ASPIRIN, BUTALBITAL, AND CAFFEINE

(AS pir in, byoo TAL bi tal, KAF een) Brand: Butalbital Compound, Fiorinal

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What is the most significant information I must know about aspirin, butalbital, and caffeine?

• Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the recent 14 days. A dangerous drug interaction could occur, leading to serious side effects.

• Stop using this medicine and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

• Do not drink alcohol while you are using this medicine. Alcohol may magnify your risk of stomach bleeding. Dangerous side effects or death can occur when alcohol is combined with butalbital.

• Butalbital may be habit-forming and should be used only by the face for whom it was prescribed. Hold this medicine in a secure seat where others can't get to it.

Aspirin must not be given to a baby or teenager who has a fever, especially if the baby also has flu symptoms or chicken pox. Aspirin can reason a serious and sometimes fatal condition called Reye's syndrome in children.

What is aspirin, butalbital, and caffeine?

Aspirin is a pain reliever, as well as an anti-inflammatory and a fever reducer.

• Butalbital is a barbiturate. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

• The combination of aspirin, butalbital, and caffeine is used to treat tension headaches. This medication is not for treating headaches that come and go.

Aspirin, butalbital, and caffeine may also be used for purposes another than those listed in this medicine guide.

What must I discuss with my healthcare provider till taking aspirin, butalbital, and caffeine?

• You must not use this medicine if you are allergic to aspirin, butalbital, or caffeine, or if you have:

· stomach ulcer;

· severe liver disease;

· nasal polyps;

· porphyria (a genetic enzyme mess that causes symptoms affecting the skin or nervous system);

· a bleeding or blood clotting mess (such as hemophilia); or

· an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Celebrex, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

• Do not use aspirin, butalbital, and caffeine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the recent 14 days. A dangerous drug interaction could occur, leading to serious side effects.

• To create certain you can safely take aspirin, butalbital, and caffeine, speak your doctor if you have any of these another conditions:

· liver or kidney disease;

· asthma or other respiratory disease;

· fluid retention;

· heart malady, congestive heart failure, tall blood pressure;

· a history of head injury or brain tumor;

· a stomach or intestinal disorder;

· a thyroid disorder;

· enlarged prostate or urination problems; or

· Addison's malady (an adrenal gland disorder).

• Butalbital may be habit forming and must be used only by the face for whom it was predesigned. Never share this medicine with other face, especially somebody with a history of drug abuse or addiction. Hold the medicine in a seat where others can't get to it.

• FDA pregnancy category C. Butalbital may reason addiction or withdrawal symptoms in a newborn if the mother takes the medicine during pregnancy. Taking aspirin during late pregnancy may reason bleeding in the mother or the child during delivery. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.

Aspirin, butalbital, and caffeine can pass into breast milk and may harm a nursing child. You must not breast-feed while you are using aspirin, butalbital, and caffeine.

Aspirin must not be given to a baby or teenager who has a fever, especially if the baby also has flu symptoms or chicken pox. Aspirin can reason a serious and sometimes fatal condition called Reye's syndrome in children.

• Serious side effects may be more likely in older adults and those who are ill or debilitated.

How must I take aspirin, butalbital, and caffeine?

• Take exactly as predesigned. Never take this medicine in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Speak your doctor if the medication seems to stop working as well in relieving your headache.

• Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medication.

• If you need surgery, speak the surgeon onward of time that you are using this medicine. You may need to stop using the medication for a short time.

• Store at room temperature away from moisture and heat. Hold track of the amount of medication used from every new bottle. Butalbital is a drug of abuse and you must be aware if anyone is using your medication improperly or without a prescription.

What happens if I miss a dose?

• Since this medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medicine regularly, take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222. An overdose of butalbital can be fatal.

• Overdose symptoms may include extreme drowsiness, confusion, restless feeling, insomnia, tremors, quick heart course, vomiting, stomach pain, rapid breathing, feeling hot, ringing in your ears, weak or shallow breathing, seizure (convulsions), or fainting.

What must I avoid while taking aspirin, butalbital, and caffeine?

• This medicine may impair your thinking or reactions. Avoid driving or operating machinery before you know how the medication will affect you.

• Ask a doctor or pharmacist till using any cough, cool, allergy, or pain medicine. Aspirin and caffeine are contained in much combination medicines. Taking determined commodity together can reason you to get too many of a determined drug. Check the label to see if a medication contains aspirin or caffeine.

• Do not drink alcohol while you are using this medicine. Alcohol may magnify your risk of stomach bleeding. Dangerous side effects or death can occur when alcohol is combined with butalbital.

What are the possible side effects of aspirin, butalbital, and caffeine?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Stop using this medicine and call your doctor at once if you have a serious side effect such as:

· shallow breathing, slow heart rate;

· quick or pounding heart course, muscle twitching;

· confusion, unusual thoughts or behavior;

· bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

· problems with urination; or

· light bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

• Smaller serious side effects include:

· drowsiness, dizziness;

· mild nausea, gas, upset stomach, stomach pain; or

· sleep problems (insomnia).

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect aspirin, butalbital, and caffeine?

• Till using this medicine, speak your doctor if you regularly use another medicines that create you sleepy (such as cool or allergy medication, sedatives, narcotic pain medication, sleeping pills, muscle relaxers, and medication for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital.

• Speak your doctor about all another medicines you use, especially:

· insulin or oral diabetes medication;

· mercaptopurine (Purinethol);

· methotrexate (Rheumatrex, Trexall);

· probenecid (Benemid);

· a blood thinner such as warfarin (Coumadin, Jantoven);

· an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), sertraline (Zoloft), trazodone (Desyrel, Oleptro), or vilazodone (Viibryd);

· other barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

· an NSAID such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

· other salicylate such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others; or

· steroid medicine such as prednisone (Deltasone, Sterapred), methylprednisolone (Medrol), fluticasone (Advair, Flonase, Flovent, Veramyst), beclomethasone (Qvar), budesonide (Pulmicort, Rhinocort, Symbicort), dexamethasone (Cortastat, Dexasone, Solurex, DexPak), mometasone (Asmanex, Nasonex), triamcinolone (Aristocort, Aristospan, Clinacort, Kenalog, Nasacort), and others.

This list is not complete and there are much another drugs that can interact with aspirin, butalbital, and caffeine. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about aspirin, butalbital, and caffeine.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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