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Diclofenac / misoprostol Pregnancy and Breastfeeding Warnings

Diclofenac / misoprostol is also known as: Arthrotec

Overview

Do not take Diclofenac/Misoprostol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Diclofenac/Misoprostol is found in breast milk. Do not breast-feed while taking Diclofenac/Misoprostol.

Diclofenac / misoprostol Pregnancy Warnings

Diclofenac-misoprostol has been assigned to pregnancy category X by the FDA. Misoprostol possesses abortifacient properties, therefore, it is considered contraindicated for use in pregnant women. Misoprostol may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus 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 material 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.

Diclofenac / misoprostol Breastfeeding Warnings

Diclofenac sodium has been found in the milk of nursing mothers. Misoprostol is rapidly metabolized in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. There are no published reports of adverse effects of misoprostol in breast-feeding infants of mothers taking misoprostol. Caution should be exercised when diclofenac-misoprostol is administered to a nursing woman.

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