
Tablets (Nylia 1/35 Oral)
1-35 mg-mcg (per each): $0.37
Tablets (Nylia 7/7/7 Oral)
0.5/0.75/1-35 mg-mcg (per each): $1.15
Tablets (Philith Oral)
0.4-35 mg-mcg (per each): $1.60
Tablets (Tarina 24 Fe Oral)
1-20 mg-mcg (24) (per each): $3.84
Tablets (Tarina FE 1/20 EQ Oral)
1-20 mg-mcg (per each): $1.23
Tablets (Tilia Fe Oral)
1-20/1-30/1-35 mg-mcg (per each): $7.26
Tablets (Tri-Legest Fe Oral)
1-20/1-30/1-35 mg-mcg (per each): $2.04
Tablets (Vyfemla Oral)
0.4-35 mg-mcg (per each): $1.60
Tablets (Wera Oral)
0.5-35 mg-mcg (per each): $1.15
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Brevicon 1/35: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets]
Brevicon 0.5/35: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [21 tablets and 7 inactive tablets]
Brevicon 0.5/35: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [21 tablets and 7 inactive tablets] [contains fd&c yellow #6(sunset yellow)alumin lake]
Loestrin 1.5/30: Ethinyl estradiol 0.03 mg and norethindrone acetate 1.5 mg [DSC] [contains corn starch, fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]
Minestrin 1/20: Ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg [DSC] [contains corn starch, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]
Select 1/35: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets]
Select 1/35: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [21 tablets and 7 inactive tablets] [contains fd&c yellow #6(sunset yellow)alumin lake]
Synphasic: Day 1-10: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [10 tablets]; Day 11-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [11 tablets]; Day 22-28: 7 inactive tablets [contains fd&c blue #2 (indigotine,indigo carmine)]
Synphasic: Day 1-10: Ethinyl estradiol 0.035 mg and norethindrone 0.5 mg [10 tablets]; Day 11-21: Ethinyl estradiol 0.035 mg and norethindrone 1 mg [11 tablets]; Day 22-28: 7 inactive tablets [contains fd&c blue #2 (indigotine,indigo carmine), fd&c yellow #6(sunset yellow)alumin lake]
Tablet Therapy Pack, Oral:
Lolo: 1-0.01 / 0.01 MG (28 ea) [contains fd&c blue #1 (brill blue) aluminum lake]
Oral: Combination hormonal contraceptives:
Administer at the same time each day at intervals not >24 hours, without regard to meals. Chewable tablets may be chewed or swallowed whole; if chewed, immediately drink a full glass of liquid (240 mL) after swallowing.
According to the manufacturer, for some products (eg, Generess Fe, Layolis FE, Lo Loestrin Fe), if severe diarrhea or vomiting occurs within 3 to 4 hours of an active tablet, consider the dose to be missed. Additional guidelines are also available (Ref).
For the 21-tablet package, one dose is taken for 21 consecutive days, followed by 7 days off the medication; a new course begins on the 8th day after the last tablet is taken.
For the 28-tablet package, one dose is taken daily without interruption.
Postmenopausal indications: Administer at the same time each day.
Oral: Postmenarche patients: Administer at the same time each day at intervals not >24 hours; without regard to meals. Chewable tablets (eg, Femcon Fe) may be chewed or swallowed whole; if chewed, immediately drink a full glass of liquid (240 mL) after swallowing.
For some products (eg, Femcon Fe, Generess Fe, Lo Loestrin Fe), if vomiting or diarrhea occurs within 3 to 4 hours of a dose, consider the dose to be missed. Additional guidelines are also available (Ref).
For the 21-tablet package, 1 dose is taken for 21 consecutive days, followed by 7 days off of the medication; a new course begins on the eighth day after the last tablet is taken.
For the 28-tablet package, 1 dose is taken daily without interruption.
Combined hormonal contraceptives may be initiated at any time during the menstrual cycle if it is reasonably sure the patient is not pregnant. Back-up contraception should be used for 7 days unless contraception is initiated within the first 5 days of menstrual bleeding; alternatively, the patient can abstain from receptive vaginal sexual intercourse with a partner who produces sperm (Ref).
Hazardous agent (NIOSH 2016 [group 2]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.
Acne vulgaris, inflammatory, moderate to severe (Estrostep Fe, Tilia Fe, Tri-Legest Fe): Treatment of moderate acne vulgaris in patients at least 15 years of age who also desire combination hormonal contraceptive therapy and plan to stay on therapy for ≥6 months.
