Ultracet Drug Information

Tramadol is a narcotic-like pain reliever. Acetaminophen is a less potent pain reliever that increases the effects of tramadol. Ultracet is used to treat moderate to severe pain.

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

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Seizures have been reported as a rare side effect of treatment with Ultracet. The risk of seizures may be increased in patients who take more than the prescribed dose, have a history of seizures or epilepsy, have head trauma, have a metabolic disorder, have a central nervous system infection, are experiencing alcohol or drug withdrawal, or are taking certain medications. Talk to your doctor about factors that may increase the risk of seizures during treatment.

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Do not drink alcohol while taking Ultracet. Alcohol may cause a dangerous decrease in breathing and/or liver problems when used during treatment with Ultracet.

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Use caution when driving, operating machinery, or performing other hazardous activities. Ultracet may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

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Do not take more of this medication than is prescribed for you. If the pain is not being controlled, talk to your doctor. Taking more than the prescribed amount of this medication could result in seizures or decreased breathing.

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Do not take other prescription or over-the-counter medicines that contain acetaminophen (Tylenol, pain relievers, cold and flu medicines, others) during treatment with Ultracet. Taking too much acetaminophen may be harmful.

What is Ultracet?

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Acetaminophen and tramadol are both pain relievers. The exact way that Ultracet works is unknown.

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Ultracet is used for the short-term (5 days or less) management of pain.

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Ultracet may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Ultracet?

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Seizures have been reported as a rare side effect of treatment with Ultracet. The risk of seizures may be increased in patients who have any of the conditions or are taking any of the medications listed below: Do not take Ultracet without first talking to your doctor if you

have a history of seizures or epilepsy;

have a head injury;

have a metabolic disorder;

have a central nervous system infection;

are experiencing alcohol or drug withdrawal;

are taking a tricyclic antidepressant such as amitriptyline (Elavil), nortriptyline (Pamelor), doxepin (Sinequan), imipramine (Tofranil), clomipramine (Anafranil), and others;

are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);

are taking a psychiatric medication such as chlorpromazine (Thorazine), fluphenazine (Prolixin), haloperidol (Haldol), loxapine (Loxitane), mesoridazine (Serentil), perphenazine (Trilafon), thioridazine (Mellaril), thiothixene (Navane), and others;

are taking a selective serotonin reuptake inhibitor (SSRI) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or citalopram (Celexa);

are taking a narcotic pain reliever such as codeine, fentanyl (Duragesic), hydromorphone (Dilaudid), meperidine (Demerol), hydrocodone (Vicodin, Lorcet, Lortab, others), morphine (MS Contin, MSIR, RMS, Roxanol, others), oxycodone (Roxicodone, Percocet, Percodan, others), propoxyphene (Darvon, Darvocet, others), and others;

are taking promethazine (Phenergan) or prochlorperazine (Compazine);

are taking sibutramine (Meridia);

are taking bupropion (Wellbutrin, Zyban); or

are taking cyclobenzaprine (Flexeril).

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Before taking Ultracet, tell your doctor if you have

kidney disease;

liver disease; or

a history of alcohol or drug dependence.

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You may not be able to take Ultracet, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

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Ultracet is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

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Ultracet passes into breast milk and may affect a nursing baby. Do not take Ultracet without first talking to your doctor if you are breast-feeding a baby.

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If you are over 65 years of age, you may be more likely to experience side effects from Ultracet. Your doctor may prescribe a lower dose or special monitoring during treatment.

How should I take Ultracet?

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Take Ultracet exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

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Take each dose with a full glass of water.

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Ultracet can be taken with or without food.

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For the short-term treatment of pain, the usual dose is 2 tablets taken every 4 to 6 hours, up to eight tablets per day. People over 65 years of age and those with other medical conditions such as seizures or epilepsy, liver disease, kidney disease, and others may need lower daily doses. Follow your doctor's directions.

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Store Ultracet at room temperature away from moisture and heat.

What happens if I miss a dose?

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Since Ultracet is taken on an as-needed basis, missing a dose is usually not a problem. Take the dose as soon as you remember, and do not take another dose for the amount of time prescribed by your doctor. Do not take a double dose of this medication.

What happens if I overdose?

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Seek emergency medical attention.

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Symptoms of a Ultracet overdose include nausea; vomiting; sweating; difficulty breathing; shallow, weak breathing; and seizures.

What should I avoid while taking Ultracet?

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Use caution when driving, operating machinery, or performing other hazardous activities. Ultracet may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

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Do not drink alcohol while taking Ultracet. Alcohol may cause a dangerous decrease in breathing and/or liver problems when used during treatment with Ultracet.

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Avoid sleeping pills, tranquilizers, sedatives and antihistamines except under the supervision of your doctor. Ultracet may cause drowsiness and these agents may worsen this effect.

What are the possible side effects of Ultracet?

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If you experience any of the following serious side effects, stop taking Ultracet and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or

seizures.

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Other, less serious side effects may be more likely to occur. Continue to take Ultracet and talk to your doctor if you experience

dizziness, drowsiness, or headache;

nervousness, tremor, or anxiety;

nausea, constipation, or diarrhea; or

itching, dry mouth, or sweating.

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The tramadol component of Ultracet may be habit forming. Physical and/or psychological dependence can occur, and withdrawal effects are possible if the medication is stopped suddenly after prolonged or high-dose treatment.

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Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Ultracet?

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Ultracet may increase the risk of seizures especially in patients who have epilepsy or another seizure disorder. Also, Ultracet may increase the risk of seizures if you are taking any of the following drugs:

a tricyclic antidepressant such as amitriptyline (Elavil), nortriptyline (Pamelor), doxepin (Sinequan), imipramine (Tofranil), clomipramine (Anafranil), and others;

a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);

an antipsychotic medication such as chlorpromazine (Thorazine), fluphenazine (Prolixin), haloperidol (Haldol), loxapine (Loxitane), mesoridazine (Serentil), perphenazine (Trilafon), thioridazine (Mellaril), thiothixene (Navane), and others;

a selective serotonin reuptake inhibitor (SSRI) such as fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or citalopram (Celexa);

a narcotic pain reliever such as codeine, fentanyl (Duragesic), hydromorphone (Dilaudid), meperidine (Demerol), hydrocodone (Vicodin, Lorcet, Lortab, others), morphine (MS Contin, MSIR, RMS, Roxanol, others), oxycodone (Roxicodone, Percocet, Percodan, others), propoxyphene (Darvon, Darvocet, others), and others;

promethazine (Phenergan) or prochlorperazine (Compazine);

bupropion (Wellbutrin, Zyban); or

cyclobenzaprine (Flexeril).

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Do not take Ultracet without first talking to your doctor if you are taking any of the medicines listed above.

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Before taking Ultracet, tell your doctor if you are taking any of the following medicines:

carbamazepine (Tegretol);

quinidine (Quinaglute Dura-Tabs, Cardioquin, Quinora, others);

warfarin (Coumadin); or

digoxin (Lanoxin, Lanoxicaps).

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You may not be able to take Ultracet, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

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Avoid sleeping pills, tranquilizers, sedatives and antihistamines except under the supervision of your doctor. Ultracet may cause drowsiness and these agents may worsen this effect.

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Drugs other than those listed here may also interact with Ultracet. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

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