Skelan Forte Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C. Naproxen sodium crosses the placenta. Due to its property to inhibit prostaglandin synthesis, naproxen use during early pregnancy may increase the risk of miscarriage, cleft palate, gastroschisis, and cardiac malformation to the fetus.
Naproxen sodium use in the last trimester of pregnancy to delay parturition is not recommended. It exposes the fetus to cardiopulmonary toxicity (i.e., patent ductus arteriosus, risk of premature closure of the ductus arteriosus and severe hypoxemia due to pulmonary hypertension), necrotizing enterocolitis, abnormal prostaglandin E levels, intracranial hemorrhage, GI bleeding, and renal dysfunction, which may progress to renal failure with oligo-hydroamniosis. The bleeding time of both the mother and the fetus may possibly be prolonged at the end of pregnancy due to platelet dysfunction. Therefore, the use of naproxen sodium in the third trimester of pregnancy is contraindicated.
Paracetamol crosses the placenta. Epidemiologic data on the use of oral paracetamol in pregnant women have demonstrated no increased risk of major congenital malformations in infants exposed in utero.
Since no studies in pregnant women and animal reproduction studies have been conducted with this fixed-dose combination, naproxen sodium + paracetamol should only be used during pregnancy only when clearly needed.
Lactation: Both naproxen sodium and paracetamol are distributed into the milk of lactating women. Naproxen sodium may produce adverse effects to the breastfed infant due to prostaglandin inhibition. Thus, the use of naproxen sodium + paracetamol should be avoided in breastfeeding women.