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Dextromethorphan

Pronunciation

Pronunciation

(deks troe meth OR fan)

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 CoughGels: 15 mg [DSC] [contains brilliant blue fcf (fd&c blue #1)]

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) [contains alcohol, usp, fd&c red #40, menthol, saccharin sodium, sodium benzoate]

Scot-Tussin Diabetes CF: 10 mg/5 mL (118.3 mL [DSC], 480 mL, 3780 mL) [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]

Vicks Nature Fusion Cough: 15 mg/15 mL (236 mL) [alcohol free, dye free, gluten free; contains polyethylene glycol, propylene glycol; honey flavor]

Liquid Extended Release, Oral:

Delsym: 30 mg/5 mL (89 mL [DSC]) [alcohol free; contains brilliant blue fcf (fd&c blue #1), disodium edta, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben; grape flavor]

Delsym: 30 mg/5 mL (89 mL [DSC], 148 mL [DSC]) [alcohol free; contains edetate disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben; orange flavor]

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) [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 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]

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]

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)

Creomulsion for Children: 5 mg/5 mL (118 mL) [cherry flavor]

Robitussin Childrens Cough LA: 7.5 mg/5 mL (118 mL) [contains fd&c red #40, propylene glycol, saccharin sodium, sodium benzoate]

Robitussin Maximum Strength: 15 mg/5 mL (118 mL [DSC]) [contains alcohol, usp, fd&c red #40, menthol, saccharin sodium, sodium benzoate; pleasant-tasting flavor]

Silphen DM Cough: 10 mg/5 mL (118 mL) [contains alcohol, usp; strawberry flavor]

Simply Cough: 5 mg/5 mL (120 mL [DSC]) [alcohol free; cherry-berry flavor]

Triaminic Long Acting Cough: 7.5 mg/5 mL (118 mL) [alcohol free, dye free; contains benzoic acid, edetate disodium, propylene glycol]

Brand Names: U.S.

  • Buckleys Cough [OTC]
  • Cough DM [OTC]
  • Creomulsion Adult [OTC]
  • Creomulsion for Children [OTC]
  • Delsym Cough Childrens [OTC]
  • Delsym [OTC]
  • ElixSure Cough [OTC]
  • Hold [OTC]
  • Little Colds Cough Formula [OTC]
  • PediaCare Childrens Long-Act [OTC]
  • Robafen Cough [OTC]
  • Robitussin 12 Hour Cough [OTC]
  • Robitussin Childrens Cough LA [OTC]
  • Robitussin CoughGels [OTC] [DSC]
  • Robitussin Lingering CoughGels [OTC]
  • Robitussin Lingering LA Cough [OTC]
  • Robitussin Maximum Strength [OTC] [DSC]
  • Scot-Tussin Diabetes CF [OTC]
  • Silphen DM Cough [OTC]
  • Simply Cough [OTC] [DSC]
  • Triaminic Long Acting Cough [OTC]
  • Trocal Cough Suppressant [OTC]
  • Vicks Nature Fusion Cough [OTC]

Pharmacologic Category

  • Antitussive
  • N-Methyl-D-Aspartate Receptor Antagonist

Pharmacology

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

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

Symptomatic relief of coughs caused by the common cold or inhaled irritants

Contraindications

Concurrent administration with or within 2 weeks of discontinuing an MAO inhibitor

Dosing: Adult

Cough suppressant: Oral: 10-20 mg every 4 hours or 30 mg every 6-8 hours; extended release: 60 mg twice daily; maximum: 120 mg/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Cough suppressant: Oral:

<4 years: Not for OTC use

4-6 years (syrup): Oral: 2.5-7.5 mg every 4-8 hours; extended release is 15 mg twice daily (maximum: 30 mg/24 hours)

6-12 years: 5-10 mg every 4 hours or 15 mg every 6-8 hours; extended release is 30 mg twice daily (maximum: 60 mg/24 hours)

Children >12 years: Refer to adult dosing.

Dietary Considerations

Some products may contain sodium.

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

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

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

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

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

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

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

Test Interactions

False-positive phencyclidine, opioids and heroin urine drug screen

Adverse Reactions

Frequency not defined.

Central nervous system: Confusion, excitement, irritability, nervousness, serotonin syndrome

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:

• 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 Considerations

Maternal use of standard OTC doses of dextromethorphan when used as an antitussive during the first trimester of pregnancy has not been found to increase the risk of teratogenic effects. Dextromethorphan is metabolized in the liver via CYP2D6 and CYP3A enzymes. The activity of both enzymes is increased in the mother during pregnancy. In the fetus, CYP2D6 activity is low in the fetal liver and CYP3A4 activity is present by ~17 weeks gestation.

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?)

• 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 health care 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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