hydrocodone/guaifenesin (Rx)

Brand and Other Names:Obredon, Flowtuss
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral solution: Schedule II

  • (2.5mg/200mg)/5mL
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Cough

Indicated for symptomatic relief of cough and to loosen mucus associated with the common cold/flu

10 mL (ie, 5mg hydrocodone/400 mg guaifenesin) PO q4-6hr; not to exceed 6 doses (60 mL) in 24 hr

<18 years: Safety and efficacy not established

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Interactions

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and hydrocodone/guaifenesin

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            Adverse Effects

            Frequency Not Defined

            Common

            • Central nervous system: Headache, dizziness, sedation (somnolence)
            • Gastrointestinal system: Nausea, diarrhea
            • Cardiovascular system: Decreased blood pressure
            • Vascular system: hot flush

            Other

            • Respiratory depression
            • Drug dependence
            • Increased intracranial pressure
            • Decreased mental alertness with impaired mental and/or physical abilities
            • Paralytic ileus
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            Warnings

            Black Box Warnings

            Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol

            Contraindications

            Known hypersensitivity to hydrocodone bitartrate, guaifenesin, or the inactive ingredients

            Coadministration with MAOI therapy or within 14 days of stopping MAOIs

            Cautions

            Hydrocodone may cause dose-related respiratory depression by directly acting on brain stem respiratory center; use with caution and keep out of reach of children

            The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing ICP

            Hydrocodone can produce drug dependence and has the potential for abuse

            May produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks; avoid concurrent use with alcohol or other CNS depressants because of additional impairment

            Caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions

            Concurrent use of anticholinergics with hydrocodone may produce paralytic ileus

            Coadministration with MAOIs or tricyclic antidepressants one may increase the effect of either the antidepressant or hydrocodone (also see Contraindications)

            Not be used for a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm requiring expectoration

            Caution in patients with diabetes, thyroid disease, Addison disease, prostatic hypertrophy, urethral stricture, or asthma

            Concomitant use of opioids, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol

            Advise both patients and caregivers about the risks of respiratory depression and sedation if this drug combination is used with benzodiazepines, alcohol, or other CNS depressants

            Caution in patients with severe renal or hepatic impairment

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            Pregnancy & Lactation

            Pregnancy Category: C; use in mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used

            Lactation: Hydrocodone is known to be distributed in human breast milk; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

            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

            Hydrocodone: Centrally-acting opioid antitussive

            Guaifenesin: Elicits expectorant action that promotes or facilitates the removal of secretions from the respiratory tract

            Pharmacokinetics

            Hydrocodone

            • Half-life: 5 hr
            • Peak plasma time: 1.25 hr
            • Peak plasma concentration: 12.6 ng/mL
            • AUC: 80.9 ng•hr/mL

            Guaifenesin

            • Half-life: 20 minutes
            • Peak plasma time: 1.25 hr
            • Peak plasma concentration: 3.7 mcg/mL
            • AUC: 4.2 mcg•hr/mL
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            Administration

            Instructions

            May take with or without food

            Measure dose with accurate milliliter measuring device

            Do not use a household teaspoon to measure the dose

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • Compare formulary status to other drugs in the same class.
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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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