Dimenhydrinate

Dimenhydrinate
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: Turky Alkathery, M.D. [2]

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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

Dimenhydrinate is an antiemetic that is FDA approved for the treatment of these symptoms associated with motion sickness:

• nausea.
• vomiting.
• dizziness.. Common adverse reactions include nausea, vomiting, xerostomia and sedation..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Uses for prevention and treatment of these symptoms associated with motion sickness:

• nausea
• vomiting
• dizziness

Dosage

• To prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity.
• To prevent or treat motion sickness, use the following dosing.

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Dimenhydrinate in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

• Uses for prevention and treatment of these symptoms associated with motion sickness:

• nausea
• vomiting
• dizziness

• Do not use in children under 2 years of age unless directed by a doctor

Dosage

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• None

Warnings

• None.

Precautions

ASK A DOCTOR BEFORE USE IF YOU HAVE

• A breathing problem such as emphysema or chronic bronchitis.
• Glaucoma.
• Difficulty in urination due to enlargement of the prostate gland.

Adverse Reactions

Clinical Trials Experience

WHEN USING THIS PRODUCT

• Marked drowsiness may occur.
• Alcohol, sedatives and tranquilizers may increase drowsiness.
• Avoid alcoholic drinks.
• Be careful when driving a motor vehicle or operating machinery*

Postmarketing Experience

• There is limited information regarding postmarketing experience.

Drug Interactions

ASK DOCTOR/PHARMACIST

• Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• If pregnant or breast-feeding, ask a health professional before use.

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

Labor and Delivery

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

Nursing Mothers

• If pregnant or breast-feeding, ask a health professional before use.

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral.

Monitoring

• There is limited information regarding Monitoring.

IV Compatibility

• There is limited information regarding IV Compatibility.

Overdosage

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

Pharmacology

Dimenhydrinate

Combination of
diphenhydramine	antiemetic
8-chlorotheophylline	stimulant
[[{{{component3}}}]]	? Class
[[{{{component4}}}]]	? Class
[[{{{component5}}}]]	? Class
Clinical data
Trade names	Dramamine
AHFS/Drugs.com	Monograph
MedlinePlus	a607046
Pregnancy category	AU: A US: B (No risk in non-human studies)
Routes of administration	Oral, Rectal, I.V.
ATC code	R06AA52
Legal status
Legal status	AU: S2 (Pharmacy only) US: OTC
Identifiers
CAS Number	523-87-5 Y
PubChem CID	10660
DrugBank	DB00985 Y
ChemSpider	10210 Y
UNII	JB937PER5C
KEGG	D00520 Y
ChEMBL	ChEMBL1200406 N
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
3D model (JSmol)	Interactive image
SMILES O=C2N(c1nc(Cl)nc1C(=O)N2C)C.O(CCN(C)C)C(c1ccccc1)c2ccccc2
InChI InChI=1S/C17H21NO.C7H7ClN4O2/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16;1-11-4-3(9-6(8)10-4)5(13)12(2)7(11)14/h3-12,17H,13-14H2,1-2H3;1-2H3,(H,9,10) Y Key:NFLLKCVHYJRNRH-UHFFFAOYSA-N Y
NY (what is this?)  (verify)

Mechanism of Action

• There is limited information regarding Mechanism of action.

Structure

Pharmacodynamics

• There is limited information regarding Pharmacodynamics.

Pharmacokinetics

• There is limited information regarding Pharmacokinetics.

Nonclinical Toxicology

• There is limited information regarding Nonclinical toxicology.

Clinical Studies

• There is limited information regarding Clinical Studies.

How Supplied

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

Storage

• Store at 15° to 30°C (59° to 86°F)

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

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

Precautions with Alcohol

• Avoid alcoholic drinks.

Brand Names

• DIMENHYDRINATE ®

Look-Alike Drug Names

• dimenhyDRINATE - diphenhydrAMINE

Drug Shortage Status

Price

References

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