Rizatriptan

34 MAXALT® and MAXALT RPD® (rizatriptan benzoate) Page 3 of 37 MAXALT® rizatriptan benzoate tablets And MAXALT RPD® rizatriptan benzoate wafers PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Nonmedicinal Ingredients oral tablets 10 mg Ferric oxide (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.

oral wafers 5 mg, 10 mg Aspartame, gelatin, glycine, mannitol and peppermint flavor. INDICATIONS AND CLINICAL USE Adults MAXALT® (rizatriptan benzoate) is indicated for:  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, ophthalmoplegic 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. Pediatrics (<18 years of age) The safety and efficacy of MAXALT® have not been established in patients under 18 years of age and its use in this age group is not recommended (see WARNINGS AND PRECAUTIONS, Special Populations and Conditions).

Acute treatment of the headache phase of migraine attacks, with or without aura, in adults.

1 INDICATIONS AND USAGE Rizatriptan benzoate tablets 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 Rizatriptan benzoate tablets 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 rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.

Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4) ] . Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.

Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1) Limitations of Use : Use only after clear diagnosis of migraine has been established (1) Not indicated for the prophylactic therapy of migraine (1) Not indicated for the treatment of cluster headache (1)