Drug Catalog - Product Detail
RIZATRIPTAN BENZOATE TB 5MG 3X6 UD
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 51991-0354-78 | BRECKENRIDGE | 18 | 5MG | TABLET |
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Description
11 DESCRIPTION Rizatriptan benzoate tablets contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Rizatriptan benzoate is described chemically as: N,N -dimethyl-5-(1 H -1,2,4-triazol-1-ylmethyl)-1 H -indole-3-ethanamine monobenzoate and its structural formula is: Its molecular formula is C 15 H 19 N 5 •C 7 H 6 O 2 , representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP 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. Rizatriptan benzoate 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: ferric oxide (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Rizatriptan benzoate tablets, 5 mg, are light pink to pink-colored, capsule-shaped, biconvex, uncoated tablets with "NAT" on one side and "123" on the other side. They are supplied as follows: NDC 51991-354-99, Blister of 6 tablets NDC 51991-354-78, Carton of 18 tablets (3 x 6 blisters) unit dose tablets. Rizatriptan benzoate tablets, 10 mg, are light pink to pink-colored, capsule-shaped, biconvex, uncoated tablets with "NAT" on one side and "121" on the other side. They are supplied as follows: NDC 51991-355-99, Blister of 6 tablets NDC 51991-355-78, Carton of 18 tablets (3 x 6 blisters) unit dose tablets. Storage Store at 20° – 25°C (68° – 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container, if product is subdivided.
Indications & Usage
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. Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.'s Rizatriptan Benzoate Tablets. However, due to Merck & Co., Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. 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 is 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 tablets are 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 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Adults: 5 mg or 10 mg single dose; separate repeat doses by at least two hours; maximum dose in a 24-hour period: 30 mg ( 2.1 ) Adjust dose if co-administered with propranolol ( 2.4 ) 2.1 Dosing Information in Adults The recommended starting dose of rizatriptan benzoate 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) Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.'s Rizatriptan Benzoate Tablets. However, due to Merck & Co., Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. 2.4 Dosage Adjustment for Patients on Propranolol Adult Patients In adult patients taking propranolol, only the 5 mg dose of rizatriptan benzoate tablets is recommended, up to a maximum of 3 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 Tablets. However, due to Merck & Co., Inc.'s marketing exclusivity rights, this drug product is not labeled with that dosage adjustment information.