Generic Name: aspirin/butalbital/caffeine/codeine (AS-pir-in/bue-TAL-bi-tal/KAF-een/KOE-deen)
Brand Name: Examples include Ascomp-Codeine and Fiorinal with Codeine
Some children have had serious and sometimes fatal breathing problems when using Ascomp-Codeine after surgery to remove tonsils or adenoids. Ascomp-Codeine should not be used in children to treat pain after surgery to remove tonsils or adenoids. Talk with your doctor for more information.
Ascomp-Codeine is used for:
Treating tension headaches. It may also be used for other conditions as determined by your doctor.
Ascomp-Codeine is a salicylate, barbiturate, caffeine, and narcotic combination. How these medicines work is not completely understood. Aspirin reduces pain and inflammation. Caffeine may work by constricting blood vessels that may cause headaches. Butalbital has a depressant effect that reduces anxiety and causes relaxation. Codeine works in the central nervous system to decrease pain.
Do NOT use Ascomp-Codeine if:
- you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), any ingredient in Ascomp-Codeine, or any other codeine- or morphine-related medicine (eg, oxycodone).
- you have von Willebrand disease, the blood disease porphyria, severe stomach or intestinal problems (eg, peptic ulcer, pseudomembranous colitis), blood clotting problems (eg, hemophilia), severe bleeding, severe liver damage, or severe low levels of vitamin K
- you are taking sodium oxybate (GHB)
- you are a child or teenager that has the flu, chickenpox, or joint problems
- the patient is a child being treated for pain after surgery to remove tonsils or adenoids
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ascomp-Codeine:
Some medical conditions may interact with Ascomp-Codeine. 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 asthma, stomach or intestinal problems (eg, inflammatory bowel disease), liver problems, the flu, nasal polyps, kidney problems, lung or respiratory tract disease, an enlarged prostate, severe heart disease, difficulty urinating, chickenpox, underactive thyroid, or vitamin K deficiency
- if you are in very poor health or have a history of stroke, anxiety, substance abuse or dependence, depression, or suicidal thoughts or behaviors
- if you have had head trauma, growths in the brain, or stomach or intestinal surgery
Some MEDICINES MAY INTERACT with Ascomp-Codeine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg warfarin), celecoxib, clopidogrel, heparin, or NSAIDs (eg, ibuprofen) because the risk of serious side effects, such as stomach ulcers and bleeding, may be increased
- Benzodiazepines (eg, chlordiazepoxide), cimetidine, HIV protease inhibitors (eg, ritonavir), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), sleeping medicines (eg, temazepam), or sodium oxybate (GHB) because they may increase the risk of Ascomp-Codeine's side effects
- Naltrexone because it may decrease Ascomp-Codeine's effectiveness
- Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinides (eg, repaglinide), methotrexate, quinolone antibiotics (eg, ciprofloxacin), or valproic acid because the risk of their side effects may be increased by Ascomp-Codeine
- Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), antipsychotics (eg, clozapine), beta-blockers (eg, atenolol), corticosteroids (eg, prednisone), doxycycline, estrogens (eg, estradiol), metronidazole, oral contraceptives (eg, norethindrone/ethinyl estradiol), probenecid, quinidine, sulfinpyrazone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because their effectiveness may be decreased by Ascomp-Codeine
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ascomp-Codeine 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 Ascomp-Codeine:
Use Ascomp-Codeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Ascomp-Codeine by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
- If you miss a dose of Ascomp-Codeine and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ascomp-Codeine.
Important safety information:
- Ascomp-Codeine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ascomp-Codeine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ascomp-Codeine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Serious stomach ulcers or bleeding can occur with the use of Ascomp-Codeine. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Ascomp-Codeine with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Tell your doctor or dentist that you take Ascomp-Codeine before you receive any medical or dental care, emergency care, or surgery.
- Ascomp-Codeine has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Ascomp-Codeine for longer than prescribed may be habit-forming.
- Aspirin has been linked to a serious illness called Reye syndrome. Do not give Ascomp-Codeine to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Ascomp-Codeine. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Use Ascomp-Codeine with caution in the ELDERLY; they may be more sensitive to its effects.
- Ascomp-Codeine should be used 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 Ascomp-Codeine while you are pregnant. Ascomp-Codeine is not recommended during the last 6 months (second and third trimesters) of pregnancy because it may cause harm to the fetus. Ascomp-Codeine is found in breast milk. If you are or will be breast-feeding while you use Ascomp-Codeine, check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time or at high doses, Ascomp-Codeine 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 Ascomp-Codeine stops working well. Do not take more than prescribed.
Some people who use Ascomp-Codeine 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 Ascomp-Codeine, you may experience WITHDRAWAL symptoms, including anxiety, dizziness, hallucinations, lightheadedness, muscle twitching, nausea, seizures, sleeplessness, trembling hands and fingers, vomiting, or weakness.
Possible side effects of Ascomp-Codeine:
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:
Dizziness; drowsiness; gas; indigestion; lightheadedness; nausea; stomach pain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; severe drowsiness; shallow breathing; unusual bruising or bleeding.
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 confusion; constriction of the pupils; fast or irregular heartbeat; loss of consciousness; nausea; ringing in the ears; sleeplessness; slow or shallow breathing; stomach pain; tremor; unusual drowsiness or dizziness; vomiting.Proper storage of Ascomp-Codeine:
Store Ascomp-Codeine at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ascomp-Codeine out of the reach of children and away from pets.
- If you have any questions about Ascomp-Codeine, please talk with your doctor, pharmacist, or other health care provider.
- Ascomp-Codeine 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 Ascomp-Codeine 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 Ascomp-Codeine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ascomp-Codeine. 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 Ascomp-Codeine.
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.