In the U.S.—

• Analgesic

Tramadol ( TRA-ma-dole) is used to relieve pain, including pain after surgery. The effects of tramadol are similar to those of narcotic analgesics. Although tramadol is not classified as a narcotic, it may become habit-forming, causing mental or physical dependence.

Tramadol is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tramadol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tramadol or narcotic analgesics. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Although studies on birth defects have not been done in pregnant women, tramadol has not been reported to cause birth defects. In animal studies, there were drug-related birth defects observed. Studies done in animals given very high (toxic) doses resulted in lower than normal birth weights and some deaths in the fetuses and birth defects in some of the newborns.

Breast-feeding—Tramadol passes into breast milk and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—There is no specific information on the relationship of age to the effects of tramadol in patients less than 16 years of age.

Older adults—Studies in older adults show that tramadol stays in the body a little longer than it does in younger adults. Your doctor will consider this when deciding on your doses.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tramadol, it is especially important that your health care provider know if you are taking any of the following:

• Carbamazepine (e.g., Tegretol)—May decrease the effects of tramadol by decreasing the amount of medicine in the body

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—Using these medicines with tramadol may increase the chance of serious side effects or increase the risk of convulsions (seizures)

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—The chance of convulsions (seizures) may be increased

• Abdominal or stomach conditions (severe)—Tramadol may hide signs of other medical conditions

• Alcohol or drug abuse, or history of—May increase the serious side effects of tramadol

• Head injury—Tramadol can hide signs of other medical conditions

• Kidney disease or
• Liver disease—The chance of side effects may be increased. Your doctor will consider this when deciding on your doses.

• Seizures—The chance of convulsions (seizures) may be increased

If you think that ULTRAM is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your medical doctor or dentist.

Dosing—

The dose of tramadol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tramadol. If your dose is different, do not change it unless your doctor tells you to do so.

The number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking tramadol.

Take ULTRAM only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Using too much of ULTRAM increases the chance of unwanted effects.

• For pain:
  • For oral dosage form (tablets):
    • Adults—One-half to two 50-milligram (mg) tablets every four to six hours as needed, no more than 8 tablets in a dayYour healthcare professional may want you to break the tablets in half for the first dose and increase your dose by half-tablets, up to a maximum of 2 full tablets per dose. By starting at a lower dose and slowly increasing the amount of medicine you take, this will help you get used to the medicine gradually.Your healthcare professional may want you to take 2 tablets for the first dose if you are having severe pain. This helps the medicine start working a little faster.
    • Children up to 16 years of age—Use and dose must be determined by your doctor.

Missed dose—

If your medical doctor or dentist has directed you to take ULTRAM according to a regular schedule and you miss a dose of ULTRAM, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store ULTRAM:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store tramadol tablets in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.