codeine/guaifenesin (Rx)

Brand and Other Names:Mytussin AC, Tussi-Organidin NR, more...Cheratussin AC, Guiatuss AC, Iophen C-NR, Virtussin AC
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

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

Cough

Temporary control of cough caused by minor throat and bronchial irritation

Loosens mucus and thins bronchial secretions

5 mL [(6.3mg/100mg)/5mL] PO q4-6hr; not to exceed 90 mL/day

5-7.5 mL [(7.5mg/225mg)/5mL] PO q4hr; not to exceed 45 mL/day

10 mL [(8mg-10mg)/100 mg - 200 mg)]/5 mL PO q4hr; not to exceed 60 mL/day

5 mL [(10mg/300mg)/5 mL] PO q4hr; not to exceed 40 mL/day

5 mL [(20 mg/200 mg)/5 mL] PO q4-6hr; not to exceed 30 mL/day

Dosage Forms & Strengths

codeine/guaifenesin

Schedule V

liquid

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

oral solution

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

oral syrup

  • (10mg/100mg)/5mL

Cough

Temporary control of cough caused by minor throat and bronchial irritation

Loosens mucus and thins bronchial secretions

<12 years

  • Not recommended

≥12 years

  • 5 mL [(6.3mg/100mg)/5mL] PO q4-6hr; not to exceed 90 mL/day
  • 5-7.5 mL [(7.5mg/225mg)/5mL] PO q4hr; not to exceed 45 mL/day
  • 10 mL [(8mg-10mg)/100 mg - 200 mg)]/5 mL PO q4hr; not to exceed 60 mL/day
  • 5 mL [(10mg/300mg)/5 mL] PO q4hr; not to exceed 40 mL/day
  • 5 mL [(20 mg/200 mg)/5 mL] PO q4-6hr; not to exceed 30 mL/day
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Interactions

Interaction Checker

and codeine/guaifenesin

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Codeine

            • Drowsiness
            • Constipation

            1-10%

            Codeine

            • 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

            Frequency Not Defined

            Codeine (serious)

            • Hypotension, with IV use
            • Seizure, with excessive doses
            • Anaphylactoid reaction (rare)
            • Respiratory depression

            Guaifensesin

            • Headache
            • Rash
            • Nausea
            • Vomiting
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            Warnings

            Contraindications

            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

            Cautions

            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

            Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to its respiratory depressant effect; because of risk of life-threatening respiratory depression and death: codeine is contraindicated in all children younger than 12 years of age; it is also contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy

            Avoid the use of codeine in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to respiratory depressant effects of codeine; risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.

            Healthcare providers should choose lowest effective dose for shortest period of time and inform patients and caregivers about these risks and signs of opioid overdose

            Dosage should not be increased if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease

            Therapy in patients with acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment is contraindicated

            Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients

            The active ingredients may produce marked drowsiness and impair mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery

            Codeine is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; the use of codeine may obscure the diagnosis or clinical course of patients with acute abdominal conditions; the concurrent use of anticholinergics may produce paralytic ileus

            Codeine therapy may result in constipation or obstructive bowel disease, especially in patients with underlying intestinal motility disorders; use with caution in patients with underlying intestinal motility disorders

            Avoid therapy in patients with head injury, intracranial lesions, or a pre-existing increase in intracranial pressure; in patients who may be susceptible to intracranial effects of CO2 retention may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; opioids also produce adverse reactions that may obscure clinical course of patients with head injuries

            The codeine may increase frequency of seizures in patients with seizure disorders, and may increase risk of seizures occurring in other clinical settings associated with seizures; monitor patients with a history of seizure disorders for worsened seizure control during therapy

            Use is contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such therapy; MAOIs may potentiate effects of codeine’s active metabolite, including respiratory depression, coma, and confusion

            May cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) monitor these patients for signs of hypotension after initiating therapy

            Not recommended for use in pregnant women; Prolonged use during pregnancy can result in withdrawal in the neonate; neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts

            Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use; if adrenal insufficiency is suspected, confirm diagnosis with diagnostic testing as soon as possible; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean patient off of opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers

            Guaifenesin is often included in combos, check brand name/other constituents

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            Pregnancy & Lactation

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

            Lactation: excreted in breast milk; caution advised

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Codeine

            • Narcotic agonist analgesic with antitussive activity, mu receptor agonist

            Guaifenesin

            • Reduces viscosity of secretions by increasing amount of respiratory tract fluid

            Absorption

            Codeine

            • Onset: 30-60 min
            • Duration: 4-6 hr

            Guaifenesin

            • Onset: 30 min
            • Duration: 4-6 hr

            Distribution

            Codeine

            • Peak plasma time: 0.5-1 hr
            • Protein bound: 25%

            Metabolism

            Codeine

            • Inactive but metabolized to morphine by CYP2D6 (missing in 5-10% of population)

            Guaifenesin

            • Metabolism: Liver
            • Metabolite: b-(2-methoxyphenoxy) lactic acid

            Elimination

            Codeine

            • Half-life: 3-4 hr
            • Excretion: urine, feces

            Guaifenesin

            • Half-life: 1 hr
            • Excretion: Urine
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            Administration

            Oral Administration

            Give with food or milk if GI upset

            Administer with special measuring device for accurate dose

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.