Cough suppressant: Oral: 10 to 20 mg every 4 hours or 20 to 30 mg every 6 to 8 hours; extended release: 60 mg twice daily; maximum: 120 mg/24 hours
There are no dosage adjustment provided in manufacturer's labeling.
There are no dosage adjustment provided in manufacturer's labeling.
(For additional information see "Dextromethorphan: Pediatric drug information")
Note: Safety and efficacy for the use of cough and cold products in infants and young children limited; the AAP warns against the use of these products for respiratory illnesses in infants and young children (AAP 2018; FDA 2017).
Cough suppressant: Oral:
Oral syrup (immediate release):
Children 2 to <6 years: 5 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Children 6 to <12 years: 10 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Children ≥12 years and Adolescents: 20 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Long-acting liquid: Children ≥12 years and Adolescents: 30 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours.
Oral capsule: Children ≥12 years and Adolescents: 30 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours.
Extended-release suspension (dextromethorphan polistirex):
Children 4 to <6 years: 15 mg every 12 hours as needed; do not exceed 30 mg in 24 hours.
Children 6 to <12 years: 30 mg every 12 hours as needed; do not exceed 60 mg in 24 hours.
Children ≥12 years and Adolescents: 60 mg every 12 hours as needed; do not exceed 120 mg in 24 hours.
There are no dosage adjustments provided in manufacturer's labeling.
There are no dosage adjustments provided in manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral, as hydrobromide:
Robafen Cough: 15 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]
Robitussin Lingering CoughGels: 15 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, polyethylene glycol, propylene glycol]
Generic: 15 mg
Gel, Oral, as hydrobromide:
ElixSure Cough: 7.5 mg/5 mL (120 mL) [alcohol free; contains carbomer 934p, propylene glycol, propylparaben; cherry bubblegum flavor]
Liquid, Oral, as hydrobromide:
Buckleys Cough: 12.5 mg/5 mL (118 mL) [alcohol free, sugar free; contains butylparaben, menthol, propylparaben, saccharin sodium]
Little Colds Cough Formula: 7.5 mg/mL (30 mL) [alcohol free, dye free, saccharin free; contains sodium benzoate; grape flavor]
PediaCare Childrens Long-Act: 7.5 mg/5 mL (118 mL) [contains brilliant blue fcf (fd&c blue #1), saccharin sodium, sodium benzoate]
Robitussin Lingering LA Cough: 15 mg/5 mL (118 mL [DSC]) [contains alcohol, usp, fd&c red #40, menthol, saccharin sodium, sodium benzoate]
Triaminic Long Acting Cough: 7.5 mg/5 mL (118 mL) [alcohol free, dye free, pseudoephedrine free; contains benzoic acid, propylene glycol]
Lozenge, Mouth/Throat, as hydrobromide:
Hold: 5 mg (10 ea)
Hold: 5 mg (10 ea) [cherry flavor]
Strip, Oral, as hydrobromide:
Triaminic Long Acting Cough: 7.5 mg (14 ea, 16 ea) [contains alcohol, usp, fd&c red #40; cherry flavor]
Triaminic Long Acting Cough: 7.5 mg (14 ea) [contains alcohol, usp, fd&c red #40, isopropyl alcohol]
Suspension Extended Release, Oral:
Cough DM: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite; orange flavor]
Delsym: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), disodium edta, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben; grape flavor]
Delsym: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate (edta) disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben; orange flavor]
Delsym Cough Childrens: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), edetate (edta) disodium, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben, soybean oil; grape flavor]
Delsym Cough Childrens: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate (edta) disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben, soybean oil; orange flavor]
GoodSense Cough DM: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (148 mL) [alcohol free, gluten free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
GoodSense Cough DM Childrens: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free, gluten free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Robitussin 12 Hour Cough: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Robitussin 12 Hour Cough: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c yellow #10 (quinoline yellow), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Robitussin 12 Hour Cough Child: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Generic: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL)
Syrup, Oral, as hydrobromide:
Robitussin Childrens Cough LA: 7.5 mg/5 mL (118 mL) [alcohol free; contains fd&c red #40, propylene glycol, saccharin sodium, sodium benzoate; fruit punch flavor]
Silphen DM Cough: 10 mg/5 mL (118 mL [DSC]) [contains alcohol, usp; strawberry flavor]
May be product dependent
Shake extended release suspension well before use. Only use dosing cup provided to measure liquid doses.
Oral: Administer liquid/suspension products with an accurate measuring device; do not use a household teaspoon (overdosage may occur).
Suspension: Shake well prior to administration.
Cough (suppressant): Temporary control of cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants; temporary relief of cough impulse to improve sleep (extended release formulations)
Benylin may be confused with Benadryl, Ventolin
Delsym may be confused with Delfen, Desyrel
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined.
Central nervous system: Dizziness, drowsiness, nervousness, restlessness
Gastrointestinal: Gastrointestinal distress, nausea, stomach pain, vomiting
Concurrent administration with or within 2 weeks of discontinuing an MAO inhibitor
Concurrent drug therapy issues:
• Serotonin syndrome: Symptoms of agitation, confusion, hallucinations, hyper-reflexia, myoclonus, shivering, and tachycardia may occur with concomitant proserotonergic drugs (ie, SSRIs/SNRIs or triptans); especially with higher dextromethorphan doses.
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).
• Debilitated patients: Use with caution in patients who are sedated, debilitated or confined to a supine position.
