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MAXALT RPD 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 MAXALT® Typical 5-HT1 Agonist Adverse Reactions As with other 5-HT1 agonists, MAXALT® 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 MAXALT® Tablets.
The most common adverse events during treatment with MAXALT® 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 MAXALT® Tablets and MAXALT RPD® 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.
General MAXALT® 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 MAXALT® (see ADVERSE EVENTS). Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that MAXALT® does not adversely affect them.
Cardiovascular Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events MAXALT® 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 MAXALT®. Because of the potential of this class of compounds (5-HT1B/1D agonists) to cause coronary vasospasm, MAXALT® 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, MAXALT® should not be administered (see CONTRAINDICATIONS).
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.
MAXALT® and MAXALT RPD® (rizatriptan benzoate) Page 14 of 37 MAXALT® 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 MAXALT® 5 mg Tablets and 24,043 attacks with MAXALT® 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 attack (defined as occurring at an incidence of at least 1%) for MAXALT® 5 mg and 10 mg, […]
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 MAXALT®, in these patients with risk factors.
However, an absence MAXALT® and MAXALT RPD® (rizatriptan benzoate) Page 6 of 37 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 MAXALT® who have or acquire risk factors predictive of CAD, as described above, should receive periodic interval cardiovascular evaluation as they continue to use MAXALT®. If symptoms consistent with angina occur after the use of MAXALT®, 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 MAXALT®. 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 additional doses of medication, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur.
Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud’s syndrome following MAXALT® administration should be evaluated for atherosclerosis or predisposition to vasospasm (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
Cardiac Events and Fatalities Associated with 5-HT1 Agonists MAXALT® may cause coronary artery vasospasm. Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of 5-HT1 agonists.
Considering the extent of use of 5-HT1 agonists in patients with migraine, the incidence of these events is extremely low. Premarketing Experience with MAXALT® Among the approximately 4200 patients who were treated with at least a single oral dose of either 5 or 10 mg rizatriptan in premarketing clinical trials of MAXALT®, electrocardiac adverse experiences were observed in 33 patients.
One patient was reported to have chest pain with possible ischemic ECG changes following a single dose of 10 mg. Postmarketing Experience with MAXALT® Serious cardiovascular events have been reported in association with the use of MAXALT®.
The uncontrolled nature of postmarketing surveillance, however, makes it impossible to determine definitively the proportion of reported cases that were actually caused by MAXALT® or to reliably assess causation in individual cases.
MAXALT® and MAXALT RPD® (rizatriptan benzoate) Page 7 of 37 Cerebrovascular Events and Fatalities Associated with 5-HT1 Agonists Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5-HT1 agonists; and some have resulted in fatalities.
In a number of cases, it appears possible that the […]