Butalbital/Aspirin/Caffeine

DEA Class;  Rx, schedule III

Common Brand Names; Fiorinal

Analgesic and Barbiturate combos

Combination prescription product used to treat tension headache, migraine, and mild to moderate pain, especially when antianxiety or relaxant effects are needed.

Indicated for the treatment of tension headache.

Hypersensitivity or intolerance to aspirin, caffeine, or butalbital

Patients with a hemorrhagic diathesis (eg, hemophilia, hypoprothrombinemia, von Willebrand’s disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage)

Patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs

Peptic ulcer or other serious gastrointestinal lesions.

Patients with porphyria

Butalbital

Dizziness, drowsiness, feeling of intoxication, lightheadedness, sedation

Abdominal pain, nausea, vomiting

Shortness of breath

Aspirin

Dyspepsia, heartburn, nausea, vomiting, stomach pain

Tinnitus (high or chronic dose)

Rash

Urticaria

Caffeine

Tachycardia, palpitations (dose dependent)

Insomnia, irritability, nervousness, restlessness, tinnitus, tremor

Diarrhea, nausea, vomiting

Diuresis

Particular caution in patients with history of GI bleed, alcoholism, or bleeding disorders

Avoid driving car or operating machinery

Avoid in severe renal impairment (ie, CrCl <10 mL/min)

Butalbital is habit-forming and potentially abusable; consequently, extended use 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

Pregnancy

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

Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment

• Lactation: Aspirin, caffeine, and barbiturates are excreted in breast milk in small amounts, but the significance of their effects on nursing infants not known; because of potential for serious adverse reactions in nursing infants from drug combination, a decision should be made whether to discontinue nursing or discontinue drug, taking into account importance of drug to mother

Adults

6 tablets or capsules/day PO.

Elderly

6 tablets or capsules/day PO.

Adolescents

Safety and efficacy have not been established. 

Children

Safety and efficacy have not been established. 

butalbital/aspirin/caffeine

Tablet/Capsule: Schedule III

50mg/325mg/40mg