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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
Fioricet with Codeine
- Capsules 30 mg codeine phosphate/325 mg acetaminophen/40 mg caffeine/50 mg butalbital
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.
Indications and Usage
Relief of symptom complex of tension (or muscle contraction) headache.
Hypersensitivity to acetaminophen, caffeine, opiates, or barbiturates; porphyria.
Dosage and AdministrationAdults and Children 12 yr of age and older
PO 1 to 2 tablets or capsules every 4 h; max, 6 tablets or capsules/day.
Store in airtight, light-resistant container at room temperature.
Drug InteractionsBeta-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.
Drowsiness; dizziness; lightheadedness; confusion; intoxicated feeling.
Nausea; vomiting; flatulence; constipation.
Shortness of breath.
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.
Category C .
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.
Prolonged use may produce drug tolerance and dependency (psychologic and physical).
Respiratory depressant effects may be enhanced and CSF pressure may be increased.
Blood dyscrasias, respiratory depression, hepatic damage, drowsiness, confusion, coma, hypotension, hypovolemic shock, nausea, tremor, vomiting, tachycardia, insomnia, restlessness.
- 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.
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