Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral, as hydrobromide:
Robafen Cough: 15 mg [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]
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]
Scot-Tussin Diabetes CF: 10 mg/5 mL (480 mL [DSC], 3780 mL [DSC]) [alcohol free, dye free, fructose free, sodium free, sorbitol free, sugar free]
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]
Trocal Cough Suppressant: 7.5 mg (1 ea [DSC])
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 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 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 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:
Creomulsion Adult: 20 mg/15 mL (118 mL [DSC])
Creomulsion for Children: 5 mg/5 mL (118 mL [DSC]) [cherry flavor]
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) [contains alcohol, usp; strawberry flavor]
Triaminic Long Acting Cough: 7.5 mg/5 mL (118 mL [DSC]) [alcohol free, dye free; contains benzoic acid, edetate disodium, propylene glycol]
Pharmacology
Mechanism of Action
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
Pharmacokinetics/Pharmacodynamics
Metabolism
Hepatic via demethylation via CYP2D6 to dextrorphan (active); CYP3A4 and CYP3A5 form smaller amounts of 3-hydroxy and 3-methoxy derivatives
Excretion
Primarily in urine as metabolites
Onset of Action
Antitussive: 15-30 minutes
Time to Peak
2-3 hours
Duration of Action
≤6 hours
Half-Life Elimination
Dextromethorphan: Extensive metabolizers: 2-4 hours; poor metabolizers: 24 hours
Use: Labeled Indications
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)
Contraindications
Concurrent administration with or within 2 weeks of discontinuing an MAO inhibitor
Dextromethorphan Images
Dosage and Administration
Dosing: Adult
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
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Cough suppressant: Oral:
Oral syrup (immediate release):
Children: 4 years to <6 years: 5 mg every 4 hours as needed; do not exceed 6 doses in 24 hours
Children 6 years 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 6 years to <12 years: 15 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours
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 years to <6 years: 15 mg every 12 hours as needed; do not exceed 30 mg in 24 hours
Children 6 years 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
Administration
Shake extended release suspension well before use. Only use dosing cup provided to measure liquid doses.
Dietary Considerations
Some products may contain sodium.
Drug Interactions
Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). 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 (High risk with Inhibitors). Monitor therapy
Asunaprevir: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Consider therapy modification
CloBAZam: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy
Cobicistat: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy
CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy
CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Consider therapy modification
Dacomitinib: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Management: Avoid concurrent use of dacomitinib with CYP2D6 subtrates that have a narrow therapeutic index. Consider therapy modification
Darunavir: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy
Imatinib: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy
Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy
Memantine: NMDA Receptor Antagonists may enhance the adverse/toxic effect of Memantine. Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the serotonergic effect of Dextromethorphan. This may cause serotonin syndrome. Avoid combination
Panobinostat: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy
Parecoxib: May increase the serum concentration of Dextromethorphan. 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). Monitor therapy
Perhexiline: CYP2D6 Substrates (High risk with Inhibitors) may increase the serum concentration of Perhexiline. Perhexiline may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). 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 (High risk with Inhibitors). Monitor therapy
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). 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. Exceptions: FLUoxetine; Isocarboxazid; Linezolid; Methylene Blue; Moclobemide; PARoxetine; Phenelzine; Tranylcypromine. Monitor therapy
Tipranavir: May increase the serum concentration of Dextromethorphan. Management: Consider avoiding dextromethorphan in patients taking tipranavir. If combined, monitor closely for increased dextromethorphan effects/toxicities. Consider therapy modification
Test Interactions
False-positive phencyclidine, opioids and heroin urine drug screen
Adverse Reactions
Frequency not defined.
Central nervous system: Dizziness, drowsiness, nervousness, restlessness
Gastrointestinal: Gastrointestinal distress, nausea, stomach pain, vomiting
Warnings/Precautions
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.
Pregnancy
Pregnancy Considerations
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).
Patient Education
What is this drug used for?
- It is used to relieve coughing.
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
