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.

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 0045-0659-60

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

You should not take tramadol if you have ever been addicted to drugs or alcohol, if you are currently intoxicated (drunk), or if you have recently used any of the following drugs:

• alcohol;
• narcotic pain medicine;
• sedatives or tranquilizers (such as Valium);
• medicine for depression or anxiety;
• medicine for mental illness (such as bipolar disorder, schizophrenia); or
• street drugs.

Seizures have occurred in some people taking tramadol. Your risk of a seizure may be higher if you have any of these conditions:

• a history of drug or alcohol addiction;
• a history of epilepsy or other seizure disorder;
• a history of head injury;
• a metabolic disorder; or
• if you are also taking an antidepressant, muscle relaxer, or medicine for nausea and vomiting.

Talk with your doctor about your individual risk of having a seizure while taking tramadol.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take tramadol:

• kidney disease;
• liver disease;
• a stomach disorder; or
• a history of depression, mental illness, or suicide attempt.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tramadol may also cause serious or fatal side effects in a newborn if the mother uses the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Tramadol should not be given to a child younger than 18 years of age.

DOSING: The recommended dose of tramadol is 50-100 mg (immediate release tablets) every 4-6 hours as needed for pain. The maximum dose is 400 mg/day. To improve tolerance patients should be started at 25 mg/day, and doses may be increased by 25 mg every 3 days to reach 100 mg/day (25 mg 4 times daily). Thereafter, doses can be increased by 50 mg every 3 days to reach 200 mg day (50 mg 4 times daily). Tramadol may be taken with or without food.

Recommended dose for extended release tablets is 100 mg daily which may be increased by 100 mg every 5 days but not to exceed 300 mg /day. Extended release tablets should be swallowed whole and not crushed or chewed.

DRUG INTERACTIONS: Carbamazepine (Tegretol, Tegretol XR , Equetro, Carbatrol) reduces the effect of tramadol by increasing its inactivation in the body. Quinidine (Quinaglute, Quinidex) reduces the inactivation of tramadol, thereby increasing the concentration of tramadol by 50%-60%. Combining tramadol with monoamine oxidase inhibitors (for example, Parnate) or selective serotonin inhibitors ((SSRIs, for example, fluoxetine Prozac]) may result in severe side effects such as seizures or a condition called serotonin syndrome.

Tramadol may increase central nervous system and respiratory depression when combined with alcohol, anesthetics, narcotics, tranquilizers or sedative hypnotics.

PREGNANCY: The safety of tramadol during pregnancy has not been established.

NURSING MOTHERS: The safety of tramadol in nursing mothers has not been established.

Tramadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using tramadol and call your doctor at once if you have any of these serious side effects:

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
• seizure (convulsions);
• a red, blistering, peeling skin rash; or
• shallow breathing, weak pulse.

Less serious side effects may include:

• dizziness, drowsiness, weakness;
• nausea, vomiting, constipation, loss of appetite;
• blurred vision;
• flushing (redness, warmth, or tingly feeling); or
• sleep problems (insomnia).