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Uses

Vascular Headaches

Acute treatment of migraine attacks with or without aura.

Not recommended for management of hemiplegic or basilar migraine or for the prophylaxis of migraine.

Safety and efficacy not established for management of cluster headaches.

Dosage and Administration

Administration

Oral Administration

Administer orally with fluids.

Dosage

Available as naratriptan hydrochloride; dosage is expressed in terms of naratriptan.

Adults

Vascular Headaches

Migraine

Oral

1 or 2.5 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 2.5-mg dose.

If headache recurs or only a partial response is achieved, may repeat dose once after 4 hours.

Following failure to respond to the first dose, reconsider diagnosis of migraine prior to administration of a second dose.

Prescribing Limits

Adults

Vascular Headaches

Migraine

Oral

Maximum 5 mg in any 24-hour period.

Safety of treating an average of >4 headaches per 30-day period not established.

Special Populations

Dosage in Hepatic Impairment

Contraindicated in patients with severe hepatic impairment. In patients with mild or moderate hepatic impairment, reduce initial dosage; maximum dosage of 2.5 mg per 24-hour period is recommended.

Dosage in Renal Impairment

Contraindicated in patients with severe renal impairment. In patients with mild or moderate renal impairment, reduce initial dosage; maximum dosage of 2.5 mg per 24-hour period is recommended.

Cautions

Contraindications

• Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).
• Coronary artery vasospasm (e.g., Prinzmetal variant angina).
• Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).
• Cerebrovascular syndromes (e.g., stroke syndrome, TIAs).
• Peripheral vascular ischemia (e.g., ischemic colitis).
• Severe hepatic impairment (e.g., Child-Pugh grade C).
• Severe renal impairment (e.g., Cl_cr ≤15 mL/minute).
• Hemiplegic or basilar migraine.
• Treatment within previous 24 hours with another 5-HT₁ receptor agonist or an ergot alkaloid. (See Specific Drugs under Interactions.)
• Known hypersensitivity to naratriptan or any ingredient in the formulation.

Warnings/Precautions

Warnings

Use only in patients in whom a clear diagnosis of migraine has been established.

Exclude other potentially serious neurologic disorders before administering naratriptan to patients not previously diagnosed with migraine or to those with atypical symptoms.

Cardiac Effects

Risk of coronary vasospasm, myocardial ischemia and/or infarction, life-threatening cardiac rhythm disturbances, and death with use of 5-HT₁ receptor agonists.

Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.

Administer initial dose to patients with risk factors for CAD who have completed a satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by an ECG) unless patient previously received the drug.

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD who are receiving intermittent long-term therapy.

Patients with symptoms suggestive of angina after receiving naratriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses. If administration resumed and such signs or symptoms recur, ECG evaluation recommended.

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other adverse cerebrovascular events, sometimes fatal, with use of 5-HT₁ receptor agonists.

Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported. Further evaluation for atherosclerosis or predisposition to vasospasm recommended if signs or symptoms of decreased arterial flow (e.g., ischemic colitis, Raynaud’s syndrome) occur following administration.

Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT₁ receptor agonists in patients with or without history of hypertension; increases may be more pronounced in geriatric patients and patients with hypertension.

Increases in mean pulmonary artery pressure and mean aortic pressure observed following naratriptan administration in patients with suspected CAD who were undergoing cardiac catheterization.

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT₁ receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs). Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea). (See Specific Drugs under Interactions.)

Sensitivity Reactions

Possible hypersensitivity reactions, including anaphylaxis or anaphylactoid reactions; may be life-threatening or fatal.

General Precautions

Ocular Effects

Possible accumulation of naratriptan in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.

Specific Populations

Pregnancy

Category C. Pregnancy Registry at 800-336-2176.

Lactation

Naratriptan and/or its metabolites are distributed into milk in rats. Caution advised if naratriptan is used.

Pediatric Use

Safety and efficacy not established in children <18 years of age.

Geriatric Use

Use not recommended. Increased risk of CAD in this patient population. Possible increased risk of adverse effects in those with renal or hepatic impairment. More pronounced increases in BP possible in geriatric patients.

Hepatic Impairment

Use with caution. (See Hepatic Impairment under Dosage and Administration and also Special Populations under Pharmacokinetics.) Contraindicated in patients with severe hepatic impairment. (See Cautions.)

Renal Impairment

Use with caution. (See Renal Impairment under Dosage and Administration and also Special Populations under Pharmacokinetics.) Contraindicated in patients with severe renal impairment. (See Cautions.)

Common Adverse Effects

Paresthesia, nausea, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms (e.g., pain, pressure).