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Acetaminophen / Butalbital / Caffeine / Codeine Dosage

Applies to the following strength(s): 325 mg-50 mg-40 mg-30 mg ; 300 mg-50 mg-40 mg-30 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Headache

1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules 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

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 AND DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
-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.
-Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to CYP2D6 polymorphism.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule III

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally as needed
-Do not exceed 6 capsules/tablets per day or 180 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 and codeine are drugs that may be abused; 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 one 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 and signs of morphine overdose
-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 understand the risks of life-threatening respiratory depression and when this risk is greatest, patients should be aware that a genetic mutation may result in greater toxicity in some patients.
-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.
-Patients should be advised to avoid potentially hazard tasks such as driving a car 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.

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