|
|
| (3 intermediate revisions by the same user not shown) |
| Line 1: |
Line 1: |
| {{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=* 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=
| |
| | |
| <!--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 [[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]]
| |