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Guaifenesin, pseudoephedrine, and dextromethorphan: Drug information

Guaifenesin, pseudoephedrine, and dextromethorphan: Drug information
(For additional information see "Guaifenesin, pseudoephedrine, and dextromethorphan: Patient drug information" and see "Guaifenesin, pseudoephedrine, and dextromethorphan: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Aquanaz PSE [OTC] [DSC];
  • Capmist DM [OTC];
  • Poly-Vent DM [OTC]
Pharmacologic Category
  • Antitussive/Decongestant/Expectorant
Dosing: Adult
Cough and upper respiratory symptoms

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

Tablets (dextromethorphan 20 mg/guaifenesin 380 mg/pseudoephedrine 60 mg): One tablet every 4 hours, up to 4 tablets per day

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

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Guaifenesin, pseudoephedrine, and dextromethorphan: Pediatric drug information")

Note: Multiple concentrations of oral liquid formulations (liquid, solution, and syrup) and strengths of oral tablets exist; close attention must be paid to the concentration when ordering or administering. Refer to product-specific labeling for approved pediatric ages. Safety and efficacy for the use of cough and cold products in infants and young children is limited; the AAP warns against the use of these products for respiratory illnesses in infants and young children; the FDA does not recommend OTC use in infants and children <2 years of age due to the risk of serious and life-threatening adverse effects (including death) and recommends to use with caution in pediatric patients ≥2 years of age (Ref).

Cough and upper respiratory symptoms

Cough and upper respiratory symptoms: Note: Approved ages and uses for generic products may vary; consult labeling for specific information.

Liquid:

Dextromethorphan 10 mg/guaifenesin 187 mg/pseudoephedrine 30 mg per 5 mL (eg, Pecgen PSE, Trispec PSE):

Children 2 to <6 years: Oral: 2.5 mL every 4 hours as needed; maximum dose: 10 mL/24 hours.

Children ≥6 to <12 years: Oral: 5 mL every 4 hours as needed; maximum dose: 20 mL/24 hours.

Children ≥12 years and Adolescents: Oral: 10 mL every 4 hours as needed; maximum dose: 40 mL/24 hours.

Tablets:

Dextromethorphan 20 mg/guaifenesin 380 mg/pseudoephedrine 60 mg per tablet (eg, Polyvent DM):

Children 6 to <12 years: Oral: 1/2 tablet every 4 hours as needed; maximum dose: 2 tablets/24 hours.

Children ≥12 years and Adolescents: Oral: One tablet every 4 hours as needed; maximum dose: 4 tablets/24 hours.

Dextromethorphan 15 mg/guaifenesin 400 mg/pseudoephedrine 60 mg per tablet (eg, Capmist DM):

Children 6 to <12 years: Oral: 1/2 tablet every 4 hours as needed; maximum dose: 2 tablets/24 hours.

Children ≥12 years and Adolescents: Oral: One tablet every 4 hours as needed; maximum dose: 4 tablets/24 hours.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

See individual agents.

Contraindications

Concurrent administration with or within 2 weeks of discontinuing a monoamine oxidase inhibitor.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Disease-related concerns:

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

• Respiratory disease: Use with caution in patients with a breathing problem or chronic cough that occurs with smoking, asthma, emphysema, or chronic bronchitis or a cough accompanied with too much mucus.

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

Special populations:

• CYP2D6 poor metabolizers: Dextromethorphan is metabolized by hepatic CYP2D6. Poor metabolizers of CYP2D6 may have exaggerated or prolonged effects of dextromethorphan. Increased risk may be seen with concomitant use of potent CYP2D6 inhibitors; use with caution (Abduljalil 2010; Jurica 2012; Sager 2014; Zhou 2009).

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

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.

