Country: United States
Language: English
Source: NLM (National Library of Medicine)
RIZATRIPTAN BENZOATE (UNII: WR978S7QHH) (RIZATRIPTAN - UNII:51086HBW8G)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
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, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablet 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 indicat
Product: 71335-1346 NDC: 71335-1346-1 10 TABLET in a BOTTLE NDC: 71335-1346-2 6 TABLET in a BOTTLE NDC: 71335-1346-3 90 TABLET in a BOTTLE NDC: 71335-1346-4 9 TABLET in a BOTTLE NDC: 71335-1346-5 30 TABLET in a BOTTLE NDC: 71335-1346-6 18 TABLET in a BOTTLE NDC: 71335-1346-7 12 TABLET in a BOTTLE
Abbreviated New Drug Application
RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE TABLET Bryant Ranch Prepack ---------- PATIENT INFORMATION Rizatriptan Benzoate Tablets Read this Patient Information before you start taking rizatriptan benzoate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Unless otherwise stated, the information in this Patient Information leaflet applies to both rizatriptan benzoate tablets and to rizatriptan benzoate orally disintegrating tablets. What is rizatriptan benzoate? Rizatriptan benzoate is a prescription medicine that belongs to a class of medicines called Triptans. Rizatriptan benzoate is available as a traditional tablet and as an orally disintegrating tablet. Rizatriptan benzoate tablets are used to treat migraine attacks with or without aura in adults Rizatriptan benzoate is not to be used to prevent migraine attacks. Rizatriptan benzoate is not for the treatment of hemiplegic or basilar migraines. It is not known if rizatriptan benzoate is safe and effective for the treatment of cluster headaches. It is not known if rizatriptan benzoate is safe and effective in children under 6 years of age. Who should not take rizatriptan benzoate tablets? Do not take rizatriptan benzoate tablets if you: • have or have had heart problems • have or have had a stroke or a transient ischemic attack (TIA) • have or have had blood vessel problems including ischemic bowel disease • have uncontrolled high blood pressure • have taken other Triptan medicines in the last 24 hours • have taken ergot-containing medicines in the last 24 hours • have hemiplegic or basilar migraines • take monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks • are allergic to rizatriptan benzoate or any of the ingredients in rizatriptan benzoate tablets. See the end of this leaflet for a complete list of ingredients in rizatriptan benzoate tablets. Talk to your doctor befor Read the complete document
RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE TABLET BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RIZATRIPTAN BENZOATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RIZATRIPTAN BENZOATE TABLETS. RIZATRIPTAN BENZOATE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Indications and Usage Acute Treatment of Migraine (1) 12/2011 INDICATIONS AND USAGE Rizatriptan benzoate is a serotonin (5-HT) 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 Adults: 5 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) DOSAGE FORMS AND STRENGTHS Rizatriptan benzoate tablets: 5 and 10 mg (3) CONTRAINDICATIONS History of ischemic heart disease or coronary artery vasospasm (4) History of stroke or transient ischemic attack (4) Peripheral vascular disease (4) Ischemic bowel disease (4) Uncontrolled hypertension (4) Recent (within 24 hours) use of another 5-HT agonist (e.g., another triptan), or of an ergotamine-containing medication (4) Hemiplegic or basilar migraine (4) MAO-A inhibitor used in the past 2 weeks (4) Hypersensitivity to rizatriptan benzoate (4) WARNINGS AND PRECAUTIONS Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1) Arrhythmias: Discontinue dosing if occurs (5.2) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk (5.3) Cerebral hemorrhage, subarachnoid Read the complete document