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butalbital, acetominophen and caffeine

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Overview

What is butalbital, acetominophen and caffeine?

Butalbital, Acetaminophen, and Caffeine Tablets USP, is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:

Butalbital, USP.............................50 mg

Acetaminophen, USP.................500 mg

Caffeine, USP..............................40 mg

Inactive Ingredients:

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:

Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:



What does butalbital, acetominophen and caffeine look like?



What are the available doses of butalbital, acetominophen and caffeine?

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What should I talk to my health care provider before I take butalbital, acetominophen and caffeine?

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How should I use butalbital, acetominophen and caffeine?

Butalbital, Acetaminophen and Caffeine Tablet is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

One tablet every four (4) hours. Total daily dosage should not exceed 6 tablets in 24 hours. Extended and repeated use of this product is not recommended because of the potential for physical dependence.


What interacts with butalbital, acetominophen and caffeine?


  • This product is contraindicated under the following conditions:


    • Hypersensitivity or intolerance to any component of this product
    • Patients with porphyria.




What are the warnings of butalbital, acetominophen and caffeine?

Because of potential drug interactions, concomitant use of tizanidine with other CYP1A2 inhibitors, such as zileuton, other fluoroquinolones, antiarrythmics (amiodarone, mexiletine, propafenone, and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine (see ) should ordinarily be avoided. If their use is clinically necessary, they should be used with caution.


What are the precautions of butalbital, acetominophen and caffeine?



General







Laboratory Tests







Drug/Laboratory Test Interactions



Carcinogenesis, Mutagenesis, Impairment of Fertility



Pregnancy

Teratogenic Effects

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Nonteratogenic Effects



Nursing Mothers



Pediatric Use






What are the side effects of butalbital, acetominophen and caffeine?



Frequently Observed






What should I look out for while using butalbital, acetominophen and caffeine?

This product is contraindicated under the following conditions:

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.


What might happen if I take too much butalbital, acetominophen and caffeine?

Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.


How should I store and handle butalbital, acetominophen and caffeine?

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