Indications and Usage for Maxalt
Maxalt® and Maxalt-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
Maxalt should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with Maxalt, the diagnosis of migraine should be reconsidered before Maxalt is administered to treat any subsequent attacks.
Maxalt is not indicated for use in the management of hemiplegic or basilar migraine .
Maxalt is not indicated for the prevention of migraine attacks.
Safety and effectiveness of Maxalt have not been established for cluster headache.
Maxalt Dosage and Administration
Dosing Information in Adults
The recommended starting dose of Maxalt is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions.
Redosing in Adults
Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.
Dosing Information in Pediatric Patients (Age 6 to 17 Years)
Dosing in pediatric patients is based on the patient’s body weight. The recommended dose of Maxalt is 5 mg in patients weighing less than 40 kg (88 lb), and 10 mg in patients weighing 40 kg (88 lb) or more.
The efficacy and safety of treatment with more than one dose of Maxalt within 24 hours in pediatric patients 6 to 17 years of age have not been established.
Administration of Maxalt-MLT Orally Disintegrating Tablets
For Maxalt-MLT Orally Disintegrating Tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within an outer aluminum pouch and patients should not remove the blister from the outer pouch until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.
Dosage Adjustment for Patients on Propranolol
In adult patients taking propranolol, only the 5-mg dose of Maxalt is recommended, up to a maximum of 3 doses in any 24-hour period (15 mg) .
For pediatric patients weighing 40 kg (88 lb) or more, taking propranolol, only a single 5-mg dose of Maxalt is recommended (maximum dose of 5 mg in a 24-hour period). Maxalt should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg (88 lb) .