Diphenhydramine

Diphenhydramine
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: Adeel Jamil, M.D. [2]

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Overview

Diphenhydramine is a Analgesic , Antihistamine that is FDA approved for the treatment of temporarily relieves symptoms of the common cold like runny nose, sneezing, itchy watery eyes, itchy nose or throat. Common adverse reactions include Xerostomia, dizziness, dyskinesia, sedatation, somnolence dryness of nasal mucosa, pharyngeal dryness, thick sputum..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itchy nose or throat

• Temporarily relieves these symptoms of the common cold:

• Runny nose
• Sneezing

• Dosing Information

• Take every 4 to 6 hours, not more than 6 doses in 24 hours

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• Chemotherapy-induced nausea and vomiting.
• Extrapyramidal disease - Medication-induced movement disorder.
• Hyperemesis gravidarum.
• Local anesthesia

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Diphenhydramine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Diphenhydramine is contraindicated in persons with known hypersensitivity.

Warnings

• Do not use with any other product containing diphenhydramine, even one used on skin
• To make a child sleepy
• Ask a doctor before use if you have glaucoma
• Trouble urinating due to an enlarged prostate gland
• A breathing problem such as emphysema or chronic bronchitis
• Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product marked drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery 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 right away.

Adverse Reactions

Clinical Trials Experience

Digestive

• Xerostomia

Neurologic

• Sedation
• Dizziness
• Dyskinesia
• Somnolence

Respiratory

• Dryness of nasal mucosa
• Pharyngeal dryness
• Thick sputum
• Bronchial dryness

=Miscellaneous

• Anaphylaxis reaction

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Diphenhydramine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

There is limited information regarding drug interactions of Diphenhydramine in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Diphenhydramine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Diphenhydramine with respect to nursing mothers.

Pediatric Use

• Keep out of reach of children.
• In case of overdose, get medical help or contact a Poison Control Center right away.

Geriatic Use

There is no FDA guidance on the use of Diphenhydramine with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Intramuscular
• Intravenous
• Oral

Monitoring

There is limited information regarding Monitoring of Diphenhydramine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Diphenhydramine in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Diphenhydramine in the drug label.

Pharmacology

There is limited information regarding Diphenhydramine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Diphenhydramine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Diphenhydramine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Diphenhydramine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Diphenhydramine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Diphenhydramine in the drug label.

How Supplied

Storage

store at 20°-25°C

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

• Avoid alcoholic drinks.

• Alcohol, sedatives and tranquilizers may increase drowsiness.

Brand Names

• Benadryl®
• Benylin Decongestant Cough®
• Diphenhist
• Diphenyl®
• Genahist®
• Geridryl®
• Nytol Quickcaps®
• Nytol Quickgels®

Look-Alike Drug Names

• Benadryl® - benazepril®
• diphenhydrAMINE® - dimenhyDRINATE®

Drug Shortage Status

Price

References

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

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