Paragard - Drug Monograph

Introduction

Paragard (copper intrauterine device) is a non-hormonal, long-acting reversible contraceptive device that provides highly effective pregnancy prevention for up to 10 years. It consists of a T-shaped polyethylene frame with copper wire wrapped around the stem and arms, releasing copper ions into the uterine cavity to prevent fertilization.

Mechanism of Action

Paragard exerts its contraceptive effect primarily through the release of copper ions, which create an inflammatory reaction in the uterine environment that is toxic to sperm. The copper ions:

• Impair sperm motility and viability through direct toxic effects
• Prevent sperm from reaching the fallopian tubes
• Alter endometrial lining to create an environment unfavorable for implantation
• May interfere with ovum transport and viability

The device does not contain hormones and does not suppress ovulation.

Indications

• Contraception for up to 10 years
• Emergency contraception when inserted within 5 days of unprotected intercourse

Dosage and Administration

• Insertion: Performed by trained healthcare provider during menstruation or anytime when pregnancy can be reasonably excluded
• Placement: Inserted into uterine cavity with strings extending through cervix
• Duration: Effective for up to 10 years
• Removal: Performed by healthcare provider at any time during menstrual cycle
• Special populations:

- Nulliparous women: Can be used - Adolescents: FDA-approved for all ages - Postpartum: Can be inserted immediately after delivery or after 4 weeks - Post-abortion: Can be inserted immediately following first or second trimester abortion

Pharmacokinetics

• Absorption: Copper ions are released continuously (approximately 50 μg/day initially, decreasing to 35 μg/day after 5 years)
• Distribution: Local action within uterine cavity with minimal systemic absorption
• Metabolism: Not applicable - copper is an elemental ion
• Elimination: Copper is excreted in menstrual fluid and cervical mucus

Contraindications

• Pregnancy or suspected pregnancy
• Current or history of pelvic inflammatory disease
• Postpartum endometritis or infected abortion within past 3 months
• Known or suspected uterine or cervical malignancy
• Undiagnosed abnormal genital bleeding
• Wilson's disease
• Allergy to any component of Paragard
• Distorted uterine cavity or conditions that increase risk of perforation
• Current purulent cervicitis, chlamydia, or gonorrhea

Warnings and Precautions

• Perforation risk: Uterine perforation may occur during insertion (approximately 1-2 per 1000 insertions)
• Expulsion: Partial or complete expulsion may occur (approximately 5% in first year), highest risk in first few months
• Pelvic inflammatory disease: Highest risk within first 20 days after insertion
• Ectopic pregnancy: Although Paragard reduces overall pregnancy risk, if pregnancy occurs, there's higher likelihood of being ectopic
• Embedment: Device may become embedded in myometrium
• Menorrhagia: May increase menstrual blood loss by approximately 30-50%
• Dysmenorrhea: May worsen menstrual cramps

Drug Interactions

No known drug interactions due to local mechanism of action. However:

• Anticoagulants may increase risk of bleeding with insertion
• Immunosuppressants may increase infection risk
• Corticosteroids may impair inflammatory response to device

Adverse Effects

• Heavier menstrual bleeding
• Longer menstrual periods
• Increased menstrual cramping
• Spotting between periods

• Backache
• Expulsion (partial or complete)
• Pain during intercourse
• Vaginitis

• Uterine perforation
• Pelvic inflammatory disease
• Embedment
• Allergic reaction to copper
• Ectopic pregnancy

Monitoring Parameters

• Post-insertion: Follow-up visit 4-6 weeks after insertion to check placement
• Regular self-checks: Patients should verify string presence after each period
• Annual exams: Routine gynecologic examinations
• Symptom monitoring: Report severe pain, fever, unusual discharge, or missing strings
• STD screening: Regular screening as appropriate based on risk factors

Patient Education

• Check strings regularly after each menstrual period
• Seek immediate medical attention for:

- Severe abdominal pain - Fever/chills - Unusual vaginal discharge - Missing strings or feeling hard plastic - Possible pregnancy symptoms

• Understand expected changes in menstrual pattern (heavier flow, more cramps)
• Device does not protect against STDs - use condoms if at risk
• Can be removed at any time by healthcare provider with rapid return to fertility
• Emergency contraception benefit when inserted within 5 days of unprotected intercourse

References

1. FDA Prescribing Information: Paragard (copper intrauterine contraceptive). 2020 2. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(4):1-66 3. Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998-2007 4. American College of Obstetricians and Gynecologists. Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Practice Bulletin No. 186. 2017 5. Trussell J. Contraceptive failure in the United States. Contraception. 2011;83(5):397-404 6. Godfrey EM, Folger SG, Jeng G, et al. Treatment of bleeding irregularities in women with copper-containing IUDs: a systematic review. Contraception. 2013;87(5):549-566 7. Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(3):1-104