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Jovia

Jovia Use In Pregnancy & Lactation

escitalopram

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women; therefore, escitalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy-Nonteratogenic Effects: Neonates exposed to escitalopram and other SSRIs or 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 have included 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 either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome.
Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (including escitalopram) in pregnancy and PPHN. Other studies do not show a significant statistical association.
Women who discontinued antidepressant drug during pregnancy shower a significant increase in relapse of their major depression compared to those women who remained on antidepressant drug without pregnancy.
When treating a pregnancy woman with escitalopram, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. This decision can only be made on a case by case basis.
Labor and Delivery: The effect of escitalopram on labor and delivery in humans is unknown.
Lactation: Escitalopram is excreted in human breast milk. Limited data from women taking 10 to 20 mg showed that exclusively breast-fed infants receive approximately 3.9% of the maternal weight-adjusted dose of escitalopram and 1.7% of the maternal weigh-adjusted dose of desmethylcitalopram. Caution should be exercised and breastfeeding infants should be observed for adverse reactions when escitalopram is administered to a breastfeeding woman.
Fertility: Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far.
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