Limitations of use: For use only in patients who have reached menarche, are unresponsive to topical acne treatments, and have no contraindications to combination hormonal contraceptive use.
Contraception: For the prevention of pregnancy.
Limitations of use: Ethinyl estradiol/norethindrone contraceptive products are for use in patients who may become pregnant; not for use prior to menarche or postmenopause. The efficacy of some products has not been established in patients with a BMI >35 kg/m2.
Osteoporosis, postmenopausal, prevention (Femhrt, Fyavolv, Jinteli): Prevention of postmenopausal osteoporosis.
Limitations of use: For use only in patients at significant risk of postmenopausal osteoporosis; consider use of nonestrogen medications.
Vasomotor symptoms associated with menopause (Femhrt, Fyavolv, Jinteli): Treatment of moderate to severe vasomotor symptoms associated with menopause.
Abnormal uterine bleeding, acute; Abnormal uterine bleeding, nonacute; Dysmenorrhea, primary, and secondary to endometriosis; Hirsutism; Hyperlactation (hypergalactia); Menstrual suppression; Polycystic ovary syndrome in patients with hyperandrogenism and/or menstrual irregularities
Femhrt may be confused with Femara
Lo Loestrin Fe may be confused with Loestrin Fe
Modicon may be confused with Mylicon
Beers Criteria: Estrogens (oral or topical patch products only), with or without progestins, are identified in the Beers Criteria as potentially inappropriate medications to be avoided in postmenopausal patients ≥65 years of age (independent of diagnosis or condition) due to their carcinogenic potential (breast and endometrium) and lack of cardioprotection or cognitive protection. Starting therapy in postmenopausal patients ≥60 years of age has greater risks (eg, heart disease, stroke, blood clots, dementia) than benefits. In postmenopausal patients already taking systemic estrogens, consider deprescribing.
Ethinyl estradiol and norethindrone is available in different dosage forms based on indication. Lower dose preparations (ie, ethinyl estradiol 0.0025 or 0.005 mg/norethindrone 0.5 or 1 mg) are available for postmenopausal indications (ie, osteoporosis prevention or vasomotor symptoms associated with menopause). Higher dose monophasic, multiphasic, and iron-containing preparations (ie, ethinyl estradiol 0.02 to 0.035 mg/norethindrone 0.4 to 1.5 mg) are available for contraception and other indications (eg, acne). Errors have occurred when lower dose preparations for postmenopausal indications have been prescribed for contraception (ISMP 2021). There are multiple brands associated with each dosage; ensure proper dosage for the indication.
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Adalimumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Ajmaline: Estrogen Derivatives may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy
Anastrozole: Estrogen Derivatives may diminish the therapeutic effect of Anastrozole. Risk X: Avoid combination
Anthrax Immune Globulin (Human): Estrogen Derivatives may enhance the thrombogenic effect of Anthrax Immune Globulin (Human). Risk C: Monitor therapy
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Antihepaciviral Combination Products: Ethinyl Estradiol-Containing Products may enhance the hepatotoxic effect of Antihepaciviral Combination Products. Risk X: Avoid combination
Aprepitant: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration with aprepitant, and to continue back-up contraception for 28 days after discontinuing aprepitant to ensure contraceptive reliability. Risk D: Consider therapy modification
Asparaginase Products: Hormonal Contraceptives may enhance the thrombogenic effect of Asparaginase Products. Management: Consider discontinuing hormonal contraceptives and using an alternative contraceptive method in patients treated with asparaginase products. Risk D: Consider therapy modification
Asunaprevir: May decrease the serum concentration of Hormonal Contraceptives. Management: Use of a high-dose oral contraceptive (at least 30 mcg of ethinyl estradiol combined with norethindrone) is recommended when combined with asunaprevir. Consider an additional barrier method when other forms of contraception are used with asunaprevir. Risk D: Consider therapy modification
Atazanavir: May decrease the serum concentration of Hormonal Contraceptives. Specifically, atazanavir/ritonavir may decrease concentrations of estrogens. Atazanavir may increase the serum concentration of Hormonal Contraceptives. Specifically, atazanavir alone may increase concentrations of estrogens and atazanavir alone or boosted may increase concentrations of progestins. Management: Dose adjustment of hormonal contraceptives or use of alternative or additional nonhormonal contraceptive may be needed when combined with atazanavir. See full interact monograph for details. Atazanavir/cobicistat with drospirenone is contraindicated. Risk D: Consider therapy modification
