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Diclofenac Pregnancy and Breastfeeding Warnings

Diclofenac is also known as: Cambia, Cataflam, Dyloject, Voltaren, Voltaren-XR, Zipsor, Zorvolex

Diclofenac Pregnancy Warnings

Administration of NSAIDs during the latter part of pregnancy may cause premature closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labor and delivery. There are no adequate and well controlled studies of diclofenac or other NSAIDs in pregnant women. The use of drugs known to inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Not recommended during last trimester of pregnancy Prior to 30 weeks gestation, use only if potential benefit justifies the potential risk to the fetus AU TGA pregnancy category: C US FDA pregnancy category: C prior to 30 weeks gestation US FDA pregnancy category: D starting at 30 weeks gestation

Diclofenac Breastfeeding Warnings

Use is not recommended Excreted into human milk: Yes The effects in the nursing infant are unknown.

The data on excretion into breast milk is limited. One women receiving 150 mg daily had milk levels of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day. Six mothers receiving 100 mg orally daily for 1 week postpartum had undetectable levels in their milk. While it does appear to pass in small amounts, some experts consider this drug to be acceptable during breast feeding, however other agents have more published information and may be preferred, especially when nursing a newborn or preterm infant.

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