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Acetaminophen with Codeine Phosphate

Pronunciation

Pronunciation: ass-cet-ah-MEE-noe-fen with KOE-deen FOSS-fate
Class: Opioid analgesic combination

Trade Names

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 (Canada)
ratio-Lenoltec No. 4 (Canada)
Triatec-30 (Canada)

Pharmacology

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.

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Indications and Usage

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.

Dosage and Administration

Tylenol No. 2 equals 15 mg codeine, 300 mg acetaminophen. Tylenol No. 3 equals 30 mg codeine, 300 mg acetaminophen. Tylenol No. 4 equals 60 mg codeine, 300 mg acetaminophen.

Max adult dose

Codeine equals 360 mg/day; acetaminophen equals 4 g/day.

Tablets
Adults

PO Usually 1 to 2 tablets every 4 h (varies according to product).

Children younger than 12 yr of age

PO 0.5 to 1 mg codeine/kg/dose every 4 to 6 h; 10 to 15 mg acetaminophen/kg/dose every 4 h to max 2.6 g/24 h.

Elixir
Children older than 12 yr of age

PO 15 mL every 4 h as needed.

Children 7 to 12 yr of age

PO 10 mL 3 times daily to 4 times daily as needed.

Children 3 to 6 yr of age

PO 5 mL 3 times daily to 4 times daily as needed.

Storage/Stability

Store in air tight, light-resistant container at room temperature.

Drug 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.

Laboratory Test Interactions

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

Warnings

These products contain 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

Excreted in breast milk.

Hepatic Function

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

Symptoms

Blood dyscrasias, respiratory depression, hepatic damage (may occur up to several days after overdose).

Patient Information

  • 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.

Copyright © 2009 Wolters Kluwer Health.

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