Dextromethorphan hydrobromide

Dextromethorphan hydrobromide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Indications and Dosing

• Cough: 30 mg ORALLY every 6 to 8 hours; MAX 120 mg/day

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dextromethorphan hydrobromide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Dextromethorphan hydrobromide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Indications and Dosing

• Cough/cold products should not be used in children younger than 2 years due to the risk of serious and life-threatening effects; dextromethorphan is commonly used as a cough suppressant in combination over-the-counter cough and cold products.

• Cough: (12 years or older) 30 mg ORALLY every 6 to 8 hours; MAX 120 mg/day

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dextromethorphan hydrobromide in pediatric patients.

Contraindications

There is limited information regarding Dextromethorphan hydrobromide Contraindications in the drug label.

Warnings

Do not use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• Cough that occurs with too much phlegm (mucus)
• Cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

When using this product

• Do not use more than directed

Stop use and ask a doctor if

• Cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding

• Ask a health professional before use.

Keep out of reach of children.

• In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Dextromethorphan hydrobromide Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Dextromethorphan hydrobromide Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Dextromethorphan hydrobromide Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Dextromethorphan hydrobromide in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dextromethorphan hydrobromide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dextromethorphan hydrobromide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dextromethorphan hydrobromide in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Dextromethorphan hydrobromide in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Dextromethorphan hydrobromide in geriatric settings.

Gender

There is no FDA guidance on the use of Dextromethorphan hydrobromide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dextromethorphan hydrobromide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dextromethorphan hydrobromide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dextromethorphan hydrobromide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dextromethorphan hydrobromide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dextromethorphan hydrobromide in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Dextromethorphan hydrobromide Administration in the drug label.

Monitoring

There is limited information regarding Dextromethorphan hydrobromide Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Dextromethorphan hydrobromide and IV administrations.

Overdosage

There is limited information regarding Dextromethorphan hydrobromide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Dextromethorphan hydrobromide Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Dextromethorphan hydrobromide Mechanism of Action in the drug label.

Structure

There is limited information regarding Dextromethorphan hydrobromide Structure in the drug label.

Pharmacodynamics

There is limited information regarding Dextromethorphan hydrobromide Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Dextromethorphan hydrobromide Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Dextromethorphan hydrobromide Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Dextromethorphan hydrobromide Clinical Studies in the drug label.

How Supplied

There is limited information regarding Dextromethorphan hydrobromide How Supplied in the drug label.

Storage

There is limited information regarding Dextromethorphan hydrobromide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Dextromethorphan hydrobromide Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Dextromethorphan hydrobromide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Dextromethorphan hydrobromide Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Dextromethorphan hydrobromide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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