Version May 2024
Acne vulgaris: Oral: One tablet once daily for 21 days, followed by 7 days off; first cycle should begin on the first day of menstrual flow. Subsequent dosing cycles should begin on the same day of the week that the first cycle was begun regardless of presence of withdrawal bleeding. Discontinue therapy 3 to 4 cycles after symptoms have resolved. Note: Retreatment may be considered with recurrence of symptoms following therapy discontinuation. Therapy should not be interrupted for spotting or breakthrough bleeding; persistent or prolonged bleeding should be evaluated. Evaluate pregnancy status if menstruation does not occur during 7-day tablet-free interval; discontinue if pregnancy is suspected.
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). Based on available data, dosage adjustment is not needed.
Use is contraindicated.
Acne vulgaris: Females: Oral: See adult dosing; not to be used prior to menarche.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Use is contraindicated.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see Cyproterone monograph.
1% to 10%:
Cardiovascular: Edema (2%), varicosity (3%)
Dermatologic: Chloasma (4%)
Endocrine & metabolic: Decreased libido (3%)
Gastrointestinal: Nausea (2%)
Genitourinary: Breast tenderness (7%), dysmenorrhea (10%)
Nervous system: Depressed mood (3%), dizziness (1%), headache (5%), nervousness (4%)
Postmarketing:
Cardiovascular: Embolism of systemic artery (involving the extremities and spleen), flushing, hypertensive crisis, livedo reticularis, palpitations, superficial thrombophlebitis, thrombosis (sinus), venous thromboembolism (including deep vein thrombosis and pulmonary embolism) (Chen 2016)
Dermatologic: Acne vulgaris, allergic skin reaction, alopecia, atrophic striae, cellulitis, eczema, erythema nodosum, neurodermatitis, pruritus, skin discoloration (blue spots), skin photosensitivity, skin pigmentation, skin rash, subcutaneous nodule, urticaria, xeroderma
Endocrine & metabolic: Diabetes mellitus, hyperprolactinemia, hyperthyroidism, menstrual disease
Gastrointestinal: Abdominal pain, cholangitis, cholestasis, Clostridioides difficile colitis, diarrhea, flatulence, malignant neoplasm of the bile duct, pancreatitis, sialadenitis, stomatitis
Genitourinary: Abortion (including missed abortion), cervical dysplasia, malignant neoplasm of breast, ovarian cyst, urinary tract infection, uterine fibroids, vaginitis
Hematologic & oncologic: Acute leukemia, hematoma (liver, subcapsular)
Hepatic: Abnormal transaminases, ascites, hepatic adenoma, hepatic carcinoma, hepatic focal nodular hyperplasia, hepatic neoplasm, hepatitis, hepatomegaly, jaundice
Hypersensitivity: Facial edema, nonimmune anaphylaxis
Infection: Herpes zoster infection
Nervous system: Cerebral thrombosis, cerebrovascular accident (Kromm 2014), chorea (hemichorea) (Sharmila 2015), confusion, depression, drowsiness, facial paresis, hydrocephalus (acute), hyperalgesia (hyperpathia), hypoesthesia, insomnia, manic reaction, migraine, paresthesia, seizure, spinal cord infarction (Meng 2015)
Ophthalmic: Conjunctival irritation, retinal vein occlusion, visual disturbance
Otic: Auditory impairment
Hypersensitivity to ethinyl estradiol, cyproterone, or any component of the formulation; breast cancer or other estrogen- or progestin-dependent neoplasms (known or suspected); history of or actual thrombophlebitis or thromboembolic disorders, cerebrovascular disorders, or myocardial infarction or coronary arterial disease; severe diabetes with vascular changes; previous or existing hepatic tumors (benign or malignant) or active hepatic disease; history of cholestatic jaundice; pregnancy; undiagnosed abnormal vaginal bleeding; ocular lesions arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields; history of otosclerosis with deterioration during pregnancy; concomitant use with other estrogen/progesterone combinations or estrogens or progestins alone; concomitant use with the hepatitis C combination regimen of ombitasvir, paritaprevir, ritonavir, with or without dasabuvir.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Bleeding irregularities: Use may be associated with amenorrhea, breakthrough bleeding or changes in menstrual flow. Evaluate persistent irregular vaginal bleeding to exclude pregnancy or neoplasm.
