hydrocodone/guaifenesin (Rx)

Brand and Other Names:Obredon, Flowtuss
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

hydrocodone/guaifenesin

oral solution: Schedule II

  • (2.5mg/200mg)/5mL

tablet: Schedule II

  • 5mg/400mg

Cough

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

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

Tablet: 1 tablet (5 mg hydrocodone/400 mg guaifenesin) PO q4-6 hr; not to exceed 6 tablets in 24 hr

Dosing Considerations

Prescribe a quantity of drug for the shortest duration that is consistent with individual patient treatment goals

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy

Reevaluate patients with unresponsive cough within 5 days for possible underlying pathology (eg, foreign body, lower respiratory tract disease)

If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse

<18 years: Safety and efficacy not established

Patients aged ≥65 yr may have increased sensitivity to opioid agonists

In general, use caution when selecting and dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function

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Interactions

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            Adverse Effects

            Frequency Not Defined

            Anaphylaxis

            Body as a whole: Coma, death, fatigue, falling injuries, lethargy Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush

            Central nervous system: Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor

            Dermatologic: Flushing, hyperhidrosis, pruritus, rash

            Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs; cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use; cases of androgen deficiency have occurred with chronic use of opioids

            Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi)

            Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention

            Laboratory: Increases in serum amylase

            Musculoskeletal: Arthralgia, backache, muscle spasm

            Ophthalmic: Miosis (constricted pupils), visual disturbances

            Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression

            Reproductive: Hypogonadism, infertility

            Respiratory: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection

            Other: Drug abuse, drug dependence, opioid withdrawal syndrome, neonatal withdrawal syndrome

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            Warnings

            Black Box Warnings

            Addiction, abuse, and misuse

            • Exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death
            • Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions

            Life-threatening respiratory depression

            • Serious, life-threatening, or fatal respiratory depression may occur
            • Monitor closely for respiratory depression, especially during initiation or following a dose increase

            Accidental ingestion

            • Accidental ingestion of even 1 dose, especially by children, can result in a fatal overdose of hydrocodone

            Risk of medication errors

            • Ensure accuracy when prescribing, dispensing, and administering; dosing errors can result in accidental overdose and death; use calibrated measuring device when administering oral solution

            Cytochrome P450 3A4 interactions

            • Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone
            • Monitor if coadministered with any CYP3A4 inhibitor or inducer

            Risks from concomitant use with benzodiazepines or other CNS depressants

            • 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

            Interaction with alcohol

            • Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking hydrocodone; coadministration may result in increased plasma levels and a potentially fatal overdose of hydrocodone

            Neonatal opioid withdrawal syndrome

            • For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome
            • Prolonged maternal use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening and requires management according to protocols developed by neonatology experts

            Contraindications

            All children aged ≤6 years; use associated with fatal respiratory depression when hydrocodone was used as recommended; not approved for individuals aged <18 years

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

            Significant respiratory depression

            Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment

            Known or suspected gastrointestinal obstruction, including paralytic ileus

            Cautions

            Contains hydrocodone, a Schedule II controlled substance; as an opioid, hydrocodone exposes users to the risks of addiction, abuse, and misuse (see Black Box Warnings)

            Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended (see Black Box Warnings)

            Children are particularly sensitive to the respiratory depressant effects of hydrocodone; because of the risk of life-threatening respiratory depression and death, hydrocodone is contraindicated in children aged <6 years (see Black Box Warnings)

            Use in patients with acute or severe bronchial asthma in an unmonitored setting or in the 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

            If cough is unresponsive, do not increase dose; reevaluate within 5 days for possibly underlying pathology

            Risk of accidental overdose and death owing to medication errors; clearly communicate dose and prescribe/dispense accurately (see Black Box Warnings)

            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 (see Black Box Warnings)

            Adrenal insufficiency reported with opioid use, more often following use >1 month

            Risk for severe hypotension, including orthostatic hypotension and syncope in ambulatory patients; risk increased 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

            Severe hypotension, including orthostatic hypotension and syncope reported in ambulatory patients; risk increased if ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs

            In patients who may be susceptible to the intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure [ICP] or brain tumors), hydrocodone may reduce respiratory drive, and the resultant CO2 retention can further increase ICP; avoid with impaired consciousness or coma

            May cause spasm of the sphincter of Oddi; opioids may increase serum amylase; monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms; contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus (see Contraindications)

            Avoid use in patients with head injury, intracranial lesions, or preexisting increased ICP; these conditions may cause patients to be susceptible to CO2 retention

            Hydrocodone may increase the frequency of seizures in patients with seizure disorders, monitor patients with a history of seizure disorders for worsened seizure control

