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Guaifenesin, Pseudoephedrine, and Dextromethorphan

Pronunciation

(gwye FEN e sin, soo doe e FED rin, & deks troe meth OR fan)

Index Terms

  • Dextromethorphan, Guaifenesin, and Pseudoephedrine
  • Pseudoephedrine, Dextromethorphan, and Guaifenesin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Kit, Oral:

Entex PAC: Entex S liquid - Dextromethorphan hydrobromide 20 mg per 5 mL; Entex T tablet - Guaifenesin 375 mg and pseudoephedrine hydrochloride 60 mg [DSC] [contains benzoic acid, edetate disodium, fd&c red #40, propylene glycol, saccharin sodium]

Liquid, Oral:

BP 8 Cough: Guaifenesin 175 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 15 mg per 5 mL (473 mL [DSC]) [alcohol free, antihistamine free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, propylene glycol, saccharin sodium; grape flavor]

Entre-Cough: Guaifenesin 175 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 15 mg per 5 mL (473 mL) [contains aspartame, fd&c red #40, methylparaben, sodium benzoate; cherry flavor]

Z-Cof 12DM: Guaifenesin 175 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 15 mg per 5 mL (473 mL [DSC]) [alcohol free, antihistamine free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, propylene glycol, saccharin sodium]

Suspension, Oral:

Entre-Cough Tannate: Guaifenesin 175 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 15 mg per 5 mL (473 mL [DSC]) [contains aspartame, fd&c red #40, methylparaben, sodium benzoate; cherry flavor]

Syrup, Oral:

TGQ 30PSE/150GFN/15DM: Guaifenesin 150 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 15 mg per 5 mL (473 mL) [contains methylparaben, propylene glycol, propylparaben; cool mint flavor]

Tablet, Oral:

Aldex GS DM: Guaifenesin 190 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 15 mg [DSC]

Capmist DM: Guaifenesin 400 mg, pseudoephedrine hydrochloride 30 mg, and dextromethorphan hydrobromide 30 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), tartrazine (fd&c yellow #5)]

Capmist DM: Guaifenesin 400 mg, pseudoephedrine hydrochloride 60 mg, and dextromethorphan hydrobromide 15 mg [scored; contains brilliant blue fcf (fd&c blue #1), tartrazine (fd&c yellow #5)]

ExeFen DMX: Guaifenesin 400 mg, pseudoephedrine hydrochloride 60 mg, and dextromethorphan hydrobromide 20 mg [DSC]

Poly-Vent DM: Guaifenesin 400 mg, pseudoephedrine hydrochloride 45 mg, and dextromethorphan hydrobromide 15 mg [DSC] [contains tartrazine (fd&c yellow #5)]

Poly-Vent DM: Guaifenesin 380 mg, pseudoephedrine hydrochloride 60 mg, and dextromethorphan hydrobromide 20 mg [scored; contains tartrazine (fd&c yellow #5)]

Sudatex-DM: Guaifenesin 400 mg, pseudoephedrine hydrochloride 40 mg, and dextromethorphan hydrobromide 20 mg [DSC]

TG 45PSE/400GFN/15DM: Guaifenesin 400 mg, pseudoephedrine hydrochloride 45 mg, and dextromethorphan hydrobromide 15 mg

Brand Names: U.S.

  • Aldex GS DM [OTC] [DSC]
  • BP 8 Cough [OTC] [DSC]
  • Capmist DM [OTC]
  • Entex PAC [OTC] [DSC]
  • Entre-Cough Tannate [OTC] [DSC]
  • Entre-Cough [OTC]
  • ExeFen DMX [OTC] [DSC]
  • Poly-Vent DM [OTC]
  • Sudatex-DM [OTC] [DSC]
  • TG 45PSE/400GFN/15DM [OTC]
  • TGQ 30PSE/150GFN/15DM
  • Z-Cof 12DM [OTC] [DSC]

Pharmacologic Category

  • Antitussive/Decongestant/Expectorant

Pharmacology

See individual agents.

