Fluanxol Depot Use In Pregnancy & Lactation

Fertility: In humans, adverse events such as hyperprolactinaemia, galactorrhoea, amenorrhoea, erectile dysfunction and ejaculation failure have been reported (see Adverse Reactions). These events may have a negative impact on female and/or male sexual function and fertility.
If clinically significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunction occur, a dose reduction (if possible) or discontinuation should be considered. The effects are reversible on discontinuation.
In preclinical fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats. Effects were seen at doses well in excess of those applied during clinical use.
Pregnancy: Fluanxol Depot should not be used during pregnancy unless clearly necessary.
Neonates exposed to antipsychotics (including Fluanxol Depot) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremors, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Lactation: Fluanxol Depot should only be used during lactation when clinical assessment reveals a compelling indication, but it is advisable to monitor the child, especially in the first 4 weeks after birth.
Concentrations of Fluanxol Depot detected in breast-milk are so low that they are unlikely to affect the child at therapeutic doses.
The dose that the child ingests is less than 0.5 % of the weight-related daily dose taken by the mother (see Pharmacology: Pharmacokinetics under Actions).