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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.
For more detailed information, please see full Prescribing Information.
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This page was last updated on March 16, 2009.
