ULTRAM

ULTRAM ?® (tramadol hydrochloride tablets) 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 n-octanol/ water log partition coefficient (logP) 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.

Ultram

Ultram is a narcotic-like pain reliever. Ultram is used to treat moderate to severe pain. Ultram extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock.

What is the most important information I should know about Ultram?

You should not take Ultram if you have ever been addicted to drugs or alcohol. Seizures (convulsions) have occurred in some people taking Ultram. You may be more likely to have a seizure while taking Ultram if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, or medicine for nausea and vomiting.

Take Ultram exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of Ultram in one day.

Side Effects:

Ultram can cause dizziness, nausea, constipation, headaches, and drowsiness. It less likely to interfere with respiration than narcotic pain killers.

Drug Interactions

The formation of the active metabolite, M1, is mediated by CYP2D6. Approximately 7% of the population has reduced activity of the CYP2D6 isoenzyme of cytochrome P-450. Based on a population PK analysis of Phase I studies with immediate-release tablets in healthy subjects, concentrations of tramadol were approximately 20% higher in "poor metabolizers" versus "extensive metabolizers," while M1 concentrations were 40% lower. In vitro drug interaction studies in human liver microsomes indicate that inhibitors of CYP2D6 (fluoxetine, norfluoxetine, amitriptyline, and quinidine) inhibit the metabolism of tramadol to various degrees, suggesting that concomitant administration of these compounds could result in increases in tramadol concentrations and decreased concentrations of M1. The full pharmacological impact of these alterations in terms of either efficacy or safety is unknown.

Recommended dosage

The usual starting dose for chronic pain is 25 milligrams once a day in the morning. The daily dosage is then increased every 3 days until it reaches 200 milligrams taken in four doses of 50 milligrams each. After the phase-in period, Ultram may be taken in doses of 50 to 100 milligrams every 4 to 6 hours, depending on the severity of pain. If rapid pain relief is needed, the phase-in steps can be skipped, though side effects will be more likely. The maximum dosage under any circumstances is 400 milligrams a day (300 milligrams for those over age 75).

For people with kidney problems, the usual starting dose is 50 to 100 milligrams every 12 hours; and the maximum per day is 200 milligrams. For those with cirrhosis, the usual dose is 50 milligrams every 12 hours.

CHILDREN: Safety and effectiveness in children under 16 years of age have not been established.

Ultram Oral Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.