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Butalbital, Aspirin, and Caffeine
Overview
What is Fiorinal?
Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) is supplied in capsule form for oral administration.
Each capsule contains the following active ingredients:
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:
CHNO molecular weight 224.26
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula:
CHO molecular weight 180.16
Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula:
CHNO molecular weight 194.19
Inactive Ingredients:
What does Fiorinal look like?
What are the available doses of Fiorinal?
Sorry No records found.
What should I talk to my health care provider before I take Fiorinal?
Sorry No records found
How should I use Fiorinal?
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.
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.
What interacts with Fiorinal?
Sorry No Records found
What are the warnings of Fiorinal?
Sorry No Records found
What are the precautions of Fiorinal?
Sorry No Records found
What are the side effects of Fiorinal?
Sorry No records found
What should I look out for while using Fiorinal?
Fiorinal is contraindicated under the following conditions:
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.
What might happen if I take too much Fiorinal?
The toxic effects of acute overdosage of Fiorinal are attributable mainly to its barbiturate component, and, to a lesser extent, aspirin. Because toxic effects of caffeine occur in very high dosages only, the possibility of significant caffeine toxicity from Fiorinal overdosage is unlikely.
How should I store and handle Fiorinal?
Store at USP controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 15°C (59°F) and 30°C (86°F). Contents under pressure. Do not puncture or incinerate. Avoid contact with eyes or other mucous membranes. Keep out of reach of children. Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)Store and Dispense Rx onlyFor all medical inquiries contact:ACTAVISMedical CommunicationsParsippany, NJ 070541-800-272-5525Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USAContent Updated: February 2014190104-1
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pharmacologically, Fiorinal combines the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital.
The clinical effectiveness of Fiorinal in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared Fiorinal with each of its major components. This study demonstrated that each component contributes to the efficacy of Fiorinal in the treatment of the target symptoms of tension headache (headache pain, psychic tension, and muscle contraction in the head, neck, and shoulder region). For each symptom and the symptom complex as a whole, Fiorinal was shown to have significantly superior clinical effects to either component alone.
Non-Clinical Toxicology
Fiorinal is contraindicated under the following conditions: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.
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Fiorinal may enhance the effects of:
Fiorinal may diminish the effects of:
Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites.
Fiorinal should be prescribed with caution for certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, coagulation disorders, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison’s disease, or prostatic hypertrophy.
Aspirin should be used with caution in patients on anticoagulant therapy and in patients with underlying hemostatic defects, and extreme caution in the presence of peptic ulcer.
Precautions should be taken when administering salicylates to persons with known allergies. Hypersensitivity to aspirin is particularly likely in patients with nasal polyps, and relatively common in those with asthma.
The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of Fiorinal. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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