Sumatriptan (oral): Difference between revisions

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{{Sumatriptan}}
{{DrugProjectFormSinglePage
{{Drugbox
|authorTag=
| Watchedfields = changed
 
| verifiedrevid = 477173943
 
| IUPAC_name = 1-[3-(2-dimethylaminoethyl)-1''H''-indol-5-yl]- ''N''-methyl-methanesulfonamide
<!--Overview-->
| image2 = Sumatriptan-3D-balls.png
 
| alt2 = Sumatriptan molecule
|genericName=
<!--Clinical data-->
 
| tradename = Imitrex, Imigran,Treximet
 
| Drugs.com = {{drugs.com|monograph|sumatriptan}}
 
| licence_US = Sumatriptan
|aOrAn=
| pregnancy_category = C
 
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
a
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
 
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM -->
|drugClass=
| legal_US    = Rx-only
 
| routes_of_administration = tablet, subcutaneous injection, nasal spray
 
<!--Pharmacokinetic data-->
 
| bioavailability = 15% (oral)/ 96% (s.c)
|indication=
| protein_bound = 14–21%
 
| metabolism = [[Monoamine oxidase|MAO]]
 
| elimination_half-life = 2.5 hours
 
| excretion = 60% [[urine]]; 40% [[feces]]
|hasBlackBoxWarning=
<!--Identifiers-->
 
| CASNo_Ref = {{cascite|correct|CAS}}
Yes
| CAS_number_Ref = {{cascite|correct|??}}
 
| CAS_number = 103628-46-2
|adverseReactions=
| ATC_prefix = N02
 
| ATC_suffix = CC01
 
| PubChem = 5358
 
| IUPHAR_ligand = 54
<!--Black Box Warning-->
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
 
| DrugBank = DB00669
|blackBoxWarningTitle=
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
Title
| ChemSpiderID = 5165
 
| UNII_Ref = {{fdacite|correct|FDA}}
|blackBoxWarningBody=
| UNII = 8R78F6L9VO
<i><span style="color:#FF0000;">ConditionName: </span></i>
| KEGG_Ref = {{keggcite|correct|kegg}}
 
| KEGG = D00451
* Content
| ChEBI_Ref = {{ebicite|correct|EBI}}
 
| ChEBI = 10650
<!--Adult Indications and Dosage-->
| ChEMBL_Ref = {{ebicite|correct|EBI}}
 
| ChEMBL = 128
<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--Chemical data-->
 
| C=14 | H=21 | N=3 | O=2 | S=1
|fdaLIADAdult=
| molecular_weight = 295.402 g/mol
 
| smiles = O=S(=O)(NC)Cc1cc2c(cc1)ncc2CCN(C)C
=====Condition1=====
| InChI = 1/C14H21N3O2S/c1-15-20(18,19)10-11-4-5-14-13(8-11)12(9-16-14)6-7-17(2)3/h4-5,8-9,15-16H,6-7,10H2,1-3H3
 
| InChIKey = KQKPFRSPSRPDEB-UHFFFAOYAF
* Dosing Information
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
 
| StdInChI = 1S/C14H21N3O2S/c1-15-20(18,19)10-11-4-5-14-13(8-11)12(9-16-14)6-7-17(2)3/h4-5,8-9,15-16H,6-7,10H2,1-3H3
:* Dosage
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
 
| StdInChIKey = KQKPFRSPSRPDEB-UHFFFAOYSA-N
=====Condition2=====
}}
 
__NOTOC__
* Dosing Information
{{CMG}}
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=
 
=====Condition1=====
 
* 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 adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} 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=
 
=====Condition1=====
 
* 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)-->
 
|offLabelPedNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* 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=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} 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=====
 
 
 
<!--Postmarketing Experience-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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-->
 
|drugInteractions=
 
* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* '''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.
 
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
 
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
 
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
 
|administration=
 
* Oral
 
* Intravenous
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
 
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
 
|drugBox=
 
 
 
<!--Mechanism of Action-->
 
|mechAction=


'''''For patient information about Sumatriptan Oral and Nasal, click [[Sumatriptan oral and nasal (patient information)|here]].'''''
*


'''''For patient information about Sumatriptan Injection, click [[Sumatriptan injection (patient information)|here]].'''''
<!--Structure-->


{{SB}} Alsuma<sup>®</sup>, Imitrex<sup>®</sup>, Imitrex STATdose Refill<sup>®</sup>, Imitrex STATdose System<sup>®</sup>, Sumavel DosePro<sup>®</sup>
|structure=


