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Diclofenac / misoprostol Pregnancy and Breastfeeding Warnings

Diclofenac / misoprostol is also known as: Arthrotec

Diclofenac / misoprostol Pregnancy Warnings

FDA pregnancy category: X Use of diclofenac-misoprostol is contraindicated. Adequate methods of contraception and time periods to observe should be encouraged.

Diclofenac-misoprostol is contraindicated for use in pregnant women. Misoprostol can cause abortion, premature birth, or birth defects when administered to a pregnant woman. Misoprostol may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Misoprostol has been used to ripen the cervix, to induce labor, and to treat postpartum hemorrhage, outside of its approved indication. A major adverse effect of these uses is hyperstimulation of the uterus. Uterine rupture, amniotic fluid embolism, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported. Higher doses of misoprostol may increase the risk of complications from uterine hyperstimulation. Abortions caused by misoprostol may be incomplete. If a woman is or becomes pregnant while taking this drug, the drug should be discontinued and the patient apprised of the potential hazard to the fetus. Cases of amniotic fluid embolism, which resulted in maternal and fetal death, have been reported with use of misoprostol during pregnancy. Severe vaginal bleeding, retained placenta, shock, fetal bradycardia, and pelvic pain have also been reported. These women were administered misoprostol vaginally and/or orally over a range of doses. Additionally, because of the known effects of nonsteroidal anti-inflammatory drugs including the diclofenac component, on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided. Diclofenac-misoprostol should only be used in a woman of childbearing potential, who requires NSAID therapy and is at high risk for the development of gastric ulcers, if pregnancy has been ruled out by a negative serum pregnancy test within 2 weeks of starting misoprostol, if she is capable of complying with effective methods of birth control and if she has been apprised of the risk should she become pregnant. Both written and oral warnings should be provided. In addition, the patient should be instructed that she must never share this drug with other individuals. Therapy should begin on the second or third day of the next normal menstrual cycle. FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Diclofenac / misoprostol Breastfeeding Warnings

Caution should be exercised when diclofenac-misoprostol is administered to a nursing woman. Excreted into human milk: Yes (diclofenac and misoprostol) Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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