Bile Acid Sequestrants: May decrease the serum concentration of Ethinyl Estradiol-Containing Products. Management: Administer ethinyl estradiol-containing products 4 hours prior to the administration of a bile acid sequestrant. Risk D: Consider therapy modification
Bimekizumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Brigatinib: May decrease the serum concentration of Hormonal Contraceptives. Management: Use a non-hormonal contraceptive during brigatinib use and for at least 4 months after the last brigatinib dose. Males with partners of reproductive potential should use contraception during treatment with brigatinib and for 3 months after brigatinib use. Risk D: Consider therapy modification
C1 inhibitors: Estrogen Derivatives may enhance the thrombogenic effect of C1 inhibitors. Risk C: Monitor therapy
Carfilzomib: Hormonal Contraceptives may enhance the thrombogenic effect of Carfilzomib. Management: Consider alternative, non-hormonal methods of contraception in patients requiring therapy with carfilzomib, especially patients using carfilzomib in combination with dexamethasone, lenalidomide plus dexamethasone, or daratumumab plus dexamethasone. Risk D: Consider therapy modification
Chenodiol: Estrogen Derivatives may diminish the therapeutic effect of Chenodiol. Risk C: Monitor therapy
Chlorprothixene: Estrogen Derivatives may enhance the adverse/toxic effect of Chlorprothixene. Estrogen Derivatives may enhance the therapeutic effect of Chlorprothixene. Risk C: Monitor therapy
Chlorprothixene: Progestins may enhance the adverse/toxic effect of Chlorprothixene. Progestins may enhance the therapeutic effect of Chlorprothixene. Risk C: Monitor therapy
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Risk C: Monitor therapy
Cobicistat: May decrease the serum concentration of Hormonal Contraceptives. Specifically, cobicistat may decrease serum concentrations of estrogens. Cobicistat may increase the serum concentration of Hormonal Contraceptives. Specifically, cobicistat may increase serum concentrations of progestins. Management: Use alternative or additional nonhormonal forms of contraception when estrogen-containing hormonal contraceptives are combined with cobicistat. Progestin-only contraceptives can be used without back up, but monitor for progestin toxicities. Risk D: Consider therapy modification
Colchicine: May enhance the adverse/toxic effect of Hormonal Contraceptives. Risk C: Monitor therapy
Colesevelam: May decrease the serum concentration of Norethindrone. Management: Oral contraceptives containing ethinyl estradiol and norethindrone should be administered at least 4 hours before colesevelam. Risk D: Consider therapy modification
Corticosteroids (Systemic): Estrogen Derivatives may increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy
Cosyntropin: Estrogen Derivatives may diminish the diagnostic effect of Cosyntropin. Management: Discontinue estrogen containing drugs 4 to 6 weeks prior to cosyntropin (ACTH) testing. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Norethindrone may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a moderate CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider therapy modification
CYP3A4 Inducers (Strong): May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a strong CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider therapy modification
CYP3A4 Inducers (Weak): May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a weak CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Hormonal Contraceptives. Risk C: Monitor therapy
Dantrolene: Estrogen Derivatives may enhance the hepatotoxic effect of Dantrolene. Risk C: Monitor therapy
Dasabuvir: Ethinyl Estradiol-Containing Products may enhance the hepatotoxic effect of Dasabuvir. Risk X: Avoid combination
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Dehydroepiandrosterone: May enhance the adverse/toxic effect of Estrogen Derivatives. Risk X: Avoid combination
Efavirenz: May decrease the serum concentration of Hormonal Contraceptives. Management: Use a back-up method during coadministration, and to continue back-up contraception for 12 weeks after stopping efavirenz to ensure contraceptive reliability. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Risk D: Consider therapy modification
Elagolix: Hormonal Contraceptives may diminish the therapeutic effect of Elagolix. Specifically, estrogen-containing hormonal contraceptives may diminish the therapeutic effects of elagolix. Elagolix may decrease the serum concentration of Hormonal Contraceptives. Specifically, concentrations of progestins may be decreased with elagolix therapy. Elagolix may increase the serum concentration of Hormonal Contraceptives. Specifically, concentrations of ethinyl estradiol may be increased with elagolix therapy. Management: Use an alternative, nonhormonal contraceptive during treatment with elagolix and for at least 28 days following discontinuation of elagolix treatment. Use of elagolix 200 mg twice daily with an estrogen-containing hormonal contraceptive is not recommended Risk D: Consider therapy modification
