Butalbital, Aspirin, and Caffeine

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Overview

What is Butalbital, Aspirin, and Caffeine?

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

Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula:

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

Inactive Ingredients:

What does Butalbital, Aspirin, and Caffeine look like?

What are the available doses of Butalbital, Aspirin, and Caffeine?

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What should I talk to my health care provider before I take Butalbital, Aspirin, and Caffeine?

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How should I use Butalbital, Aspirin, and Caffeine?

Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP 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 Butalbital, Aspirin, and Caffeine?

Butalbital, Aspirin, and Caffeine Capsules, USP is contraindicated under the following conditions:

What are the warnings of Butalbital, Aspirin, and Caffeine?

The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

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 Butalbital, Aspirin, and Caffeine Capsules, USP 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 are the precautions of Butalbital, Aspirin, and Caffeine?

General

Butalbital, Aspirin, and Caffeine Capsules, USP 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.

Information for Patients

Patients should be informed that Butalbital, Aspirin, and Caffeine Capsules, USP contains aspirin and should not be taken by patients with an aspirin allergy.

Butalbital, Aspirin, and Caffeine Capsules, USP may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking Butalbital, Aspirin, and Caffeine Capsules, USP.

Alcohol and other CNS depressants may produce an additive CNS depression when taken with Butalbital, Aspirin, and Caffeine Capsules, USP and should be avoided.

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

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.

Butalbital, Aspirin, and Caffeine Capsules, USP may enhance the effects of:

Butalbital, Aspirin, and Caffeine Capsules, USP 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.

Drug/Laboratory Test Interactions

Aspirin:

Carcinogenesis, Mutagenesis, Impairment of Fertility

Adequate long-term studies have been conducted in mice and rats with aspirin, alone or in combination with other drugs, in which no evidence of carcinogenesis was seen. No adequate studies have been conducted in animals to determine whether aspirin has a potential for mutagenesis or impairment of fertility. No adequate studies have been conducted in animals to determine whether butalbital has a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Usage in Pregnancy

Pregnancy Category C

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last 2 months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Studies of aspirin use in pregnant women have not shown that aspirin increases the risk of abnormalities when administered during the first trimester of pregnancy. In controlled studies involving 41,337 pregnant women and their offspring, there was no evidence that aspirin taken during pregnancy caused stillbirth, neonatal death or reduced birth weight. In controlled studies of 50,282 pregnant women and their offspring, aspirin administration in moderate and heavy doses during the first four lunar months of pregnancy showed no teratogenic effect.

Therapeutic doses of aspirin in pregnant women close to term may cause bleeding in mother, fetus, or neonate. During the last 6 months of pregnancy, regular use of aspirin in high doses may prolong pregnancy and delivery.

Labor and Delivery

Ingestion of aspirin prior to delivery may prolong delivery or lead to bleeding in the mother or neonate.

Nursing Mothers

Aspirin, caffeine, and barbiturates are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from Butalbital, Aspirin, and Caffeine Capsules, USP, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

What are the side effects of Butalbital, Aspirin, and Caffeine?

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 butalbital, aspirin, and caffeine capsules. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.

What should I look out for while using Butalbital, Aspirin, and Caffeine?

Butalbital, Aspirin, and Caffeine Capsules, USP 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 Butalbital, Aspirin, and Caffeine Capsules, USP 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 Butalbital, Aspirin, and Caffeine?

The toxic effects of acute overdosage of Butalbital, Aspirin, and Caffeine Capsules, USP 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 Butalbital, Aspirin, and Caffeine Capsules, USP overdosage is unlikely.

How should I store and handle Butalbital, Aspirin, and Caffeine?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Butalbital, Aspirin, and Caffeine Capsules, USPRx onlyWatson Laboratories, IncBASPC01/07S0107Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Butalbital, Aspirin, and Caffeine Capsules, USPRx onlyWatson Laboratories, IncBASPC01/07S0107Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Butalbital, Aspirin, and Caffeine Capsules, USPRx onlyWatson Laboratories, IncBASPC01/07S0107Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Butalbital, Aspirin, and Caffeine Capsules, USPRx onlyWatson Laboratories, IncBASPC01/07S0107Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Butalbital, Aspirin, and Caffeine Capsules, USPRx onlyWatson Laboratories, IncBASPC01/07S0107Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Butalbital, Aspirin, and Caffeine Capsules, USPRx onlyWatson Laboratories, IncBASPC01/07S0107Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320Butalbital, Aspirin, and Caffeine Capsules, USPRx onlyWatson Laboratories, IncBASPC01/07S0107Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pharmacologically, Butalbital, Aspirin, and Caffeine Capsules, USP combines the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital.

The clinical effectiveness of butalbital, aspirin, and caffeine capsules in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared butalbital, aspirin, and caffeine capsules with each of its major components. This study demonstrated that each component contributes to the efficacy of butalbital, aspirin, and caffeine capsules 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, butalbital, aspirin, and caffeine capsules was shown to have significantly superior clinical effects to either component alone.

Non-Clinical Toxicology

Butalbital, Aspirin, and Caffeine Capsules, USP 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 Butalbital, Aspirin, and Caffeine Capsules, USP 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.

Butalbital, Aspirin, and Caffeine Capsules, USP may enhance the effects of:

Butalbital, Aspirin, and Caffeine Capsules, USP 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.

Butalbital, Aspirin, and Caffeine Capsules, USP 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 butalbital, aspirin, and caffeine capsules. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.

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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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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