Yes

Analgesic, Narcotic; Antitussive

Dental: Treatment of postoperative pain

Medical: Treatment of mild to moderate pain; antitussive in lower doses; dextromethorphan has equivalent antitussive activity but has much lower toxicity in accidental overdose

C-II

C/D (if used for prolonged periods or in high doses at term)

Hypersensitivity to codeine or any component

Use with caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists (morphine, hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone); respiratory diseases including asthma, emphysema, COPD, or severe liver or renal insufficiency; some preparations contain sulfites which may cause allergic reactions; tolerance or drug dependence may result from extended use

Percentage unknown: Increased AST, ALT

>10%:

Central nervous system: Drowsiness

Gastrointestinal: Constipation

1% to 10%:

Cardiovascular: Tachycardia or bradycardia, hypotension

Central nervous system: Dizziness, lightheadedness, false feeling of well being, malaise, headache, restlessness, paradoxical CNS stimulation, confusion

Dermatologic: Rash, urticaria

Gastrointestinal: Xerostomia, anorexia, nausea, vomiting,

Genitourinary: Decreased urination, ureteral spasm

Hepatic: Increased LFTs

Local: Burning at injection site

Ocular: Blurred vision

Neuromuscular & skeletal: Weakness

Respiratory: Shortness of breath, dyspnea

Miscellaneous: Histamine release

<1%: Convulsions, hallucinations, mental depression, nightmares, insomnia, paralytic ileus, biliary spasm, stomach cramps, muscle rigidity, trembling

Symptoms of overdose include CNS and respiratory depression, gastrointestinal cramping, constipation

Naloxone 2 mg I.V. (0.01 mg/kg for children) with repeat administration as necessary up to a total of 10 mg

CYP2D6 and 3A3/4 enzyme substrate; CYP2D6 enzyme inhibitor

Increased toxicity: CNS depressants, phenothiazines, TCAs, other narcotic analgesics, guanabenz, MAO inhibitors, neuromuscular blockers

Store injection between 15°C to 30°C, avoid freezing; do not use if injection is discolored or contains a precipitate; protect injection from light

Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; causes cough supression by direct central action in the medulla; produces generalized CNS depression

Onset of action: Oral: 0.5-1 hour; I.M.: 10-30 minutes

Peak action: Oral: 1-1.5 hours; I.M.: 0.5-1 hour

Duration of action: 4-6 hours

Absorption: Oral: Adequate

Distribution: Crosses the placenta; appears in breast milk

Protein binding: 7%

Metabolism: Hepatic to morphine (active)

Half-life: 2.5-3.5 hours

Elimination: 3% to 16% excreted in urine as unchanged drug, norcodeine, and free and conjugated morphine

Doses should be titrated to appropriate analgesic effect; when changing routes of administration, note that oral dose is 2/3 as effective as parenteral dose

Children: Oral, I.M., S.C.: 0.5-1 mg/kg/dose every 4-6 hours as needed; maximum: 60 mg/dose

Adults: Oral, I.M., I.V., S.C.: 30 mg/dose; range: 15-60 mg every 4-6 hours as needed

Antitussive: Oral (for nonproductive cough):

Children: 1-1.5 mg/kg/day in divided doses every 4-6 hours as needed: Alternative dose according to age:

2-6 years: 2.5-5 mg every 4-6 hours as needed; maximum: 30 mg/day

6-12 years: 5-10 mg every 4-6 hours as needed; maximum: 60 mg/day

Adults: 10-20 mg/dose every 4-6 hours as needed; maximum: 120 mg/day

Dosing adjustment in renal impairment:

Cl_cr 10-50 mL/minute: Administer 75% of dose

Cl_cr <10 mL/minute: Administer 50% of dose

Dosing adjustment in hepatic impairment: Probably necessary in hepatic insufficiency

Alcohol: Additive CNS effects, avoid or limit alcohol; watch for sedation

Food: Glucose may cause hyperglycemia; monitor blood glucose concentrations

Not intended for I.V. use due to large histamine release and cardiovascular effects

Pain relief, respiratory and mental status, blood pressure, heart rate

Therapeutic: Not established; Toxic: >1.1 mg/mL

Drowsiness is common; may cause euphoria, confusion, insomnia, hallucinations, or depression

Concurrent use with psychotropics may produce additive toxicity; concurrent use with fluoxetine or paroxetine may result in loss of pain control

No information available to require special precautions

<1% of patients experience dry mouth

If self-administered, use exactly as directed (do not increase dose or frequency); may cause physical and/or psychological dependence. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). May cause dizziness, drowsiness, confusion, agitation, impaired coordination, or blurred vision (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); nausea or vomiting, or loss of appetite (frequent mouth care, small frequent meals, sucking lozenges, or chewing gum may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help - if constipation remains an unresolved problem, consult prescriber about use of stool softeners). Report confusion, insomnia, excessive nervousness, excessive sedation or drowsiness, or shakiness; acute GI upset; difficulty breathing or shortness of breath; facial flushing, rapid heartbeat or palpitations; urinary difficulty; unusual muscle weakness; or vision changes. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. If you are breast-feeding, take medication immediately after breast-feeding or 3-4 hours prior to next feeding.

Observe patient for excessive sedation, respiratory depression, implement safety measures, assist with ambulation

Injection, as phosphate: 30 mg (1 mL, 2 mL); 60 mg (1 mL, 2 mL)

Solution, oral: 15 mg/5 mL

Tablet, as sulfate: 15 mg, 30 mg, 60 mg

Tablet, as phosphate, soluble: 30 mg, 60 mg

Tablet, as sulfate, soluble: 15 mg, 30 mg, 60 mg

Cardan E, "Fatal Case of Codeine Poisoning," Lancet, 1981, 1(8233):1313.

de Groot AC and Conemans J, "Allergic Urticarial Rash From Oral Codeine," Contact Dermatitis, 1986, 14(4):209-14.

Desjardins PJ, Cooper SA, Gallegos TL, et al, "The Relative Analgesic Efficacy of Propiram Fumarate, Codeine, Aspirin, and Placebo in Postimpaction Dental Pain," J Clin Pharmacol, 1984, 24(1):35-42.

"Drugs for Pain," Med Lett Drugs Ther, 1998, 40(1033):79-84.

Ferrell BA, "Pain Management in Elderly People," J Am Geriatr Soc, 1991, 39(1):64-73.

Forbes JA, Keller CK, Smith JW, et al, "Analgesic Effect of Naproxen Sodium, Codeine, a Naproxen-Codeine Combination and Aspirin on the Postoperative Pain of Oral Surgery," Pharmacotherapy, 1986, 6(5):211-8.

Ivey HH and Kattwinkel J, "Danger of Actifed-C," Pediatrics, 1976, 57(1):164-5.

Kaiko RF, Wallenstein SL, Rogers AG, et al, "Narcotics in the Elderly," Med Clin North Am, 1982, 66(5):1079-89.

Wilkins D, Rollins DE, Seaman J, et al, "Quantitative Determination of Codeine and Its Major Metabolites in Human Hair by Gas Chromatography - Positive Ion Chemical Ionization Mass Spectrometry: A Clinical Application," J Anal Toxicol, 1995, 19(5):269-74.