Pill Identifier App

Dextromethorphan (Systemic)


VA CLASSIFICATION
Primary: RE302

Commonly used brand name(s): Balminil DM; Balminil DM Children; Benylin Adult Formula Cough Suppressant; Benylin DM; Benylin DM 12 Hour; Benylin DM For Children 12 Hour; Benylin DM for children; Benylin Pediatric Cough Suppressant; Broncho-Grippol-DM; Calmylin #1; Cough-X; Creo-Terpin; Delsym; Delsym Cough Formula; Diabe-TUSS DM Syrup; Hold DM; Koffex DM; Novahistex DM; Novahistine DM; Pertussin CS Children's Strength; Pertussin DM Extra Strength; Robitussin Maximum Strength Cough Suppressant; Robitussin Pediatric; Robitussin Pediatric Cough Suppressant; Sucrets 4 Hour Cough Suppressant; Triaminic DM Long Lasting For Children; Trocal; Vicks 44 Cough Relief.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antitussive—{23}{24}{25}{26}

Indications

Accepted

Cough (treatment)—Dextromethorphan is indicated for the temporary symptomatic relief of nonproductive cough due to minor throat and bronchial irritation occurring with colds or inhaled irritants. {01} {04} {08} {10} {14} {20} {40} {44} {45} {46} {47} {48} {49} {50} {51} {52} {53} {54} {55}


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. {01} {04} {08} {20} {40} {41} {42} {43}

Biotransformation:

Hepatic. Rapidly and extensively metabolized to dextrorphan (active metabolite). {01} {04} {27}

Onset of action:

Usually within one-half hour, {01} {04} {20} after 10- to 20-mg doses every 4 hours or 30 mg every 6 to 8 hours {08} {40}.

Duration of action:

Up to 6 hours. {01} {04} {20}

Note: The extended-release oral polistirex suspension delivers dextromethorphan from an ion-exchange complex over a period of 9 to 12 hours. {10} One 60-mg dose of polistirex dextromethorphan delivers a plasma concentration similar to two 30-mg doses of dextromethorphan hydrobromide given every 6 hours {40}.


Elimination:
    Primarily renal (excreted as unchanged dextromethorphan and demethylated metabolites, including dextrorphan). {01} {04} {10} {15} {20} {35}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Adequate and well-controlled studies in humans have not been done. {08} {23} {24} {25} {26} {40} {42} {44} {45} {46} {47} {49} {51} {53} {54}

Breast-feeding

It is not known whether dextromethorphan is distributed into breast milk. However, problems in humans have not been documented. {08} {23} {24} {25} {26} {40} {42} {44} {45} {46} {47} {49} {51} {53} {54}

Pediatrics

Appropriate studies on the relationship of age to the effects of dextromethorphan have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date. {11} {18}


Geriatrics


No information is available on the relationship of age to the effects of dextromethorphan in geriatric patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Central nervous system (CNS) depression–producing medications, including psychiatric, emotional, and Parkinson's disease medications, other (see Appendix II )     (concurrent use may potentiate the CNS depressant effects of these medications or dextromethorphan {23} {24} {25} {26} {44} {45} {46} {47} {48} {49} {50} {51} {53} {54})


» Monoamine oxidase (MAO) inhibitors, including furazolidone, phenelzine, procarbazine, selegiline, and tranylcypromine {08} {40} {41} {42} {43} {44} {45} {46} {47} {48} {49} {50} {51} {53} {54} {55}    (concurrent use with dextromethorphan, and also use of monoamine oxidase inhibitors within 2 to 3 weeks of dextromethorphan, may cause adrenergic crisis, collapse, coma, dizziness, excitation, hypertension, hyperpyrexia, intracerebral bleeding, lethargy, nausea, psychotic behavior, spasms, and tremors {01} {03} {04} {05} {06} {20} {23} {24} {25} {26} {32} {33} {54})


» Amiodarone or
» Fluoxetine or
» Quinidine    (inhibition of the cytochrome P4502D6 enzyme system by amiodarone, fluoxetine, or quinidine may cause a decrease in the hepatic metabolism of dextromethorphan, which may result in increased dextromethorphan serum concentrations; higher concentrations of dextromethorphan have been associated with an increased incidence of side effects {01} {31} {37})


» Smoking tobacco    (inhibition of cough reflex by dextromethorphan may lead to retention of secretions {08} {10} {19} {42} {43} {44} {45} {46} {47} {48} {49} {50} {51} {53} {54} {55})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Asthma    (dextromethorphan may impair expectoration and thus increase airway resistance {08} {10} {23} {24} {25} {26} {42} {43} {44} {45} {46} {47} {48} {49} {50} {51} {53} {54} {55})


» Bronchitis, chronic or
» Cough, productive or
» Emphysema or    (inhibition of cough reflex by dextromethorphan may lead to retention of secretions {08} {10} {19} {42} {43} {44} {45} {46} {47} {48} {49} {50} {51} {53} {54} {55})