Elexacaftor, Tezacaftor, and Ivacaftor: Hormonal Contraceptives may enhance the adverse/toxic effect of Elexacaftor, Tezacaftor, and Ivacaftor. Specifically, the risk for rash may be increased. Risk C: Monitor therapy
Encorafenib: May decrease the serum concentration of Hormonal Contraceptives. Risk X: Avoid combination
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination
Etravirine: May decrease the serum concentration of Hormonal Contraceptives. Specifically, progestin concentrations may decrease. Etravirine may increase the serum concentration of Hormonal Contraceptives. Specifically, estrogen concentrations may increase. Risk C: Monitor therapy
Exemestane: Estrogen Derivatives may diminish the therapeutic effect of Exemestane. Risk X: Avoid combination
Exenatide: Hormonal Contraceptives may diminish the therapeutic effect of Exenatide. Exenatide may decrease the serum concentration of Hormonal Contraceptives. Management: Administer oral hormonal contraceptives at least one hour prior to exenatide. Monitor blood glucose more frequently when patients treated with exenatide initiate therapy with a hormonal contraceptive. Increases in exenatide doses may be needed. Risk D: Consider therapy modification
Felbamate: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing felbamate to ensure contraceptive reliability. Risk D: Consider therapy modification
Ferric Maltol: May decrease the serum concentration of Ethinyl Estradiol-Containing Products. Management: Ferric maltol labeling recommends separating administration of ethinyl estradiol-containing products from ferric maltol by at least four hours to minimize the potential for any interaction. Risk D: Consider therapy modification
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fezolinetant: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Fezolinetant. Risk X: Avoid combination
Flibanserin: Hormonal Contraceptives may increase the serum concentration of Flibanserin. Risk C: Monitor therapy
Fosaprepitant: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration with fosaprepitant, and to continue back-up contraception for 28 days after discontinuing fosaprepitant to ensure contraceptive reliability. Risk D: Consider therapy modification
Fostemsavir: May increase the serum concentration of Ethinyl Estradiol-Containing Products. Management: Ethinyl estradiol daily dose should not exceed 30 mcg during coadministration with fostemsavir. Monitor patients closely for any evidence of a thromboembolism. Risk D: Consider therapy modification
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Glecaprevir and Pibrentasvir: Ethinyl Estradiol-Containing Products may enhance the hepatotoxic effect of Glecaprevir and Pibrentasvir. Glecaprevir and Pibrentasvir may increase the serum concentration of Ethinyl Estradiol-Containing Products. Management: Use of glecaprevir/pibrentasvir and products containing more than 20 mcg of ethinyl estradiol is not recommended. Lower dose ethinyl estradiol-containing products may be used. Risk D: Consider therapy modification
Griseofulvin: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing griseofulvin to ensure contraceptive reliability. Risk D: Consider therapy modification
Growth Hormone Analogs: Estrogen Derivatives may diminish the therapeutic effect of Growth Hormone Analogs. Management: Initiate somapacitan at 2 mg once weekly in patients receiving oral estrogens. Monitor for reduced efficacy of growth hormone analogs; increased doses may be required. Risk D: Consider therapy modification
Guanethidine: Estrogen Derivatives may diminish the therapeutic effect of Guanethidine. Risk C: Monitor therapy
Hemin: Estrogen Derivatives may diminish the therapeutic effect of Hemin. Risk X: Avoid combination
Hyaluronidase: Estrogen Derivatives may diminish the therapeutic effect of Hyaluronidase. Risk C: Monitor therapy
Hydrocortisone (Systemic): Estrogen Derivatives may increase the serum concentration of Hydrocortisone (Systemic). Estrogen Derivatives may decrease the serum concentration of Hydrocortisone (Systemic). Risk C: Monitor therapy
Immune Globulin: Estrogen Derivatives may enhance the thrombogenic effect of Immune Globulin. Risk C: Monitor therapy
Indium 111 Capromab Pendetide: Estrogen Derivatives may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination
Interleukin-6 (IL-6) Inhibiting Therapies: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Ivosidenib: May decrease the serum concentration of Hormonal Contraceptives. Management: Consider alternative methods of contraception (ie, non-hormonal) in patients receiving ivosidenib. Risk D: Consider therapy modification
Ixazomib: May decrease the serum concentration of Hormonal Contraceptives. More specifically, use of ixazomib with dexamethasone may decrease the serum concentrations of hormonal contraceptives. Management: Patients of reproductive potential should use a non-hormonal contraceptive method during treatment with ixazomib and for at least 90 days after the last ixazomib dose. Risk D: Consider therapy modification
Lactic Acid, Citric Acid, and Potassium Bitartrate: Ethinyl Estradiol may diminish the therapeutic effect of Lactic Acid, Citric Acid, and Potassium Bitartrate. Risk X: Avoid combination
