Tramadol hydrochloride is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2- [(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The molecular weight of tramadol hydrochloride is 299.8.

Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The water/n-octanol partition coefficient is 1.35 at pH 7.

Ultram tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and wax.

INDICATIONS
Tramadol is indicated for the management of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION

For the treatment of painful conditions tramadol 50 mg to 100 mg can be administered as needed for relief every four to six hours, not to exceed 400 mg per day. For moderate pain tramadol 50 mg may be adequate as the initial dose, and for more severe pain, tramadol 100 mg is usually more effective as the initial dose.

Individualization of Dose: Available data do not suggest that a dosage adjustment is necessary in elderly patients 65 to 75 years of age unless they also have renal or hepatic impairment. For elderly patients over 75 years old, not more than 300 mg/day in divided doses as above is recommended. In all patients with creatine clearance less than 30 ml/min, it is recommended that the dosing interval of tramadol HCl 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 patients with cirrhosis is 50 mg every 12 hours. Patients receiving chronic carbamazepine doses up to 800 mg daily may require up to twice the recommended dose of tramadol HCl.

HOW SUPPLIED

Ultram 50 mg (white, film-coated capsule-shaped tablet) is engraved "McNeil" on one side and "659" on the other side.

Dispense in a tight container. Store at controlled room temperature (up to 25°C, 77°F).

PATIENT INFORMATION

Tramadol HCl is used to relieve moderate to severe pain. This drug should be used as directed and only for the period of time determined by the physician. This drug can cause dizziness or tiredness and in some cases nausea, constipation and headache. Avoid the use of alcohol or other depressants such as sleeping pills or tranquilizers. Be especially careful when performing potentially hazardous tasks such as driving or operating machinery while taking this drug. Please tell your pharmacist or physician if you are pregnant or nursing.