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Copper intrauterine device: Drug information

Copper intrauterine device: Drug information
For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Paragard Intrauterine Copper
Pharmacologic Category
  • Contraceptive
Dosing: Adult
Contraception

Contraception: IUD:

Initiation of therapy: Patients not currently using a hormonal contraceptive or intrauterine contraception: One IUD to be inserted into the uterine cavity; may be inserted at any time during the menstrual cycle as long as it is reasonably certain the patient is not pregnant.

Continuation of contraception: Replace by the end of 10 years. When it is time to replace, a new device may be inserted immediately after the previous IUD is removed if otherwise appropriate. Do not leave any one device in place for >10 years.

Switching from a Different Contraceptive to Copper IUDa

Current method

Instructions for switching to copper IUD

a May be inserted immediately as long as it is reasonably certain the patient is not pregnant. Discontinue previous method of contraception on day of IUD insertion. Back-up contraception is not needed (CDC [Curtis 2016a]).

Hormonal contraceptive (oral, transdermal, vaginal)

Copper IUD may be inserted anytime during the menstrual cycle; discontinue previous method.

Injectable progestin

Copper IUD may be inserted anytime during the menstrual cycle; discontinue previous method.

Implant or another IUD

Copper IUD may be inserted on the same day the implant or IUD is removed, any time during the menstrual cycle.

Use after Childbirth, Abortion, or Miscarriagea, b

a Back-up contraception is not needed with proper insertion (CDC [Curtis 2016a]).

b The copper IUD may be inserted within 10 minutes following delivery of the placenta (CDC [Curtis 2016b]), any time postpartum, or within 7 days following a first- or second-trimester spontaneous or induced abortion; do not insert if puerperal sepsis or septic abortion is present (CDC [Curtis 2016a]; CDC [Curtis 2016b]).

Use after childbirth

Copper IUD may be inserted immediately postpartum.

The risk of expulsion may be increased if insertion occurs prior to complete uterine involution.

The risk of perforation is increased in lactating patients.

Use after abortion or miscarriage

Copper IUD may be inserted immediately after an abortion or miscarriage.

The risk of expulsion may be increased following abortion compared to other times. The risk of expulsion is higher following second-trimester abortion than first-trimester abortion.

Emergency contraception

Emergency contraception (off-label use): IUD: A copper IUD may be inserted as an emergency contraceptive within 5 days of the first act of unprotected sex; may also be inserted beyond 5 days of unprotected intercourse if not >5 days after ovulation (CDC [Curtis 2016a]; Turok 2013; Wu 2010).

Dosing: Pediatric
Prevention of pregnancy

Prevention of pregnancy: Females: Refer to adult dosing; not to be used prior to menarche.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined:

Endocrine & metabolic: Heavy menstrual bleeding, spotty menstruation

Genitourinary: Abnormal vaginal hemorrhage, cervical perforation, dysmenorrhea, dyspareunia, ectopic pregnancy, embedment of intrauterine system in the myometrium, endometriosis (may be asymptomatic), pelvic cramps, pelvic inflammatory disease (may be asymptomatic), pelvic pain, spontaneous migration of the IUD, uterine perforation, vaginitis

Hematologic & oncologic: Anemia

Infection: Sepsis (including Group A streptococcal sepsis), infection (including severe and actinomycosis)

Neuromuscular & skeletal: Back pain

Miscellaneous: Female birth control device expulsion from genital tract

Postmarketing: Abdominal distention, amenorrhea, breakage of IUD, dizziness, fever, hypersensitivity reaction (including metal allergy), muscle spasm, nausea, pelvic region infection (uterus), Stevens-Johnson syndrome

Contraindications

Hypersensitivity to copper or any component of the formulation; pregnancy or suspicion of pregnancy; abnormalities of the uterus resulting in distortion of the uterine cavity; acute pelvic inflammatory disease; postpartum endometritis or postabortal endometritis in the past 3 months; known or suspected uterine or cervical malignancy; uterine bleeding of unknown etiology; conditions associated with increased susceptibility to pelvic infections; untreated acute cervicitis or vaginitis or other lower genital tract infection; Wilson disease; a previously placed IUD that has not been removed.

Warnings/Precautions

Concerns related to adverse effects:

• Bleeding irregularities: Menstrual bleeding patterns may be altered with use of the IUD. Unexplained vaginal bleeding should be evaluated prior to insertion (CDC [Curtis 2016b]). If bleeding irregularities develop during use, appropriate diagnostic measures should be taken to rule out endometrial pathology or displacement of the device (CDC [Curtis 2016a]; CDC [Curtis 2016b]).

• Ectopic pregnancy: If pregnancy occurs with the device in place, evaluate for an ectopic pregnancy. May be used in patients with a history of ectopic pregnancy (CDC [Curtis 2016b]).