LamoTRIgine: Estrogen Derivatives (Contraceptive) may decrease the serum concentration of LamoTRIgine. Management: Larger doses of lamotrigine may be needed when combined with estrogens. Specific dosing recommendations vary based on other concomitant medications and which medication is being initiated or discontinued. See interaction monograph for details. Risk D: Consider therapy modification
Lenalidomide: Estrogen Derivatives may enhance the thrombogenic effect of Lenalidomide. Risk C: Monitor therapy
Lixisenatide: Hormonal Contraceptives may diminish the therapeutic effect of Lixisenatide. Lixisenatide may decrease the serum concentration of Hormonal Contraceptives. Management: Administer oral hormonal contraceptives 1 hour before or at least 11 hours after administration of lixisenatide. Additionally, monitor blood glucose more frequently when patients treated with lixisenatide initiate therapy with a hormonal contraceptive. Risk D: Consider therapy modification
Lomitapide: Estrogen Derivatives may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 40 mg/day. Risk D: Consider therapy modification
Mavacamten: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative contraceptive that is not sensitive to CYP3A4 induction or a back-up method during coadministration, and to continue back-up contraception for 4 months after stopping mavacamten to ensure contraceptive reliability. Risk D: Consider therapy modification
Melatonin: Estrogen Derivatives may increase the serum concentration of Melatonin. Risk C: Monitor therapy
MetyraPONE: Estrogen Derivatives may diminish the diagnostic effect of MetyraPONE. Management: Consider alternatives to the use of the metyrapone test in patients taking estrogen derivatives. Risk D: Consider therapy modification
MetyraPONE: Progestins may diminish the diagnostic effect of MetyraPONE. Management: Consider alternatives to the use of the metyrapone test in patients taking progestins. Risk D: Consider therapy modification
MiFEPRIStone: May diminish the therapeutic effect of Hormonal Contraceptives. Management: Nonhormonal contraception should be used during, and for 4 weeks following, mifepristone treatment for hyperglycemia due to Cushing syndrome. If used for pregnancy termination, hormonal contraceptives can be used after pregnancy expulsion is confirmed. Risk D: Consider therapy modification
Mitotane: May decrease the serum concentration of Hormonal Contraceptives. Management: Effective nonhormonal contraception is recommended for those of reproductive potential during treatment with mitotane as well as after discontinuation of mitotane for as long as mitotane plasma levels are detectable. Risk X: Avoid combination
Mivacurium: Estrogen Derivatives may increase the serum concentration of Mivacurium. Risk C: Monitor therapy
Mobocertinib: May decrease the serum concentration of Hormonal Contraceptives. Risk X: Avoid combination
Mycophenolate: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients of childbearing potential who are taking hormonal contraceptives should use an additional form of barrier contraception during treatment with mycophenolate and for 6 weeks after mycophenolate discontinuation. Risk D: Consider therapy modification
Nirmatrelvir and Ritonavir: May decrease the serum concentration of Hormonal Contraceptives. Specifically, nirmatrelvir and ritonavir may decrease concentrations of estrogens. Nirmatrelvir and Ritonavir may increase the serum concentration of Hormonal Contraceptives. Specifically, nirmatrelvir and ritonavir may increase concentrations of progestins. Management: Use additional nonhormonal forms of contraception (back-up method) when estrogen-containing hormonal contraceptives are combined with nirmatrelvir/ritonavir. Progestin-only contraceptives can be used without back-up, but monitor for progestin toxicities. Risk D: Consider therapy modification
Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): May enhance the thrombogenic effect of Estrogen Derivatives. Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may increase the serum concentration of Estrogen Derivatives. Risk C: Monitor therapy
Octreotide: May decrease the serum concentration of Hormonal Contraceptives. Management: Women should use an alternative non-hormonal method of contraception or a back-up method when octreotide is combined with hormonal contraceptives. Risk D: Consider therapy modification
Olutasidenib: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Avoid use of olutasidenib with sensitive or narrow therapeutic index CYP3A4 substrates when possible. If concurrent use with olutasidenib is unavoidable, monitor closely for evidence of decreased concentrations of the CYP3A4 substrates. Risk D: Consider therapy modification
Omaveloxolone: May decrease the serum concentration of Hormonal Contraceptives. Risk X: Avoid combination
Ospemifene: Estrogen Derivatives may enhance the adverse/toxic effect of Ospemifene. Risk X: Avoid combination
