Butalbital APAP
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Butalbital, structure presents as 5-allyl-5-isobutylbarbituric acid, is a barbiturate with an intermediate duration of action. It has the same chemical formula as talbutal but a different structure. Butalbital is often combined with other medications, such as paracetamol (acetaminophen) or aspirin, and is commonly prescribed for the treatment of pain and headache. The various formulations combined with codeine are FDA approved for the treatment of tension headaches.
Combinations include:
- Butalbital and paracetamol (acetaminophen) (trade names: Axocet, Bucet, Bupap, Cephadyn, Dolgic, Phrenilin, Phrenilin Forte, Sedapap)
- Butalbital, paracetamol (acetaminophen), and caffeine (trade names: Fioricet, Esgic, Esgic-Plus)
- Butalbital and aspirin (trade name: Axotal)
- Butalbital, aspirin, and caffeine (trade names Fiorinal, Fiormor, Fiortal, Fortabs, Laniroif)
- Butalbital, paracetamol (acetaminophen), caffeine, and codeine phosphate (Fioricet #3 with Codeine)
- Butalbital, aspirin, caffeine, and codeine phosphate (trade name: Fiorinal #3 with Codeine)
Each Fioricet tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg
Inactive Ingredients: crospovidone, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Acetaminophen
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
Caffeine USES: This medication is a pain reliever and sedative. It is used to relieve mild to moderate pain and tension headaches.
OTHER USES: This medication may also be used to treat migraine headaches.
HOW TO USE: To prevent upset stomach, take this medication with food or milk. Pain medications work best if they are used as the first signs of pain (or first signs of migraine) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well. Take this as prescribed. Do not increase your dose or take it more frequently without your doctor's approval. This medication contains acetaminophen. Do not take more acetaminophen than recommended (see Side Effects section).
SIDE EFFECTS: May cause lightheadedness, dizziness, drowsiness, stomach upset, nausea, and sleeping disturbances the first few days as your body adjusts to the medication. If these symptoms persist or become bothersome, inform your doctor. Notify your doctor immediately if you develop: a rapid/ irregular heartbeat. If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Tell your doctor immediately if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially of: liver disease, alcohol or narcotic dependence, emotional/mental conditions, heart disease (arrhythmias, recent MI), stomach/intestinal ulcers, any allergies. This product contains acetaminophen. Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information. To prevent oversedation, avoid using alcohol and other sedative type medications while taking this. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. This medication contains caffeine. Avoid drinking large amounts of caffeinated beverages while taking this medication as excessive nervousness and irritability can occur. This medication should be used during pregnancy only if clearly needed. Small amounts of this medication appear in breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription drugs you may use, especially of: "blood thinners" Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use that cause drowsiness such as: medicine for sleep (e.g., sedatives), tranquilizers, anti-anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Acetaminophen is an ingredient in many nonprescription products and in some combination prescription medications. Read the labels carefully before taking other pain relievers, fever reducers, or cold products to see if they also contain acetaminophen. Consult your pharmacist if you are uncertain if your other prescription or nonprescription products contain acetaminophen. (Also see adult maximum daily dose information in Side Effects section). This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include vomiting, unusual drowsiness, lack of feeling alert, slow or shallow breathing, cold or clammy skin, loss of consciousness, severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue.
NOTES: Do not share this product with others.
MISSED DOSE: Not applicable.
STORAGE: Store at room temperature away from moisture and sunlight. Do not store in the bathroom.