Indications
Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use:
- Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks.
- Naratriptan is not indicated for the prevention of migraine attacks.
- Safety and effectiveness of naratriptan have not been established for cluster headache. Naratriptan is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use:
- Use only if a clear diagnosis of migraine has been established. ( 1 )
- Not indicated for the prophylactic therapy of migraine attacks. ( 1 )
- Not indicated for the treatment of cluster headache. ( 1 )
Contraindications
Naratriptan 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 [see Warnings and Precautions ( 5.1 )]
- Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 )]
- 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 [see Warnings and Precautions ( 5.4 )]
- Peripheral vascular disease [see Warnings and Precautions ( 5.5 )]
- Ischemic bowel disease [see Warnings and Precautions ( 5.5 )]
- Uncontrolled hypertension [see Warnings and Precautions ( 5.8 )]
- Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions ( 7.1 , 7.2 )]
- Hypersensitivity to naratriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions ( 5.9 )]
- Severe renal or hepatic impairment [see Use in Specific Populations ( 8.6 , 8.7 ), Clinical Pharmacology ( 12.3 )]
- History of coronary artery disease or coronary artery vasospasm ( 4 )
- Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 )
- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 )
At a glance
- Brand name
- Naratriptan
- Active substance
- naratriptan hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Hikma
- Status
- Prescription
- FDA approval
- 7 Jul 2010
- Application
- ANDA090381-002



