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Morphine / naltrexone Pregnancy and Breastfeeding Warnings

Morphine / naltrexone is also known as: Embeda

Morphine / naltrexone Pregnancy Warnings

Morphine-naltrexone has been assigned to pregnancy category C by the FDA. Animal studies on morphine have failed to reveal evidence of increased risk of congenital malformations in humans. Animal studies on naltrexone have revealed evidence of an embryocidal effect. There are no controlled data in human pregnancy. Morphine-naltrexone should only be given during pregnancy when benefit outweighs risk.

Chronic use of morphine in later pregnancy has been associated with neonatal withdrawal. Neonatal withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, abnormal crying, tremor, vomiting diarrhea and subsequent weight loss or failure to gain weight, and may result in death. The onset, duration and severity of neonatal withdrawal syndrome vary based on the drug used, duration of use, dose of last maternal use, and rate of elimination by the newborn.

Morphine / naltrexone Breastfeeding Warnings

Morphine is excreted into human milk in trace amounts. Adverse effects in the nursing infant are unlikely. Naltrexone and 6-beta-naltrexol are also excreted into human milk. The effects on the nursing infant are unknown. Because of the potential for serious adverse reactions due to morphine-naltrexone in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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