Butalbital Acetaminophen Caffeine

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.

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg

Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:

Butalbital 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)

The combination of acetaminophen, Butalbital, Caffeine comes as a capsule and tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen, Butalbital, Caffeine exactly as directed. Do not take more than six tablets or capsules in 1 day. If you think that you need more to relieve your symptoms, call your doctor.

Brand names of combination products of Butalbital

• Medigesic^® (containing Acetaminophen, Butalbital, Caffeine)
• Minotal^® (containing Acetaminophen, Butalbital, Caffeine)
• Mygracet^® (containing Acetaminophen, Butalbital, Caffeine)
• Nonbac^® (containing Acetaminophen, Butalbital, Caffeine)
• Orbivan^® (containing Acetaminophen, Butalbital, Caffeine)
• Pacaps^® (containing Acetaminophen, Butalbital, Caffeine)
• Pharmagesic^® (containing Acetaminophen, Butalbital, Caffeine)
• Quala Cet^® (containing Acetaminophen, Butalbital, Caffeine)
• Repan^® (containing Acetaminophen, Butalbital, Caffeine)
• Tenake^® (containing Acetaminophen, Butalbital, Caffeine)
• Tencet^® (containing Acetaminophen, Butalbital, Caffeine)
• Triad^® (containing Acetaminophen, Butalbital, Caffeine)
• Two-Dyne^® (containing Acetaminophen, Butalbital, Caffeine)
• Zebutal^® (containing Acetaminophen, Butalbital, Caffeine)
• Fioricet^® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
• Phrenilin^® with Caffeine and Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)

Acetaminophen (Tylenol) is a pain reliever and a fever reducer. Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. is a widely used over-the-counter analgesic (pain reliever) and antipyretic (fever reducer). It is commonly used for the relief of headaches, other minor aches and pains, and is a major ingredient in numerous cold and flu remedies. In combination with opioid analgesics, paracetamol can also be used in the management of more severe pain such as post surgical pain and providing palliative care in advanced cancer patients.

Acetaminophen side effects

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can damage your liver.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• low fever with nausea, stomach pain, and loss of appetite;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

The main mechanism of action of Acetaminophen is considered to be the inhibition of cyclooxygenase (COX), and recent findings suggest that it is highly selective for COX-2. While it has analgesic and antipyretic properties comparable to those of aspirin or other NSAIDs, its peripheral anti-inflammatory activity is usually limited by several factors, one of which is high level of peroxides present in inflammatory lesions. However, in some circumstances, even peripheral anti-inflammatory activity comparable to other NSAIDs can be observed.

What is acetaminophen, butalbital, and caffeine (Fioricet)? 

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. 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 acetaminophen, butalbital, and caffeine is used to treat tension headaches that are caused by muscle contractions.

Acetaminophen, butalbital, and caffeine may also be used for other purposes not listed in this medication guide.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;
• feeling light-headed or short of breath;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• drowsiness;
• dizziness, confusion or lightheadedness;
• dry mouth;
• nausea, vomiting, stomach pain, loss of appetite;
• feeling anxious or jittery;
• drunk feeling; or
• headache.

How should I take acetaminophen, butalbital, and caffeine? 

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Take the medicine with food or milk if it upsets your stomach.

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Store this medication at room temperature away from moisture and heat. Keep track of how much medicine has been used from each new bottle. Butalbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What other drugs will affect acetaminophen, butalbital, and caffeine? 

The following drugs can interact with acetaminophen, butalbital, and caffeine. Tell your doctor if you are using any of these:

• an antibiotic;
• a blood thinner such as warfarin (Coumadin);
• isoniazid;
• zidovudine (Retrovir, AZT);
• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
• gout medications such as probenecid (Benemid) or sulfinpyrazone;
• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
• an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.