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Fiorinal-Cod Indications, Dosage, Storage, Stability - Butalbital Compound With Codeine
INDICATIONS
Butalbital compound with Codeine is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy of Butalbital compound with Codeine is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: Butalbital compound with Codeine, codeine, Butalbital compound, and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital compound with Codeine proved statistically significantly superior to each of its components (Butalbital compound, codeine) and to placebo on measures of pain relief.
Evidence supporting the efficacy and safety of Butalbital compound with Codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.
DOSAGE AND ADMINISTRATION
One or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
HOW SUPPLIED
No information provided.
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