Contrave

Contrave Use In Pregnancy & Lactation

Manufacturer:

Patheon

Distributor:

Zuellig

Marketer:

iNova
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amounts of data from the use of naltrexone/bupropion in pregnant women. The combination has not been tested in reproductive toxicity studies. Studies with naltrexone in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions); animal studies with bupropion show no clear evidence of reproductive harm. The potential risk for humans is unknown.
Naltrexone/bupropion should not be used during pregnancy or in women currently attempting to become pregnant.
Breast-feeding: Naltrexone and bupropion and their metabolites are excreted in human milk.
Since there is limited information on the systemic exposure to naltrexone and bupropion in infants/newborns being breast-fed, a risk to the newborns/infants cannot be excluded.
Naltrexone/bupropion should not be used during breast-feeding.
Fertility: There are no data on fertility from the combined use of naltrexone and bupropion. No effect on fertility in reproductive toxicity studies have been observed with bupropion. Naltrexone administered orally to rats caused a significant increase in pseudopregnancy and a decrease in pregnancy rates at approximately 30 times the naltrexone dose provided by naltrexone/bupropion. The relevance of these observations to human fertility is not known (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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