Usual Adult Dose for Headache

Butalbital 50 mg/acetaminophen 300 or 325 mg:
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Comments:

• Due to high rate of physical dependence, the extended use of this drug is not recommended.
• The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Usual Pediatric Dose for Headache

12 years or older:
Butalbital 50 mg/acetaminophen 300 or 325 mg:
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Comments:

• Due to high rate of physical dependence, the extended use of this drug is not recommended.
• The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

Dose Adjustments

Elderly: Dose selection should be cautious generally starting at the low end of the dosing range.

The drug should not be abruptly discontinued in the physically dependent person.

Precautions

US BOXED WARNING: Hepatotoxicity

• Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most cases of liver injury are associated with acetaminophen use at doses that exceed 4000 mg per day, and often involve more than 1 acetaminophen-containing product.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally as needed; do not exceed recommended doses
• Do not exceed 4000 mg of acetaminophen per day; when calculating daily acetaminophen doses, be sure to include the amount in this product as well as all acetaminophen-containing products and all routes of administration.

• Butalbital use is associated with a high rate of physical dependence; extended use is not recommended.
• Acetaminophen induced hepatotoxicity is mostly preventable by ensuring maximum daily acetaminophen doses are not exceeded; use of more than 1 acetaminophen-containing product at one time should be discouraged.
• Serious skin reaction may occur; discontinue therapy at first appearance of skin rash or any other sign of hypersensitivity.

• Monitor for potential abuse
• Monitor for respiratory depression, especially with concomitant CNS depressant use
• Monitor for nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in upper right part of the stomach, yellow of the skin or eyes, and/or flu-like symptoms as this may be an indication of acetaminophen overdose.
• Monitor for skin reactions

• Patients should be advised that this drug has the potential to cause physical and psychological dependence, and tolerance; patients should be instructed to take this drug as prescribed, in the amounts prescribed, and no more frequently than prescribed.
• Patients should be advised that severe liver damage may occur if more than the recommended amount of acetaminophen is taken; if they suspect they may have taken too much acetaminophen or if they experience nausea, vomiting, loss of appetite, or yellowing of the skin or eyes they should seek medical help promptly.
• Patients should be discouraged from using multiple acetaminophen-containing products concurrently; patients should be instructed to check with their healthcare provider or pharmacist if they have questions on what products contain acetaminophen.
• Patients should be advised to avoid alcohol use while taking this drug.
• Women of childbearing potential should be advised to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.