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Guaifenesin, pseudoephedrine, and dextromethorphan: Drug information

Guaifenesin, pseudoephedrine, and dextromethorphan: Drug information
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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): 1 tablet every 4 hours; maximum: 4 tablets per 24 hours.

Tablets (dextromethorphan 15 mg/guaifenesin 400 mg/pseudoephedrine 60 mg): 1 tablet every 4 hours; maximum: 4 tablets per 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: Adult

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

Dosing: Liver 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: Liver Impairment: Pediatric

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

Adverse Reactions

See individual agents.

Contraindications

OTC labeling: When used for self-medication, do not exceed recommended dose; do not use with or within 14 days of stopping a monoamine oxidase inhibitor.

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

Warnings/Precautions

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 older adults; 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): When used for self-medication (OTC), consult health care provider prior to use if you have persistent or chronic cough (associated with asthma, chronic bronchitis, emphysema, or smoking), cough is accompanied by excessive phlegm (mucous), heart disease, high BP, thyroid disease, diabetes, and/or trouble urinating due to an enlarged prostate gland. Discontinue use and contact health care provider if new symptoms occur, do not improve within 7 days, or are accompanied by fever, rash, or persistent headache, or if nervousness, dizziness, or sleeplessness occur.

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): $0.06

Liquid (Tusnel Pediatric Oral)

15-5-50 mg/5 mL (per mL): $0.06

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.

Medication Safety Issues
High alert medication

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (pediatric liquid medications requiring measurement) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

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

Alpha1-Blockers: May decrease therapeutic effects of Alpha-/Beta-Agonists. Risk C: Monitor

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

Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Benzylpenicilloyl Polylysine: Coadministration of Alpha-/Beta-Agonists and Benzylpenicilloyl Polylysine may alter diagnostic results. 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

Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor

Bromocriptine: May increase hypertensive effects 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 increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Chloroprocaine (Systemic): May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor

Cocaine (Topical): May increase hypertensive effects 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 serum concentration of Dextromethorphan. Risk C: Monitor

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

Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor

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

Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May increase vasoconstricting effects of Alpha-/Beta-Agonists. Risk X: Avoid

Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor

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

Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor

Hexoprenaline: May increase adverse/toxic effects of Alpha-/Beta-Agonists. Risk X: Avoid

Iobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may decrease therapeutic effects 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

Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid

Landiolol: Sympathomimetics may decrease therapeutic effects of Landiolol. Risk C: Monitor

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

Lisuride: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk X: Avoid

Mavorixafor: May increase serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk X: Avoid

Memantine: NMDA Receptor Antagonists may increase adverse/toxic effects of Memantine. Risk C: Monitor

Metergoline: May increase adverse/toxic effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor

Methotrimeprazine: May increase CNS depressant effects of Products Containing Ethanol. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid

MetroNIDAZOLE (Systemic): May increase adverse/toxic effects of Products Containing Ethanol. A disulfiram-like reaction may occur. Risk X: Avoid

MetroNIDAZOLE (Topical): May increase adverse/toxic effects of Products Containing Ethanol. A disulfiram-like reaction may occur. Risk C: Monitor

Monoamine Oxidase Inhibitors: Dextromethorphan may increase serotonergic effects of Monoamine Oxidase Inhibitors. This may cause serotonin syndrome. Risk X: Avoid

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

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

Pergolide: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor

Reserpine: May decrease therapeutic effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor

Secnidazole: Products Containing Ethanol may increase adverse/toxic effects of Secnidazole. Risk X: Avoid

Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors): Dextromethorphan may increase serotonergic effects of Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors). This could result in serotonin syndrome. Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors) may increase 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 increase serotonergic effects 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

Serotonin/Norepinephrine Reuptake Inhibitor: May increase tachycardic effects of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitor may increase vasopressor effects 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 increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor

Spironolactone: May decrease vasoconstricting effects of Alpha-/Beta-Agonists. Risk C: Monitor

Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor

Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor

Tranylcypromine: May increase hypertensive effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid

Tricyclic Antidepressants: May increase vasopressor effects 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

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
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  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/
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  4. Capmist DM Tablets (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. Powell, OH: Capital Pharma; 2020.
  5. 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]
  6. 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.
  7. 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.
  8. 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]
  9. Pecgen PSE (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. San Juan, PR: Kramer Novis; July 2018.
  10. Poly-Vent DM (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. Quitman, MS: Poly Pharmaceuticals; 2018.
  11. 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]
  12. 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]
  13. Trispec PSE (dextromethorphan/guaifenesin/pseudoephedrine) [prescribing information]. Carolina, PR: Deliz Pharmaceutical Corp; 2020.
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