Dynastat Use In Pregnancy & Lactation

Pregnancy: Parecoxib sodium is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin, it may cause premature closure of the ductus arteriosus or uterine inertia (see Contraindications, Pharmacology: Pharmacodynamics and Toxicology: Preclinical Safety Data under Actions).
NSAID use during the second or third trimester of pregnancy may cause foetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible upon discontinuation. Pregnant women on NSAIDs should be closely monitored for amniotic fluid volume.
Parecoxib is contraindicated in the third trimester of pregnancy (see Contraindications).
There are no adequate data from the use of parecoxib sodium in pregnant women or during labour. However, inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of miscarriage after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors, including parecoxib, has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality (see Pharmacology: Pharmacodynamics and Toxicology: Preclinical Safety Data under Actions). During the first and second trimester of pregnancy, Dynastat should not be given unless clearly necessary.
Lactation: Administration of a single dose of parecoxib to lactating women resulted in the transfer of a relatively small amount of parecoxib and its active metabolite into breast milk, and this resulted in a low relative dose for the infant (less than 1% of the weight-adjusted maternal dose). Because of the potential for adverse reactions in nursing infants from parecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Fertility: The use of parecoxib, as with any medicinal product known to inhibit cyclooxygenase/prostaglandin synthesis, is not recommended in women attempting to conceive (see Contraindications, Pharmacology: Pharmacodynamics and Toxicology: Preclinical Safety Data under Actions).
Based on the mechanism of action, the use of NSAIDs, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including Dynastat should be considered.