Warnings: Additional Pediatric Considerations

Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported. Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

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

Tablet, Oral:

Aquanaz PSE: Guaifenesin 375 mg, pseudoephedrine hydrochloride 60 mg, and dextromethorphan hydrobromide 20 mg [DSC] [contains fd&c blue #1 (brill blue) aluminum lake, fd&c yellow #5 (tartrazine)aluminum lake]

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

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

Generic Equivalent Available: US

Yes

Pricing: US

Liquid (Pecgen PSE Oral)

30-10-187 mg/5 mL (per mL): $0.05

Liquid (Trispec PSE Oral)

30-10-187 mg/5 mL (per mL): $0.11

Liquid (Tusnel Oral)

30-15-200 mg/5 mL (per mL): $0.05

Liquid (Tusnel Pediatric Oral)

15-5-50 mg/5 mL (per mL): $0.08

Liquid (Tusnel-DM Pediatric Oral)

7.5-2.5-25 mg/mL (per mL): $0.20

Tablets (Desgen DM Oral)

30-10-200 mg (per each): $0.16

Tablets (Poly-Vent DM Oral)

60-20-380 mg (per each): $0.76

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Administer without regard to food.

Administration: Pediatric

Oral: Administer without regard to food. Administer oral liquid and suspension with an accurate measuring device (eg, calibrated oral syringe, measuring cup); do not use a household teaspoon (overdosage may occur).

Use: Labeled Indications

Cough and upper respiratory tract symptoms: Temporarily relieves nasal congestion, sneezing, nasal/throat irritation, itchy/watery eyes, and controls cough due to minor throat and bronchial irritation associated with the common cold, hay fever, or other upper respiratory allergies; helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive; reduces swelling of nasal passages.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

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

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

Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: 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. Risk D: Consider therapy modification

Bromocriptine: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modification

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

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

Chloroprocaine (Systemic): May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy

Cocaine (Topical): 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. Risk D: Consider therapy modification

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Dextromethorphan. Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Dextromethorphan. Risk C: Monitor therapy

Disulfiram: May enhance the adverse/toxic effect of Products Containing Ethanol. Management: Do not use disulfiram with dosage forms that contain ethanol. Risk X: Avoid combination

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

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Risk X: Avoid combination

FentaNYL: Decongestants may decrease the serum concentration of FentaNYL. Risk C: Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Iobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Lisuride: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk X: Avoid combination

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

Methotrimeprazine: Products Containing Ethanol may enhance the adverse/toxic effect of Methotrimeprazine. Specifically, a disulfiram-like reaction may occur and CNS depressant effects may be increased. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid combination

Monoamine Oxidase Inhibitors: Dextromethorphan may enhance the serotonergic effect of Monoamine Oxidase Inhibitors. This may cause serotonin syndrome. Risk X: Avoid combination

Ornidazole: May enhance the adverse/toxic effect of Products Containing Ethanol. Specifically, a disulfiram-like reaction may occur. Risk X: Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

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

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Pergolide: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy

Reserpine: May diminish the therapeutic effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy

Secnidazole: Products Containing Ethanol may enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination

Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors): Dextromethorphan may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors). This could result in serotonin syndrome. Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors) may increase the serum concentration of Dextromethorphan. Management: Consider alternatives to this drug combination. The dose of dextromethorphan/bupropion product should not exceed 1 tablet once daily. Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity. Risk D: Consider therapy modification

Serotonergic Agents (High Risk): Dextromethorphan may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Risk C: 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. Management: If possible, avoid coadministration of direct-acting alpha-/beta-agonists and serotonin/norepinephrine reuptake inhibitors. If coadministered, monitor for increased sympathomimetic effects (eg, increased blood pressure, chest pain, headache). Risk D: Consider therapy modification

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

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

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

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha-/Beta-Agonists. Management: Avoid, if possible, the use of alpha-/beta-agonists in patients receiving tricyclic antidepressants. If combined, monitor for evidence of increased pressor effects and consider reductions in initial dosages of the alpha-/beta-agonist. Risk D: Consider therapy modification

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

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Refer to individual monographs.

