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|Ultram ER

TRAMADOL (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Ultram
• Ultram ER

† Not commercially available in Canada.

Category

• Analgesic

Description

Tramadol (TRA-ma-dole) is used to relieve pain, including pain after surgery. The long-acting tablets are used for chronic ongoing pain. 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
• Extended-release (long-acting) tablets (U.S.)
• Tablets (U.S.)

Before Using This Medicine

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. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

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 tablets in patients less than 16 years of age and tramadol extended-release tablets in patients less than 18 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.

• Neuroleptic drugs (antipsychotic drugs) (chlorpromazine [e.g., Thorazine], clozapine [e.g., Clozaril], haloperidol [e.g., Haldol], loxapine [e.g., Loxitane]) or
• Other drugs that lower seizure threshold (epilepsy drugs)—May increase chances of seizures so caution is recommended

Other medical problems—The presence of other medical problems may affect the use of tramadol. Make sure you tell your doctor if you have any other medical problems, especially:

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

• Addiction problems or
• Suicidal—Tramadol should not be used.

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

• Epilepsy or
• History of seizures
• Increased risk for seizures caused by alcohol and drug withdrawal, brain or spinal cord infections, or head trauma—Risk of seizures may be increased.

• 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.

Proper Use of This Medicine

If you think that this medicine 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 this medicine 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 this medicine increases the chance of unwanted effects.

• For chronic pain:
  • For oral dosage form (long-acting tablets):
    • Adults—100 mg once a day. Your doctor may increase your dose as needed. You should not take more than 300 mg per day.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.
• 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 day
      Your 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 this medicine according to a regular schedule and you miss a dose of this medicine, 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 this medicine:

• 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.

Precautions While Using This Medicine

This medicine will add to the effects of alcohol and other CNS depressants (medicine that causes drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above while you are using this medicine .

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Dizziness, lightheadedness, or fainting may occur , especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for awhile. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Taking tramadol together with medicines that are used during surgery or dental or emergency treatments may cause increased side effects.

If you think you or someone else may have taken an overdose of tramadol, get emergency help at once . Signs of an overdose include convulsions (seizures) and pinpoint pupils of the eyes.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Less common or rare

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

Anxiety; body aches; diarrhea; fast heartbeat; fever, runny nose, or sneezing; gooseflesh; high blood pressure; increased sweating; increased yawning; loss of appetite; nausea or vomiting; nervousness, restlessness or irritability; shivering or trembling; stomach cramps; trouble in sleeping; unusually large pupils; weakness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 03/09/2006

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