S-Linear 10mg Tablet

Pregnancy

There are no adequate and well-controlled studies in pregnant women; therefore, use during pregnancy only if the potential benefit justifies the potential risk to the fetus

In some cases, the clinical picture is consistent with serotonin syndrome

Effect on labor and delivery in humans is unknown

Neonates exposed to escitalopram and other SSRIs/SNRIs

• Neonates exposed to SSRIs/SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding
• Such complications can arise immediately upon delivery
• Reported clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying
• These features are consistent with toxic effects of SSRIs and SNRIs or, possibly, drug discontinuation syndrome

Lactation

Escitalopram is excreted in human breast milk

Limited data from women taking 10-20 mg escitalopram showed that exclusively breast-fed infants receive a ~3.9% of the maternal weight-adjusted dose of escitalopram and 1.7% of the maternal weight-adjusted dose of desmethylcitalopram

Caution should be exercised and breastfeeding infants should be observed for adverse reactions when administered to a nursing woman

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

 

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

 

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.