Butalbital and Acetaminophen

Cephadyn Tablets (Butalbital and Acetaminophen Tablets) 50 mg/650 mg are supplied in bottles of 100 tablets, NDC 59702-650-01 and in bottles of 500 tablets, NDC 59702-650-50. Each tablet contains butalbital 50 mg (Warning: May be habit-forming) and acetaminophen 650 mg. Tablets are uncoated, blue, capsule-shaped and are debossed “A” score “P” on one side and “110” on the other side.

Storage

Protect from light and moisture. Store at controlled room temperature, 15°C to 30°C (59°F to 86°F) [see USP].

Dispense in a tight, light-resistant container with a child-resistant closure.

Manufactured for: Atley Pharmaceuticals, Ashland, VA 23005. Manufactured by: Mikart, Inc. Atlanta, GA 30318. Rev. 09/03

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

• If you take butalbital and acetaminophen on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, oral:

Allzital: Butalbital 25 mg and acetaminophen 325 mg

Bupap: Butalbital 50 mg and acetaminophen 300 mg

Marten-Tab: Butalbital 50 mg and acetaminophen 325 mg

Generic: Butalbital 50 mg and acetaminophen 300 mg, Butalbital 50 mg and acetaminophen 325 mg

Capsule, oral:

Phrenilin Forte: Butalbital 50 mg and acetaminophen 650 mg [may contain benzyl alcohol] [DSC]

• Allzital
• Bupap
• Marten-Tab
• Phrenilin Forte [DSC]

Butalbital: Short- to intermediate-acting barbiturate; depresses the sensory cortex, decreases motor activity, alters cerebellar function, and produces drowsiness, sedation, hypnosis, and dose-dependent respiratory depression.

Acetaminophen: Inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation.

Absorption

Butalbital: Well absorbed

Excretion

Butalbital: Urine (59% to 88% as unchanged drug or metabolites)

Half-Life Elimination

Butalbital: ~35 hours

Protein Binding

Butalbital: 45%

There are no dosage adjustments provided in the manufacturer's labeling; use with caution in severe impairment.

Store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light and moisture.

Acetaminophen may produce false-positive tests for urinary 5-hydroxyindoleacetic acid.

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 4,000 mg per day, and often involve more than one acetaminophen-containing product.