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Acute Abdominal Conditions The administration of Ultram may complicate the clinical assessment of patients with acute abdominal conditions.

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Use in Renal and Hepatic Disease Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite M1. In patients with creatinine clearances of less than 30 ml/min dosing reduction is recommended (see DOSAGE AND ADMINISTRATION).

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With the prolonged half-life in these conditions, achievement of steady state is delayed, so that it may take several days for elevated plasma concentrations to develop.

Information for Patients Patients being treated with Ultram should receive the following information:

Ultram may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

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Teratogenic Effects: tramadol and aleve, Usage in Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Ultram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Tramadol has been shown to be embryotoxic and fetotoxic in mice, rats and rabbits and maternally toxic doses 3 to 15 times the maximum human dose or higher (120 mg/kg in mice, tramadol and aleve, 25 mg/kg or higher in rats and 75 mg/kg or higher in rabbits), but was not teratogenic at these dose levels, tramadol and aleve. 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, tramadol and aleve, 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) dose 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, tramadol hcl no prescription, 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, tramadol and aleve.

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 for 40 women given tramadol during labor, tramadol and aleve.

The effect of Ultram, hydrocodone cough asthma, if any, on the later growth, tramadol hcl no prescription, 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 nursing mothers because its safety in infants and newborns has not been studied. Following a single 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours postdose was 100 µg of tramadol (0.1% of the maternal dose) and 27 µg of M1.

Pediatric Use The pediatric use of Ultram (tramadol hydrochloride) is not recommended because safety and efficacy in patients under 16 years of age have not been established.

Use in the Elderly In subjects over the age of 75 years, tramadol and aleve, serum concentrations are slightly elevated and the elimination half-life is slightly elevated and the elimination half-life is slightly prolonged, hydrocodone cough asthma. The aged also can be expected to vary more widely in their ability to tolerate adverse drug effects. Daily doses in excess of 300 mg are not recommended in patients over 75


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