Maxalt (Rizatriptan Benzoate) - Indications and Dosage

INDICATIONS AND USAGE

MAXALT is indicated for the acute treatment of migraine attacks with or without aura in adults.

MAXALT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of MAXALT have not been established for cluster headache, which is present in an older, predominantly male population.

DOSAGE AND ADMINISTRATION

In controlled clinical trials, single doses of 5 and 10 mg of MAXALT Tablets or MAXALT-MLT were effective for the acute treatment of migraines in adults. There is evidence that the 10-mg dose may provide a greater effect than the 5-mg dose (see CLINICAL PHARMACOLOGY, Clinical Studies). Individuals may vary in response to doses of MAXALT Tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of the 10-mg dose with the potential risk for increased adverse events.

Redosing: Doses should be separated by at least 2 hours; no more than 30 mg should be taken in any 24-hour period.

The safety of treating, on average, more than four headaches in a 30-day period has not been established.

Patients receiving propranolol: In patients receiving propranolol, the 5-mg dose of MAXALT should be used, up to a maximum of 3 doses in any 24-hour period. (See CLINICAL PHARMACOLOGY, Drug Interactions.)

For MAXALT-MLT Orally Disintegrating Tablets, administration with liquid is not necessary. The orally disintegrating tablet is packaged in a blister within an outer aluminum pouch. Patients should be instructed not to 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.

HOW SUPPLIED

No. 3732 — MAXALT Tablets, 5 mg, are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other. They are supplied as follows:

NDC 0006-0266-12, carton of 12 tablets.

No. 3733 — MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other. They are supplied as follows:

NDC 0006-0267-12, carton of 12 tablets.

No. 3800 — MAXALT-MLT Orally Disintegrating Tablets, 5 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified triangle on one side, and measuring 10.0-11.5 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:

NDC 0006-3800-12, 4 x unit of use carrying case of 3 orally disintegrating tablets (12 tablets total).

No. 3801 — MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:

NDC 0006-3801-12, 4 x unit of use carrying case of 3 orally disintegrating tablets (12 tablets total).

Storage

Store MAXALT Tablets at room temperature, 15-30°C (59-86°F). Dispense in a tight container, if product is subdivided.

Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15-30°C (59-86°F). The patient should be instructed not to remove the blister from the outer aluminum pouch until the patient is ready to consume the orally disintegrating tablet inside.

MAXALT Tablets are manufactured for:

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

By:

MSD, Ltd. Cramlington

Northumberland, NE23 3JU, UK

MAXALT-MLT Orally Disintegrating Tablets are manufactured for:

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

By:

Catalent UK Swindon, Zydis Ltd.

Swindon, Wiltshire, SN5 8RU, UK

US Patent No.: 5,298,520

Issued February 2008

9652506