» Diabetes    (some dextromethorphan products contain sugar and may impair blood glucose control {42} {43})


Hepatic function impairment    (metabolism of dextromethorphan may be impaired {04} {10})


Respiratory depression    (dextromethorphan may make this condition worse {01} {08} {23} {24} {25} {26})


Sensitivity to dextromethorphan {10} {23} {24} {25} {26} {41} {42} {43} {44} {45} {54} , other ingredients, such as procaine, butacaine, benzocaine, or other “caine” anesthetics, or other inactive ingredients {54}    (may result in adverse effects such as insomnia, dizziness, weakness, tremors, and arrhythmias {42} {43})




Side/Adverse Effects

Note: Toxic psychosis (hyperactivity, visual and auditory hallucinations) has been reported after ingestion of 300 mg or more of dextromethorphan. {08} {16} {17} {40}
Respiratory depression has been reported to occur with very high doses. {01} {04} {07} {08} {11} {13} {40} {42} {43}
Dextromethorphan abuse and dependence may occur rarely, especially following prolonged use of high doses. {28} {29}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
    
Confusion{23}{24}{25}{26}
    
constipation{23}{24}{25}{26}
    
headache{08}{40}
    
mild dizziness {01}{04}{08}{23}{24}{25}{26}{40}{41}{42}{43}
    
mild drowsiness {01}{04}{08}{23}{24}{25}{26}{40}{41}{42}{43}
    
nausea or vomiting {01}{04}{08}{23}{24}{25}{26}{40}{41}{42}{43}
    
stomach pain {01}{04}{41}{42}{43}





Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center {44} {45} {46} {47} {48} {49} {50} {51} {53} {54} {55} (see Poison Control Center Listing ).

Clinical effects of overdose
Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate—not necessarily inclusive:
{42}{43}Symptoms of overdose
    
Ataxia (shakiness and unsteady walk)
    
blurred vision
    
coma
    
confusion{01}{04}{31}
    
drowsiness or dizziness{04}{31}
    
respiratory depression{01} (slowed breathing)
    
severe nausea or vomiting{04}{31}
    
severe unusual excitement, nervousness, restlessness, or irritability{01}{04}{31}
    
urinary retention (difficulty in urination)



Treatment of overdose
Treatment is symptomatic and is directed toward the affected body systems. Gastric lavage, assisted respiration, vital sign monitoring, and intravenous (i.v.) naloxone are some of the possible prescribed treatments. {17} {40} {42} {43}


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Dextromethorphan (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to dextromethorphan or other ingredients
Other medications, especially other CNS depressants, MAO inhibitors, amiodarone, fluoxetine, quinidine, and smoking tobacco
Other medical problems, especially asthma, chronic bronchitis, productive cough, emphysema, diabetes, hepatic function impairment, and respiratory depression

Proper use of this medication
» Importance of not using more medication than the amount prescribed because of habit-forming potential {37}

» Proper dosing
Missed dose: If on a scheduled dosing regimen—Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage

Precautions while using this medication
Checking with physician if cough persists after medication has been used for 7 days; if sore throat persists for more than 2 days {54}; if high fever, skin rash, or continuing headache is present with cough {08} {40} {41} {42} {43} {44} {45} {46} {47} {48} {49} {50} {51} {53} {54} {55}; or if asthma {40} or high blood pressure {41} is present

Using lozenges with caution to prevent choking


Oral Dosage Forms

DEXTROMETHORPHAN HYDROBROMIDE LOZENGES

Usual adult and adolescent dose
Antitussive
Oral, 5 to 15 mg every two {54} to four {46} {55} hours, as needed.


Usual adult prescribing limits
Up to to 90 mg {46} per day.

Usual pediatric dose
Antitussive
Children up to 2 years of age: Dosage must be individualized by physician.

Children 2 to 6 years of age: Oral, 5 mg every four hours, as needed {54}.

Children 6 to 12 years of age: Oral, 5 to 15 mg every two {54} to six {46} hours, as needed.

Children 12 years of age and older: See Usual adult and adolescent dose .


Note: Administration of a specific product to a pediatric patient depends upon the ability to achieve suitable dosage for the age of the child.


Usual pediatric prescribing limits
Children 2 to 6 years of age: 30 mg per day {54}.

Children 6 to 12 years of age: 60 mg per day {46} {54} {55}.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


5 mg (OTC) [Cough-X{54} (benzocaine 2 mg) (corn syrup) (menthol) (sucrose)] [Hold DM{55} ( corn syrup) (sucrose)]


7.5 mg (OTC) [Trocal{56}]


15 mg (OTC) [Sucrets 4 Hour Cough Suppressant{46} ( corn syrup) (menthol) ( sucrose)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. {46} {54}

Protect from moisture {54}.


DEXTROMETHORPHAN HYDROBROMIDE SYRUP USP

Usual adult and adolescent dose
Antitussive
Oral, 30 mg every six to eight hours {23} {41} {42} {44} {45} {47} {50} {51} {52} {53}, as needed.


