Acetaminophen and codeine

U.S. BRAND NAMES — Capital® and Codeine; Tylenol® With Codeine
CANADIAN BRAND NAMES — ratio-Emtec; ratio-Lenoltec; Triatec-30; Triatec-8 Strong; Triatec-8; Tylenol Elixir with Codeine; Tylenol No. 1 Forte; Tylenol No. 1; Tylenol No. 2 with Codeine; Tylenol No. 3 with Codeine; Tylenol No. 4 with Codeine
SYNONYMS — Codeine and Acetaminophen
THERAPEUTIC CATEGORY Analgesic, Narcotic
DOSING — Oral (doses should be titrated to appropriate analgesic effect):
(For additional information see "Acetaminophen and codeine: Drug information")
Children: Analgesic: 0.5-1 mg codeine/kg/dose every 4-6 hours 3-6 years: 5 mL 3-4 times/day as needed 7-12 years: 10 mL 3-4 times/day as needed >12 years: 15 mL every 4 hours as needed
Adults: 1-2 tablets every 4 hours; maximum dose: 12 tablets/24 hours
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product; [CAN] = Canadian brand name
Caplet: ratio-Lenoltec No. 1 [CAN], Tylenol No. 1 [CAN]: Acetaminophen 300 mg, codeine phosphate 8 mg, and caffeine 15 mg [not available in the U.S.] Tylenol No. 1 Forte [CAN]: Acetaminophen 500 mg, codeine phosphate 8 mg, and caffeine 15 mg [not available in the U.S.]
Elixir, oral [C-V]: Acetaminophen 120 mg and codeine phosphate 12 mg per 5 mL (5 mL, 10 mL, 12.5 mL, 15 mL, 120 mL, 480 mL) [contains alcohol 7%] Tylenol® with Codeine [DSC]: Acetaminophen 120 mg and codeine phosphate 12 mg per 5 mL (480 mL) [contains alcohol 7%; cherry flavor] Tylenol Elixir with Codeine [CAN]: Acetaminophen 160 mg and codeine phosphate 8 mg per 5 mL (500 mL) [contains alcohol 7%, sucrose 31%; cherry flavor; not available in the U.S.]
Suspension, oral [C-V] (Capital® and Codeine): Acetaminophen 120 mg and codeine phosphate 12 mg per 5 mL (480 mL) [alcohol free; fruit punch flavor]
Tablet [C-III]: Acetaminophen 300 mg and codeine phosphate 15 mg; acetaminophen 300 mg and codeine phosphate 30 mg; acetaminophen 300 mg and codeine phosphate 60 mg ratio-Emtec [CAN], Triatec-30 [CAN]: Acetaminophen 300 mg and codeine phosphate 30 mg [not available in the U.S.] ratio-Lenoltec No. 1 [CAN]: Acetaminophen 300 mg, codeine phosphate 8 mg, and caffeine 15 mg [not available in the U.S.] ratio-Lenoltec No. 2 [CAN], Tylenol No. 2 with Codeine [CAN]: Acetaminophen 300 mg, codeine phosphate 15 mg, and caffeine 15 mg [not available in the U.S.] ratio-Lenoltec No. 3 [CAN], Tylenol No. 3 with Codeine [CAN]: Acetaminophen 300 mg, codeine phosphate 30 mg, and caffeine 15 mg [not available in the U.S.] ratio-Lenoltec No. 4 [CAN], Tylenol No. 4 with Codeine [CAN]: Acetaminophen 300 mg and codeine phosphate 60 mg [not available in the U.S.] Triatec-8 [CAN]: Acetaminophen 325 mg, codeine phosphate 8 mg, and caffeine 30 mg [not available in the U.S.] Triatec-8 Strong [CAN]: Acetaminophen 500 mg, codeine phosphate 8 mg, and caffeine 30 mg [not available in the U.S.] Tylenol® with Codeine No. 3: Acetaminophen 300 mg and codeine phosphate 30 mg [contains sodium metabisulfite] Tylenol® with Codeine No. 4: Acetaminophen 300 mg and codeine phosphate 60 mg [contains sodium metabisulfite]
GENERIC AVAILABLE — Yes
ADMINISTRATION — Oral: Administer with food to decrease GI upset; shake suspension well before use
USE — Relief of mild to moderate pain
ADVERSE REACTIONS Acetaminophen: Dermatologic: Rash Hematologic: Blood dyscrasias (neutropenia, pancytopenia, leukopenia) Hepatic: Hepatic necrosis with overdose Renal: Renal injury with chronic use Miscellaneous: Hypersensitivity reactions (rare)
Codeine: Cardiovascular: Palpitations, hypotension, bradycardia, peripheral vasodilation Central nervous system: CNS depression, dizziness, drowsiness, sedation, elevated intracranial pressure Dermatologic: Pruritus Endocrine & metabolic: Antidiuretic hormone release Gastrointestinal: Nausea, vomiting, constipation, biliary tract spasm Genitourinary: Urinary retention Ocular: Miosis Respiratory: Respiratory depression Miscellaneous: Histamine release, physical and psychological dependence with prolonged use
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, codeine phosphate, or any component (see Warnings)
PRECAUTIONS — Use with caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists (morphine, hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone) or respiratory disease/compromise.
G-6-PD deficiency: Although several case reports of acetaminophen-associated hemolytic anemia have been reported in patients with G-6-PD deficiency, a direct cause and effect relationship has not been well established (concurrent illnesses such as fever or infection may precipitate hemolytic anemia in patients with G-6-PD deficiency); therefore, acetaminophen is generally thought to be safe when given in therapeutic doses to patients with G-6-PD deficiency.
WARNINGS — Some tablets contain metabisulfite which may cause allergic reactions in susceptible individuals. Elixir may contain sodium benzoate; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse; avoid use of acetaminophen and codeine products containing sodium benzoate in neonates; in vitro and animal studies have shown that benzoate displaces bilirubin from protein binding sites
RESTRICTIONS — C-III; C-V
DRUG INTERACTIONS — See Acetaminophen and Codeine
FOOD INTERACTIONS — Rate of absorption of acetaminophen may be decreased when given with food high in carbohydrates
PREGNANCY RISK FACTOR — C (show table)
MECHANISM OF ACTION — See individual monographs for Acetaminophen and Codeine
PHARMACOKINETICS — See individual monographs for Acetaminophen and Codeine
PATIENT INFORMATION — Codeine may be habit-forming; avoid abrupt discontinuation after prolonged use; may cause drowsiness and impair ability to perform activities requiring mental alertness or physical coordination; avoid alcohol
(For additional information see "Acetaminophen and codeine: Patient drug information")
NURSING IMPLICATIONS — Observe patient for excessive sedation, respiratory depression
ADDITIONAL INFORMATION — Tylenol® With Codeine elixir contains saccharin