ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

ULTRAM ER should not be used in patients with:

• creatinine clearance less than 30 mL/min,
• severe hepatic impairment (Child-Pugh Class C) (See WARNINGS, Use in Renal and Hepatic Disease).

ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and Drug, Abuse And Addiction).

Adults (18 years of age and over)

ULTRAM ER should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. ULTRAM ER should not be administered at a dose exceeding 300 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. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of ULTRAM ER have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.

In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, 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. ULTRAM ER should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

ULTRAM ER (tramadol hydrochloride) Extended-release tablets are supplied in the following package and dose strength forms:

100-mg, round, white tablets, imprinted with “100ER” on one side in black ink

Bottle of 30 tablets – NDC 0062-0653-30
Bottle of 90 tablets – NDC 0062-0653-90

200-mg, round, white tablets, imprinted with “200ER” on one side in black ink

Bottle of 30 tablets – NDC 0062-0655-30
Bottle of 90 tablets – NDC 0062-0655-90

300-mg, round, white tablets, imprinted with “300ER” on one side in black ink

Bottle of 30 tablets – NDC 0062-0657-30
Bottle of 90 tablets – NDC 0062-0657-90

Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F).

Manufactured by: Biovail Corporation, Mississauga, ON L5N 8M5, Canada Made in Canada Distributed by: PriCara, a unit of Ortho-McNeil, Inc., Raritan, NJ 08869 Rev. 07/06. FDA Rev date: 8/3/2006

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