• Pediatric: Use with caution in atopic children. Not for OTC use in children <4 years of age.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
• Tartrazine: Some products may contain tartrazine.
Other warnings/precautions:
• Abuse/misuse: Healthcare providers should be alert to problems of abuse or misuse. Abuse can cause death, brain damage, seizure, loss of consciousness, and irregular heartbeat.
• Self-medication (OTC use): When used for self medication (OTC) notify healthcare provider if symptoms do not improve within 7 days, or are accompanied by fever, rash or persistent headache. Do not use for persistent or chronic cough (as with smoking, asthma, chronic bronchitis, emphysema) or if cough is accompanied by excessive phlegm unless directed to do so by healthcare provider.
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).
Anecdotal reports of abuse of dextromethorphan-containing cough/cold products have increased, especially among teenagers.
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).
Substrate of CYP2B6 (minor), CYP2C19 (minor), CYP2C9 (minor), CYP2D6 (major), CYP2E1 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
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
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, CNS depressant effects may be increased. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid combination
Monoamine Oxidase Inhibitors: May enhance the serotonergic effect of Dextromethorphan. This may cause serotonin syndrome. Risk X: Avoid combination
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
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. If combined, monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes). 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
Dextromethorphan is metabolized in the liver via CYP2D6 and CYP3A enzymes. The activity of both enzymes is increased in the mother during pregnancy (Tracy 2005; Wadelius 1997). In the fetus, CYP2D6 activity is low in the fetal liver and CYP3A4 activity is present by ~17 weeks' gestation (Jacqz-Aigrain 1992).
When an antitussive is needed during pregnancy, dextromethorphan at standard OTC doses is generally considered acceptable. Some sources recommend use be reserved for significant maternal need; products containing alcohol should be avoided (Chasnoff 1981; Conover 2003; Koren 1998; Ward 2005).
Information related to the presence of dextromethorphan in breast milk has not been located. Data are not available to make recommendations for use in breastfeeding women (WHO 2002). Products containing alcohol should be avoided.
Some products may contain sodium.
Decreases the sensitivity of cough receptors and interrupts cough impulse transmission by depressing the medullary cough center through sigma receptor stimulation; structurally related to codeine
Onset of action: Antitussive: 15 to 30 minutes.
Metabolism: Hepatic via demethylation via CYP2D6 to dextrorphan (active); CYP3A4 and CYP3A5 form smaller amounts of 3-hydroxy and 3-methoxy derivatives.
Half-life elimination:
Dextromethorphan:
Pediatric patients: Excluding poor metabolizers (Guenin 2014).
Children 2 to 5 years: 4.09 ± 1.44 hours.
Children 6 to 11 years: 4.8 ± 1.59 hours.
Children ≥12 years and Adolescents: 6.41 ± 1.639 hours.
Adults: Extensive metabolizers: 2 to 4 hours; poor metabolizers: 24 hours.
Time to peak:
Children 2 to 5 years: 1.44 ± 0.563 hours (Guenin 2014).
Children 6 to 11 years: 2.12 ± 0.801 hours (Guenin 2014).
Children ≥12 years and Adolescents: 2.04 ± 0.865 hours (Guenin 2014).
Adults: Mean range: 2.1 to 2.6 hours (Silvasti 1987).
Peak concentration:
Pediatric patients: Excluding poor metabolizers (Guenin 2014).
Children 2 to 5 years (following doses of 7.5 to 11.25 mg): 1.47 ± 1.597 ng/mL.
Children 6 to 11 years (following doses of 15 to 24.75 mg): 1.26 ± 1.211 ng/mL.
Children ≥12 years and Adolescents (following doses of 30 mg): 4.9 ± 4.215 ng/mL.
Adults (following doses of 60 mg): Mean range: 5.2 to 5.8 ng/mL (Silvasti 1987).
Excretion: Primarily in urine as metabolites.
Metabolism: Pharmacokinetic parameters are affected by the genetic predisposition of CYP2D6 activity (Guenin 2014).
Capsules (Dextromethorphan HBr Oral)
15 mg (per each): $0.14 - $0.16
Capsules (Robitussin Lingering CoughGels Oral)
15 mg (per each): $0.26
Gel (ElixSure Cough Oral)
7.5 mg/5 mL (per mL): $0.04
Liquid (Buckleys Cough Oral)
12.5 mg/5 mL (per mL): $0.04
Liquid (PediaCare Childrens Long-Act Oral)
7.5 mg/5 mL (per mL): $0.05
Liquid (Triaminic Long Acting Cough Oral)
7.5 mg/5 mL (per mL): $0.04
Lozenge (Hold Mouth/Throat)
5 mg (per each): $0.24
Strip (Triaminic Long Acting Cough Oral)
7.5 mg (per each): $0.35
Suspension Extended Release (Delsym Cough Childrens Oral)
30 mg/5 mL (per mL): $0.19
Suspension Extended Release (Delsym Oral)
30 mg/5 mL (per mL): $0.19
Suspension Extended Release (Dextromethorphan Polistirex ER Oral)
30 mg/5 mL (per mL): $0.09
Suspension Extended Release (Robitussin 12 Hour Cough Child Oral)
30 mg/5 mL (per mL): $0.10
Suspension Extended Release (Robitussin 12 Hour Cough Oral)
30 mg/5 mL (per mL): $0.10
Syrup (Robitussin Childrens Cough LA Oral)
7.5 mg/5 mL (per mL): $0.05
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