Diphenhydramine: Difference between revisions

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{{DrugProjectFormSinglePage
{{Details0|Diphenhydramine (oral)}}
|authorTag={{AJ}}
{{Details0|Diphenhydramine (Injection)}}
|OTC=Yes
{{Details0|Diphenhydramine (topical)}}
|genericName=Diphenhydramine hydrochloride
|aOrAn=a
|drugClass=Analgesic and antihistamine
|indicationType=treatment
|indication=temporarily relieves symptoms of the [[common cold]] like
[[Runny nose]], [[Sneezing]], [[Itchy]] watery [[eyes]], [[Itchy]] nose or [[throat]]
|adverseReactions=[[Xerostomia]], [[dizziness]], [[dyskinesia]], [[sedation]], [[somnolence]], dryness of [[nasal mucosa]], [[pharyngeal dryness]], thick sputum.
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* 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=* [[Chemotherapy]]-induced [[nausea]] and [[vomiting]].
* [[Extrapyramidal]] [[disease]] - [[Medication]]-induced [[movement disorder]].
* [[Hyperemesis gravidarum]].
* [[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-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
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=*
 
<!--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=*
 
<!--Patient Counseling Information-->
|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 [[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]]

Latest revision as of 15:52, 6 May 2015