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HOME >> API >> API List 3 >> Tramadol HCl >> Precautions

PRECAUTIONS
Tramadol Hcl CAS Registry Number 22204-88-2

Acute Abdominal Conditions

The administration of Tramadol Hcl  may complicate the clinical assessment of patients with acute abdominal conditions.
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  Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. In cirrhotic patients, dosing reduction is recommended

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.
Carcinogenesis, Mutagenesis, Impairment of Fertility as light, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m2 or 0.36 times the maximum daily human dosage of 246 mg/m2)for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study (dosing orally up to 30 mg/kg,180 mg/m2, or 0.73 times the maximum daily human dosage).

Tramadol was not mutagenic in the following assays:Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the absence of metabolic activation), dominant lethal mutation tests in mice, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans.
Labor and Delivery

Tramadol Hcl  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 Tramadol Hcl , if any, on the later growth, development, and functional maturation of the child is unknown.
Nursing Mothers

Tramadol Hcl  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, the cumulative excretion in breast milk within 16 hours postdose was 100 ug of tramadol (0.1% of the maternal dose) and 27 ug of M1.
Pediatric Use

The safety and efficacy of Tramadol Hcl  in patients under 16 years of age have not been established. The use of Tramadol Hcl  in the pediatric population is not recommended.

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