Dextromethorphan hydrobromide

Jump to navigation Jump to search

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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Dextromethorphan hydrobromide is an antitussive that is FDA approved for the treatment of cough. Common adverse reactions include dizziness, somnolence, fatigue.

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

Dosing

  • Do not take more than 4 doses in any 24-hour period
  • This adult product is not intended for use in children under 12 years of age
  • Measure only with dosing cup provided
  • Keep dosing cup with product
  • tsp = teaspoon, mL = milliliter
This image is provided by the National Library of Medicine.

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 FDA-Labeled Use of Dextromethorphan hydrobromide in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–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

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

Neurologic: Dizziness, Somnolence

Other: Fatigue

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

Oral

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

Template:Px
Template:Px
Dextromethorphan hydrobromide
Systematic (IUPAC) name
(4bS,8aR,9S)-3-Methoxy-11-methyl-6,7,8,8a,9,10-hexahydro-5H-9,4b-(epiminoethano)phenanthrene
Identifiers
CAS number 125-71-3
ATC code R05DA09
PubChem 15978238
DrugBank DB00514
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 271.40 g/mol
SMILES eMolecules & PubChem
Physical data
Melt. point 111 °C (232 °F)
Pharmacokinetic data
Bioavailability 11%[1]
Metabolism Hepatic (liver) enzymes: major CYP2D6, minor CYP3A4, and minor CYP3A5
Half life 2-4 hours (extensive metabolisers); 24 hours (poor metabolisers)[2]
Excretion Renal
Therapeutic considerations
Pregnancy cat.

A(AU) C(US)

Legal status

Pharmacy Only (S2)(AU) ?(CA) ?(UK) OTC(US)

Dependence Liability Low
Routes Oral

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

  • Store at 20º-25ºC (68º-77ºF). Do not refrigerate.

Images

Drug Images

{{#ask: Page Name::Dextromethorphan hydrobromide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Dextromethorphan hydrobromide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

  • Benylin
  • Creomulsion
  • Delsym.

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.

  1. ↑ Kukanich B, Papich MG (2004). "Plasma profile and pharmacokinetics of dextromethorphan after intravenous and oral administration in healthy dogs". J. Vet. Pharmacol. Ther. 27 (5): 337–41. doi:10.1111/j.1365-2885.2004.00608.x. PMID 15500572.
  2. ↑ "Balminil DM, Benylin DM (dextromethorphan) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 15 April 2014.

{{#subobject: 

 |Label Page=Dextromethorphan hydrobromide
 |Label Name=Dextromethorphanfig01.jpg

}}

{{#subobject: 

 |Label Page=Dextromethorphan hydrobromide
 |Label Name=Dextromethorphan ingredients and appearance.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Dextromethorphan_hydrobromide&oldid=1135142"