Hydrochloride Tablets

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ULTRAM ®

(tramadol hydrochloride tablets)

ULTRAM ® (tramadol hydrochloride

tablets) is a medication indicated for the management of moderate to moderately severe

pain.

ULTRAM received U.S. Food and Drug Administration (FDA) approval in March 1995. Tramadol

has been prescribed in more than 55 million patients worldwide and ULTRAM has been

prescribed in more than 21 million patients in the United States.

ULTRAM is a centrally acting synthetic analgesic, not a non-steroidal anti-inflammatory

drug (NSAID). ULTRAM has no anti-inflammatory activity and no potential for

prostaglandin-mediated side effects. Unlike NSAIDs, ULTRAM does not have the potential to

compromise the efficacy of certain antihypertensive agents (diuretics, beta blockers,

ACE-inhibitors).

While the mode of action of ULTRAM is not completely understood, animal studies suggest

that at least two complementary mechanisms appear applicable: binding of parent and M1

metabolite to opioid receptors and weak inhibition of the reuptake of norephinephrine and

serotonin.

For the treatment of painful conditions, ULTRAM 50 mg can be administered as needed for

relief every four to six hours, not to exceed 400 mg per day. For elderly patients over 75

years of age, the maximum dose should not exceed 300 mg per day. In patients with

preexisting kidney problems (creatinine clearance of less than 30 mL/min) or with advanced

cirrhosis of the liver, see Dosage and Administration in the full U.S. Prescribing

Information. For some patients, starting ULTRAM at a lower dose and titrating slowly

upward improves tolerability.

The most frequently reported side effects experienced with ULTRAM were constipation,

nausea, dizziness, headache, somnolence, and vomiting.

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