Generic Name: oxycodone/acetaminophen (OX-i-KOE-done/a-SEET-a-MIN-oh-fen)
Brand Name: Roxicet
Roxicet solution 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.
Roxicet solution is used for:
Relieving moderate to moderately severe pain. Roxicet solution may also be used to treat other conditions as determined by your doctor.
Roxicet solution is a combination of a narcotic and an analgesic/antipyretic. It works in the brain and nervous system to decrease pain.
Do NOT use Roxicet solution if:
- you are allergic to any ingredient in Roxicet solution
- you have high blood carbon dioxide levels (hypercarbia) or a certain severe bowel problem (eg, paralytic ileus)
- you have severely slow or difficult breathing or severe asthma, or you are having an asthma attack
- you are taking sodium oxybate (GHB)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Roxicet solution:
Some medical conditions may interact with Roxicet solution. 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 or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had an allergic reaction to any codeine- or morphine-related medicine (eg, hydrocodone, dihydrocodeine, hydromorphone)
- if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
- if you have or recently have had any head injury, increased pressure in the brain, growths in the brain (eg, tumors), or infection of the brain or nervous system
- if you have a history of heart problems (eg, cor pulmonale), low blood pressure, the blood disease porphyria, stomach or bowel problems (eg, blockage, paralysis), inflammation of the pancreas (pancreatitis), gallbladder problems, liver problems (eg, hepatitis), kidney problems, seizures, thyroid problems, adrenal gland problems (eg, Addison disease), curvature of the spine (scoliosis), prostate problems (eg, an enlarged prostate), or trouble urinating
- if you are in very poor health; are dehydrated or have low blood volume; or have drowsiness, stomach pain, or severe diarrhea caused by antibiotic use (pseudomembranous colitis)
- if you drink alcohol; have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or actions; or are going through withdrawal from alcohol or other substances
Some MEDICINES MAY INTERACT with Roxicet solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticholinergics (eg, scopolamine, oxybutynin) because the risk of a certain severe bowel problem (paralytic ileus) may be increased
- Cimetidine, muscle relaxants (eg, cyclobenzaprine), phenothiazines (eg, chlorpromazine), or sulfinpyrazone because the risk of side effects, such as severe drowsiness, slow or difficult breathing, confusion, and seizures, may be increased
- Azole antifungals (eg, itraconazole, ketoconazole), beta-blockers (eg, propranolol), clarithromycin, isoniazid, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Roxicet solution's side effects
- Buprenorphine, butorphanol, nalbuphine, naltrexone, pentazocine, or rifamycins (eg, rifampin) because they may decrease Roxicet solution's effectiveness
- Lamotrigine, loop diuretics (eg, furosemide), or zidovudine because their effectiveness may be decreased by Roxicet solution
- Anticoagulants (eg, warfarin) or sodium oxybate (GHB) because the risk of their side effects may be increased by Roxicet solution
- Medicines that may harm the liver (eg, acetaminophen, methotrexate, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if Roxicet solution 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 Roxicet solution:
Use Roxicet solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Roxicet solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you have been taking Roxicet solution regularly or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose.
- If Roxicet solution is no longer needed, dispose of the unused medicine by flushing it down the toilet. You may also check with your pharmacist for other ways to dispose of Roxicet solution.
- If you miss a dose of Roxicet solution 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 Roxicet solution.
Important safety information:
- Roxicet solution may cause dizziness, light-headedness, blurred vision, or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Roxicet solution. Using Roxicet solution alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
- Roxicet solution may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not drink alcohol while you are taking Roxicet solution.
- Check with your doctor before you take medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using Roxicet solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or take more often than prescribed without checking with your doctor.
- Tell your doctor or dentist that you take Roxicet solution before you receive any medical or dental care, emergency care, or surgery.
- Roxicet solution may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Roxicet solution, talk with your doctor or pharmacist.
- Roxicet solution may harm your liver. Your risk may be greater if you drink alcohol while you are using Roxicet solution. Talk to your doctor before you take Roxicet solution 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.
- Roxicet solution 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.
- Roxicet solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Roxicet solution.
- Use Roxicet solution with caution in the ELDERLY; they may be more sensitive to its side effects, especially breathing problems and drowsiness.
- Use Roxicet solution with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Roxicet solution while you are pregnant. Roxicet solution is found in breast milk. Do not breast-feed while taking Roxicet solution.
When used for long periods of time or at high doses, Roxicet solution 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 Roxicet solution stops working well. Do not take more than prescribed.
Some people who take Roxicet solution for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Roxicet solution, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
Possible side effects of Roxicet solution:
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; dizziness; drowsiness; flushing; light-headedness; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; hearing loss; mental or mood changes (eg, agitation, anxiety, depression); seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; slow or difficult breathing; stomach or back pain; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, persistent loss of appetite); tremors; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; 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 cold or clammy skin; fainting; limp muscles; loss of consciousness; persistent nausea or vomiting; pinpoint pupils; severe dizziness, drowsiness, or light-headedness; slow heartbeat; slow, shallow, or abnormal breathing; stomach pain; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite); unusual sweating.Proper storage of Roxicet solution:
Store Roxicet solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Roxicet solution out of the reach of children and away from pets.
- If you have any questions about Roxicet solution, please talk with your doctor, pharmacist, or other health care provider.
- Roxicet solution 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 Roxicet solution 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 Roxicet solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Roxicet solution. 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 Roxicet solution.
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.