Fluanxol/Fluanxol Depot

Fluanxol/Fluanxol Depot Use In Pregnancy & Lactation

flupentixol

Manufacturer:

Lundbeck

Distributor:

B L Hua
Full Prescribing Info
Use In Pregnancy & Lactation
Fluanxol Depot: If the patient is pregnant or breast-feeding, thinks she might be pregnant or is planning to have a baby, the patient should ask the doctor for advice before taking this medicine.
Pregnancy: Fluanxol: Flupentixol should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus.
Neonates exposed to antipsychotics (including flupentixol) 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 reproduction toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fluanxol Depot: If the patient is pregnant or thinks she might be pregnant, tell the doctor. Fluanxol Depot should not be used during pregnancy unless clearly necessary.
The following symptoms may occur in newborn babies, of mothers that have used Fluanxol Depot in the last trimester (last three months of the pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If the baby develops any of these symptoms patient may need to contact the doctor.
Breast-feeding: Fluanxol: 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 daily dose. Breast-feeding can be continued during flupentixol therapy if considered of clinical importance but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.
Fluanxol Depot: If patient is breastfeeding, ask the doctor for advice. Do not use Fluanxol Depot when breast-feeding, as small amounts of the medicine can pass into the breast milk.
Fertility: Fluanxol: In humans, adverse events such as hyperprolactinaemia, galactorrhoea, amenorrhoea, libido decreased, 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 clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions 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 dose well in excess of those applied during clinical use.
Fluanxol Depot: Animal studies have shown that Fluanxol Depot affects the fertility. Please ask the doctor for advice.
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