Rizatriptan Benzoate 10 mg/1
Rizatriptan Benzoate · TABLET · Rising Pharma Holdings, Inc.
Rizatriptan Benzoate is a tablet containing rizatriptan benzoate at 10 mg/1, taken oral. Manufactured by Rising Pharma Holdings, Inc..
Key Facts
- Brand Name
- Rizatriptan Benzoate
- Generic Name
- Rizatriptan Benzoate
- NDC Code (Product)
57237-088- Manufacturer
- Rising Pharma Holdings, Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202490
- Marketing Start
- 12/31/2012
Recall History
MACLEODS PHARMA USA, INC
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
MACLEODS PHARMA USA, INC
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Ascend Laboratories, LLC
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
MACLEODS PHARMA USA, INC
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Ascend Laboratories, LLC
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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. 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 …
Dosage & 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) 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) 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) Dosing in pediatric patients is based on the patient's…
Contraindications
4 CONTRAINDICATIONS Rizatriptan benzoate tablets are contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1) ] . Coronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions (5.1) ] . History of stroke or transient ischemic attack (TIA) [s ee Warnings and Precautions (5.4) ] . Peripheral vascular disease (PVD) [see Warnings and Precautions (5.5) ] . Ischemic bowel disease [see Warnings and Precautions (5.5) ] . Uncontrolled hypertension [see Warnings and Precautions (5.8) ] . Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions (7.2 and 7.3) ] . Hemiplegic or basilar migraine [see Indications and Usage (1) ]. Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see Drug Interactions (7.5) and Clinical Pharmacology (12.3) ] . Hypersensitivity to rizatriptan or any of the excipients (angioedema and an…
Drug Interactions
7 DRUG INTERACTIONS 7.1 Propranolol The dose of rizatriptan benzoate should be adjusted in propranolol-treated patients, as propranolol has been shown to increase the plasma AUC of rizatriptan by 70% [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] . 7.2 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and rizatriptan benzoate within 24 hours is contraindicated [see Contraindications (4) ] . 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, co-administration of rizatriptan benzoate and other 5-HT 1 agonists within 24 hours of each other is contraindicated [see Contraindications (4) ] . 7.4 SSRIs/SNRIs and Serotonin Syndrome Cases of serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7) ] . 7.5 Monoamine Oxidase Inhibitors Rizatriptan benzoate is contraindicated in patients taking M…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina [see Warnings and Precautions (5.1) ] . Arrhythmias [see Warnings and Precautions (5.2) ]. Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3) ] . Cerebrovascular Events [see Warnings and Precautions (5.4) ] . Other Vasospasm Reactions [see Warnings and Precautions (5.5) ] . Medication Overuse Headache [see Warnings and Precautions (5.6) ] . Serotonin Syndrome [see Warnings and Precautions (5.7) ] . Increase in Blood Pressure [see Warnings and Precautions (5.8) ] . 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 . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates …
Frequently Asked Questions
What is Rizatriptan Benzoate used for?
Rizatriptan Benzoate contains Rizatriptan Benzoate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Rizatriptan Benzoate a controlled substance?
Rizatriptan Benzoate is not classified as a controlled substance by the DEA.
What is the generic name for Rizatriptan Benzoate?
The generic name for Rizatriptan Benzoate is Rizatriptan Benzoate. There are 5 other brand versions of Rizatriptan Benzoate.
What is the NDC code for Rizatriptan Benzoate 10 mg/1?
The NDC (National Drug Code) for Rizatriptan Benzoate 10 mg/1 is 57237-088, listed by Rising Pharma Holdings, Inc..