Usual Adult Dose for Migraine

Initial dose: 6.25 mg or 12.5 mg orally as a single dose
Repeat dose: If headache is relieved, but returns, may repeat with 1 dose orally provided there is a minimum interval of 2 hours between doses.
Maximum daily dose: 25 mg

Comments:

• The safety of treating an average of more than 4 migraines per month has not been established.
• The 12.5 mg dose tends to be more effective in adults, however as individuals may vary in their response, the dose should be individualized.
• The effectiveness of a second dose has not been established in clinical trials.

Use: For the acute treatment of migraine attacks in patients with a history of migraine with or without aura.

Usual Pediatric Dose for Migraine

Adolescents (12 to 17 years):
Initial dose: 6.25 mg or 12.5 mg orally as a single dose
Repeat dose: If headache is relieved, but returns, may repeat 1 dose orally provided there is a minimum interval of 2 hours between doses.
Maximum daily dose: 25 mg

Comments:

• The safety of treating an average of more than 4 migraines per month has not been established.
• Individuals may vary in their response, the dose should be individualized.
• The efficacy in adolescents on migraine-associated symptoms (nausea, photophobia, and phonophobia) and the effectiveness of a second dose have not been established in clinical trials.

Use: For the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more when untreated.

Renal Dose Adjustments

• Severe renal impairment:

Initial dose: 6.25 mg orally as a single dose
Repeat dose: If headache is relieved, but returns, may repeat 1 dose provided there is a minimum interval of 2 hours between doses.
Maximum daily dose: 12.5 mg

• Mild or moderate renal impairment: No adjustment recommended

Liver Dose Adjustments

Initial dose: 6.25 mg orally as a single dose
Repeat dose: If headache is relieved, but returns, may repeat 1 dose provided there is a minimum interval of 2 hours between doses.
Maximum daily dose: 12.5 mg

Dose Adjustments

Elderly: Dose selection should be cautious generally starting at the lower dose.

Precautions

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration advice:

• May take with or without food
• If the headache is relieved after the initial dose, but returns, a second dose may be taken no sooner than 2 hours later; do not take more than 2 doses in 24 hours

General:

• This drug should only be used 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.
• Medication overuse headaches may present as migraine-like headaches or as a marked increase in migraine frequency; for patients using acute migraine medications 10 or more days per month consider withdrawal of the overused drugs and treatment of withdrawal symptoms.

Monitoring:

• 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, in those who acquire risk factors for CAD, and in patients who experience signs or symptoms suggestive of angina following dosing.
• Monitor for serotonin syndrome if concomitant use of selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs) is necessary, particularly when starting therapy and with any increase in dose.

Patient advice:

• 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 if they occur.
• Patients should be informed of the possibility of developing medication overuse headaches.
• 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.