Generic Name: tramadol/acetaminophen (TRAM-a-dol/a-SEET-a-MIN-oh-fen)
Brand Name: Ultracet
Ultracet contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.
Ultracet is used for:
Treating short-term (5 days or less) pain in certain patients.
Ultracet is an analgesic combination. It works in certain areas of the brain and nervous system to decrease pain. The combination may provide better pain relief than either medicine alone.
Do NOT use Ultracet if:
- you are allergic to any ingredient in Ultracet or to any other codeine- or morphine-related medicine (eg, oxycodone, hydrocodone, dihydrocodeine, hydromorphone)
- you have severe or persistent diarrhea due to taking an antibiotic
- you have suicidal thoughts or actions, or a history of alcohol or other substance abuse or addiction
- you are intoxicated with alcohol or certain medicines, including opioids or narcotics (eg, morphine, codeine), or sedatives or sleeping medicines (eg, temazepam, zolpidem)
- you have liver problems
- you are taking carbamazepine, sodium oxybate (GHB), or any other medicine containing tramadol or acetaminophen
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ultracet:
Some medical conditions may interact with Ultracet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you drink alcohol; are going through withdrawal from alcohol or other substances; or if you have a history of alcohol or other substance abuse, mood or mental problems (eg, depression), or suicidal thoughts or actions
- if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system
- if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]) or seizures (eg, epilepsy)
- if you have or have a history of a recent stomach or bowel injury, or any other stomach or bowel problem (eg, pain, inflammation, ulcers)
- if you have heart problems (eg, cor pulmonale), liver problems (eg, hepatitis), pancreas problems, kidney problems, thyroid problems, prostate problems (eg, enlargement of the prostate gland), a blockage of the bladder, diabetes, high blood pressure, or metabolism problems
Some MEDICINES MAY INTERACT with Ultracet. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Alpha-2-receptor blockers (eg, yohimbine), anorexiants (eg, phentermine), butyrophenones (eg, haloperidol), cyclobenzaprine, furazolidone, linezolid, lithium, loxapine, certain medicines for mental or mood disorders (eg, olanzapine), molindone, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine, selegiline), nefazodone, phenothiazines (eg, promethazine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), St. John's wort, thioxanthenes (eg, thiothixene), tiagabine, tricyclic antidepressants (eg, amitriptyline), or "triptans" (eg, sumatriptan) because the risk of seizures or a serious side effect called serotonin syndrome may be increased
- Azole antifungals (eg, ketoconazole), isoniazid, macrolide antibiotics (eg, erythromycin), opioid pain medicines (eg, codeine, hydrocodone), quinidine, sleeping medicines (eg, zolpidem), sodium oxybate (GHB), or other products containing tramadol or acetaminophen because they may increase the risk of Ultracet's side effects
- Carbamazepine or rifampin because they may decrease Ultracet's effectiveness
- Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by Ultracet
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ultracet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Ultracet:
Use Ultracet as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Ultracet by mouth with or without food.
- Do not take Ultracet for more than 5 days unless advised to do so by your doctor.
- Do not take more than 8 tablets per day. Do not take more than 4 tablets per day if you have kidney problems.
- If you miss a dose of Ultracet and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ultracet.
Important safety information:
- Ultracet may cause drowsiness and dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ultracet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are using Ultracet.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using Ultracet; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Ultracet may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you use a lot of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Ultracet.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Ultracet. Your risk may be greater if you take Ultracet with certain other medicines (eg, "triptans," MAOIs, antidepressants). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Ultracet may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
- Do NOT take more than the recommended dose or take for longer than prescribed without checking with your doctor.
- Tell your doctor or dentist that you take Ultracet before you receive any medical or dental care, emergency care, or surgery.
- Ultracet may harm your liver. Your risk may be greater if you drink alcohol while you are using Ultracet. Talk to your doctor before you take Ultracet or other fever reducers if you drink alcohol.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Ultracet has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.
- Use Ultracet with caution in the ELDERLY; they may be more sensitive to its effects.
- Ultracet should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Ultracet may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ultracet while you are pregnant. Ultracet is found in breast milk. Do not breast-feed while taking Ultracet.
When used for long periods of time or at high doses, Ultracet may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Ultracet stops working well. Do not take more than prescribed.
Some people who use Ultracet for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE.
If you suddenly stop taking Ultracet, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goosebumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
Possible side effects of Ultracet:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; mildly increased sweating; nausea; tiredness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); chest pain; confusion; difficult or painful urination; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mental or mood changes (eg, agitation, depression); red, swollen, blistered, or peeling skin; seizures (convulsions); severe nausea, vomiting, or diarrhea; severe or persistent headache or dizziness; slow or shallow breathing; suicidal thoughts or behaviors; symptoms of liver problems (eg, yellowing of the eyes or skin, pale stools, dark urine, stomach pain, persistent loss of appetite); tremor; unusual tiredness or weakness; unusually pale skin; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold, clammy skin; decreased urination; difficult, shallow, or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; nausea and vomiting; pinpoint pupils; seizure (convulsions); slow or irregular heartbeat; stomach or bowel pain; symptoms of liver damage (eg, yellowing of the eyes or skin, pale stools, dark urine, loss of appetite); unusual bruising or bleeding.Proper storage of Ultracet:
Store Ultracet at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ultracet out of the reach of children and away from pets.
- If you have any questions about Ultracet, please talk with your doctor, pharmacist, or other health care provider.
- Ultracet is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Ultracet or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ultracet. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ultracet. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Ultracet.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.