Ultram (Tramadol Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

ULTRAM^® is indicated for the management of moderate to moderately severe pain in adults.

DOSAGE AND ADMINISTRATION

Adults (17 years of age and over)

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of ULTRAM^® can be improved by initiating therapy with the following titration regimen: ULTRAM^® should be started at 25 mg/day qAM and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg q.i.d.). Thereafter 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, ULTRAM^® 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, ULTRAM^® 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 ULTRAM^® 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.

HOW SUPPLIED

ULTRAM^® (tramadol hydrochloride) Tablets - 50 mg are white, capsule-shaped, coated tablet imprinted "ULTRAM" on one side and "06 59" on the scored side.

Bottles of 100 tablets: NDC 50458-659-60

Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 –30°C (59 – 86°F).

Manufactured by:

Janssen Ortho, LLC
Gurabo, Puerto, Rico 00778

Manufactured for:

PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Raritan, New Jersey 08869

© OMPJI 2003
Revised September 2009

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