Copper-containing Intrauterine Device

Paragard T 380A

Approved 15 Nov 1984IntrauterineSystem

Indications

Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. ( 1 )

Contraindications

The use of Paragard is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy [see Warnings and Precautions ( 5.1 , 5.2 ) and Use in Specific Populations ( 8.1 )] Abnormalities of the uterus resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) [see Warnings and Precautions ( 5.4 )] Postpartum endometritis or postabortal endometritis in the past 3 months [see Warnings and Precautions ( 5.4 )] Known or suspected uterine or cervical malignancy Uterine bleeding of unknown etiology Untreated acute cervicitis or vaginitis or other lower genital tract infection Conditions associated with increased susceptibility to pelvic infections [see Warnings and Precautions ( 5.4 )] Wilson’s disease [see Warnings and Precautions ( 5.9 )] A previously placed IUD or IUS that has not been removed Hypersensitivity to any component of Paragard including to copper or any of the trace elements present in the copper component of Paragard [see Adverse Reactions ( 6.2 ) and Description ( 11 )] Pregnancy or suspicion of pregnancy ( 4 ) Abnormalities of the uterus resulting in distortion of the uterine cavity ( 4 ) Acute pelvic inflammatory disease (PID) ( 4 ) Postpartum endometritis or postabortal endometritis in past 3 months ( 4 ) Known or suspected uterine or cervical malignancy ( 4 ) Uterine bleeding of unknown etiology ( 4 ) Untreated acute cervicitis or vaginitis or other lower genital tract infection ( 4 ) Conditions associated with increased susceptibility to pelvic infections ( 4 ) Wilson’s disease ( 4 ) A previously placed IUD or IUS that has not been removed ( 4 ) Hypersensitivity to any component of Paragard including copper or any trace elements present in the copper components of Paragard ( 4 )

Warnings and precautions

Contraindications

Adverse reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions ( 5.1 )] Intrauterine pregnancy [see Warnings and Precautions ( 5.2 )] Septic abortion [see Warnings and Precautions ( 5.2 )] Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions ( 5.3 )] Pelvic Inflammatory Disease and Endometritis [see Warnings and Precautions ( 5.4 )] Embedment [see Warnings and Precautions ( 5.5 )] Perforation [see Warnings and Precautions ( 5.6 )] Expulsion [see Warnings and Precautions ( 5.7 )] Bleeding Pattern Alterations [see Warnings and Precautions ( 5.9 )] Adverse reactions reported in clinical trials include: anemia, backache, dysmenorrhea, dyspareunia, expulsion (complete or partial), prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact name of manufacturer at toll-free phone # or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Table 2: Summary of Rates* (No. per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure in two trials [see Clinical Studies ( 14 )]. The WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the US.

In the WHO Study, 100% were parous and the mean age at enrollment was 29 years old. The US Composite Study was a meta-analysis that evaluated randomized, double-blind, comparative studies of copper T IUSs, including Paragard in 3,536 women in the US. In the US Composite Study, 64% were nulliparous, 49% were nulligravida, 68% were under age 25 at the time of enrollment (median age 23 years old). Table 2 shows discontinuation rates from the two clinical studies by adverse reaction and year.

Table 2: Summary of Rates* (No. per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the US Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials. The following adverse reactions have also been observed: anemia, backache, dysmenorrhea, dyspareunia, complete or partial expulsion, prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Paragard. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: abdominal distension, nausea General Disorders and Administration Site Conditions: device breakage, pyrexia Immune System Disorders : allergy to metals, hypersensitivity Infections and Infestations: endometritis/uterine infection Musculoskeletal and Connective Tissue Disorders : muscle spasms Nervous System Disorders : dizziness Reproductive System and Breast Disorders: amenorrhea Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome

Paragard T 380A

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Paragard T 380A

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Ectopic Pregnancy Evaluate

5.2Risks with Intrauterine Pregnancy

5.3Sepsis

5.5Embedment

5.6Perforation Partial

Interactions

Pregnancy and breastfeeding

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information

At a glance