Butalbital, acetaminophen and caffeine

What is Butalbital, acetaminophen and caffeine?

• Butalbital, acetaminophen and caffeine (Fioricet) is combination drug product is intended as a treatment for tension headache.
• It consists of a fixed combination of butalbital, a barbiturate, acetaminophen an analgesic and caffeine, a xanthine.

Butalbital structure

Butalbital ball-and-stick

Paracetamol-skeletal

Paracetamol-from-xtal-3D-balls

Caffeineredraw

Caffeine molecule ball from xtal (2)

What are the uses of this medicine?

• Butalbital, acetaminophen and caffeine (Fioricet) tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

How does this medicine work?

• This combination drug product is intended as a treatment for tension headache.
• It is a combination preparation of acetaminophen, butalbital, and caffeine. '
• Acetaminophen exerts antipyretic and analgesic activities by inhibiting prostaglandin synthesis.
• Butalbital, a barbiturate with an intermediate duration of action, depresses the central nervous system and exerts sedative activity. Caffeine is a central nervous system stimulant and causes constriction of dilated cerebral blood vessels.
• This combination is used for the relief and treatment of migraine and tension headaches.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity or intolerance to any component of this product
• porphyria

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• especially anticoagulants ('blood thinners') such as warfarin (Coumadin), antidepressants, antihistamines, pain medications, sedatives, sleeping pills, tranquilizers.

Is this medicine FDA approved?

• The combination was approved for medical use in the United States in 1984.
• It is available as a generic medication.
• In 2020, the combination butalbital/acetaminophen/caffeine was the 201st most commonly prescribed medication in the United States, with more than 2 million prescriptions.

How should this medicine be used?

Recommended dosage:

• One or 2 tablets every 4 hours as needed.
• Total daily dosage should not exceed 6 tablets.

Administration:

• 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.
• This medication can be habit-forming.
• Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a capsule and tablet

This medicine is available in fallowing brand namesː

• Alagesic
• Americet
• Anolor
• Anoquan
• Arcet
• Dolgic
• Dolmar
• Endolor
• Esgic
• Ezol
• Femcet
• Fioricet
• Fiorpap
• G-1
• Ide-cet
• Isocet
• Margesic
• Medigesic
• Minotal
• Mygracet
• Nonbac
• Pacaps
• Pharmagesic
• Quala Cet
• Repan
• Tenake
• Tencet
• Triad
• Two-Dyne
• Zebutal

What side effects can this medication cause?

The most common side effects of this medicine include:

• drowsiness
• lightheadedness
• dizziness
• sedation
• shortness of breath
• nausea
• vomiting
• abdominal pain
• intoxicated feeling

Less common side effects may include:

• Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.
• Autonomic Nervous: dry mouth, hyperhidrosis.
• Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.
• Cardiovascular: tachycardia.
• Musculoskeletal: leg pain, muscle fatigue.
• Genitourinary: diuresis.
• Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.
• Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

What special precautions should I follow?

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

• Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
• Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
• Butalbital and Acetaminophen Tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.
• This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
• Alcohol and other Central Nervous System (CNS) depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Do not take Butalbital, Acetaminophen and Caffeine Tablets, USP if you are allergic to any of its ingredients. If you develop signs of allergy such as a rash or difficulty breathing stop taking Butalbital, Acetaminophen and Caffeine Tablets, USP and contact your healthcare provider immediately. Tell your doctor if you have or have ever had liver disease, porphyria, or depression.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Barbiturate overdose:

• drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock

Acetaminophen overdosage:

• hepatic necrosis
• Renal tubular necroses, hypoglycemic coma, and coagulation defects

• Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise.

Caffeine overdose:

• Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.
• Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.
• Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption.
• Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity.
• To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• This product should be given to a pregnant woman only when clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients below the age of 12 have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BUTALBITAL
• ACETAMINOPHEN
• CAFFEINE

Inactive ingredients:

• SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• STEARIC ACID
• CROSPOVIDONE
• POVIDONE
• STARCH, CORN

Who manufactures and distributes this medicine?

Distributed by:

• Par Pharmaceutical
• Chestnut Ridge, NY

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F); dispense in a tight, light-resistant container as defined in the USP.

• Dailymed label info on Butalbital, acetaminophen and caffeine
• FDA Butalbital, acetaminophen and caffeine

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