Butalbital / Acetaminophen / Caffeine / Codeine Phosphate

Pronunciation: BYOO-TAL-bih-tuhl/uh-seet-uh-MIN-oh-fen/kaff-EEN/KOE-deen FOSS-fate
Class: Narcotic analgesic

Trade Names

Fioricet with Codeine
- Capsules 30 mg codeine phosphate/325 mg acetaminophen/40 mg caffeine/50 mg butalbital

Pharmacology

Butalbital has generalized depressant effect on CNS and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects; its analgesic effects may be mediated through inhibition of prostaglandin synthetase enzyme complex. Caffeine is thought to produce constriction of cerebral blood vessels. Codeine binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways and altering perception of and response to pain.

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Indications and Usage

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

Contraindications

Hypersensitivity to acetaminophen, caffeine, opiates, or barbiturates; porphyria.

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), corticosteroids, doxycycline, estrogens (including oral contraceptives), felodipine, griseofulvin, nifedipine, phenylbutazone, quinidine, theophylline, warfarin

Effects of these drugs may be decreased.

Carbamazepine, sulfinpyrazone

May increase risk of hepatotoxicity.

MAOIs

May increase CNS effects.

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

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

Tricyclic antidepressants

Antidepressant effects may decrease.

Laboratory Test Interactions

With Chemstrip bG and Dextrostix home blood glucose systems, may cause false decrease in mean glucose values; may increase serum amylase; may give false-positive urinary 5-hydroxyindoleacetic acid test results.

Adverse Reactions

Cardiovascular

Tachycardia.

CNS

Drowsiness; dizziness; lightheadedness; confusion; intoxicated feeling.

Dermatologic

Rash.

GI

Nausea; vomiting; flatulence; constipation.

Respiratory

Shortness of breath.

Precautions

Warnings

This product contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product.


Pregnancy

Category C .

Lactation

Undetermined.

Children

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

Labor and Delivery

Delivery may be prolonged and newborn may experience respiratory depression or withdrawal.

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.

Overdosage

Symptoms

Blood dyscrasias, respiratory depression, hepatic damage, drowsiness, confusion, coma, hypotension, hypovolemic shock, nausea, tremor, vomiting, tachycardia, insomnia, restlessness.

Patient Information

  • Caution patient that dependency/tolerance may result from long-term use.
  • Remind patient to take medication with full glass of water.
  • Instruct patient not to discontinue drug abruptly after long-term regular use.
  • Caution patient to avoid intake of alcoholic beverages and other CNS depressants without health care provider approval.
  • Caution patient to avoid any hazardous activity (eg, driving, operating heavy machinery) if dizziness, drowsiness, or a decrease in mental acuity occurs.
  • Warn patient that orthostatic hypotension may occur. Instruct patient to change positions slowly and to sit or lie down if symptoms occur.
  • Warn patient that constipation could occur. Advise patient to increase dietary fiber and fluids unless contraindicated.
  • Instruct patient to report these symptoms to health care provider: persistent or recurrent pain occurs before next scheduled dose, difficulty breathing, blurred vision, increased drowsiness, vomiting, constipation, urinary retention, yellowing of skin or gums.

Copyright © 2009 Wolters Kluwer Health.

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