Naratriptan

Naratriptan tablets are indicated for the acute treatment of migraine 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 tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks. Naratriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of naratriptan tablets have not been established for cluster headache. Naratriptan tablets are a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. Not indicated for the prophylactic therapy of migraine attacks. Not indicated for the treatment of cluster headache.

Naratriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides (including substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system. The therapeutic activity of naratriptan tablets for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Recommended dose: 1 mg or 2.5 mg. May repeat dose after 4 hours if needed, not to exceed 5 mg in any 24 hour period. Mild or moderate renal or hepatic impairment: recommended starting dose is 1 mg not to exceed 2.5 mg in any 24 hour period.

Naratriptan tablets are 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 [s ee Warnings and Precautions ] Peripheral vascular disease Ischemic bowel disease Uncontrolled hypertension Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide) Hypersensitivity to naratriptan tablets (angioedema and anaphylaxis seen) Severe renal or hepatic impairment History of coronary artery disease or coronary artery vasospasm.

Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. Arrhythmias: Discontinue naratriptan tablets if occurs. Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia, evaluate for CAD in patients at high risk. Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue naratriptan tablets if occurs. Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue naratriptan tablets if occurs. Medication overuse headache: Detoxification may be necessary. Serotonin syndrome: Discontinue naratriptan tablets if occurs.

The following adverse reactions are discussed in more detail in other sections of the prescribing information: Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina Arrhythmias Chest, throat, neck, and/or jaw pain/tightness/pressure Cerebrovascular events Other vasospasm reactions Medication overuse headache Serotonin syndrome Increase in blood pressure Hypersensitivity reactions Most common adverse reactions (≥2 % and > placebo) were paresthesias, nausea, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms.

Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and naratriptan tablets within 24 hours of each other is contraindicated.

Store at 20° to 25°C (68° to 77°F).