Usual Adult Dose for Migraine

Use only after a clear diagnosis of migraine has been established

Initial dose: 5 mg or 10 mg orally, once

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

Maximum dose: 30 mg in a 24-hour period

Comments:

• The 10 mg dose may provide greater effect, however there may be a greater risk of adverse reactions.
• 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 4 or more migraine attacks in a 30-day period has not been established; the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials.

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

Usual Pediatric Dose for Migraine

Use only after a clear diagnosis of migraine has been established

6 years or older and weight less than 40 kg:

• Initial dose: 5 mg orally once

6 years or older and weight 40 kg or greater:

• Initial dose: 10 mg orally once

Maximum: 1 dose in any 24-hour period

Comments:

• 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 4 or more migraine attacks in a 30-day period has not been established; the safety and effectiveness of more than 1 dose within 24 hours has not been established.

Use: For the acute treatment of migraine with or without aura in patients 6 years or older.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Use with caution; dose adjustment may be considered in patients with severe hepatic impairment, however, no specific guidelines have been suggested

Dose Adjustments

CONCOMITANT USE WITH PROPRANOLOL:
Adults:

• Initial dose: 5 mg orally once
• Maximum dose: 3 doses (15 mg) in any 24-hour period

Pediatrics:

• Weight less than 40 kg: Use is not recommended
• Weight 40 kg or greater: Maximum dose: 5 mg in any 24-hour period

ELDERLY: Dose selection should be cautious, generally starting at the low end of the dosing range.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to active substance or any product ingredients (angioedema and anaphylaxis seen)
• Uncontrolled hypertension
• Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease
• Coronary artery vasospasm including Prinzmetal's angina
• History of stroke or transient ischemic attacks
• Peripheral vascular disease
• Ischemic bowel disease
• Recent use (within 24 hours) of another 5-HT1 agonist (e.g., another triptan), ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide)
• Concurrent or recent (past 2 weeks) use of MAO-A inhibitors
• Hemiplegic or basilar migraine

Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions

Dialysis

Data not available

Other Comments

Administration advice:
Oral tablets:

• Take orally with or without food

Orally Disintegrating Tablets (ODT):

• Remove ODT from foil pouch at time of use
• Peel open blister pack with dry hands and place ODT on tongue; do not push tablet through the blister
• ODT will dissolve on tongue and can be swallowed with saliva, no additional liquid is needed

General:

• This drug should be used only where a clear diagnosis of migraine has been established; if a patient does not respond to first dose, 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.
• Medication overuse headaches may present as migraine-like headaches or as a marked increase in migraine frequency; for patients using acute migraine medications (e.g. ergotamine, triptans, opioids) for 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, consider periodic cardiovascular evaluation in intermittent long-term users with cardiovascular risk factors
• Monitor blood pressure
• Monitor for serotonin syndrome; if concomitant use of selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs) are necessary, monitor closely when starting therapy or with a new or increased dose of a serotonergic medication

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
• Phenylketonurics should be aware that the orally disintegrating tablets contain phenylalanine.
• 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.
• 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

• How often can you take Maxalt?
• How long does it take for Maxalt to work?
• Does Maxalt have caffeine in it?