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NRA-RIZATRIPTAN ODT is a brand name for Rizatriptan, supplied as a tablet (orally disintegrating). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................................... 3 CONTRAINDICATIONS ................................................................................................................ 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Serious cardiac events, including some that have been fatal, have occurred following use of 5-HT1 agonists. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD.
Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS). Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Experience in Controlled Clinical Trials with rizatriptan benzoate Typical 5-HT1 Agonist Adverse Reactions As with other 5-HT1 agonists, rizatriptan benzoate has been associated with sensations of heaviness, pressure, tightness or pain which may be intense.
These may occur in any part of the body including the chest, throat, neck, jaw and upper limb. Acute Safety Adverse experiences to rizatriptan were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of rizatriptan benzoate tablets.
The most common adverse events during treatment with rizatriptan benzoate were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness. These events appeared to be dose-related. In long-term extension studies where patients were allowed to treat multiple attacks for up to 1 year, 4% (59 out of 1525 patients) withdrew because of adverse experiences.
Tables 1 and 2 list the adverse events regardless of drug relationship (incidence ≥ 1% and greater than placebo) after a single dose of rizatriptan benzoate tablets and wafers, respectively. Most of the adverse events appear to be dose-related.
The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.
NRA-Rizatriptan ODT is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes, valvular heart disease or cardiac arrhythmias (especially tachycardias). , atherosclerotic disease, congenital heart disease) should not receive NRA-Rizatriptan ODT.
, stable angina of effort and vasospastic forms of angina such as the Prinzmetal’s variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks (TIAs).
Peripheral vascular disease includes, but is not limited to, ischemic bowel disease, or Raynaud’s syndrome (see WARNINGS AND PRECAUTIONS). Because rizatriptan benzoate may increase blood pressure, it is contraindicated in patients with uncontrolled or severe hypertension (see WARNINGS AND PRECAUTIONS).
NRA-Rizatriptan ODT is contraindicated within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide. NRA-Rizatriptan ODT is contraindicated in patients with hemiplegic, ophthalmoplegic or basilar migraine.
Concurrent administration of MAO inhibitors or use of rizatriptan within 2 weeks of discontinuation of MAO inhibitor therapy is contraindicated (see DRUG INTERACTIONS). Because there are no data available, NRA-Rizatriptan ODT is contraindicated in patients with severe hepatic impairment.
NRA-Rizatriptan ODT is contraindicated in patients who are hypersensitive to rizatriptan or any component of the formulation. WARNINGS AND PRECAUTIONS General NRA-Rizatriptan ODT should only be used where a clear diagnosis of migraine has been established.
For a given attack, if a patient has no response to the first dose of rizatriptan, the diagnosis of migraine should be reconsidered before administration of a second dose. NRA-Rizatriptan ODT Page 5 of 38 Psychomotor Effect Dizziness, somnolence and asthenia/fatigue were experienced by some patients in clinical trials with rizatriptan benzoate (see ADVERSE EVENTS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 * The term “sensations” encompasses adverse events described as pain, discomfort, pressure, heaviness, constriction, tightness, heat/burning sensation, paresthesia, numbness, tingling, weakness and strange sensations. † Data from Studies 022, 025, 029 and 030.
3 * The term ”sensations” encompasses adverse events described as pain, discomfort, pressure, heaviness, constriction, tightness, heat/burning sensation, paresthesia, numbness, tingling, weakness and strange sensations. † Data from Studies 039 and 049.
NRA-Rizatriptan ODT Page 14 of 38 Rizatriptan benzoate was generally well-tolerated. Adverse experiences were typically mild in intensity and were transient. The frequencies of adverse experiences in clinical trials did not increase when up to three doses were taken within 24 hours.
The incidences of adverse experiences were not affected by age, gender or use of prophylactic medications. There were insufficient data to assess the impact of race on the incidence of adverse events. Long-Term Safety In long-term extension studies, a total of 1854 patients treated 16,150 migraine attacks with rizatriptan benzoate 5 mg tablets and 24,043 attacks with rizatriptan benzoate 10 mg tablets over a period of up to 1 year.
In general, the types of clinical adverse experiences observed in the extension studies were similar to those observed in the acute studies. However, the incidences of most clinical adverse events were approximately 3-fold higher in extension, as expected, based on increased observation time.
The most common adverse events per […]
Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that rizatriptan benzoate does not adversely affect them. Cardiovascular Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events rizatriptan benzoate has been associated with transient chest and/or neck pain and tightness which may resemble angina pectoris.
Following the use of other 5-HT1 agonists, in rare cases these symptoms have been identified as being the likely result of coronary vasospasm or myocardial ischemia. Rare cases of serious coronary events or arrhythmia have occurred following use of other 5-HT1 agonists, and may therefore also occur with rizatriptan benzoate.
Because of the potential of this class of compounds (5-HT1B/1D agonists) to cause coronary vasospasm, rizatriptan benzoate should not be given to patients with documented ischemic or vasospastic coronary artery disease (see CONTRAINDICATIONS).
, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease.
The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is unknown. If, during the cardiovascular evaluation, the patient’s medical history, electrocardiographic or other investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, NRA-Rizatriptan ODT should not be administered (seeCONTRAINDICATIONS).
For patients with risk factors predictive of CAD, who are considered to have a satisfactory cardiovascular evaluation, the first dose of rizatriptan should be administered in the setting of a physician’s office or similar medically staffed and equipped facility.
Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following rizatriptan benzoate, in these patients with risk factors.
However, an absence of drug-induced cardiovascular effects on the occasion of the initial dose does not preclude the possibility of such effects occurring with subsequent administrations. Intermittent long-term users of rizatriptan benzoate who have or acquire risk factors predictive of CAD, as described above, should receive periodic interval cardiovascular evaluation as they continue to use rizatriptan benzoate.
If symptoms consistent with angina occur after the use of rizatriptan benzoate, ECG evaluation should be carried out to look for ischemic changes. NRA-Rizatriptan ODT Page 6 of 38 The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to rizatriptan benzoate.
Discomfort in the chest, neck, throat and jaw (including pain, pressure, heaviness and tightness) has been reported after administration of rizatriptan. Because drugs in this class may cause coronary artery vasospasm, patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of CAD or a predisposition to Prinzmetal’s variant angina before receiving […]