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Non-teratogenic effects
Tramadol alone was evaluated in peri-and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/ kg (300 mg/ m 2 or 1.6 times the maximum daily human tramadol dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/ kg (480 mg/ m 2 or 2.6 times the maximum daily human tramadol dosage). There are no adequate and well-controlled studies in pregnant women. ULTRACET should be used during pregnancy only if the potential benefit justifies the po-tential risk to the fetus. Neonatal seizures, neonatal with-drawal syndrome, fetal death and still birth have been reported with tramadol hydrochloride during post-marketing. Labor and Delivery Text Continues Below
ULTRACET should not be used in pregnant women prior to or during labor unless the potential benefits out-weigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. (See DRUG ABUSE AND DEPENDENCE.) Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the um-bilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor. The effect of ULTRACET, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers ULTRACET is not recommended for obstetrical pre-operative medication or for post-delivery analgesia in nursing mothers because its safety in infants and new-borns has not been studied. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours post-dose was 100 µg of tramadol (0.1% of the maternal dose) and 27 µg of M1.
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