Butalbital / Aspirin / Caffeine / Codeine Phosphate

Pronunciation: BYOO-TAL-bih-tuhl/ASS-pihr-in/Kaff-EEN/KOE-deen FOSS-fate
Class: Narcotic analgesic

Trade Names

Fiorinal with Codeine
- Capsules 30 mg codeine phosphate/325 mg aspirin/40 mg caffeine/50 mg butalbital

Fiorinal-C ½ (Canada)
Fiorinal-C ¼ (Canada)
ratio-Tecnal C ½ (Canada)
ratio-Tecnal C ¼ (Canada)
Trianal C½ (Canada)
Trianal C¼ (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. Codeine binds to opiate receptors in CNS, causing inhibition of ascending pain pathways and altering perception of and response to pain.

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Indications and Usage

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

Contraindications

Hypersensitivity to salicylates, aspirin, caffeine, opiates, 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 decreased.

Corticosteroids

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

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

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

Probenecid, sulfinpyrazone

Uricosuric effects may be decreased.

Tricyclic antidepressants

Antidepressant effects 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. Codeine component may increase serum amylase or lipase levels.

Adverse Reactions

Cardiovascular

Tachycardia.

CNS

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

Dermatologic

Rash; pruritus.

GI

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

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

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

Renal Function

Use caution because of decreased elimination.

Hepatic Function

Use caution because of decreased elimination.

Drug dependency

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

Head injury

Respiratory depressant effects may be enhanced and CSF pressure may be increased.

Peptic ulcer, coagulation abnormalities, and preoperative states

Use 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, 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.
  • Warn patient to avoid any hazardous activity (eg, driving, operating heavy machinery) if dizziness, drowsiness or a decrease in mental acuity occurs.
  • Instruct patient to avoid sudden position changes to prevent orthostatic hypotension.
  • Tell patient to notify health care provider if any surgical procedures are required. Aspirin therapy should be discontinued 5 days before surgery to reduce potential for bleeding problems.
  • Advise patient to report the following symptoms to health care provider: persistent or recurring pain before next scheduled dose, difficulty breathing, blurred vision, buzzing in ears, increased drowsiness, vomiting, abdominal pain, tarry stools, unusual bruising or bleeding.

Copyright © 2009 Wolters Kluwer Health.

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