• Intrauterine pregnancy: Septic abortion with septicemia, septic shock, and death may occur if pregnancy occurs with the IUD in place. The risk of miscarriage, premature labor, premature delivery, and sepsis are increased if an intrauterine pregnancy occurs and continues with the IUD in place. If pregnancy occurs, the device should be removed if the strings are visible (pregnancy loss may occur). If the strings are not visible but it is determined that the device is still in place, the patient should be informed of the risks if pregnancy is continued.

• Pelvic inflammatory disease: An increased risk of pelvic inflammatory disease (PID) (including asymptomatic cases) and actinomycosis infections have been associated with IUD use and may cause tubal damage (with associated ectopic pregnancy and infertility), hysterectomy, sepsis, and death. Risk of PID or endometriosis is greater in patients with a history of either condition; risk factors associated with sexually transmitted infections (STIs) (eg, multiple sex partners); and increased susceptibility to infection (eg, leukemia, AIDS, intravenous drug abuse). Administration of antibiotics during device insertion does not decrease the risk of PID. Counsel patients to monitor and seek evaluation for signs and symptoms of pelvic infection (eg, fever, genital lesions/sores, lower abdominal/pelvic pain, odorous discharge, unexplained bleeding). Evaluate and treat appropriately, including antibiotic therapy and STI testing. Reassess in 48 to 72 hours; consider IUD removal if no clinical improvement. In cases of severe or recurrent PID or endometriosis, remove IUD. Treat symptomatic PID potentially due to actinomyces with antibiotics and remove IUD.

• Perforation: Partial or total perforation of the uterine wall or cervix may occur during placement of the device and may not be detected until later. Perforation may result in pregnancy (due to decreased contraceptive efficacy), as well as migration, leading to abscesses, adhesions, intestinal obstruction/penetration, and/or peritonitis. Insertion into a uterine cavity that is <6 cm, fixed, retroverted, or incompletely involuted may increase the risk of expulsion, bleeding, pain, and perforation. The risk of perforation may also be increased in lactating patients. If perforation occurs, remove the IUD immediately. Imaging followed by laparoscopy or laparotomy may be needed to remove the IUD from the peritoneal cavity.

• Sepsis: Severe infection and sepsis, including group A streptococcal sepsis, have been reported; in some cases, severe pain occurred within hours, followed by sepsis within days of IUD insertion. The copper IUD should not be inserted in patients with postpartum sepsis or immediately following a septic abortion (CDC [Curtis 2016b]).

• Vasovagal reactions: Vasovagal reactions (eg, bradycardia, syncope, seizure) may occur during insertion of the IUD.

Disease-related concerns:

• Bleeding disorders: Thrombocytopenia may increase the risk of bleeding; use caution in patients with severe thrombocytopenia who may be at risk of spontaneous bleeding. Prior to initiation of therapy, consultation with a specialist may be required (CDC [Curtis 2016b]).

• Cervical or endometrial cancer: Patients diagnosed with cervical or endometrial cancer prior to IUD insertion should not use an IUD for pregnancy prevention (may have in increased risk of bleeding or infection when the device is inserted). Patients diagnosed after insertion of an IUD may continue; however, the IUD will most likely need to be removed during treatment (CDC [Curtis 2016b]).

• Gestational trophoblastic disease: Patients with gestational trophoblastic disease are at increased risk of adverse events if pregnancy occurs; use of a copper IUD may be appropriate for prevention of pregnancy in some situations with close medical supervision. However, patients with persistently elevated beta-hCG concentrations or malignant disease with evidence or suspicion of intrauterine disease should not initiate therapy with a copper IUD due to risks of infection, hemorrhage, or perforation. Consider benefits of effective contraception versus risks of continuation/removal in patients who have a copper IUD already in place (CDC [Curtis 2016b]).

• Sexually transmitted disease: Use of a copper IUD should not be initiated in patients with purulent cervicitis, chlamydial, or gonococcal infection. The IUD does not need to be removed if diagnosis occurs with the IUD in place, as long as there is treatment with appropriate antibiotics, and consideration is given to personal risk factors and patient preference (CDC [Curtis 2016b]).

• Tuberculosis: The copper IUD may be inserted in patients with nonpelvic tuberculosis; do not initiate treatment in cases of pelvic infection and consider removal when pelvic infection occurs with the IUD in place (CDC [Curtis 2016b]).

• Wilson disease: There is a theoretical concern that the copper from the IUD may exacerbate Wilson disease.

Dosage form specific issues:

• Embedment: If partial or total embedment in the myometrium occurs, removal may become difficult and surgical removal may be required.

