Fiorinal
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Questions & Answers
Side Effects & Adverse Reactions
Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking.
Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders. Aspirin administered preoperatively may prolong the bleeding time. Butalbital is habit-forming and potentially abusable. Consequently, the extended use of Fiorinal is not recommended. Results from epidemiologic studies indicate an association between aspirin and Reye’s Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Fiorinal is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Fiorinal in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
History
There is currently no drug history available for this drug.
Other Information
Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) is supplied in capsule form for oral administration.
Each capsule contains the following active ingredients:
| butalbital, USP . . . . . . . . . . . . . | 50 mg |
| aspirin, USP . . . . . . . . . . . . . . . | 325 mg |
| caffeine, USP . . . . . . . . . . . . . . | 40 mg |
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:
C11H16N2O3 molecular weight 224.26
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula:
C9H8O4 molecular weight 180.16
Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula:
C8H10N4O2 molecular weight 194.19
Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, and talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are printed with edible ink containing red iron oxide.
Sources
Fiorinal Manufacturers
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Watson Pharma, Inc.
![Fiorinal (Butalbital, Aspirin, And Caffeine) Capsule [Watson Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fiorinal | Actavis Pharma, Inc.
One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
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