Diphenhydramine (oral): Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{AJ}}
|OTC=Yes
|genericName=Diphenhydramine hydrochloride
|aOrAn=a
|drugClass=Analgesic and antihistamine
|indicationType=treatment
|indicationType=treatment
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|indication=temporarily relieves symptoms of the [[common cold]] like
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
[[Runny nose]], [[Sneezing]], [[Itchy]] watery [[eyes]], [[Itchy]] nose or [[throat]]
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Diphenhydramine (oral) in adult patients.
|adverseReactions=[[Xerostomia]], [[dizziness]], [[dyskinesia]], [[sedation]], [[somnolence]], dryness of [[nasal mucosa]], [[pharyngeal dryness]], thick sputum.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Diphenhydramine (oral) in adult patients.
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Diphenhydramine (oral) in pediatric patients.
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Diphenhydramine (oral) in pediatric patients.
 
|alcohol=Alcohol-Diphenhydramine (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=* 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
 
[[File:Diphenhydramine dosage table01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Diphenhydramine in adult patients.
 
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non-Guideline-Supported Use</i> of Diphenhydramine in adult patients.
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Diphenhydramine in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Diphenhydramine in pediatric patients.
 
<!--Contraindications-->
|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.
|clinicalTrials=====Digestive=====
* [[Xerostomia]]
 
=====Neurologic=====
* [[Sedation]]
* [[Dizziness]]
* [[Dyskinesia]]
* [[Somnolence]]
 
=====Respiratory=====
* Dryness of [[nasal mucosa]]
* [[Pharyngeal]] dryness
* Thick [[sputum]]
* [[Bronchial]] dryness
 
=====Miscellaneous=====
* [[Anaphylaxis]] reaction
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of Diphenhydramine in the drug label.
 
<!--Drug Interactions-->
|drugInteractions=There is limited information regarding <i>drug interactions</i> of Diphenhydramine in the drug label.
|FDAPregCat=B
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''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.
|useInLaborDelivery=There is no FDA guidance on use of Diphenhydramine during labor and delivery.
|useInNursing=There is no FDA guidance on the use of Diphenhydramine with respect to nursing mothers.
|useInPed=* Keep out of reach of children.
* In case of overdose, get medical help or contact a [[Poison]] Control Center right away.
|useInGeri=There is no FDA guidance on the use of Diphenhydramine with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of Diphenhydramine with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of Diphenhydramine with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of Diphenhydramine in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of Diphenhydramine in patients with hepatic impairment.
|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=* [[Intramuscular]]
* [[Intravenous]]
* [[Oral]]
|monitoring=There is limited information regarding <i>Monitoring</i> of Diphenhydramine in the drug label.
 
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of Diphenhydramine in the drug label.
 
<!--Overdosage-->
|overdose=There is limited information regarding <i>Chronic Overdose</i> of Diphenhydramine in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox={{Drugbox2
| Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 460791686
| IUPAC_name = 2-(diphenylmethoxy)-''N'',''N''-dimethylethanamine
| image = Diphenhydramine 2D skeletal.png
| width = 200
| image2 = Diphenhydramine ball-and-stick animation.gif
 
<!--Clinical data-->
| tradename = Benadryl, Unisom, Sominex, ZzzQuil,
| Drugs.com = {{drugs.com|monograph|diphenhydramine-hydrochloride}}
| MedlinePlus = a682539
| pregnancy_AU = A
| pregnancy_US = B
| legal_AU = S2
| legal_status = [[Over-the-counter drug|Over-the-counter]]
| routes_of_administration = Oral, parenteral ([[Intramuscular injection|IM]] and [[Intravenous therapy|IV]]), topical, suppository
| dependency_liability = Very low
 
<!--Pharmacokinetic data-->
| bioavailability = 40–60%<ref name="pmid2866055">{{cite journal | author = Paton DM, Webster DR | title = Clinical pharmacokinetics of H1-receptor antagonists (the antihistamines) | journal = Clin. Pharmacokinet. | volume = 10 | issue = 6 | pages = 477–97 | year = 1985 | pmid = 2866055 | doi = 10.2165/00003088-198510060-00002 }}</ref>
| protein_bound = 98–99%
| metabolism = Various [[cytochrome P450]] liver enzymes: [[CYP2D6]] (80%), [[CYP3A4|3A4]] (10%)<ref>{{cite web | author = | title = Showing Diphenhydramine (DB01075) | url = http://www.drugbank.ca/drugs/DB01075 | publisher = DrugBank | accessdate = 5 September 2009 }}</ref>
| elimination_half-life = 8 hours (children)<ref name="pmid2391399">{{cite journal | author = Simons KJ, Watson WT, Martin TJ, Chen XY, Simons FE | title = Diphenhydramine: pharmacokinetics and pharmacodynamics in elderly adults, young adults, and children | journal = J. Clin. Pharmacol. | volume = 30 | issue = 7 | pages = 665–71 |date=July 1990 | pmid = 2391399 | doi = 10.1002/j.1552-4604.1990.tb01871.x }}</ref><br />9 to 12 hours (adults)<ref name="pmid2391399" /><br />17 hours (elderly)<ref name="pmid2391399" />
| excretion = 94% through the urine, 6% through feces<ref name="pmid3962845">{{cite journal | author = Garnett WR | title = Diphenhydramine | journal = Am. Pharm. | volume = NS26 | issue = 2 | pages = 35–40 |date=February 1986 | pmid = 3962845 | doi = }}</ref>
 
