Diphenhydramine: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{AJ}}
|authorTag={{AJ}}
|genericName=antihistamine
|genericName=Diphenhydramine hydrochloride
|aOrAn=a
|aOrAn=a
|drugClass=Analgesic ,  Antihistamine
|indicationType=treatment
|indicationType=treatment
|adverseReactions=<!--Black Box Warning-->
|indication=temporarily relieves symptoms of the common cold like
runny nose, sneezing, itchy watery eyes, itchy nose or throat
 
|adverseReactions=[[Xerostomia]], [[dizziness]], [[dyskinesia]], [[sedatation]], [[somnolence]]
dryness of nasal mucosa, [[pharyngeal dryness]], thick sputum.
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Line 13: Line 18:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
|fdaLIADAdult=* Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
:* Runny nose
sneezing
:* Sneezing
itchy, watery eyes
:* Itchy, watery eyes
itchy nose or throat
:* Itchy nose or throat
temporarily relieves these symptoms of the common cold:
runny nose
sneezing
 
take every 4 to 6 hours, not more than 6 doses in 24 hours
 
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:  
 
* Class of Recommendation:
 
* Strength of Evidence:  
 
* Dosing Information
 
:* Dosage


=====Condition2=====
* Temporarily relieves these symptoms of the common cold:
 
:* Runny nose
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
:* Sneezing
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
* Dosing Information


:* Dosage
:* Take every 4 to 6 hours, not more than 6 doses in 24 hours
 
|offLabelAdultGuideSupport=* Chemotherapy-induced nausea and vomiting.
=====Condition2=====
* Extrapyramidal disease - Medication-induced movement disorder.
 
* Hyperemesis gravidarum.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* Local anesthesia
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Diphenhydramine in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->
Line 67: Line 53:


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Diphenhydramine in pediatric patients.
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Diphenhydramine in pediatric patients.


* Dosing Information
<!--Contraindications-->
 
|contraindications=* Diphenhydramine is contraindicated in persons with known hypersensitivity.
:* Dosage


=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1


<!--Warnings-->
|warnings=* Do not use with any other product containing diphenhydramine, even one used on skin
|warnings=Do not use
* To make a child sleepy
with any other product containing diphenhydramine, even one used on skin
* Ask a doctor before use if you have glaucoma
to make a child sleepy
* Trouble urinating due to an enlarged prostate gland
Ask a doctor before use if you have
* A breathing problem such as emphysema or chronic bronchitis
glaucoma
* Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
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
When using this product
Line 119: Line 80:
Keep out of reach of children.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
In case of overdose, get medical help or contact a Poison Control Center right away.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials======Digestive=====
 
* Xerostomia
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 


=====Neurologic=====
=====Neurologic=====
 
* Sedation
 
* Dizziness
 
* Dyskinesia
* Somnolence


=====Respiratory=====
=====Respiratory=====
* Dryness of nasal mucosa
* Pharyngeal dryness
* Thick sputum
* Bronchial dryness


 
=====Miscellaneous====
 
* Anaphylaxis reaction
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====






<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of Diphenhydramine in the drug label.


=====Body as a Whole=====
=====Body as a Whole=====
Line 241: Line 156:


<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=There is limited information regarding <i>drug interactions</i> of Diphenhydramine in the drug label.
:* Description
|FDAPregCat=B
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Diphenhydramine in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of Diphenhydramine during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=There is no FDA guidance on the use of Diphenhydramine with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=* Keep out of reach of children.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
* In case of overdose, get medical help or contact a Poison Control Center right away.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGeri=There is no FDA guidance on the use of Diphenhydramine with respect to geriatric patients.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInGender=There is no FDA guidance on the use of Diphenhydramine with respect to specific gender populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInRace=There is no FDA guidance on the use of Diphenhydramine with respect to specific racial populations.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInRenalImpair=There is no FDA guidance on the use of Diphenhydramine in patients with renal impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInHepaticImpair=There is no FDA guidance on the use of Diphenhydramine in patients with hepatic impairment.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInReproPotential=There is no FDA guidance on the use of Diphenhydramine in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of Diphenhydramine in patients who are immunocompromised.


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Intramuscular
 
* Intravenous
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Oral
|monitoring=There is limited information regarding <i>Monitoring</i> of Diphenhydramine in the drug label.


* Description


<!--IV Compatibility-->
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of Diphenhydramine in the drug label.


<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Chronic Overdose</i> of Diphenhydramine in the drug label.
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->
Line 304: Line 205:


<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of Diphenhydramine in the drug label.


<!--Clinical Studies-->
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of Diphenhydramine in the drug label.


<!--How Supplied-->
<!--How Supplied-->
Line 314: Line 215:
<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
|storage=store at 20°-25°C
|storage=store at 20°-25°C
|fdaPatientInfo=* 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
|alcohol=* Avoid alcoholic drinks.


|fdaPatientInfo=marked drowsiness may occur
* Alcohol, sedatives and tranquilizers may increase drowsiness.
avoid alcoholic drinks
|brandNames=* Benadryl®
excitability may occur, especially in children
* Benylin Decongestant Cough®
alcohol, sedatives and tranquilizers may increase drowsiness
* Diphenhist
be careful when driving a motor vehicle or operating machinery
* Diphenyl®
|alcohol=avoid alcoholic drinks
* Genahist®
 
* Geridryl®
alcohol, sedatives and tranquilizers may increase drowsiness
* Nytol Quickcaps®
 
* Nytol Quickgels®
|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>
|lookAlike=* Benadryl® - benazepril®
 
* diphenhydrAMINE® - dimenhyDRINATE®
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date =  }}</ref>
 
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Revision as of 18:44, 15 December 2014

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]

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.

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

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

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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