==Overview==
*


'''Sumatriptan''' is a synthetic drug belonging to the [[triptan]] class, used for the treatment of [[migraine]] headaches. Structurally, it is an analog of the naturally occurring neuro-active [[alkaloids]] [[dimethyltryptamine]] ([[O-Desmethyltramadol|DMT]]), [[bufotenine]], and [[5-methoxy-dimethyltryptamine]], with an N-methyl sulfonamidomethyl- group at position C-5 on the [[indole]] ring.<ref>The presence of the [[Sulfonamide (chemistry)|sulfonamide]] group in the molecule does not make sumatriptan a "sulfa drug", since it does not have any [[anti-microbial]] properties.</ref>
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


==Category==
<!--Pharmacodynamics-->


Serotonin Receptor Agonists; Antimigraine Agents
|PD=


==FDA Package Insert==
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


====IMITREX (sumatriptan succinate) injection====
<!--Pharmacokinetics-->


'''  [[IMITREX injection indications and usage|Indications and Usage]]'''
|PK=
'''| [[IMITREX injection dosage and administration|Dosage and Administration]]'''
'''| [[IMITREX injection dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[IMITREX injection contraindications|Contraindications]]'''
'''| [[IMITREX injection warnings and precautions|Warnings and Precautions]]'''
'''| [[IMITREX injection adverse reactions|Adverse Reactions]]'''
'''| [[IMITREX injection drug interactions|Drug Interactions]]'''
'''| [[IMITREX injection use in specific populations|Use in Specific Populations]]'''
'''| [[IMITREX injection overdosage|Overdosage]]'''
'''| [[IMITREX injection description|Description]]'''
'''| [[IMITREX injection clinical pharmacology|Clinical Pharmacology]]'''
'''| [[IMITREX injection nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[IMITREX injection clinical studies|Clinical Studies]]'''
'''| [[IMITREX injection how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[IMITREX injection patient counseling information|Patient Counseling Information]]'''
'''| [[IMITREX injection labels and packages|Labels and Packages]]'''


====IMITREX (sumatriptan succinate) tablet====
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


'''  [[IMITREX tablet indications and usage|Indications and Usage]]'''
<!--Nonclinical Toxicology-->
'''| [[IMITREX tablet dosage and administration|Dosage and Administration]]'''
'''| [[IMITREX tablet dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[IMITREX tablet contraindications|Contraindications]]'''
'''| [[IMITREX tablet warnings and precautions|Warnings and Precautions]]'''
'''| [[IMITREX tablet adverse reactions|Adverse Reactions]]'''
'''| [[IMITREX tablet drug interactions|Drug Interactions]]'''
'''| [[IMITREX tablet use in specific populations|Use in Specific Populations]]'''
'''| [[IMITREX tablet overdosage|Overdosage]]'''
'''| [[IMITREX tablet description|Description]]'''
'''| [[IMITREX tablet clinical pharmacology|Clinical Pharmacology]]'''
'''| [[IMITREX tablet nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[IMITREX tablet clinical studies|Clinical Studies]]'''
'''| [[IMITREX tablet how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[IMITREX tablet patient counseling information|Patient Counseling Information]]'''
'''| [[IMITREX tablet labels and packages|Labels and Packages]]'''


====IMITREX (sumatriptan) spray====
|nonClinToxic=


'''  [[IMITREX spray indications and usage|Indications and Usage]]'''
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
'''| [[IMITREX spray dosage and administration|Dosage and Administration]]'''
'''| [[IMITREX spray dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[IMITREX spray contraindications|Contraindications]]'''
'''| [[IMITREX spray warnings and precautions|Warnings and Precautions]]'''
'''| [[IMITREX spray adverse reactions|Adverse Reactions]]'''
'''| [[IMITREX spray drug interactions|Drug Interactions]]'''
'''| [[IMITREX spray use in specific populations|Use in Specific Populations]]'''
'''| [[IMITREX spray overdosage|Overdosage]]'''
'''| [[IMITREX spray description|Description]]'''
'''| [[IMITREX spray clinical pharmacology|Clinical Pharmacology]]'''
'''| [[IMITREX spray nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[IMITREX spray clinical studies|Clinical Studies]]'''
'''| [[IMITREX spray how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[IMITREX spray patient counseling information|Patient Counseling Information]]'''
'''| [[IMITREX spray labels and packages|Labels and Packages]]'''


==Adverse Effects==
<!--Clinical Studies-->


Large doses of sumatriptan can cause [[sulfhemoglobinemia]], a rare condition in which the blood changes from red to greenish-black, due to the integration of [[sulfur]] into the [[hemoglobin]] molecule.<ref>{{cite news|url=http://news.bbc.co.uk/2/hi/health/6733203.stm|title=Patient bleeds dark green blood|date=8 June 2007|work=BBC News|accessdate=6 March 2010}}</ref> If sumatriptan is discontinued, the condition reverses within a few weeks.
|clinicalStudies=


Serious cardiac events, including some that have been fatal, have occurred following the use of sumatriptan injection or tablets. Events reported have included coronary artery vasospasm, transient myocardial ischemia, [[myocardial infarction]], [[ventricular tachycardia]], and ventricular fibrillation. {{Citation needed|date=December 2011}}
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