• Expulsion: Partial or total expulsion of the device may occur and may result in pregnancy due to loss of contraceptive protection. The risk of expulsion is increased when the device is inserted immediately after delivery or abortion. If the IUD is not inserted immediately postpartum, the manufacturer recommends waiting until the second postpartum month to decrease the risk of expulsion due to incomplete uterine involution. Insertion following a second trimester abortion is associated with a higher risk of expulsion than when insertion occurs following a first trimester abortion. Insertion into a uterine cavity that is <6 cm may increase the risk of expulsion, bleeding, pain, and perforation. Imaging may be required to confirm expulsion; remove a partially expelled IUD.

• Medical diathermy: Avoid using medical equipment with high level Radiofrequency (eg, diathermy) in patients with metal-containing IUDs, including the copper IUD; may heat intrauterine tissue.

• MRI: A patient with the copper IUD can be safely scanned in an MR system meeting the following conditions: a static magnetic field of 3.0 T or 1.5 T; maximum spatial field gradient of 4,000 gauss/cm (40 T/m); and maximum MR system reported, whole body averaged specific absorption rate of 2 W/kg (Normal Operating Mode).

Other warnings/precautions:

• Appropriate use: Insertion should be done by a trained health care provider.

• Emergency contraception (off-label use): When used for emergency contraception, patients were required to have ≥1 spontaneous normal cycle(s) following discontinued hormonal contraception, or a recent delivery, miscarriage, or induced abortion, plus a negative urine pregnancy test in addition to the usual contraindications to IUD insertion (Wu 2010). The criteria for copper IUD insertion in nonemergency pregnancy prevention should be applied when used for emergency contraception (CDC [Curtis 2016b]).

• HIV infection protection: Copper IUDs do not protect against HIV infection or other sexually transmitted diseases. Patients with HIV infection may use the copper IUD for contraception (CDC [Curtis 2016b]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Intrauterine Device, Intrauterine:

Paragard Intrauterine Copper:

Generic Equivalent Available: US

No

Administration: Adult

IUD: To be inserted into uterine cavity. Full administration and removal instructions are provided with the device. Insertion should be done by a trained health care provider. Analgesics may be used. Paracervical block using lidocaine may also reduce pain during insertion (CDC [Curtis 2016a]). Insert into the uterine cavity to the recommended depth with the provided insertion device; do not force into the uterus. Transvaginal ultrasound may be used to check proper placement. Remove if not positioned properly and insert a new IUD; do not reinsert removed IUD. Following insertion, only the threads should be visible; trim so that 3 to 4 cm protrude into the vagina. Note the date of placement, the device lot number, and the length of the threads in the patient record.

Because testosterone may cause vaginal atrophy, consider pretreating with vaginal estrogen for 2 weeks prior to insertion for patients on gender-affirming testosterone therapy (Bonnington 2020).

Administration: Pediatric

Intrauterine: Full administration and removal instructions are provided with the device. Insertion should be done by a trained health care provider. Analgesics may be used. Paracervical block using lidocaine may also reduce pain during insertion (CDC [Curtis 2016a]). Insert into the uterine cavity to the recommended depth with the provided insertion device; do not force into the uterus. Transvaginal ultrasound may be used to check proper placement. Remove if not positioned properly and insert a new IUD; do not reinsert removed IUD. Following insertion, only the threads should be visible; trim so that 3 to 4 cm protrude into the vagina and note the length of the threads in the patient record.

Use: Labeled Indications

Contraception: For the prevention of pregnancy for up to 10 years.

Limitations of use: For use in patients who may become pregnant; not for use prior to menarche or postmenopause.

Use: Off-Label: Adult

Emergency contraception

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

In a study evaluating use for emergency contraception (off-label indication), eligible patients were required to have ≥1 spontaneous normal cycle(s) following discontinued hormonal contraception, or a recent delivery, miscarriage, or induced abortion, plus a negative urine pregnancy test in addition to the usual contraindications to IUD insertion (Wu 2010).

All available forms of contraception, including the copper IUD, can be considered for patients on gender-affirming testosterone therapy after evaluating patient preferences and medical conditions (Bonnington 2020; Krempasky 2020). The copper IUD may be associated with high rates of dysmenorrhea and menorrhagia (Krempasky 2020).

Pregnancy Considerations

Use during pregnancy is contraindicated.

Septic abortion with septicemia, septic shock, and death may occur if pregnancy occurs with the IUD in place. The risk of miscarriage, premature labor, premature delivery, and sepsis are increased if an intrauterine pregnancy occurs and continues with the IUD in place. If pregnancy occurs, the device should be removed if the strings are visible (pregnancy loss may occur). If the strings are not visible but it is determined that the device is still in place, the patient should be informed of the risks if pregnancy is continued.