OXcarbazepine: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing oxcarbazepine to ensure contraceptive reliability. Risk D: Consider therapy modification
Perampanel: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients should use an alternative, nonhormonal-based form of contraception during the concurrent use of perampanel and for 1 month after discontinuing perampanel. Risk D: Consider therapy modification
Pexidartinib: May decrease the serum concentration of Hormonal Contraceptives. Risk X: Avoid combination
Pitolisant: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with pitolisant and for at least 21 days after discontinuation of pitolisant treatment. Risk D: Consider therapy modification
Pomalidomide: Estrogen Derivatives may enhance the thrombogenic effect of Pomalidomide. Risk C: Monitor therapy
Proguanil: Ethinyl Estradiol-Containing Products may decrease serum concentrations of the active metabolite(s) of Proguanil. Risk C: Monitor therapy
Protease Inhibitors: May decrease the serum concentration of Hormonal Contraceptives. Specifically, protease inhibitors may decrease concentrations of estrogens. Protease Inhibitors may increase the serum concentration of Hormonal Contraceptives. Specifically, protease inhibitors may increase concentrations of progestins. Management: Use alternative or additional nonhormonal forms of contraception when estrogen-containing hormonal contraceptives are combined with protease inhibitors. Progestin-only contraceptives can be used without back up, but monitor for progestin toxicities. Risk D: Consider therapy modification
Raloxifene: Estrogen Derivatives may enhance the adverse/toxic effect of Raloxifene. Risk X: Avoid combination
Repotrectinib: May decrease the serum concentration of Hormonal Contraceptives. Risk X: Avoid combination
Retinoic Acid Derivatives: May diminish the therapeutic effect of Progestins (Contraceptive). Retinoic Acid Derivatives may decrease the serum concentration of Progestins (Contraceptive). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Microdosed progesterone-only preparations (ie, minipills that do not contain estrogen) are considered an inadequate method of contraception. Risk D: Consider therapy modification
Roflumilast-Containing Products: Ethinyl Estradiol-Containing Products may increase serum concentrations of the active metabolite(s) of Roflumilast-Containing Products. Ethinyl Estradiol-Containing Products may increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
ROPINIRole: Estrogen Derivatives may increase the serum concentration of ROPINIRole. Risk C: Monitor therapy
Selegiline: Ethinyl Estradiol-Containing Products may increase the serum concentration of Selegiline. Risk C: Monitor therapy
Succinylcholine: Estrogen Derivatives may increase the serum concentration of Succinylcholine. Risk C: Monitor therapy
Sugammadex: May diminish the therapeutic effect of Hormonal Contraceptives. Management: Patients receiving any hormonal contraceptive (oral or non-oral) should use an additional, nonhormonal contraceptive method during and for 7 days following sugammadex treatment. Risk D: Consider therapy modification
Tacrolimus (Systemic): Estrogen Derivatives may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Taurursodiol: May decrease the serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid combination
Tazemetostat: May decrease the serum concentration of Hormonal Contraceptives. Management: Individuals of childbearing potential should use a non-hormonal contraceptive method during treatment with tazemetostat and for 6 months after. Males with partners of childbearing potential should use contraception during treatment and for 3 months after. Risk D: Consider therapy modification
Tetrahydrocannabinol and Cannabidiol: May decrease the serum concentration of Hormonal Contraceptives. Management: Product labeling recommends that patients taking hormonal contraceptives should use an additional, non-hormonal contraceptive or reliable barrier method during treatment with tetrahydrocannabinol and cannabidiol buccal spray. Risk D: Consider therapy modification
Thalidomide: Hormonal Contraceptives may enhance the thrombogenic effect of Thalidomide. Risk C: Monitor therapy
Theophylline Derivatives: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy
Thyroid Products: Estrogen Derivatives may diminish the therapeutic effect of Thyroid Products. Risk C: Monitor therapy
Tirzepatide: May decrease the serum concentration of Hormonal Contraceptives. Management: Patients using oral hormonal contraceptives should switch to a non-oral contraceptive method, or add a barrier method of contraception, for 4 weeks after initiation of tirzepatide and for 4 weeks after each dose escalation of tirzepatide. Risk D: Consider therapy modification
TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Risk D: Consider therapy modification
