Exulten Use In Pregnancy & Lactation



United Pharma


Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Sertraline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy-Nonteratogenic Effects: Neonates exposed to sertraline and other SSRIs or SNRIs, late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support and tube feeding which can arise immediately upon delivery. These complications which include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture is consistent with serotonin syndrome. Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).
When treating a pregnant woman with sertraline during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment. The physician may consider tapering sertraline in the third trimester.
Labor and Delivery: The effect of sertraline on labor and delivery is unknown.
Lactation: It is not known if sertraline or its metabolites is excreted in human milk. Exercise caution when sertraline is administered to a breastfeeding woman.
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