Naratriptan

Naratriptan
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: Alberto Plate [2]

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Overview

Naratriptan is an antimigraine and5-HT1 serotonin receptor agonist that is FDA approved for the treatment of migraine with or without aura in adults.. Common adverse reactions include paresthesias, nausea, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Naratriptan FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Naratriptan in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Naratriptan in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Naratriptan FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Naratriptan in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Naratriptan in pediatric patients.

Contraindications

AMERGE is contraindicated in patients with:

• Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina
• Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
• History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because such patients are at a higher risk of stroke.
• Peripheral vascular disease.
• Ischemic bowel disease.
• Uncontrolled hypertension.
• Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide)
• Hypersensitivity to AMERGE (angioedema and anaphylaxis seen)
• Severe renal impairment or hepatic impairment.

Warnings

There is limited information regarding Naratriptan Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Naratriptan Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Naratriptan Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Naratriptan in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Naratriptan in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Naratriptan during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Naratriptan in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Naratriptan in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Naratriptan in geriatric settings.

Gender

There is no FDA guidance on the use of Naratriptan with respect to specific gender populations.

Race

There is no FDA guidance on the use of Naratriptan with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Naratriptan in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Naratriptan in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Naratriptan in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Naratriptan in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Naratriptan Administration in the drug label.

Monitoring

There is limited information regarding Naratriptan Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Naratriptan and IV administrations.

Overdosage

There is limited information regarding Naratriptan overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Naratriptan Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Naratriptan Mechanism of Action in the drug label.

Structure

There is limited information regarding Naratriptan Structure in the drug label.

Pharmacodynamics

There is limited information regarding Naratriptan Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Naratriptan Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Naratriptan Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Naratriptan Clinical Studies in the drug label.

How Supplied

There is limited information regarding Naratriptan How Supplied in the drug label.

Storage

There is limited information regarding Naratriptan 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 Naratriptan Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Naratriptan interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Naratriptan Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Naratriptan Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

Naratriptan
NARATRIPTAN tablet® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Naratriptan
ClinicalTrials.gov

Naratriptan

Clinical data
Trade names	Amerge
AHFS/Drugs.com	Monograph
MedlinePlus	a601083
Pregnancy category	AU: B3 US: C (Risk not ruled out)
Routes of administration	Oral
ATC code	N02CC02 (WHO)
Legal status
Legal status	In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability	74%
Metabolism	Hepatic
Elimination half-life	5-8 hours
Excretion	Renal
Identifiers
IUPAC name N-methyl-2-[3-(1-methylpiperidin-4-yl)-1H-indol-5-yl]ethanesulfonamide
CAS Number	121679-13-8 Y
PubChem CID	4440
IUPHAR/BPS	45
DrugBank	DB00952 Y
ChemSpider	4287 Y
UNII	QX3KXL1ZA2
KEGG	D08255 Y
ChEBI	CHEBI:7478 Y
ChEMBL	ChEMBL1278 Y
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C17H25N3O2S
Molar mass	335.465 g/mol
3D model (JSmol)	Interactive image
SMILES O=S(=O)(NC)CCc3ccc1c(c(cn1)C2CCN(C)CC2)c3
InChI InChI=1S/C17H25N3O2S/c1-18-23(21,22)10-7-13-3-4-17-15(11-13)16(12-19-17)14-5-8-20(2)9-6-14/h3-4,11-12,14,18-19H,5-10H2,1-2H3 Y Key:AMKVXSZCKVJAGH-UHFFFAOYSA-N Y
(verify)

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]

For patient information about Naratriptan, click here.

Synonyms / Brand Names: NARATRIPTAN

Overview

Naratriptan (trade names include Amerge and Naramig) is a triptan drug marketed by GlaxoSmithKline and is used for the treatment of migraine headaches. Naratriptan is available in 2.5 mg tablets. It is a selective 5-HT₁ receptor subtype agonist.

Category

Serotonin Receptor Agonists; Antimigraine Agents

FDA Package Insert

Indications and Usage | Dosage and Administration | Dosage Forms and Strengths | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Use in Specific Populations | Overdosage | Description | Clinical Pharmacology | Nonclinical Toxicology | Clinical Studies | How Supplied/Storage and Handling | Patient Counseling Information | Labels and Packages

Indication

Naratriptan is used for the treatment of the acute migraine attacks and the symptoms of migraine, including severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light.

Mechanism of action

The causes of migraine are not clearly understood; however, the efficacy of naratriptans and other triptans is believed to be due to their activity as 5HT (serotonin) agonists.

Efficacy

A meta-analysis of 53 clinical trials has shown that all triptans are effective for treating migraine at marketed doses and that naratriptan, although less effective than sumatriptan and rizatriptan was more effective than placebo in reducing migraine symptoms at two hours and efficacy was demonstrated in almost two thirds of subjects after four hours of treatment.

Side effects

Side effects include: dizziness, drowsiness, tingling of the hands or feet, nausea, dry mouth and unsteadiness. If these effects persist or worsen, notify your doctor promptly. Side-effects which are unlikely and which should be promptly reported include: chest pain/pressure, throat pain/pressure, unusually fast/slow/irregular pulse, one-sided muscle weakness, vision problems, cold/bluish hands or feet, stomach pain, bloody diarrhea, mental/mood changes, and fainting. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing (swelling of the throat).

The use of naratriptan with MAOIs and serotonergic drugs may result in the life threatening serotonin syndrome. Make sure your doctor/pharmacist is aware of all your current medications (including as needed medications) before taking this drug.

Exclusivity

In the United States, the Food and Drug Administration (FDA) approved naratriptan on February 11, 1998. It was covered by U.S. Patent no. 4997841; the FDA lists the patent as expiring on July 7, 2010.

In July 2010, in the wake of the patent expiration, several drug manufacturers, including Roxane Labs, Sandoz and Teva Pharmaceuticals, announced that they were launching generic Naratriptan medications.

The drug continues to be covered by European patent 0303507 in Germany, Spain, France and the United Kingdom through March 10, 2012, and by Australian patent 611469 in Australia through June 17, 2013. It had previously been covered by Canadian patent 1210968; but both Sandoz and Novopharm have offered generic equivalents in Canada since that patent's expiration December 1, 2009.