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Butalbital / Aspirin / Caffeine

Pronunciation: BYOO-TAL-bih-tuhl/ASS-pihr-in/kaff-EEN
Class: Nonnarcotic analgesic

For Professionals Side Effects Interactions More...

Trade Names

Fiorinal
- Capsules 325 mg aspirin/40 mg caffeine/50 mg butalbital

Fiortal
- Capsules 325 mg aspirin/40 mg caffeine/50 mg butalbital

Butalbital Compound
- Capsules 325 mg aspirin/40 mg caffeine/50 mg butalbital
- Tablets 325 mg aspirin/40 mg caffeine/50 mg butalbital

ratio-Tecnal (Canada)
Trianal (Canada)

Pharmacology

Butalbital has generalized depressant effect on CNS and, in very high doses, has peripheral effects. Aspirin has analgesic, antipyretic, anti-inflammatory, and antirheumatic effects; its analgesic and anti-inflammatory effects may be mediated through inhibition of prostaglandin synthetase enzyme complex. Aspirin also irreversibly inhibits platelet aggregation. Caffeine is thought to produce constriction of cerebral blood vessels.

Indications and Usage

Relief of symptom complex of tension (or muscle contraction) headache.

Contraindications

Hypersensitivity to salicylates, aspirin, caffeine, or barbiturates; porphyria; bleeding disorders; syndrome of nasal polyps, angioedema, and bronchospastic reactivity to aspirin or other NSAIDs; peptic ulcer.

Dosage and Administration

Adults and Children 12 yr of age and older

PO 1 to 2 tablets or capsules every 4 h; max, 6 tablets or capsules/day.

Storage/Stability

Store in airtight, light-resistant container at room temperature.

Drug Interactions

Beta-blockers (eg, propranolol), doxycycline, estrogens (including oral contraceptives), felodipine, griseofulvin, nifedipine, phenylbutazone, quinidine, theophylline

Effects of these drugs may be increased.

Corticosteroids

May enhance renal Cl of aspirin; sudden discontinuation of corticosteroids may result in symptoms of salicylism; effects of corticosteroids may be decreased.

Insulin, oral antidiabetic agents

Hypoglycemic effects may be increased.

MAOIs

May increase CNS effects.

Methotrexate, 6-mercaptopurine

Bone marrow toxicity may occur.

NSAIDs

Increased GI ulceration or bleeding may occur.

Other CNS depressants (eg, ethanol, narcotics, general anesthetics, tranquilizers, sedative-hypnotics)

Increased drowsiness, dizziness, and other CNS depressive effects may occur.

Sulfinpyrazone, probenecid

Uricosuric effects may be decreased.

Tricyclic antidepressants

Antidepressant levels/effect may decrease.

Warfarin

Anticoagulant effects may be increased or decreased.

Laboratory Test Interactions

Blood tests

Serum amylase; fasting blood glucose; cholesterol; protein; serum hepatic aminotransferase (ALT); uric acid; prothrombin time.

Urine tests

Glucose, 5-hydroxyindoleacetic acid; Gerhardt ketone, vanillylmandelic acid; uric acid; diacetic acid; spectrophotometric detection of barbiturates.

Adverse Reactions

Cardiovascular

Tachycardia.

CNS

Drowsiness; dizziness; lightheadedness; confusion; mental depression; unusual excitement; nervousness.

Dermatologic

Rash.

GI

Nausea; vomiting; flatulence; heartburn; abdominal pains; constipation.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 12 yr of age not established.

Renal Function

Use with caution because of decreased elimination.

Hepatic Function

Use with caution because of decreased elimination.

Drug dependency

Prolonged use may produce drug dependency (psychologic and physical) and tolerance.

Peptic ulcer, coagulation abnormalities and preoperative states

Use with extreme caution because of increased bleeding time.

Reye syndrome

May occur in children because of aspirin component; do not use for chickenpox or flu symptoms.

Overdosage

Symptoms

Hyperthermia, tachycardia, respiratory depression, bleeding, drowsiness, confusion, coma, hypotension, hypovolemic shock, nausea, vomiting, tremor, tinnitus, fluid and electrolyte abnormalities, insomnia, restlessness.

Patient Information

Caution patient that dependency/tolerance may result from long-term use.
Tell patient to take with food or full glass of water.
Instruct patient not to discontinue abruptly after long-term regular use.
Caution patient to avoid intake of alcoholic beverages and other CNS depressants without health care provider approval.
Warn patient to avoid any hazardous activity (eg, driving, smoking) if dizziness, drowsiness, or decrease in mental acuity occurs.
Instruct patient to avoid sudden position changes to avoid orthostatic hypotension.
Advise patient to notify health care provider if any surgical procedures are required. Discontinue aspirin therapy 5 days prior to surgery to reduce potential for bleeding problems.
Advise patient to report these symptoms to health care provider: persistent or recurrent pain before next scheduled dose, difficulty breathing, buzzing in ears, increased drowsiness, vomiting, abdominal pain, tarry stools, unusual bruising or bleeding.