• Cholestasis: Use is not recommended in patients with a history of cholestatic jaundice or jaundice associated with pregnancy. Temporarily discontinue if severe generalized pruritus develops. Discontinue of cholestatic jaundice develops.
• Hepatic adenomas or carcinomas: Use of estrogen/progestogen combinations is associated with hepatic adenomas and focal nodular hyperplasia (rare); rupture may cause fatal intra-abdominal hemorrhage. Discontinue use and consider the possibility of a hepatic tumor in the presence of severe upper abdominal pain, liver enlargement, or signs of intra-abdominal hemorrhage.
• Lipid effects: May adversely affect lipid levels, including serum triglycerides. Patients with hypertriglyceridemia may be at increased risk of pancreatitis.
• Thromboembolic disorders: Discontinue use if an arterial or venous thromboembolic event occurs (eg, cerebrovascular accident, deep venous thrombosis, myocardial infarction, pulmonary embolism). The risk of venous thromboembolism with cyproterone/ethinyl estradiol appears to be greater than that of levonorgestrel-containing combined oral contraceptives and similar to that of desogestrel- and drospirenone-containing combined oral contraceptives. Progesterone and/or estrogen should not be taken while on this medication. The increased the risk of venous thromboembolism greatest during first year of use. Patients with activated protein C resistance, hyperhomocysteinemia, protein C or S deficiency, prothrombin mutation, antithrombin III deficiency, or antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) may have increased risk of venous or arterial thromboembolism, or cerebrovascular accident. Discontinue use if patient is immobilized for an extended period of time (eg, following accident, long-term illness); nonhormonal acne therapy should be used until patient is able to resume regular activities.
Disease-related concerns:
• Breast cancer: Breast cancer is a hormonal sensitive tumor, and the prognosis may be worse with estrogen/progestogen combinations. Use caution when prescribing estrogen/progestin combinations to patients with risk factors for breast cancer or fibrocystic disease of the breast.
• Cardiovascular disease: Use with caution in patients with risk factors for coronary artery disease (eg, hypertension, hypercholesterolemia, morbid obesity, diabetes, increasing age, or cigarette smoking); may lead to increased risk for cardiovascular disease. Patients with androgen-related conditions (severe acne, hirsutism) may have an increased cardiovascular risk. Discontinue use if a significant rise in BP occurs at any time during therapy. Patients with concurrent obesity, hypertension, and diabetes should receive alternative acne therapy.
• Connective tissue disease: Use with caution; may exacerbate connective tissue disease (eg, systemic lupus erythematosus, rheumatoid arthritis, synovitis).
• Depression: Use with caution in patients with depression; consider alternative therapy if depression recurs.
• Diabetes: Use caution in patients with diabetes or prediabetes; monitor closely. Patients with concurrent diabetes, hypertension and obesity should use alternative treatments for acne.
• Diseases exacerbated by fluid retention: Use with caution in patients with diseases which may be exacerbated by fluid retention, including asthma, epilepsy, or cardiac or renal dysfunction.
• Fibroids: Use with caution in patients with fibroids (leiomyomata); discontinue use with sudden enlargement, pain, or tenderness of fibroids.
• Gallbladder disease: May increase the risk of gallbladder disease.
• Hepatic impairment: Discontinue if jaundice, or severe generalized pruritus develops during therapy or if liver function becomes abnormal.
• Hereditary angioedema: Estrogens may induce or exacerbate symptoms in patients with hereditary angioedema. Discontinuation of therapy may be necessary.
