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rabbits and maternally toxic doses 3 to 15 times the maximum human dose or higher (120 mg kg in mice, 25 mg kg or higher in rats and 75 mg kg or higher in rabbits), but was not teratogenic at these dose levels. No harm to the fetus due to tramadol was seen at doses that were not maternally toxic. No drug-related teratogenic effects were observed in progeny of mice, rats or rabbits treated with tramadol by various routes (up to 140 mg kg for mice, 80 mg kg for rats or 300 mg kg for rabbits). Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supemumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups in rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg kg, a dose that would cause extreme maternal toxicity in the rabbit. In peri- and post-natal studies in rats, progeny of dams receiving oral (gavage) do tramadol tablets


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Se levels of 50 mg kg or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg kg (6 to 10 times the maximum human dose). No toxicity was observed for progeny of dams receiving 8, 10, 20, 25 or 40 mg kg. Maternal toxicity was observed at all dose levels, but effects on progeny were evident only at higher dose levels where maternal toxicity was more severe. Labor and Delivery Ultram should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks, because safe use in pregnancy has not been established. 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 Ultram, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers Ultram is not recommended for obstetrical preoperative medication or for post-delivery analgesia in

tramadol tablets In divided doses produced analgesia comparable with five doses of acetaminophen 300 mg with codeine phosphate 30 mg (Tylenol® with Codeine 3) daily five doses of aspirin 325 mg with codeine phosphate 30 mg daily and with two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (Tylox®) daily. Following the double-blind period tramadol tablets, some patients took Ultram in an open period for up to two years. INDICATIONS Ultram is indicated for the management of moderate to moderately severe pain. CONTRAINDICATION Ultram should not be administered to patients who have previously demonstrated hypersensitivity to tramadol or in cases of acute intoxication wit tramadol tablets.

tramadol tablets H alcohol tramadol tablets, hypnotics tramadol tablets, centrally acting analgesics tramadol tablets, opioids or psychotropic drugs. WARNING Seizure Risk Tramadol causes seizures in animal models tramadol tablets, and a few seizures have been reported in humans receiving excessive single oral doses (700 mg) or large intravenous doses (300 mg). Administration of Ultram may enhance the seizure risk in patients taking MAO inhibitors tramadol tablets, neuroleptics tramadol tablets, other drugs that reduce the seizure threshold patients with epilepsy tramadol tablets, or patients otherwise at increased risk for seizure. In animal studies tramadol tablets, naloxone administration increased the risk of convulsions. Use with CNS Depressants Ultram should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol tramadol tablets, opioids tramadol tablets, anesthetic agents tramadol tablets, phenothiazines tramadol tablets, tranquilizers or sedative hypnotics. Use with MAO Inhibitors Ultram should be used with great caution in patients taking monoamine oxidase inhibitors tramadol tablets, since tramadol inhibits the uptake of norepinephrine and serotonin. PRECAUTIONS Respiratory Depression When large doses of Ultram are administered with anesthetic medications or alcohol tramadol tablets, respiratory depression may result. Cases of intraoperative respiratory depression tramadol tablets, usually with large intravenous doses of tramadol and with concurrent administration of respiratory depressants tramadol tablets, have been reported.

tramadol tablets En administered to patients receiving CNS depressants such as alcohol tramadol tablets, opioids tramadol tablets, anesthetic agents tramadol tablets, phenothiazines tramadol tablets, tranquilizers or sedative hypnotics. Use with MAO Inhibitors Ultram should be used with great caution in patients taking monoamine oxidase inhibitors tramadol tablets, since tramadol inhibits the uptake of norepinephrine and serotonin. PRECAUTIONS Respiratory Depression When large doses of Ultram are administered with anesthetic medications or alcohol tramadol tablets, respiratory depression may result. Cases of intraoperative respiratory depression tramadol tablets, usually with large intravenous doses of tramadol and with concurrent administration of respiratory depressants tramadol tablets, have been reported .

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