Rx Product Guide

   
   
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Butalbital / Acetaminophen / Caffeine / Codeine Phosphate (BYOO-TAL-bih-tuhl/uh-seet-uh-MIN-oh-fen/kaff-EEN/KOE-deen FOSS-fate)
Trade Name(s):   Fioricet with Codeine
  ·Capsules 30 mg codeine phosphate/325 mg acetaminophen/40?mg caffeine/50 mg butalbital

Indicates Canadian Trade Name.


Class: Narcotic analgesic

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

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

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.
Lab Test Interferences: 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:
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: Signs & symptoms Blood dyscrasias, respiratory depression, hepatic damage, drowsiness, confusion, coma, hypotension, hypovolemic shock, nausea, tremor, vomiting, tachycardia, insomnia, restlessness.

Patient/Family Education:
  • 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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