MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.
Its empirical formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.
MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.
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 [see Clinical Studies].
Redosing In Adults
Although the effectiveness of a second dose or subsequent doses has not been established in placebocontrolled 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
Sections or subsections omitted from the full prescribing information are not listed.
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) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
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) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].