• Hypertension: May be used with caution in patients with well controlled hypertension. Monitor BP and discontinue therapy if BP rises significantly. Patients with concurrent diabetes, hypertension and obesity should use alternative treatments for acne.
• Metabolic/Endocrine diseases: Careful evaluation is recommended prior to starting therapy in patients with metabolic or endocrine diseases and when metabolism of calcium and phosphorus is abnormal; monitor regularly as indicated. Patients with concurrent diabetes, hypertension and obesity should use alternative treatments for acne.
• Migraine: Use with caution in patients with a history of migraine. Evaluate new, recurrent, severe, or persistent headaches. Discontinue if severe headache of unknown etiology or worsening of preexisting migraine headaches occur.
• Ocular changes: Use with caution in patients with myopia; progressive astigmatic error, possibly leading to keratoconus, has been observed in some myopic patients receiving estrogen/progesterone. Patients with family history of such disorders may experience rapid advancement of these ocular disorders. Changes in contact lens tolerance or development of visual changes should be evaluated by an ophthalmologist. Discontinue use if loss of vision, papilledema, or ophthalmic vascular lesions occur.
Special populations:
• Body weight: Patients with a combination of diabetes, hypertension and obesity should use alternative treatments for acne.
• Smoking: Cigarette smoking increases the risk of serious cardiovascular events from estrogen/progestin combinations. This risk increases with age, particularly in patients >35 years of age, and with the number of cigarettes smoked. Patients using this combination should not smoke.
• Surgical patients: Whenever possible, drug should be discontinued at least 4 weeks prior to elective surgery; associated with an increased risk of thromboembolism or during periods of prolonged immobilization. Medication should not be restarted until first menstrual period after hospital discharge following surgery.
Not available in the US
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Cleo-35: Ethinyl estradiol 0.035 mg and cyproterone 2 mg [contains corn starch]
Cyestra-35: Ethinyl estradiol 0.035 mg and cyproterone 2 mg
Diane-35: Ethinyl estradiol 0.035 mg and cyproterone 2 mg
Generic: Ethinyl estradiol 0.035 mg and cyproterone 2 mg
Administer at the same time each day. Swallow tablet whole. A missed dose may be taken within the next 12 hours. If >12 hours, discard unused tablet and resume at usual scheduled times.
Oral: Administer at the same time each day. Swallow tablet whole. A missed dose may be taken within the next 12 hours. If >12 hours, discard unused tablet and resume at usual scheduled times.
This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Cyproterone and ethinyl estradiol may cause carcinogenicity, teratogenicity, reproductive toxicity, genotoxicity, and has a structural or toxicity profile similar to existing hazardous agents. Assess risk to determine appropriate containment strategy (USP-NF 2017).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules (NIOSH 2016).
Note: Not approved in the US.
Acne: Treatment of severe acne with associated symptoms of androgenization (including mild hirsutism or seborrhea).
Limitations of use: Not for use prior to menarche or post-menopause. Should be used only when acne is unresponsive to topical therapy and oral antibiotic treatments. Should not be used solely for contraception; however, will provide reliable contraception if taken as recommended for approved indications.
ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
Substrate of CYP2C9 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP1A2 (weak)
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.
