Full Prescribing Information
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Indication
AXERT tablets are indicated for the acute treatment of migraine with or without aura in adults.
AXERT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine.
Safety and effectiveness of AXERT have not been established for cluster headache, which is present in an older, predominantly
male population.
IMPORTANT SAFETY INFORMATION
AXERT tablets should be used only when a clear diagnosis of migraine has been established. AXERT, like other triptans, has
been associated with coronary vasospasm and therefore should not be given to patients with ischemic heart disease or to
patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including
Prinzmetal's variant angina), or other significant underlying cardiovascular disease. AXERT, like other triptans in this
class, should not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by risk factors
(family history, high cholesterol, high blood pressure, diabetes, or obesity). Because AXERT may increase blood pressure,
it should not be given to patients with uncontrolled hypertension.
The development of a potentially life-threatening serotonin syndrome may occur with triptans, including AXERT treatment, particularly when combined with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If combined treatment with AXERT and an antidepressant is clinically warranted, patients should be closely observed for signs and symptoms of the serotonin syndrome such as mental status changes, hyperthermia, diaphoresis, labile blood pressure, tachycardia, hyperreflexia, incoordination and/or gastrointestinal symptoms, especially during treatment initiation and dosage escalation. Patients with the serotonin syndrome require immediate medical attention.
The most common side effects are nausea, sleepiness, paresthesia, headache and dry mouth.
Ask your healthcare professional about the side effects and other important considerations before taking AXERT.
For more detailed information, please see full Prescribing Information.
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