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Tramadol and weight loss. Sease 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). Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. In cirrhotic patients, dosing reduction is recommended (see DOSAGE AND ADMINISTRATION). 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation te tramadol and
 

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St, 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. A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice (dosing orally up to 30 mg kg 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 rate carcinogenicity study. No effects on fertility were observed for tramadol at oral dose levels up to 50 mg kg i tramadol and


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tramadol and weight loss N ------------------------------------------------ Body System From 1% to <5% Less Than 1% ----------------------------------------------------------------------- Body as a Whole Malaise Allergic reaction; Accidental injury; Weight loss Cardiovascular Vasodilation Syncope; Orthostatic hypotension; Tachycardia Central Nervous System Anxiety; Confusion; Seizure (see WARNINGS); Coordination Paresthesia; Cognitive disturbance; dysfunction; Euphoria; Nervous- Hallucinations; Tremor; ness; Sleep dis- Amnesia; Difficulty in order concentration; Abnormal gait Gastrointestinal Abdominal pain; Anorexia; Flatulence Musculoskeletal Hypertonia Respiratory Dyspnea Skin Rash Urticaria tramadol and weight loss, Vesicles Special Senses Visual disturbance Dysgeusia Urogenital Urinary retention; Dysuria; Menstrual dis- Urinary frequency; order Menopausal symptoms Other adverse experiences tramadol and weight loss, casual relationship undetermined: A variety of other adverse events were reported infrequently in patients taking Ultram during clinical trials. A casual relationship between Ultram and these events has not been determined. However tramadol and weight loss, the most significant events are listed below as alerting information to the physician. Body as a whole: Suicidal tendency. Cardiovascular: Abnormal ECG tramadol and weight loss, hypertension tramadol and weight loss, myocardial ischemia tramadol and weight loss, palpitations. Central Nervous System: Migraine Gas.

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