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
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
C1 inhibitors: Estrogen Derivatives may enhance the thrombogenic effect of C1 inhibitors. Risk C: Monitor therapy
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
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): Ethinyl Estradiol-Containing Products may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Estrogen Derivatives. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Estrogen Derivatives. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Estrogen Derivatives. 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
Dehydroepiandrosterone: May enhance the adverse/toxic effect of Estrogen Derivatives. Risk X: Avoid combination
Exemestane: Estrogen Derivatives may diminish the therapeutic effect of Exemestane. Risk X: Avoid combination
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
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
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
LamoTRIgine: Ethinyl Estradiol-Containing Products may decrease the serum concentration of LamoTRIgine. Management: Larger doses of lamotrigine may be needed when combined with ethinyl estradiol. 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
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
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
Mivacurium: Estrogen Derivatives may increase the serum concentration of Mivacurium. Risk C: Monitor therapy
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
Ospemifene: Estrogen Derivatives may enhance the adverse/toxic effect of Ospemifene. Risk X: Avoid combination
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 Estrogen Derivatives. Protease Inhibitors may increase the serum concentration of Estrogen Derivatives. Risk C: Monitor therapy
Raloxifene: Estrogen Derivatives may enhance the adverse/toxic effect of Raloxifene. Risk X: Avoid combination
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
Tacrolimus (Systemic): Estrogen Derivatives may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Thalidomide: Estrogen Derivatives 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
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
Tranexamic Acid: Estrogen Derivatives 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
Valproate Products: Estrogen Derivatives may decrease the serum concentration of Valproate Products. Risk C: Monitor therapy
CNS effects of caffeine may be enhanced if combination hormonal contraceptives are used concurrently with caffeine. Grapefruit juice increases ethinyl estradiol concentrations and would be expected to increase progesterone serum levels as well. Management: Monitor patients closely with concurrent use.
Pregnancy should be ruled out prior to treatment.
This product should not be prescribed only for the prevention of pregnancy; however, it will provide reliable contraception if taken as recommended for the approved indications. The risk of venous thromboembolic events may be increased compared to other combination hormonal contraceptives; use of other estrogen/progestogen combination should not be used during treatment with cyproterone/ethinyl estradiol. Patients with uncertain compliance should also use a nonhormonal contraceptive (eg, barrier method) when contraception is needed.
Upon discontinuation of therapy, patients should use a nonhormonal contraceptive to delay pregnancy until at least one normal spontaneous cycle has occurred. Patients with amenorrhea prior to use may remain anovulatory or amenorrheic after discontinuation of therapy.
Additional warnings and precautions associated with combination hormonal contraceptive products should be considered.
Feminization of a male fetus is possible. Use is contraindicated in known or suspected pregnancy. Also consider warnings and precautions associated with combination hormonal contraceptive products.
Cyproterone and ethinyl estradiol are present in breast milk.
Based on product labeling, the estimated daily exposure to a breastfed infant is ~0.2% and 0.02% of the daily maternal dose of cyproterone acetate and ethinyl estradiol, respectively. Estrogen/progestogen combinations may reduce milk production. Breastfeeding is not recommended by the manufacturer.
Although this product is not primarily indicated for contraception, additional warnings and precautions associated with combination hormonal contraceptive products should be considered.
Prior to therapy: Assessment of pregnancy status; BP; physical exam with reference to breasts, liver, extremities, abdomen and pelvic organs; Papanicolaou smear (sexually active patients); urinalysis. Repeat examinations at regular intervals during therapy, including a yearly breast examination.
The first follow-up visit should be 3 months after initiation of treatment. If a menstrual period is missed, the possibility of pregnancy should be considered. Monitor patient 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 hyperlipidemias. Adequate diagnostic measures should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding.
The need for continued treatment should be evaluated periodically; discontinue 3 to 4 cycles after resolution of symptoms.
Evaluate hypothalamic-pituitary function in patients with persistent (≥6 months) amenorrhea (especially associated with breast secretion) following discontinuation of therapy.
Ethinyl estradiol: Estrogens are responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Estrogens modulate the pituitary secretion of gonadotropins, luteinizing hormone, and follicle-stimulating hormone through a negative feedback system. Estrogen increases levels of sex hormone-binding globulin (SHBG) and may reduce unbound androgen levels. Ethinyl estradiol is a synthetic derivative of estradiol. The addition of the ethinyl group prevents rapid degradation by the liver.
Cyproterone: Steroidal compound with antiandrogenic, antigonadotropic and progestin-like activity.
See individual agents.
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