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 58-73-1
| ATC_prefix = D04
| ATC_suffix = AA32
| ATC_supplemental =  {{ATC|D04|AA33}}, {{ATC|R06|AA02}}
| PubChem = 3100
| IUPHAR_ligand = 1224
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB01075
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 2989
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 8GTS82S83M
| KEGG_Ref = {{keggcite|changed|kegg}}
| KEGG = D00669
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 4636
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 657
 
<!--Chemical data-->
| C = 17 | H = 21 | N = 1 | O = 1
| molecular_weight = 255.355 g/mol
| smiles = O(CCN(C)C)C(c1ccccc1)c2ccccc2
| InChI = 1/C17H21NO/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16/h3-12,17H,13-14H2,1-2H3
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C17H21NO/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16/h3-12,17H,13-14H2,1-2H3
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = ZZVUWRFHKOJYTH-UHFFFAOYSA-N
}}
}}
|mechAction=* Diphenhydramine is an inverse agonist of the [[histamine]] [[H1 receptor]]. It is a member of the [[ethanolamine]] class of [[antihistaminergic]] agents. By reversing the effects of [[histamine]] on the [[capillaries]], it can reduce the intensity of [[allergic]] symptoms. It also crosses the [[blood–brain barrier]] and [[antagonizes]] the [[H1 receptors]] centrally. Its effects on central [[H1 receptors]] cause [[drowsiness]].
* Like many other first-generation [[antihistamines]], diphenhydramine is also a potent [[antimuscarinic]] (a [[competitive antagonist]] of [[muscarinic]] [[acetylcholine receptors]]) and, as such, at high doses can cause [[anticholinergic syndrome]].
<!--Structure-->
|structure=[[File:Diphenhydramine structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of Diphenhydramine in the drug label.
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of Diphenhydramine in the drug label.
<!--How Supplied-->
|howSupplied=* Each tablet contains: calcium 20 mg
|storage=* Store at 20°-25°C
|packLabel=[[File:Diphenhydramine drug lable01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:Diphenhydramine dosage table01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=* Marked [[drowsiness]] may occur
* Avoid [[alcoholism|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.
* [[Alcohol]], [[sedatives]] and [[tranquilizers]] may increase [[drowsiness]].
|brandNames=* Benadryl®
* Benylin Decongestant Cough®
* Diphenhist
* Diphenyl®
* Genahist®
* Geridryl®
* Nytol Quickcaps®
* Nytol Quickgels®
|lookAlike=* Benadryl®  - benazepril®
* diphenhydrAMINE®  - dimenhyDRINATE®
|drugShortage=
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage}}
{{LabelImage}}
<!--Pill Image-->
<!--Label Display Image-->
<!--Category-->
[[Category:Drug]]

Revision as of 15:21, 6 May 2015

Diphenhydramine (oral)
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.
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

Diphenhydramine (oral) is a Analgesic and 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, sedation, 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:
  • Temporarily relieves these symptoms of the common cold:
  • Dosing Information
  • Take every 4 to 6 hours, not more than 6 doses in 24 hours
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 Diphenhydramine in adult patients.

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)

There is limited information regarding FDA-Labeled Use of Diphenhydramine (oral) 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

Warnings

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=

Neurologic
Respiratory
Miscellaneous

Postmarketing Experience

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

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

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

Template:Px
Template:Px
Diphenhydramine (oral)
Systematic (IUPAC) name
2-(diphenylmethoxy)-N,N-dimethylethanamine
Identifiers
CAS number 58-73-1
ATC code D04AA32 D04AA33 (WHO), R06AA02 (WHO)
PubChem 3100
DrugBank DB01075
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 255.355 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 40–60%[1]
Protein binding 98–99%
Metabolism Various cytochrome P450 liver enzymes: CYP2D6 (80%), 3A4 (10%)[2]
Half life 8 hours (children)[3]
9 to 12 hours (adults)[3]
17 hours (elderly)[3]
Excretion 94% through the urine, 6% through feces[4]
Therapeutic considerations
Pregnancy cat.

A(AU) B(US)

Legal status

Pharmacy Only (S2)(AU) Over-the-counter

Dependence Liability Very low
Routes Oral, parenteral (IM and IV), topical, suppository

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Diphenhydramine (oral) 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

  • Each tablet contains: calcium 20 mg

Storage

  • Store at 20°-25°C

Images

Drug Images

{{#ask: Page Name::Diphenhydramine (oral) |?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

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

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

Patient Counseling Information

Precautions with Alcohol

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.

  1. ↑ Paton DM, Webster DR (1985). "Clinical pharmacokinetics of H1-receptor antagonists (the antihistamines)". Clin. Pharmacokinet. 10 (6): 477–97. doi:10.2165/00003088-198510060-00002. PMID 2866055.
  2. ↑ "Showing Diphenhydramine (DB01075)". DrugBank. Retrieved 5 September 2009.
  3. ↑ 3.0 3.1 3.2 Simons KJ, Watson WT, Martin TJ, Chen XY, Simons FE (July 1990). "Diphenhydramine: pharmacokinetics and pharmacodynamics in elderly adults, young adults, and children". J. Clin. Pharmacol. 30 (7): 665–71. doi:10.1002/j.1552-4604.1990.tb01871.x. PMID 2391399.
  4. ↑ Garnett WR (February 1986). "Diphenhydramine". Am. Pharm. NS26 (2): 35–40. PMID 3962845.

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