Usual Adult Dose for Migraine

Use only after a clear diagnosis of migraine has been established

Initial dose: 20 mg or 40 mg orally, once

• Provided there has been some response to first dose, a second dose may be administered at least 2 hours later if migraine returns or symptoms recur.

• Doses should be individualized as responses vary; in clinical trials, benefit was observed with 20 mg, 40 mg, and 80 mg doses; however an increased incidence of side effects was observed at the 80 mg dose.
• This drug should not be used to treat basilar or hemiplegic migraines because these patients are at a greater risk of stroke.
• The safety of treating an average of 3 or more migraine attacks in a 30-day period has not been established.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Severe hepatic impairment: Use is contraindicated
Mild to moderate hepatic impairment: No adjustment recommended

Dose Adjustments

CYP450 3A4 Inhibitors:

• This drug should not be used within at least 72 hours of treatment with ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir, or any drug that has potent CYP450 3A4 inhibition described in its labeling.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally at first sign of a migraine
• A second dose may be taken if benefit was realized from the first dose; allow at least 2-hours to elapse before taking a second dose; no more than 2 doses should be taken in any 24-hour period.

• This drug should be used only where a clear diagnosis of migraine has been established; if a patient does not respond, the diagnosis of migraine should be reconsidered before treating subsequent attacks.
• This drug is not intended to treat cluster headaches, hemiplegic, or basilar migraines or for the prophylactic treatment of migraines.
• For patients with coronary artery disease (CAD) risk factors, a cardiovascular evaluation should be performed prior to initiating therapy; for patients who have satisfactorily completed a cardiovascular evaluation, consider administering first dose in a medically supervised setting and performing an ECG immediately following administration.

• ECG monitoring should be considered in the interval following the first dose in patients with risk factors for coronary artery disease (CAD) who have satisfactorily completed a cardiovascular evaluation, consider periodic cardiovascular evaluation in intermittent long-term users with, or who acquire cardiovascular risk factors.
• Monitor blood pressure, especially in the elderly and in those with renal impairment.
• Monitor for serotonin syndrome if concomitant use of selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs) are necessary, particularly when starting therapy or with a new or increased dose of a serotonergic medication.

• Patients should be advised to talk with their doctor or pharmacist before taking any new medications or supplements.
• Patients should be aware of the risk of serious cardiovascular side effects and the importance of seeking medical advice promptly if they occur.
• Patients experiencing no relief from a first dose of this medication should be instructed not to take a second dose without first talking to their healthcare provider.
• This drug may impair judgment, thinking, or motor skills; have patient avoid driving or operating machinery until adverse effects are determined.
• Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.