Acetaminophen, butalbital, and caffeine

Name: Acetaminophen, butalbital, and caffeine

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Acetaminophen, butalbital, and caffeine dosing information

Usual Adult Dose for Headache:

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL 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.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache:

12 years or older:

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL 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.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Adult Dose for Headache

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL 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.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache

12 years or older:

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL 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.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

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.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally as needed
-Do not exceed 6 capsules/tablets per day or 90 mL of oral liquid per day; do not exceed 4000 mg of acetaminophen per day; when calculating daily acetaminophen doses, be sure to include all acetaminophen-containing products and all routes of administration.
-Oral liquid is 7.368% alcohol.

Storage requirements: Protect from light and moisture

General:
-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 doses are not exceeded; use of more than 1 acetaminophen-containing product at a time should be discouraged as the use of multiple acetaminophen-containing products increases the risk of excess acetaminophen doses.
-Serious skin reaction may occur; discontinue therapy at first appearance of skin rash or any other sign of hypersensitivity.

Monitoring:
-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

Patient advice:
-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.

Acetaminophen / butalbital / caffeine Breastfeeding Warnings

Acetaminophen, butalbital, and caffeine are excreted into human milk in small concentrations. The significance of the effects on nursing infants has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (acetaminophen); Yes (barbiturates); Yes (caffeine)

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