Butalbital/acetaminophen

What is Butalbital/acetaminophen?

• Butalbital/acetaminophen (Butapap) combination drug product is intended as a treatment for tension headache.
• It contains butalbital, a barbiturate and paracetamol (acetaminophen), an analgesic.

Butalbital structure

Butalbital ball-and-stick

Paracetamol-skeletal

Paracetamol-from-xtal-3D-balls

What are the uses of this medicine?

• Butalbital/acetaminophen (Butapap) is used for the relief of the symptom complex of tension (or muscle contraction) headache.

How does this medicine work?

• It consists of a fixed combination of butalbital and acetaminophen.
• The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

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 healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• monoamine oxidase (MAO) inhibitors
• narcotic analgesics
• alcohol
• general anesthetics
• tranquilizers such as chlordiazepoxide
• sedative-hypnotics
• other CNS depressants

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.

How should this medicine be used?

Recommended dosage:

• Butalbital and Acetaminophen Tablets 50 mg/300 mg: One or two tablets every four hours.
• Total daily dosage should not exceed 6 tablets.

Administration:

• The combination of acetaminophen, Butalbital comes as a 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 Tablet for oral administration, contains Butalbital, USP 50 mg, Acetaminophen, USP 300 mg.

This medicine is available in fallowing brand namesː

• Butapap

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 is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
• 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 and Acetaminophen Tablets 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 and Acetaminophen Tablets and contact your healthcare provider immediately.

What to do in case of emergency/overdose?

Symptoms of overdose 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.

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.
• These products should be given to a pregnant woman only when clearly needed.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BUTALBITAL
• ACETAMINOPHEN

Inactive ingredients:

• Pregelatinized Starch, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, D&C Yellow #10 Lake, and FD&C Red #40 Lake.

Who manufactures and distributes this medicine?

Manufactured by: Nexgen Pharma, Inc., Irvine, CA, USA

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

• Store at 20°C to 25°C (68°F to 77°F).

• Dailymed label info on Butalbital/acetaminophen
• FDA Butalbital/acetaminophen

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