PARAGARD T 380A

The efficacy of Paragard for use in females of reproductive potential for prevention of pregnancy for up to 10 years was demonstrated in two trials: WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the U.S. In the WHO study, 100% were parous and the mean age at enrollment was 29 years old. The U.S. Composite Study was a meta-analysis that evaluated several randomized, double-blind, comparative studies of copper T IUSs, including the Paragard in 3,536 women in the U.S. In the U.S. study, 64% were nulliparous, 49% were...

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 Precauti...

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 postabor...

Ectopic Pregnancy : Promptly evaluate women who become pregnant for ectopic pregnancy while using Paragard. ( 5.1 ) Risks with Intrauterine Pregnancy : Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock and death if pregnancy occurs. Remove Paragard if pregnancy occurs with Paragard in place. ( 5.2 ) Sepsis : Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion ( 5.3 ) Pelvic Inflammatory Disease ...

7 DRUG INTERACTIONS No drug-drug interaction or drug-herbal supplement interaction studies have been conducted with Paragard.