Preferred Pharmaceuuticals, Inc.
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Preferred Pharmaceuuticals, Inc. Drugs
2.1 Dosing Information in Adults
The recommended starting dose of rizatriptan benzoate orally disintegrating tablets 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 (14.1)].
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.
2.2 Dosing Information in Pediatric Patients (Age 6 to 17 Years)
2.3 Administration of Rizatriptan Benzoate Orally Disintegrating Tablets
For rizatriptan benzoate orally disintegrating tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister. 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.
2.4 Dosage Adjustment for Patients on Propranolol
Adult Patients: In adult patients taking propranolol, only the 5 mg dose of rizatriptan benzoate orally disintegrating tablets is recommended, up to a maximum of three doses in any 24-hour period (15 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Pediatric Patients: Dosage adjustment information of rizatriptan benzoate for pediatric patients (6 to 17 years old) taking propranolol is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Orally Disintegrating Tablets. However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that dosage adjustment information.
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