Tobacco (Smoked): May enhance the adverse/toxic effect of Estrogen Derivatives (Contraceptive). Specifically, the risk of serious cardiovascular events (eg, stroke, venous thromboembolism, myocardial infarction) may be increased. Management: Avoid cigarette smoking in patients who use estrogen containing contraceptives whenever possible. If combined, monitor for signs and symptoms of serious cardiovascular events (eg, stroke, venous thromboembolism, myocardial infarction). Risk D: Consider therapy modification
Topiramate: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing topiramate to ensure contraceptive reliability. Risk D: Consider therapy modification
Tranexamic Acid: Hormonal Contraceptives may enhance the thrombogenic effect of Tranexamic Acid. Risk X: Avoid combination
Ulipristal: May diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal. Risk X: Avoid combination
Ursodiol: Estrogen Derivatives may diminish the therapeutic effect of Ursodiol. Risk C: Monitor therapy
Ustekinumab: May decrease the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor therapy
Vaborbactam: May decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing meropenem/vaborbactam to ensure contraceptive reliability. Risk D: Consider therapy modification
Valproate Products: Estrogen Derivatives may decrease the serum concentration of Valproate Products. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Hormonal Contraceptives may increase the serum concentration of Vitamin K Antagonists. Hormonal Contraceptives may decrease the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy
Voriconazole: Hormonal Contraceptives may increase the serum concentration of Voriconazole. Voriconazole may increase the serum concentration of Hormonal Contraceptives. Risk C: Monitor therapy
Due to the increased risk of venous thromboembolism (VTE) postpartum, do not initiate combination hormonal contraceptives in any patient <21 days following delivery. The risk decreases to baseline by postpartum day 42. In patients who are between 21 and 42 days after delivery, consider risk factors for VTE (eg, ≥35 years of age, previous VTE, thrombophilia, immobility, preeclampsia, transfusion at delivery, cesarean delivery, peripartum cardiomyopathy, BMI ≥30 kg/m2, postpartum hemorrhage, smoking) (CDC [Curtis 2016b]). The manufacturer does not recommend use until ≥4 weeks after delivery in patients who choose not to breastfeed due to the risk of VTE.
All available forms of contraception, including combination hormonal contraceptives, can be considered for patients on gender-affirming testosterone therapy after evaluating patient preferences and medical conditions (eg, risk for VTE) (Bonnington 2020; Krempasky 2020).
Combination oral contraceptives (COCs) may be an option for menstrual suppression in patients who have reached menarche when fewer or no menses are desired (ACOG 2022; SOGC [Kirkham 2019]). Future fertility is not decreased. Base the decision to use a COC or other hormonal preparation on patient preference, their ability to use the method, method effectiveness, potential contraindications, drug interactions, and adverse events. Consider for patients requesting menstrual suppression, including (but not limited to) adolescents, athletes, persons with physical and/or cognitive disabilities, persons on gender-affirming hormone therapy, and persons with limited access to menstrual products or other challenges to hygiene management (ACOG 2022).
A COC is a preferred therapy for treating hyperandrogenism and/or menstrual irregularities associated with polycystic ovary syndrome. A specific formulation is not recommended; product selection should follow available criteria for use guidelines, using a lower dose estrogen product (Teede 2018).
Combination hormonal contraceptives are used to prevent pregnancy; discontinue if pregnancy occurs. In general, the inadvertent use of combination hormonal contraceptives early in pregnancy has not been associated adverse fetal or maternal effects (CDC [Curtis 2016b]).
Contraceptive steroids may be present in breast milk. Adverse health outcomes, or consistent effects on infant growth or illness due to exogenous estrogens have not been reported following use of combination hormonal contraceptives in breastfeeding patients (CDC [Curtis 2016b]). Because estrogen containing contraceptives may reduce milk production, the manufacturer recommends use of other forms of contraception until the child is weaned.
Due to the increased risk of venous thromboembolism (VTE) postpartum, do not start combination hormonal contraceptives in patients who are breastfeeding <21 days following delivery. The risk decreases to baseline by postpartum day 42. In patients who are between 21 and 42 days after delivery, consider risk factors for VTE (eg, age ≥35 years, previous VTE, thrombophilia, immobility, preeclampsia, transfusion at delivery, cesarean delivery, peripartum cardiomyopathy, BMI ≥30 kg/m2, postpartum hemorrhage, smoking). Evaluate risks, benefits, and alternatives to combination hormonal contraception when initiating treatment in patients who are breastfeeding (CDC [Curtis 2016b]). The manufacturer does not recommend use until ≥4 weeks after delivery in patients who choose not to breastfeed due to the risk of VTE.