            Do not discontinue abruptly; gradually taper dose to avoid withdrawal symptoms (see Adult Dosing)

            May impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery

            Opioid agonists increase biliary tract pressure that results in increased plasma amylase or lipase levels; test results for these enzymes may be unreliable for 24 hr after opioid dose

            Drug interaction overview

            • CYP inhibitors or inducers
              • Also see Black Box Warnings
              • CYP3A4 or CYP2D6 inhibitors: Coadministration with CYP3A4 or CYP2D6 inhibitors may increase hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression
              • CYP3A4 inducers: Discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in hydrocodone plasma concentration Monitor if coadministered with any CYP3A4 inhibitor or inducer
            • Coadministration with benzodiazepines or other CNS depressants
              • Also see Black Box Warnings
              • Profound sedation, respiratory depression, coma, and death may result from the concomitant use with benzodiazepines or other CNS depressants
              • Examples include nonbenzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol
              • If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use
            • Serotonergic drugs
              • Coadministration of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome
              • If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment
              • Discontinue if serotonin syndrome is suspected
            • MAOIs
              • Opioid use not recommended concurrently with MAOIs or within 14 days of stopping MAOI
              • MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (eg, respiratory depression, coma)
              • If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression
            • Mixed or partial opioid agonists
              • Avoid coadministration with mixed agonist/antagonist (eg, nalbuphine, butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who are receiving a full opioid agonist owing to reduced analgesic effect and/or precipitation of withdrawal
            • Muscle relaxants
              • Hydrocodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression
              • Monitor for signs of respiratory depression that may be greater than expected and decrease dose or hydrocodone or muscle relaxant as needed
            • Diuretics
              • Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone
            • Anticholinergic drugs
              • Coadministration with anticholinergic drugs may increase risk of urinary retention and/or severe constipation
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            Pregnancy & Lactation

            Pregnancy

            Not recommended for use in pregnant women, including during or immediately prior to labor

            Hydrocodone

            • Prolonged use of opioid analgesics during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth (see Black Box Warnings)
            • Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight
            • Onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing, amount of last maternal use, and rate of elimination of the drug by the newborn

            Guaifenesen

            • Based on the animal data, advise pregnant women of the potential risk to a fetus
            • Guaifenesin administered orally to pregnant rats during organogenesis was embryolethal at a dose ~1 times the MRHD and produced teratogenic effects at a dose ~2 times the MRHD

            Labor and delivery

            • Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates
            • An opioid antagonist (eg, naloxone) must be available for reversal of opioid-induced respiratory depression in the neonate

            Infertility

            • Chronic opioid use may cause reduced fertility in females and males of reproductive potential
            • Unknown whether these effects on fertility are reversible

            Lactation

            Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise women not to breastfeed during treatment

            Hydrocodone

            • Present in human milk
            • Variable concentrations of hydrocodone and hydromorphone (active metabolite) reported in breast milk when administered to nursing mothers in the early postpartum period
            • Potential for sedation and respiratory depression in the breastfed infant

            Guaifenesin

            • Data are not available regarding if guaifenesin is present in breast milk

            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

            Absorption

            Hydrocodone

            • Peak plasma time: 1.7 hr
            • Peak plasma concentration: 10.7 ng/mL
            • AUC: 69.94 ng•hr/mL

            Guaifenesin

            • Peak plasma time: 30 min
            • Peak plasma concentration: 1.82 mcg/mL
            • AUC: 2.67 mcg·hr/mL

            Distribution

            Hydrocodone: Not extensively protein bound

            Metabolism

            Hydrocodone: CYP3A4 mediated N-demethylation to norhydrocodone is the primary metabolic pathway of hydrocodone with a lower contribution from CYP2D6 mediated O-demethylation to hydromorphone

            Elimination

            Hydrocodone

            • Half-life: 5 hr
            • Excretion: Parent drug and metabolites primarily excreted by kidneys

            Guaifenesin

            • Half-life: 0.95 hr
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            Administration

            Oral Administration

            May take with or without food

            Oral solution

            • Measure dose with accurate milliliter measuring device
            • Do not use a household teaspoon to measure the dose

            Discontinuation

            • Do not abruptly discontinue in a physically-dependent patient; taper the dose gradually, by 25-50% q2-4days, while monitoring carefully for signs and symptoms of withdrawal
            • If the patient develops signs or symptoms of withdrawal, increase dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both

            Storage

            20-25°C (68-77°F)

            Dispense in a tight, light-resistant container with child-resistant closure

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            Formulary

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            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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