Dosage and Administration
For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride can be improved by initiating therapy with a titration regimen: The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, tramadol hydrochloride 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.
For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, tramadol hydrochloride 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day.
Individualization of Dose
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.
- In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.
- The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours.
- In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.
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How Supplied
Tramadol Hydrochloride Tablets - 50 mg (normal convex, film-coated, white
unscored tablet debossed “TL/50” on one side and “G” on the other).
Bottles of 100 NDC57315-038-01
Bottles of 1000 NDC57315-038-02
Unit dose of 100 (10 x 10) NDC57315-038-03
Dispense in a tight, light-resistant container. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
MANUFACTURED BY:
ALPHAPHARM PTY LTD
15 Garnet St
Carole Park Qld 4300
Australia
725/7
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