Deanxit Use In Pregnancy & Lactation

Pregnancy: Deanxit should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus. Due to the risk of neonatal withdrawal symptoms it is recommended that Deanxit treatment is stopped about 14 days before delivery by tapering off the dosage.
Neonates exposed to antipsychotics (including Deanxit) 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, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data).
Breast-feeding: As flupentixol is found in breast milk in low concentrations, it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is less than 0.5% of the weight related maternal dose (in mg/kg).
It is not known whether melitracen is excreted in breast milk. However, another tricyclic antidepressant, amitriptyline, is found in breast milk in low concentrations and it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is about 2% of the weight related maternal daily dose (in mg/kg). As melitracen has the same lipophilic properties as amitriptyline, it is assumed that it occurs in breast milk in similar concentrations.
Breast-feeding can be continued during Deanxit therapy if considered of clinical importance but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.
Fertility: In humans, adverse events have been reported that may have a negative impact on female and/or male sexual function and fertility. If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered. The effect is reversible on discontinuation.
In preclinical fertility studies in rats, where flupentixol and melitracen were administered separately slight effects on fertility were noted. Flupentixol slightly affected the pregnancy rate of female rats, whereas melitracen slightly repressed fertility and fecundity of male rate. Effects were seen at doses well in excess of those applied during clinical use.