Rx Product Guide

   
   
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Acetaminophen with Codeine Phosphate (ass-cet-ah-MEE-noe-fen with KOE-deen FOSS-fate)
Trade Name(s):   Tylenol w/Codeine
  ·Elixir 12 mg codeine phosphate/120 mg acetaminophen
  Capital w/Codeine
  ·Suspension 12 mg codeine phosphate/120 mg acetaminophen
  Tylenol w/Codeine No. 2
  ·Tablets 15 mg codeine phosphate/300 mg acetaminophen
  Aceta w/ Codeine
  ·Tablets 30 mg codeine phosphate/300 mg acetaminophen
  Tylenol w/Codeine No. 3
  ·Tablets 30 mg codeine phosphate/300 mg acetaminophen
  Phenaphen w/Codeine No. 3
  ·Capsules 30 mg codeine phosphate/325 mg acetaminophen
  Tylenol w/Codeine No. 4
  ·Tablets 60 mg codeine phosphate/300 mg acetaminophen
  Phenaphen w/Codeine No. 4
  ·Capsules 60 mg codeine phosphate/325 mg acetaminophen
ratio-Emtec-30
ratio-Lenoltec No. 4
Triatec-30

Indicates Canadian Trade Name.


Class: Opioid analgesic combination

Action: Inhibits synthesis of prostaglandins; binds to opiate receptors in CNS and peripherally blocks pain impulse generation; produces antipyresis by direct action on hypothalamic heat-regulating center; causes cough suppression by direct central action in medulla; may produce generalized CNS depression; does not have significant anti-inflammatory or antiplatelet effects.

Indications: Relief of mild to moderate pain; analgesic-antipyretic therapy in presence of aspirin allergy, hemostatic disturbances, bleeding diatheses, upper GI disease and gouty arthritis.

Contraindications: Hypersensitivity to codeine phosphate or similar compounds.

Interactions:
Carbamazepine, hydantoins, sulfinpyrazone May result in increased risk of hepatotoxicity.
Cimetidine Effects of codeine may be enhanced, increasing toxicity.
CNS depressants (eg, barbiturates, ethyl alcohol, other narcotics) May result in additive CNS depressant effects and toxicity.
Tricyclic antidepressants, phenothiazines May cause additive CNS depressant effects and toxicity.
Lab Test Interferences: With Chemstrip bG , Dextrostix , and Visidex II home blood glucose systems, drug may cause false decrease in mean glucose values. False-positive results may occur in urinary 5-hydroxy-indoleacetic acid test.

Adverse Reactions:

cardiovascular:
Flushing.

cns:
Lightheadedness; dizziness; sedation; euphoria; insomnia; disorientation; incoordination.

dermatologic:
Pruritus.

gi:
Nausea; vomiting; dry mouth; constipation; abdominal pain.

respiratory:
Dyspnea; respiratory depression; decreased cough reflex.

miscellaneous:
Histamine release.
Precautions:
Pregnancy: Category C .
Lactation: Excreted in breast milk.
Hepatic function impairment: Acetaminophen intake must be limited to 2 g/day or less.
Sulfite sensitivity: Caution is needed with sulfite sensitive patients; some commercial preparations contain sodium bisulfite.
Overdosage: Signs & symptoms Blood dyscrasias, respiratory depression, hepatic damage (may occur up to several days after overdose).

Patient/Family Education:
  • Caution patient that drug dependency or tolerance may result from long-term use.
  • Instruct patient not to discontinue medication abruptly after long-term regular use.
  • Caution patient to avoid intake of alcohol and other CNS depressants without consulting health care provider.
  • Advise patient that drug may cause drowsiness, and to use caution while driving or performing other tasks requiring mental alertness.
  • Instruct patient to notify health care provider if the following signs/symptoms occur: persistence or recurrence of pain before next scheduled dose; difficulty breathing; blurred vision; increased drowsiness; severe nausea; vomiting; urinary retention; or yellowing of skin, sclera, or gums.
  • Warn patient that orthostatic hypotension may occur; instruct patient to change positions slowly and to sit or lie down if symptoms occur.
  • Explain that diaphoresis is a common adverse reaction and does not indicate a problem.
  • Warn patient that constipation may occur. Advise patient to increase dietary fiber and fluids unless contraindicated.
  • Caution patient against taking OTC medications that contain acetaminophen.


   
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