Use: Labeled Indications

Cough and upper respiratory tract symptoms: Temporarily relieves nasal congestion and controls cough due to minor throat and bronchial irritation; helps loosen phlegm and thin bronchial secretions to make coughs more productive

Contraindications

Hypersensitivity to guaifenesin, pseudoephedrine, sympathomimetic amines, dextromethorphan, or any component of the formulation; concomitant or within 2 weeks of monoamine oxidase inhibitor (MAOI) therapy; severe hypertension; severe coronary artery disease; newborns or premature infants; breast-feeding.

Dosing: Adult

Cough and upper respiratory tract symptoms: Oral: Note: Dosing may vary by product. Consult specific product labeling.

Liquid (dextromethorphan 15 mg/guaifenesin 175 mg/pseudoephedrine 30 mg per 5 mL): 10 mL every 8 hours, up to 30 mL per day.

Liquid (dextromethorphan 15 mg/guaifenesin 200 mg/pseudoephedrine 30 mg per 5 mL): 10 mL every 6 hours, up to 40 mL per day.

Liquid (dextromethorphan 20 mg per 5 mL) and tablets (guaifenesin 375 mg/pseudoephedrine 60 mg):

Liquid: 5 mL every 4 hours, up to 20 mL per day.

Tablets: One tablet every 4 to 6 hours, up to 4 tablets per day.

Tablets (dextromethorphan 15 mg/guaifenesin 190 mg/pseudoephedrine 30 mg): Two tablets every 6 hours, up to 8 tablets per day.

Tablets (dextromethorphan 15 mg/guaifenesin 400 mg/pseudoephedrine 60 mg): One tablet every 4 hours, up to 4 tablets per day.

Tablets (dextromethorphan 20 mg/guaifenesin 400 mg/pseudoephedrine 60 mg): One tablet every 4 to 6 hours, up to 4 tablets per day.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Cough and upper respiratory tract symptoms: Oral:

Note: Dosing may vary by product. Consult specific product labeling.

Drops (dextromethorphan 2.5 mg/guaifenesin 25 mg/pseudoephedrine 7.5 mg per mL):

Children 2 to 5 years: 2 mL every 4 to 6 hours, up to 8 mL per day

Liquid (dextromethorphan 5 mg/guaifenesin 50 mg/pseudoephedrine 15 mg per 5 mL):

Children 2 to 5 years: 5 mL every 4 to 6 hours, up to 20 mL per day

Children 6 to 11 years: 10 mL every 4 to 6 hours, up to 40 mL per day

Liquid (dextromethorphan 15 mg/guaifenesin 175 mg/pseudoephedrine 30 mg per 5 mL):

Children 6 to 11 years: 5 mL every 8 hours, up to 15 mL per day

Children ≥12 years and Adolescents: 10 mL every 8 hours, up to 30 mL per day

Liquid (dextromethorphan 15 mg/guaifenesin 200 mg/pseudoephedrine 30 mg per 5 mL):

Children 6 to <12 years: 5 mL every 6 hours, up to 20 mL per day

Children >12 years and Adolescents: 10 mL every 6 hours, up to 40 mL per day

Liquid (dextromethorphan 20 mg per 5 mL) and tablets (guaifenesin 375 mg/pseudoephedrine 60 mg):

Children 6 to 11 years:

Liquid: 2.5 mL every 4 hours, up to 10 mL per day

Tablets: One-half tablet every 4 to 6 hours, up to 2 tablets per day

Children ≥12 years and Adolescents:

Liquid: 5 mL every 4 hours, up to 20 mL per day

Tablets: One tablet every 4 to 6 hours, up to 4 tablets per day

Tablets (dextromethorphan 15 mg/guaifenesin 190 mg/pseudoephedrine 30 mg):

Children 6 to 11 years: One tablet every 6 hours, up to 4 tablets per day

Children ≥12 years and Adolescents: Two tablets every 6 hours, up to 8 tablets per day

Tablets (dextromethorphan 15 mg/guaifenesin 400 mg/pseudoephedrine 60 mg):

Children 6 to 11 years: One-half tablet every 4 hours, up to 2 tablets per day

Children ≥12 years and Adolescents: One tablet every 4 hours, up to 4 tablets per day

Tablets (dextromethorphan 20 mg/guaifenesin 400 mg/pseudoephedrine 60 mg):

Children 6 to <12 years: One-half tablet every 4 to 6 hours, up to 2 tablets per day

Children >12 years and Adolescents: One tablet every 4 to 6 hours, up to 4 tablets per day

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

Administer without regard to food.

