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

You should not take tramadol if you have ever been addicted to drugs or alcohol.

Seizures (convulsions) have occurred in some people taking tramadol. You may be more likely to have a seizure while taking tramadol 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 tramadol 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 tramadol in one day.

Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal. Overdose symptoms of a tramadol overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma.

Tramadol may be habit-forming and should be used only by the person it was prescribed for. Tramadol should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not stop using tramadol suddenly, or you could have unpleasant withdrawal symptoms such as anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is traMADOL?

Tramadol is a narcotic-like pain reliever.

Tramadol is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock.

Tramadol may also be used for other purposes not listed in this medication guide.


Precautions

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.

Before taking tramadol, tell your doctor if you are allergic to any drugs, or if you have:

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

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

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.

Do not drink alcohol while you are taking tramadol. Alcohol may cause a dangerous decrease in your breathing when used together with tramadol.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by tramadol. Tell your doctor if you regularly use any of these other medicines.

Tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal.

Overdose symptoms may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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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:

  • 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).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

You may be more likely to have a seizure (convulsions) if you take tramadol while you are using certain other medicines. Do not take tramadol without telling your doctor if you also use any of the following medications:

  • an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or
  • an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor); paroxetine (Paxil), or sertraline (Zoloft).

Before taking tramadol, tell your doctor if you also use:

  • carbamazepine (Tegretol);
  • warfarin (Coumadin);
  • digoxin (Lanoxin, Lanoxicaps);
  • ketoconazole (Nizoral);
  • erythromycin (E-Mycin, E.E.S., Ery-Tab);
  • rifampin (Rifadin, Rimactane, Rifater);
  • St. John's wort;
  • quinidine (Quinaglute, Quinadex, Cardioquin, Quinora); or
  • drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety).

This list is not complete and there may be other drugs that can interact with tramadol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04