Tussionex pennkinetic Pregnancy Warnings
Use is not recommended unless clearly needed
US FDA pregnancy category: C
Comments: Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.
Animal studies have not been conducted with this combination product. Hydrocodone has shown teratogenicity in hamsters when given in doses 37 times the maximum recommended human dose. Babies born to mothers regularly taking opioids during pregnancy may become physically dependent. Opioids given to mothers shortly before delivery may produce some degree of respiratory depression in the newborn, especially if high doses are used. A statistically significant association between maternal use of chlorpheniramine and inguinal hernia and eye or ear anomalies was found in a small, retrospective study. Other studies have shown not shown this association. There are no adequate and well-controlled studies in pregnant women.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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Tussionex pennkinetic Breastfeeding Warnings
Maternal use of narcotics during breastfeeding can cause infant drowsiness, CNS system depression, and even death; newborn infants are particularly sensitive. Withdrawal symptoms can occur in infants if hydrocodone is discontinued after a prolonged period (i.e., if the mother stops the drug or stops breastfeeding). Occasional, small doses of chlorpheniramine (2 to 4 mg) appear to be acceptable; however, larger doses or prolonged use may cause effects in the infant or decrease milk supply; non-sedating antihistamines are generally preferred.
A decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother
Excreted into human milk: Yes (chlorpheniramine); Yes (hydrocodone)
Comments: Breastfed infants should be closely monitored for increased sedation, difficulty breastfeeding, breathing difficulties, or limpness; mothers should be counseled to seek medical assistance promptly if these develop.
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