Usual Adult Dose for Migraine

Oral:

• Initial dose: 1.25 or 2.5 mg orally once (may break the scored 2.5 mg tablet in half to obtain 1.25 mg dose); may repeat in 2 hours if migraine has not resolved or returns after a transient improvement
• Maintenance Dose: Adjust dose based on individual response

Maximum single dose: 5 mg
Maximum daily dose: 10 mg in a 24-hour period

Orally Disintegrating Tablets:

• Initial dose: 2.5 mg orally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement
• Maintenance Dose: Adjust dose based on individual response

Maximum single dose: 5 mg
Maximum daily dose: 10 mg in a 24-hour period

Nasal Spray:

• Initial dose: 2.5 mg intranasally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement
• Maintenance Dose: Adjust dose based on individual response

Maximum single dose: 5 mg
Maximum daily dose: 10 mg in a 24-hour period

Comments:

• This drug should only be used after a clear diagnosis of migraine has been established; if a patient has no response for the first migraine attack, reconsider the diagnosis of migraine before treating any subsequent attacks.
• Do not break the oral disintegrating tablet, they are not scored.
• In trials, the majority of patients had headache response following a 2.5 mg or 5 mg dose compared with a 1 mg dose; little added benefit was observed with the 5 mg dose compared to the 2.5 mg dose, but adverse events were more frequent.
• The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura.

Usual Pediatric Dose for Migraine

Age 12 years and older:

Nasal Spray:

• Initial dose: 2.5 mg intranasally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement
• Maintenance Dose: Adjust dose based on individual response

Maximum single dose: 5 mg
Maximum daily dose: 10 mg in a 24-hour period

Comments:

• This drug should only be used after a clear diagnosis of migraine has been established; if a patient has no response to this drug for the first migraine attack, reconsider the diagnosis of migraine before treating any subsequent attacks.
• The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura.

Renal Dose Adjustments

Use caution; No adjustment recommended

Liver Dose Adjustments

Mild Hepatic Impairment: No dosage adjustment recommended

Moderate to Severe Hepatic Impairment:
Oral tablets:
Initial dose: 1.25 mg (obtained by breaking oral tablet in one-half)
Maximum daily dose should not exceed 5 mg per day

Oral disintegrating tablets (ODT): Not recommended for initial dosing as ODT should not be broken in half
Nasal Spray: Not recommended

Dose Adjustments

Elderly Patients:

• Dose selection should be cautious, usually starting at the lower end of the dosing range

Concomitant use with Cimetidine:

• Maximum single dose should not exceed 2.5 mg
• Maximum daily dose should not exceed 5 mg in a 24-hour period

Precautions

Safety and efficacy of nasal spray have not been established in patients younger than 12 years.
Safety and efficacy of oral tablets and oral disintegrating tablets 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 when headache starts
• May repeat dose after 2 hours if needed

Oral:

• May take with or without food
• May split scored tablets if necessary to obtain correct dose

Oral disintegrating tablet

• Place tablet on tongue where it will dissolve and can be swallowed with saliva; do not break tablets
• Remove tablets from blister pack just prior to use; remove by peeling the blister pack open; do not push through pack as this will damage the tablets

Nasal:

• Remove protective cap just prior to use; there is 1 dose in the nasal sprayer; do not try to prime sprayer or dose will be lost.
• Blow nose gently to clear nasal passage
• Keeping head in an upright position, gently close 1 nostril with finger and breathe out gently through mouth
• With the other hand, place nasal spray device in other nostril as far as it feels comfortable, tilt head back slightly and breathe in gently though nose, at the same time press plunger firmly to deliver dose.
• After delivering dose, breathe in gently through mouth for 5 to 10 seconds; the patient may feel liquid in the back of nose or throat, this is normal.

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; for patients who have satisfactorily completed a cardiovascular evaluation, consider administering first dose in a medically supervised setting and obtain and ECG after dosing.
• 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.
• The oral disintegrating tablets contain phenylalanine and should not be used by patients with Phenylketonuria.

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, consider periodic cardiovascular evaluation in intermittent long-term users.
• Monitor blood pressure
• 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.

Frequently asked questions

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