Rizatriptan 5 mg Immediate Release Tablets*** — Generic For Maxalt — Rising Pharma

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

Indications And Usage

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)

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)

Pediatric patients 6 to 17 years: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patients 40 kg (88 lb) or more (2.2)

Adjust dose if co-administered with propranolol (2.4)

Dosage Forms And Strengths

Rizatriptan Benzoate Tablets USP: 5 mg 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-HT1 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 or any of the excipients (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 hemorrhage, and stroke: Discontinue dosing if occurs (5.4)
• Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs (5.5)
• Medication overuse headache: Detoxification may be necessary (5.6)
• Serotonin syndrome: Discontinue dosing if occurs (5.7)

• 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 hemorrhage, and stroke: Discontinue dosing if occurs (5.4)
• Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs (5.5)
• Medication overuse headache: Detoxification may be necessary (5.6)
• Serotonin syndrome: Discontinue dosing if occurs (5.7)

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 hemorrhage, and stroke: Discontinue dosing if occurs (5.4)

Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs (5.5)

Medication overuse headache: Detoxification may be necessary (5.6)

Serotonin syndrome: Discontinue dosing if occurs (5.7)

Adverse Reactions

The most common adverse reactions in adults were (incidence ≥ 5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Rising Health, LLC at 1-833-395-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use In Specific Populations

Pregnancy: Based on animal data, may cause fetal harm (8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2019