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

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina

AMERGE is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of AMERGE. Some of these reactions occurred in patients without known CAD. AMERGE may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving AMERGE. If there is evidence of CAD or coronary artery vasospasm, AMERGE is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of AMERGE in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of AMERGE. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of AMERGE.

Arrhythmias

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue AMERGE if these disturbances occur. AMERGE is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.

Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure

Sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw commonly occur after treatment with AMERGE and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. 5-HT1 agonists, including AMERGE, are contraindicated in patients with CAD and those with Prinzmetal’s variant angina.

Cerebrovascular Events

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA). Discontinue AMERGE if a cerebrovascular event occurs.

Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine, exclude other potentially serious neurological conditions. AMERGE is contraindicated in patients with a history of stroke or TIA.

Other Vasospasm Reactions

AMERGE may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional doses of AMERGE.

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.

Medication Overuse Headache

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

Serotonin Syndrome

Serotonin syndrome may occur with AMERGE, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors [see Drug Interactions (7.3)]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue AMERGE if serotonin syndrome is suspected.

Increase in Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with AMERGE. AMERGE is contraindicated in patients with uncontrolled hypertension.

Anaphylactic/Anaphylactoid Reactions

There have been reports of anaphylaxis and anaphylactoid and hypersensitivity reactions, including angioedema, in patients receiving AMERGE. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. AMERGE is contraindicated in patients with a history of hypersensitivity reaction to AMERGE.

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.