Combination oral contraceptives (COCs) are a recommended option for the treatment of persistent idiopathic hyperlactation (hypergalactia) in patients requiring medication therapy. Consider postpartum age, patient preferences, potential adverse drug reactions, and interactions prior to therapy. COCs containing ethinyl estradiol 0.02 to 0.035 mg are recommended. Do not initiate treatment <6 weeks postpartum; discontinue once milk production decreases (may significantly decrease within 7 days). If COC therapy is continued, monitoring of milk production is recommended (ABM [Johnson 2020]).
Ensure adequate calcium and vitamin D intake when used for the prevention of osteoporosis.
Hormonal contraceptives: Assessment of pregnancy status (prior to therapy); personal or family history of thrombotic or thromboembolic disorders (prior to therapy); BP (prior to therapy and yearly); weight (optional; BMI at baseline may be helpful to monitor changes during therapy); assess potential health status changes at routine visits (CDC [Curtis 2016a]).
Determining if reasonably certain a person is not pregnant (CDC [Curtis 2016a]): If the patient has no signs or symptoms of pregnancy and meets any one of the following criteria, a health care provider can be reasonably certain the person is not pregnant:
≤7 days after the start of normal menses
No sexual intercourse since last menses
Correct and consistent use of reliable contraception
≤7 days after spontaneous or induced abortion
<4 weeks postpartum
<6 months postpartum, amenorrheic, and exclusively breastfeeding or ≥85% of feeds are breastfeeds
If all doses have not been taken on schedule and one menstrual period is missed, consider the possibility of pregnancy. If 2 consecutive menstrual periods are missed, assess pregnancy status before a new dosing cycle is started.
Monitor patients for vision changes; BP; signs and symptoms of thromboembolic disorders; signs or symptoms of depression; glycemic control in patients with diabetes; lipid profiles in patients being treated for hyperlipidemia. Perform adequate diagnostic measures to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding.
Postmenopausal indications:
Prior to therapy, baseline risk for breast cancer and cardiovascular disease. During therapy, age-appropriate breast and pelvic exams; BP; unscheduled bleeding lasting >6 months for endometrial pathology (sooner in patients who are obese, have diabetes, or have a history of endometrial cancer); serum triglycerides (2 weeks after starting therapy in patients with baseline level >200 mg/dL); thyroid-stimulating hormone (6 to 12 weeks after starting oral therapy in patients taking thyroid replacement) (ES [Stuenkel 2015]).
Menopausal symptoms: Efficacy beginning 1 to 3 months after starting therapy, then every 6 to 12 months as appropriate. Evaluate duration of treatment at least annually (ES [Stuenkel 2015]).
Note: Monitoring of follicle-stimulating hormone and serum estradiol is not useful when managing vasomotor symptoms of menopause.
Prevention of osteoporosis: Bone density measurement.
Combination oral contraceptives inhibit ovulation via a negative feedback mechanism on the hypothalamus, which alters the normal pattern of gonadotropin secretion of a follicle-stimulating hormone (FSH) and luteinizing hormone by the anterior pituitary. The follicular phase FSH and midcycle surge of gonadotropins are inhibited. In addition, combination hormonal contraceptives produce alterations in the genital tract, including changes in the cervical mucus, rendering it unfavorable for sperm penetration even if ovulation occurs. Changes in the endometrium may also occur, producing an unfavorable environment for nidation. Combination hormonal contraceptive drugs may alter the tubal transport of the ova through the fallopian tubes. Progestational agents may also alter sperm fertility.
In postmenopausal patients, exogenous estrogen is used to replace decreased endogenous production. The addition of progestogen reduces the incidence of endometrial hyperplasia and risk of endometrial cancer in patients with an intact uterus.
Norethindrone: See individual monograph.
Ethinyl estradiol:
Absorption: Rapid
Bioavailability: 43% to 55%
Distribution: Vd: 2 to 4 L/kg
Protein binding: >95% to albumin
Metabolism: Hepatic via oxidation and conjugation in GI tract; hydroxylated via CYP3A4 to metabolites; first-pass effect; enterohepatic recirculation; reversibly converted to estrone and estriol
Half-life elimination: 19 to 24 hours
Excretion: Urine (as estradiol, estrone, and estriol); feces
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