The most common side-effects<ref>[http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4180b_09_05_Imitrex%20label%20tablet%2012-04%20Sponsor.pdfsumatriptan Tablets]</ref> reported by at least 2% of patients in controlled trials of sumatriptan (25, 50, and 100&nbsp;mg tablets) for migraine are atypical sensations (paresthesias and warm/cold sensations) reported by 4% in the placebo group and 5–6% in the sumatriptan groups, pain and other pressure sensations (including chest pain) reported by 4% in the placebo group and 6–8% in the sumatriptan groups, neurological events ([[vertigo]]) reported by less than 1% in the placebo group and less than 1% to 2% in the sumatriptan groups. Malaise/fatigue occurred in less than 1% of the placebo group and 2–3% of the sumatriptan groups. Sleep disturbance occurred in less than 1% in the placebo group to 2% in the sumatriptan group.
<!--How Supplied-->


==Mechanism of Action==
|howSupplied=


Sumatriptan is structurally similar to [[serotonin|serotonin (5-HT)]], and is a selective [[agonist]] for [[5-HT1D|5-HT<sub>1D</sub>]] and [[5-HT1B|5-HT<sub>1B</sub>]] receptors which are present on the cranial vasculature.<ref>{{cite journal |author=Razzaque Z, Heald MA, Pickard JD, ''et al.'' |title=Vasoconstriction in human isolated middle meningeal arteries: determining the contribution of 5-HT1B- and 5-HT1F-receptor activation |journal=Br J Clin Pharmacol |volume=47 |issue=1 |pages=75–82 |year=1999 |pmid=10073743 |pmc=2014192|doi=10.1046/j.1365-2125.1999.00851.x}}</ref> By activating these receptors, sumatriptan causes [[vasoconstriction]] and reduces neurogenic [[inflammation]] associated with antidromic neuronal transmission correlating with relief of [[migraine]].
*


Sumatriptan is also shown to decrease the activity of the [[trigeminal nerve]], which, it is presumed, accounts for sumatriptan's efficacy in treating [[Cluster Headache|cluster headaches]]. The injectable form of the drug has been shown to abort a cluster headache within fifteen minutes in 96% of cases.<ref>[http://dx.doi.org/10.1056/NEJM199108013250505 Treatment of acute cluster headache with sumatriptan. The Sumatriptan Cluster Headache Study Group. N Engl J Med 1991;325:322-6.]</ref>
<!--Patient Counseling Information-->


==Pharmacokinetics==
|fdaPatientInfo=


Sumatriptan is administered in several forms; tablets, [[subcutaneous injection]], and nasal spray. Oral administration (as [[succinate]]) suffers from poor [[bioavailability]], partly due to presystemic [[metabolism]]—some of it gets broken down in the stomach and bloodstream before it reaches the target arteries. A new rapid-release tablet formulation has the same bioavailability, but the maximum concentration is achieved on average 10–15 minutes earlier. When injected, sumatriptan is faster-acting (usually within 10 minutes), but the effect lasts for a shorter time. Sumatriptan is metabolised primarily by [[Monoamine oxidase|monoamine oxidase A]] into an [[indole acetic acid]] analogue, part of which is further conjugated with [[glucuronic acid]]. These metabolites are excreted in the urine and bile.  Only about 3% of the active drug may be recovered unchanged.
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


There is no simple, direct relationship between sumatriptan concentration (pharmacokinetics) per se in the blood and its anti-migraine effect (pharmacodynamics).  This paradox has, to some extent, been resolved by comparing the rates of absorption of the various sumatriptan formulations, rather than the absolute amounts of drug that they deliver.<ref>{{cite pmid|14756852}}</ref><ref>{{cite pmid|15953294}}</ref>
<!--Precautions with Alcohol-->


==Approval==
|alcohol=


Sumatriptan was the first clinically available [[triptan]] (in 1991). In the United States, it is available only by medical prescription. However, it can be bought over the counter in the UK and Sweden in 50&nbsp;mg dosage. Several dosage forms for sumatriptan have been approved, including [[Tablet (pharmacy)|tablets]], solution for [[Injection (medicine)|injection]], and nasal [[inhaler]]s.
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


On April 15, 2008, the US FDA approved [[Treximet]], a combination of sumatriptan and [[naproxen]], an [[NSAID]].<ref>[http://www.gsk.com/media/pressreleases/2008/2008_us_pressrelease_10034.htm GSK press release – Treximet (sumatriptan and naproxen sodium) tablets approved by FDA for acute treatment of migraine]</ref> This combination has shown a benefit over either medicine used separately.<ref name="pmid17405970">{{cite journal |author=Brandes JL, Kudrow D, Stark SR, ''et al.'' |title=Sumatriptan-naproxen for acute treatment of migraine: a randomized trial |journal=JAMA |volume=297 |issue=13 |pages=1443–54 |date=April 2007|pmid=17405970 |doi=10.1001/jama.297.13.1443 |url=http://jama.ama-assn.org/cgi/pmidlookup?view=long&pmid=17405970}}</ref>
<!--Brand Names-->


