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Nce 6 Anorexia 3 Insomnia 2 Central & Peripheral Nervous System Dizziness 3 Skin and Appendages Sweating Increased 4 Pruritus 2 Reproductive Disorders, Male * Prostatic Disorder 2 Incidence at least 1%, causal relationship at least possible or greater: the following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of ULTRACET. Body as a Whole – Asthenia, fatigue, hot flushes Central and Peripheral Nervous System – Dizziness, headache, tremor Gastrointestinal System – Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting Psychiatric Disorders – Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence Skin and Appendages – Pruritus, rash, increased sweating. Selected Adverse events occurring at less than 1%: the following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in ULTRACET clinical trials. Body as a W
tramadol hydrochloride tablets label O be embryotoxic and fetotoxic in rats at a maternally toxic dose tramadol hydrochloride tablets label, 50 434 mg kg tramadol acetaminophen (300 2604 mg m2 or 1.6 times the maximum daily human tramadol acetaminophen dosage of 185 1591 mg m2) tramadol hydrochloride tablets label, but was not teratogenic at this dose level. Embryo and fetal toxicity consisted of decreased fetal weights and increased supernumerary ribs. 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 m2 or 1.6 times the maximum daily human tramadol dosage) or greater had decreased weights tramadol hydrochloride tablets label, and pup survival was decreased early in lactation at 80 mg kg tramadol hydrochloride tablets label.
tramadol hydrochloride tablets label (480 mg m2 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 potential risk to the fetus. Neonatal seizures tramadol hydrochloride tablets label, neonatal withdrawal syndrome tramadol hydrochloride tablets label, fetal death and still birth have been reported with tramadol hydrochloride during post-marketing. Labor and Delivery ULTRACET® should not be used in pregnant women prior to or during labor unless the potential benefits outweigh 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 umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor. The effect of ULTRACET tramadol hydrochloride tablets label, if any tramadol hydrochloride tablets label, on the later growth tramadol hydrochloride tablets label, development tramadol hydrochloride tablets label, and functional maturation of the child is unknown. Nursing Mothers ULTRACET® is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol tramadol hydrochloride tablets label, the cumulative excretion in breast milk within 16 hou.
tramadol hydrochloride tablets label Thdrawal 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 umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor. The effect of ULTRACET tramadol hydrochloride tablets label, if any tramadol hydrochloride tablets label, on the later growth tramadol hydrochloride tablets label, development tramadol hydrochloride tablets label, and functional maturation of the child is unknown. Nursing Mothers ULTRACET® is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol tramadol hydrochloride tablets label, the cumulative excretion in breast milk within 16 hour.
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