Mechanism of Action

See individual agents.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Neocoff dm | Robitussin CF;
  • (CN) China: Dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride | Li zhu ke le;
  • (CO) Colombia: Protusin | Tosfedrin plus;
  • (DO) Dominican Republic: Protusin;
  • (HK) Hong Kong: Dextro plus | Sigma relief;
  • (ID) Indonesia: Sudafed dm;
  • (IN) India: Benylin e | Gecoff | M&b | Rizkof;
  • (JO) Jordan: Joswe Nocuf;
  • (KR) Korea, Republic of: Copuron | Greencophle | Mccough | Modcough | Thymicol;
  • (LV) Latvia: Calmylin 3;
  • (PE) Peru: Benylin tos y congestion | Silenai expectorante;
  • (PH) Philippines: Vicks formula 44 c;
  • (PK) Pakistan: Benylin e | Torax G;
  • (PR) Puerto Rico: Actinel | Actinel pediatric | Aldex Gs DM | Ambenyl d | Aquanaz pse | Bionel | Bionel Pediatric | Bp 8 Cough | Capmist DM | Desgen dm tabs | Despec dm | Entre Cough | ExeFen-Dmx | Gfn/Pse/Dm | Maxifed DM | Maxifed dmx | Medent dm | Medent-Dmi | Mintab c | Neotuss-d | Nortuss-de | Novahistine dmx | Profen ii dm | Protuss dm | Pseudovent dm | Relasin dm | Robitussin cold & cough | Ru Tuss DM | S-Pack DM | Santuss | Sudafed cough | Sudatex DM | Syn rx dm | Tidafen dm | Tri-vent dm | Trikof D | Trispec pse | Trispec-pe | Tuss Da NR | Tussidex | Z Cof I;
  • (SA) Saudi Arabia: Robitussin CF;
  • (TR) Turkey: Gudef;
  • (TW) Taiwan: Sato cough
  1. Abduljalil K, Frank D, Gaedigk A, et al. Assessment of activity levels for CYP2D6*1, CYP2D6*2, and CYP2D6*41 genes by population pharmacokinetics of dextromethorphan. Clin Pharmacol Ther. 2010;88(5):643-651. doi:10.1038/clpt.2010.137. [PubMed 20881950]
  2. American Academy of Pediatrics (AAP). Cough and cold medicines should not be prescribed, recommended or used for respiratory illnesses in young children. Updated June 12, 2018. Available at http://www.choosingwisely.org/clinician-lists/american-academy-pediatrics-cough-and-cold-medicines-for-children-under-four/
  3. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  4. Capmist DM Tablets (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. Powell, OH: Capital Pharma; December 2017.
  5. Capmist DM Tablets (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. Powell, OH: Capital Pharma; 2020.
  6. Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications--two states, 2005. MMWR Morb Mortal Wkly Rep. 2007;56(1):1-4. [PubMed 17218934]
  7. Food and Drug Administration (FDA). Most young children with a cough or cold don't need medicines. July 18, 2017. Available at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm422465.htm. Last accessed November 2, 2018.
  8. Food and Drug Administration (FDA). Use caution when giving cough and cold products to kids. Updated February 8, 2018. Available at https://www.fda.gov/drugs/resourcesforyou/specialfeatures/ucm263948.htm. Last accessed November 2, 2018.
  9. Jurica J, Bartecek R, Zourkova A, et al. Serum dextromethorphan/dextrorphan metabolic ratio for CYP2D6 phenotyping in clinical practice. J Clin Pharm Ther. 2012;37(4):486-490. doi:10.1111/j.1365-2710.2012.01333.x. [PubMed 22548589]
  10. Pecgen PSE (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. San Juan, PR: Kramer Novis; July 2018.
  11. Poly-Vent DM (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. Quitman, MS: Poly Pharmaceuticals; 2020.
  12. Sager JE, Lutz JD, Foti RS, et al. Fluoxetine- and norfluoxetine-mediated complex drug-drug interactions: in vitro to in vivo correlation of effects on CYP2D6, CYP2C19, and CYP3A4. Clin Pharmacol Ther. 2014;95(6):653-662. doi:10.1038/clpt.2014.50. [PubMed 24569517]
  13. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  14. Trispec PSE (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. Carolina, PR: Deliz Pharmaceutical Corp; 2020.
  15. Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: part II. Clin Pharmacokinet. 2009;48(12):761-804. doi:10.2165/11318070. [PubMed 19902987]
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