In July 2009, the US FDA approved a single-use [[jet injector]] formulation of sumatriptan. The device delivers a subcutaneous injection of 6&nbsp;mg sumatriptan, without the use of a needle. [[Autoinjector]]s with needles have been previously available in Europe and North America for several years.<ref name=Brandes>{{cite pmid|19849720}}</ref>
|brandNames=


Phase III studies with a [[iontophoretic]] [[transdermal patch]] (Zelrix/Zecuity) started in July 2008.<ref>{{ClinicalTrialsGov|NCT00724815|The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine (NP101-007)}}</ref> This patch uses low [[voltage]] controlled by a pre-programmed [[Integrated circuit|microchip]] to deliver a single dose of sumatriptan through the skin within 30 minutes.<ref>[http://www.nupathe.com/description.php?secid=3&subsecid=7#_ELECTRONIC_DRUG SmartRelief -electronically assisted drug delivery (iontophoresis)]</ref><ref>{{cite journal|pmid=19438727|year=2009|last1=Pierce|first1=M|last2=Marbury|first2=T|last3=O'Neill|first3=C|last4=Siegel|first4=S|last5=Du|first5=W|last6=Sebree|first6=T|title=Zelrix: a novel transdermal formulation of sumatriptan|volume=49|issue=6|pages=817–25|doi=10.1111/j.1526-4610.2009.01437.x|journal=Headache}}</ref> Zecuity was approved by the US FDA in January 2013.<ref>[http://ir.nupathe.com/press-releases/nupathe-s-zecuity-approved-by-the-fda-for-the-acut-nasdaq-path-975802NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine]</ref>
* ®<ref>{{Cite web | title = | url = }}</ref>


===Generics===
<!--Look-Alike Drug Names-->


On November 6, 2008, [[Par Pharmaceutical]] announced that it would begin shipping generic versions of sumatriptan injection (sumatriptan succinate injection) 4&nbsp;mg and 6&nbsp;mg starter kits and 4&nbsp;mg and 6&nbsp;mg pre-filled syringe cartridges to the trade immediately.  In addition, Par anticipates launching the 6&nbsp;mg vials early in 2009.<ref>{{cite news |title=PAR PHARMACEUTICAL BEGINS SHIPMENT OF SUMATRIPTAN INJECTION |url=http://www.parpharm.com/media/NR_20081106.jsp |work=Par Pharmaceutical |date= 2008-11-06|accessdate=2008-11-25 }} {{Dead link|date=October 2010|bot=H3llBot}}</ref>
|lookAlike=


[[Mylan|Mylan Laboratories Inc.]], Ranbaxy, Sandoz, Dr. Reddy's Pharmaceuticals and other companies have received FDA approval for generic versions of Imitrex tablets in 25-, 50-, and 100-milligram doses since 2009. The drug is available in U.S. and European markets, since Glaxo's patent protections have expired in those jurisdictions.  However, sales of a generic delivered via nasal spray are still restricted in the United States.
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date = }}</ref>


See also Sumavel DosePro (above).<ref name=Brandes/>
<!--Drug Shortage Status-->


==Chemistry==
|drugShortage=
}}


[[File:Sumatriptan synth.png|600px]]
<!--Pill Image-->


{{US patent|4,785,016}}
{{PillImage
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
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==References==
<!--Label Display Image-->


{{Reflist|2}}
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}
 
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


{{Antimigraine preparations}}
<!--Category-->


[[Category:Drugs]]
[[Category:Drug]]

Revision as of 16:01, 4 December 2014

Sumatriptan (oral)
Black Box Warning
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];

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Sumatriptan (oral) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Sumatriptan (oral) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sumatriptan (oral) 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 Sumatriptan (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Sumatriptan (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sumatriptan (oral) in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Sumatriptan (oral) 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

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sumatriptan (oral) 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

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

There is no FDA guidance on use of Sumatriptan (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sumatriptan (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Sumatriptan (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Sumatriptan (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Sumatriptan (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sumatriptan (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sumatriptan (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sumatriptan (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sumatriptan (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sumatriptan (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Sumatriptan (oral) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Sumatriptan (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Sumatriptan (oral) in the drug label.

Pharmacology

There is limited information regarding Sumatriptan (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Sumatriptan (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Sumatriptan (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sumatriptan (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sumatriptan (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Sumatriptan (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Sumatriptan (oral) in the drug label.

Precautions with Alcohol

  • Alcohol-Sumatriptan (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

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