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, usually starting at the low end of the dose range.
The drug should not be abruptly discontinued in the physically dependent person.
Precautions
Safety and efficacy have not been established in patients younger than 12 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 per day
Storage requirements: Protect from light and moisture
General:
Butalbital is a drug that may be abused; extended use is not recommended.
Monitoring:
Monitor for potential abuse
Monitor liver function tests in patients with severe hepatic disease
Monitor renal function tests in patients with severe renal disease
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 that this drug contains aspirin and should not be taken by patients with an aspirin allergy.
Patients should be advised to avoid alcohol use while taking this drug.
Patients should be advised to avoid potentially hazardous 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.
