Dr Angio Recall
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Side Effects & Adverse Reactions
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FDA Safety Alerts
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Rizatriptan benzoate orally disintegrating 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 Orally Disintegrating 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 orally disintegrating 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 orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
• Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
• Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.
• Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.
There is currently no drug history available for this drug.
Rizatriptan benzoate orally disintegrating tablets contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D ) receptor agonist.
Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:
Its molecular formula is C15H19N5•C7H6O2, 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 orally disintegrating tablets are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively).
Each orally disintegrating tablet contains following inactive ingredients:
microcrystalline cellulose, colloidal silicon dioxide, carboxymethyl cellulose calcium, magnesium stearate, mannitol, aspartame, and peppermint flavor.
Dr Angio Manufacturers
Angio Lab Co., Ltd.
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