Usual adult prescribing limits
Up to 120 mg per day. {23} {42} {44} {47} {50} {51} {53}

Usual pediatric dose
Antitussive
Children up to 2 years of age: Dosage must be individualized by physician. {25} {41} {43} {44} {45} {49} {51} {52} {53}

Children 2 to 6 years of age: Oral, 3.5 mg every four hours {49} or 7.5 mg every six to eight hours {23} {25} {41} {43} {44} {45} {51} {52} {53}.

Children 6 to 12 years of age: Oral, 7 mg every four hours {49} or 15 mg every six to eight hours {23} {25} {41} {43} {44} {45} {47} {50} {51} {52} {53}.

Children 12 years of age and older: See Usual adult and adolescent dose .


Note: Dosage must be individualized for children up to 6 years of age, for dextromethorphan syrups containing alcohol {49} {50}.


Usual pediatric prescribing limits
Children 2 to 6 years of age: Up to 30 mg per day {23} {25} {43} {44} {51} {53}.

Children 6 to 12 years of age: Up to 60 mg per day {23} {25} {43} {44} {47} {50} {51} {53}.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


3.5 mg per 5 mL (OTC) [Pertussin CS Children's Strength{49} (alcohol-free) (sucrose)]


7.5 mg per 5 mL (OTC) [Benylin Pediatric Cough Suppressant{53} (alcohol-free) (sugar-free)] [Robitussin Pediatric Cough Suppressant{45} (alcohol-free) (sugar-free)]


10 mg per 15 mL (OTC) [Creo-Terpin{57} (alcohol 25%)]


15 mg per 5 mL (OTC) [Benylin Adult Formula Cough Suppressant{51} (alcohol-free) (sugar-free)] [Diabe-TUSS DM Syrup{52} (alcohol-free ) (sugar-free)] [Pertussin DM Extra Strength{50} (alcohol 4%) ( sugar)] [Robitussin Maximum Strength Cough Suppressant{44} (alcohol 1.4%) (glucose) (high fructose corn syrup)][Generic]{58}


30 mg per 15 ml (OTC) [Vicks 44 Cough Relief{47} ( alcohol) (high fructose corn syrup)]

Canada—


7.5 mg per 5 mL (OTC) [Balminil DM Children{36} ( alcohol-free)] [Benylin DM for children{25} ( alcohol-free) (sucrose-free)] [Novahistine DM{43} (alcohol-free) (glucose)] [Robitussin Pediatric{41} (alcohol-free) (sugar-free)]


15 mg per 5 mL (OTC) [Balminil DM{34} (alcohol-free ) (sucrose or sucrose-free)] [Benylin DM{23} (alcohol-free) ( artificial sweetener) (sucrose-free)] [Broncho-Grippol-DM{21} (alcohol-free ) (sugar-free)] [Calmylin #1{09} (alcohol-free) (natural honey flavoring )] [Koffex DM{22} (alcohol-free) (sucrose or sucrose-free)] [Novahistex DM{42} (alcohol-free) (glucose)]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing. {41} {51} {53}


DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION

Usual adult and adolescent dose
Antitussive
Oral, 60 mg every twelve hours, as needed. {08} {24} {48}


Usual adult prescribing limits
Up to 120 mg per day. {08} {24} {48}

Usual pediatric dose
Antitussive
Children up to 2 years of age: Dosage must be individualized by physician. {08} {24} {40} {48}

Children 2 to 6 years of age: Oral, 15 mg every twelve hours, as needed. {08} {24} {26} {40} {48}

Children 6 to 12 years of age: Oral, 30 mg every twelve hours, as needed. {08} {24} {26} {40} {48}

Children 12 years of age and older: See Usual adult and adolescent dose .


Usual pediatric prescribing limits
Children 2 to 6 years of age: Up to 30 mg per day {08} {24} {26} {40} {48}.

Children 6 to 12 years of age: Up to 60 mg per day {08} {24} {26} {40} {48}.

Usual geriatric dose
See Usual adult and adolescent dose

Strength(s) usually available
U.S.—


30 mg (equivalent of dextromethorphan hydrobromide) per 5 mL (OTC) [Delsym Cough Formula{48} (alcohol-free) ( high fructose corn syrup) (sucrose)]

Canada—


15 mg (equivalent of dextromethorphan hydrobromide) per 5 ml (OTC) [Benylin DM For Children 12 Hour{26} (alcohol-free) (sucralose) (sucrose-free)]


30 mg (equivalent of dextromethorphan hydrobromide) per 5 mL (OTC) [Benylin DM 12 Hour{24} (alcohol-free) ( sucralose) (sucrose-free)] [Delsym{08} (alcohol-free) ( corn syrup) (granulated sugar)] [Triaminic DM Long Lasting For Children{40} (alcohol-free ) (corn syrup) (sugar )]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well.



Revised: 06/11/1999



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