Butalbital, Aspirin, And Caffeine

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.

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.

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 may enhance the effects of:

• Oral anticoagulants, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites.
  
  
• Oral antidiabetic agents and insulin, causing hypoglycemia by contributing an additive effect, if dosage of Butalbital, Aspirin, and Caffeine Capsules exceeds maximum recommended daily dosage.
  
  
• 6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion.
  
  
• Non-steroidal anti-inflammatory agents, increasing the risk of peptic ulceration and bleeding by contributing additive effects.
  
  
• Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Butalbital, Aspirin, and Caffeine Capsules 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 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:

     
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 

Pharmacologically, Butalbital, Aspirin, and Caffeine Capsules 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, 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.