Dietary Considerations

Some products may contain phenylalanine.

Storage

Store at room temperature.

Drug Interactions

Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity. Consider therapy modification

Ajmaline: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy

Alkalinizing Agents: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

Analgesics (Opioid): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Asunaprevir: May increase the serum concentration of CYP2D6 Substrates. Consider therapy modification

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Benzylpenicilloyl Polylysine: Alpha-/Beta-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Consider therapy modification

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Carbonic Anhydrase Inhibitors: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy

Cobicistat: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy

Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates. Monitor therapy

CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates. Consider therapy modification

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Avoid combination

Darunavir: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

FentaNYL: Alpha-/Beta-Agonists (Indirect-Acting) may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Monitor therapy

Imatinib: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Lumefantrine: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy

MAO Inhibitors: May enhance the serotonergic effect of Dextromethorphan. This may cause serotonin syndrome. Avoid combination

Memantine: NMDA Receptor Antagonists may enhance the adverse/toxic effect of Memantine. Monitor therapy

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Methylene Blue: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Avoid combination

Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Monitor therapy

Panobinostat: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of sensitive CYP2D6 substrates when possible, particularly those substrates with a narrow therapeutic index. Consider therapy modification

Parecoxib: May increase the serum concentration of Dextromethorphan. Monitor therapy

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates. Monitor therapy

Perhexiline: CYP2D6 Substrates may increase the serum concentration of Perhexiline. Perhexiline may increase the serum concentration of CYP2D6 Substrates. Monitor therapy

QuiNIDine: May increase the serum concentration of Dextromethorphan. Management: Avoid concurrent use of these agents when possible, unless the increased psychoactive effects of dextromethorphan are desired. Since codeine activation is also inhibited by quinidine, codeine is unlikely to be suitable as an alternative antitussive. Consider therapy modification

QuiNINE: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the serotonergic effect of Dextromethorphan. Selective Serotonin Reuptake Inhibitors may increase the serum concentration of Dextromethorphan. Management: Avoid the concurrent use of dextromethorphan and SSRIs, particularly fluoxetine and paroxetine, when possible. The risk for this interaction may persist for several weeks following discontinuation of fluoxetine or paroxetine. Exceptions: FluvoxaMINE. Consider therapy modification

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid. Monitor therapy

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Consider therapy modification

Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

TraMADol: Serotonin Modulators may enhance the adverse/toxic effect of TraMADol. The risk of seizures may be increased. TraMADol may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Urinary Acidifying Agents: May decrease the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy

Test Interactions

See individual agents.

Adverse Reactions

See individual agents.

Warnings/Precautions

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease); contraindicated with severe disease.

• Diabetes: Use with caution in patients with diabetes mellitus.

• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or glaucoma.

• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.

• Pediatric: May cause excitation or increased irritability in children. Use with caution in atopic children. Contraindicated for use in newborns and premature infants.

• Sedentary patients: Use with caution in debilitated, sedated and/or patients confined to the supine position.

Other warnings/precautions:

• Cough: Appropriate use: Underlying cause of cough should be determined prior to prescribing.

• Self-medication (OTC use): Do not exceed recommended dose.

Pregnancy Considerations

See individual agents.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience anxiety or insomnia. Have patient report immediately to prescriber agitation, tremors, shortness of breath, difficult urination, hallucinations, seizures, tachycardia, bradycardia, arrhythmia, severe dizziness, or passing out (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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