Drug Database - Ultracet

Generic Name: acetaminophen & tramadol
(ah-see-tah-MIH-no-fen / TRA-ma-doll)

Brand Names: Ultracet®

Classification: Pain Reliever

Issue Date: 2001

Acetaminophen and tramadol are both pain relievers. Together Acetaminophen and tramadol is called Ultracet and is used for the short-term (5 days or less) management of pain.

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.

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.

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.

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.

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.

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.

Take each dose with a full glass of water. Ultracet can be taken with or without food.

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.

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.

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:

• history of seizures or epilepsy
• head injury
• metabolic disorder
• central nervous system infection
• experiencing alcohol or drug withdrawal

Do not take Ultracet if you are taking a tricyclic antidepressant such as:

• amitriptyline (Elavil®)
• nortriptyline (Pamelor®)
• doxepin (Sinequan®)
• imipramine (Tofranil®)
• clomipramine (Anafranil®)

Do not take Ultracet if you are taking a monoamine oxidase inhibitor (MAOI) such as:

• isocarboxazid (Marplan®)
• phenelzine (Nardil®)
• tranylcypromine (Parnate®)

Do not take Ultracet if you are taking a psychiatric medication such as:

• chlorpromazine (Thorazine®)
• fluphenazine (Prolixin®)
• haloperidol (Haldol®)
• loxapine (Loxitane®)
• mesoridazine (Serentil®)
• perphenazine (Trilafon®)
• thioridazine (Mellaril®)
• thiothixene (Navane®)

Do not take Ultracet if you are taking a selective serotonin reuptake inhibitor (SSRI) such as:

• fluoxetine (Prozac®, Sarafem®)
• fluvoxamine (Luvox®)
• paroxetine (Paxil®)
• sertraline (Zoloft®)
• citalopram (Celexa®)

Do not take Ultracet if you are taking a narcotic pain reliever such as:

• codeine
• fentanyl (Duragesic®)
• hydromorphone (Dilaudid®)
• meperidine (Demerol®)
• hydrocodone (Vicodin®, Lorcet®, Lortab®)
• morphine (MSContin®, MSIR®, RMS®, Roxanol®)
• oxycodone (Roxicodone®, Percocet®, Percodan®)
• propoxyphene (Darvon®, Darvocet®)

Do not take Ultracet if you are taking:

• promethazine (Phenergan®)
• prochlorperazine (Compazine®)
• sibutramine (Meridia®)
• bupropion (Wellbutrin®, Zyban®)
• cyclobenzaprine (Flexeril®)

Before taking Ultracet, tell your doctor if you have:

• kidney disease
• liver disease
• history of alcohol or drug dependence

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.

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.

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.

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.

Symptoms of a Ultracet overdose include:

• nausea
• vomiting
• sweating
• difficulty breathing
• shallow, weak breathing
• seizures

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

Call your doctor at once if you have any of these SERIOUS side effects:

• seizure (convulsions)

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
• headache
• nervousness
• tremor
• anxiety
• nausea
• constipation, or diarrhea
• itching
• dry mouth
• sweating

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.

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.

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:

• amitriptyline (Elavil®)
• nortriptyline (Pamelor®)
• doxepin (Sinequan®)
• imipramine (Tofranil®)
• clomipramine (Anafranil®)
• isocarboxazid (Marplan®)
• phenelzine (Nardil®)
• tranylcypromine (Parnate®)
• chlorpromazine (Thorazine®)
• fluphenazine (Prolixin®)
• haloperidol (Haldol®)
• loxapine (Loxitane®)
• mesoridazine (Serentil®)
• perphenazine (Trilafon®)
• thioridazine (Mellaril®)
• thiothixene (Navane®)
• fluoxetine (Prozac®, Sarafem®)
• fluvoxamine (Luvox®)
• paroxetine (Paxil®)
• sertraline (Zoloft®)
• citalopram (Celexa®)
• codeine
• fentanyl (Duragesic®)
• hydromorphone (Dilaudid®)
• meperidine (Demerol®)
• hydrocodone (Vicodin®, Lorcet®, Lortab®)
• morphine (MSContin®, MSIR®, RMS®, Roxanol®)
• oxycodone (Roxicodone®, Percocet®, Percodan®)
• propoxyphene (Darvon®, Darvocet®)
• promethazine (Phenergan®)
• prochlorperazine (Compazine®)
• sibutramine (Meridia®)
• bupropion (Wellbutrin®, Zyban®)
• cyclobenzaprine (Flexeril®)

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

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

• carbamazepine (Tegretol®)
• quinidine (Quinaglute Dura-Tabs®, Cardioquin®, Quinora®)
• warfarin (Coumadin®)
• digoxin (Lanoxin®, Lanoxicaps®)

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.

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.

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.

Drugs other than those listed here may also interact with Ultracet. 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.