Breastfeeding Considerations

An increase in copper breast milk concentrations has not been observed following insertion of the copper IUD.

The risk of perforation with IUD is increased in lactating patients (limited data). The copper IUD may be inserted immediately postpartum in breastfeeding patients, including patients who had a cesarean delivery. The risk of infection is not increased; the risk of expulsion may be increased and this risk should be considered along with the need for effective contraception and patient access to placement at a later time (CDC [Curtis 2016b]).

According to the manufacturer, the decision to breastfeed while the IUD is in place should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. However, use of the copper IUD is not expected to impact lactation and is considered compatible with breastfeeding (ABM [Berens 2015]; WHO 2002).

Monitoring Parameters

Prior to insertion, assess pregnancy status; bimanual examination and cervical inspection; weight (optional; BMI at baseline may be helpful to monitor changes during therapy); STD screen (unless already screened according to CDC STD treatment guidelines) (CDC [Curtis 2016a]).

Monitor for vasovagal reactions following insertion. Threads should be visible but length of thread may change over time; remove device if there is evidence that it has become displaced, broken, perforated the uterus, or partially expelled. Transvaginal ultrasound may be used to check placement. Reexamine following first menses postinsertion of IUD. Evaluate for abdominal or pelvic pain, cramping, tenderness, malodorous discharge, infection, bleeding, fever, or missed period. Assess potential health status changes at routine visits (CDC [Curtis 2016a]).

Mechanism of Action

The mechanism of action is not well defined but may involve interfering with sperm transport, fertilization, and prevention of implantation. A copper IUD may prevent fertilization by interfering with the ability of sperm to reach the fallopian tube, or decrease the sperm's ability to fertilize by causing a foreign body reaction and chemical changes that may be toxic. Implantation can rarely occur with a copper IUD; however, the number of fertilized ova is decreased when compared to sexually active women not using a contraceptive. When fertilized ova are present, they do not develop normally (Rivera, 1999). The number of women with a copper IUD who have an unintended pregnancy within the first year of insertion following typical use and perfect use is <1%.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CH) Switzerland: Multiload cu 250 | Multiload cu 375 | Nova t 380;
  • (DE) Germany: Femena | Melbeagold;
  • (EG) Egypt: Nova t;
  • (LT) Lithuania: Nova t 380;
  • (PE) Peru: Nova t;
  • (SA) Saudi Arabia: Nova t380
  1. American College of Obstetricians and Gynecologists (ACOG). Practice bulletin no. 152: emergency contraception. Obstet Gynecol. 2015;126(3):e1-e11. doi: 10.1097/01.AOG.0000471180.02939.1a. [PubMed 26287787]
  2. Berens P, Labbok M; Academy of Breastfeeding Medicine. ABM clinical protocol #13: contraception during breastfeeding, revised 2015. Breastfeed Med. 2015;10(1):3-12. doi: 10.1089/bfm.2015.9999. [PubMed 25551519]
  3. Bonnington A, Dianat S, Kerns J, et al. Society of Family Planning clinical recommendations: contraceptive counseling for transgender and gender diverse people who were female sex assigned at birth. Contraception. 2020;102(2):70-82. doi:10.1016/j.contraception.2020.04.001 [PubMed 32304766]
  4. Curtis KM, Jatlaoui TC, Tepper NK, et al. US selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016a;65(4):1‐66. doi: 10.15585/mmwr.rr6504a1. [PubMed 27467319]
  5. Curtis KM, Tepper NK, Jatlaoui TC, et al. US medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep. 2016b;65(3):1‐103. doi: 10.15585/mmwr.rr6503a1. [PubMed 27467196]
  6. Krempasky C, Harris M, Abern L, Grimstad F. Contraception across the transmasculine spectrum. Am J Obstet Gynecol. 2020;222(2):134-143. doi:10.1016/j.ajog.2019.07.043 [PubMed 31394072]
  7. ParaGard (copper IUD) [prescribing information]. Trumbull, CT: Cooper Surgical Inc; September 2019.
  8. Rivera R, Yacobson I, Grimes D. The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices. Am J Obstet Gynecol. 1999;181(5, pt 1):1263-1269. [PubMed 10561657]
  9. Turok DK, Godfrey EM, Wojdyla D, et al. Copper T380 intrauterine device for emergency contraception: highly effective at any time in the menstrual cycle. Hum Reprod. 2013;28(10):2672-2676. [PubMed 23945595]
  10. World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. http://www.who.int/maternal_child_adolescent/documents/55732/en/.
  11. Wu S, Godfrey EM, Wojdyla D, et al. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. BJOG. 2010;117(10):1205-1210. [PubMed 20618314]
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