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Codeine/Guaifenesin

    DEA Class; Rx

    Common Brand Names; Mytussin AC, Tussi-Organidin NR, Cheratussin AC, Guiatuss AC, Iophen C-NR, Virtussin AC

    • Antitussives, Narcotic Combos

    Codeine is an opiate agonist antitussive agent; guaifenesin is an expectorant
    Used in combination to treat cough
    Not indicated in pediatric patients under 18 years of age; contraindicated for cough and cold in neonates, infants and children less than 12 years of age; contraindicated in adolescent pediatric patients 12 to 18 years after tonsillectomy or adenoidectomy

    Indicated for the temporary relief of nonproductive cough due to minor throat and bronchial irritation as may occur with the common cold, acute bronchitis, or inhaled irritants.

    Codeine

    • Absolute: Acute abdominal condition, diarrhea associated with toxins, pseudomembranous colitis, respiratory depression

    • Relative: Asthma (acute), inflammatory bowel disease, respiratory impairment

    Guaifenesin

    • Do not use as self-medication in chronic or persistent coughs

    • Hypersensitivity

    Codeine

    • Drowsiness
    • Constipation
    • Bradycardia, hypotension, tachycardia
    • Confusion, dizziness, false feeling of well being, headache, lightheadedness, malaise, paradoxical CNS stimulation, restlessness, weakness
    • Rash, urticaria
    • Anorexia, nausea, vomiting, xerostomia
    • LFT’s increased
    • Ureteral spasm, urination decreased
    • Dyspnea
    • Burning at injection site, blurred vision, histamine release
    • Hypotension, with IV use
    • Seizure, with excessive doses
    • Anaphylactoid reaction (rare)
    • Respiratory depression

    Guaifensesin

    • Headache
    • Rash
    • Nausea
    • Vomiting

    Use caution in cardiac arrhythmias, emotional lability, gallbladder disease, hepatic impairment, renal impairment, surethral stricture, urinary tract surgery

    Ibuprofen is more effective than codeine for pain from musculoskeletal injuries in children

    Children are particularly sensitive to the respiratory depressant effects of codeine; because of risk of life-threatening respiratory depression and death, the use of codeine products is contraindicated in children less than 12 years of age, and in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy

    Use in children also exposes them to risks of addiction, abuse, and misuse, which can lead to overdose and death; because benefits of symptomatic treatment of cough associated with allergies or common cold do not outweigh risks of use of codeine in pediatric patients, use is not indicated in patients younger than 18 years of age

    Life-threatening respiratory depression and death have occurred in children who received codeine; codeine is subject to variability in metabolism based upon CYP2D6 genotype; based upon post-marketing reports, children < 12 years appear to be more susceptible to respiratory depressant effects of codeine, particularly if there are risk factors for respiratory depression; cases of death have been reported in the post-operative period following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine

    Pregnancy category: C; category D if used for prolonged periods or in high doses at term

    Lactation: excreted in breast milk; caution advised

    Adults

    Codeine 120 mg/day PO and guaifenesin 2,400 mg/day PO.

    Geriatric

    Codeine 120 mg/day PO and guaifenesin 2,400 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    12 years: Safety and efficacy have not been established.
    Less than 12 years: Use is contraindicated.

    Infants

    Use is contraindicated.

    Codeine/guaifenesin

    Schedule V

    oral liquid

    • (6.3mg/100mg)/5mL
    • (8mg/200mg)/5mL
    • (10mg/200mg)/5mL
    • (10mg/100mg)/5mL
    • (10mg/300mg)/5mL

    oral solution

    • (10mg/100mg)/5mL
    • (7.5mg/225mg)/5mL

    oral syrup

    • (10mg/100mg)/5mL