Rhea Escitalopram

Rhea Escitalopram Use In Pregnancy & Lactation



H. Lundbeck




Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Limited clinical data are available regarding exposure to escitalopram during pregnancy.
Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Escitalopram should not be used during pregnancy unless clearly needed and after careful consideration of the risk/benefit ratio.
Newborns should be observed if maternal use of escitalopram continues into the later stages of pregnancy, particularly in the third trimester. If escitalopram is used until or shortly before birth, discontinuation effects in the newborn are possible.
The following symptoms may occur in the newborn after maternal SSRI/SNRI use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms could be due to either discontinuation effects or excess serotonergic activity. In a majority of instances, such complications begin immediately or soon (<24 hours) after delivery.
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.
Breast-feeding: It is expected that escitalopram will be excreted into human milk and breastfeeding is not recommended during the treatment.
Fertility: Animal data have shown that some SSRIs may affect sperm quality (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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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