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ANALAB CAPSULES is administered orally. Since food does not affect substantially the rate or extent of absorption of tramadol hydrochloride administered alone, it can be administered without regard to meal.
Patients 17 years of age and older with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect may initially receive ANALAB CAPSULES using a dosage titration regimen;
the recommended initial dosage is 25 mg daily in the morning, increased by increments of 25 mg every 3 days as separate doses up to a dosage of 25 mg 4 times daily. Thereafter, daily dosage may be
increased as tolerated by 50 mg every 3 days, up to 50 mg 4 times daily. Following titration, 50 - 100 mg may be administered every 4 - 6 hours as needed.
Patients 17 years of age and older requiring rapid of analgesia, and in whom the benefit of rapid onset of analgesia outweighs the risk of drug discontinuance secondary to adverse effects associated with higher initial dosage, may receive a ANALAB CAPSULES dosage of 50 - 100 mg every 4 - 6 hours. Do not exceed 400 mg/day.
Dosage in Renal Function Impairment: Impaired renal function results in a decreased rate and extent of excretion of tramadol hydrochloride and its active metabolite, M1. In patients with a creatinine clearance (CrCl) less than 30 mL/min, adjustment of the dosing regimen is recommended. Patients may receive an oral ANALAB CAPSULES dosage of 50 - 100 mg and increase the dosing interval to 12 hours, with a maximum daily dose of 200 mg. Because hemodialysis only removes 7% of an administered dose, dialysis patients can receive their regular dose on the day of dialysis.
Dosage in Hepatic Function Impairment: Metabolism of tramadol hydrochloride and M1 is reduced in patients with advanced cirrhosis of the liver, resulting in both a larger AUC for tramadol hydrochloride and longer tramadol hydrochloride and M1 elimination half-lives (13 hours for tramadol hydrochloride and 19 hours for M1). In cirrhotic patients, adjustment of the dosing regimen is recommended. The recommended dosage for adults with hepatic cirrhosis is 50 mg every 12 hours.
