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MYLAN-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.
MYLAN-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 MYLAN-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 MYLAN-RIZATRIPTAN ODT may increase blood pressure, it is contraindicated in patients with uncontrolled or severe hypertension (see WARNINGS AND PRECAUTIONS).
MYLAN-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. MYLAN-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, MYLAN-RIZATRIPTAN ODT is contraindicated in patients with severe hepatic impairment.
MYLAN-RIZATRIPTAN ODT is contraindicated in patients who are hypersensitive to rizatriptan or any component of the formulation. WARNINGS AND PRECAUTIONS General MYLAN-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. Psychomotor Effect Dizziness, somnolence and asthenia/fatigue were experienced by some patients in clinical trials with rizatriptan benzoate (see ADVERSE EVENTS).
Patients should be advised to avoid driving a MYLAN-RIZATRIPTAN ODT Page 5 of 38 car or operating hazardous machinery until they are reasonably certain that MYLAN- RIZATRIPTAN ODT 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rizatriptan in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 MYLAN- RIZATRIPTAN ODT.
Because of the potential of this class of compounds (5-HT1B/1D agonists) to cause coronary vasospasm, MYLAN-RIZATRIPTAN ODT 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, MYLAN- RIZATRIPTAN ODT should not be administered (see CONTRAINDICATIONS).
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 MYLAN-RIZATRIPTAN ODT 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 MYLAN-RIZATRIPTAN ODT who have or acquire risk factors predictive of CAD, as described above, should receive periodic interval cardiovascular evaluation as they continue to use MYLAN-RIZATRIPTAN ODT.
If symptoms consistent with angina occur after the use of MYLAN-RIZATRIPTAN ODT, ECG evaluation should be carried out to look for ischemic changes. The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to MYLAN-RIZATRIPTAN ODT.
Discomfort in the chest, neck, throat and jaw (including pain, pressure, heaviness and MYLAN-RIZATRIPTAN ODT Page 6 of 38 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 […]