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APO-RIZATRIPTAN is a brand name for Rizatriptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE..................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND…
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 Typical 5-HT1 Agonist Adverse Reactions As with other 5-HT1 agonists, rizatriptan 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.
The most common adverse events during treatment with rizatriptan 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.
Table 1 lists the adverse events regardless of drug relationship (incidence ≥ 1% and greater than placebo) after a single dose of rizatriptan. 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. 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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† Data from Studies 022, 025, 029 and 030. Rizatriptan 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 5 mg and 24,043 attacks with rizatriptan 10 mg 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 rizatriptan 5 mg and 10 mg, respectively, were as follows: nausea (3%, 4%), dizziness (2%, 2%), somnolence (2%, 4%), asthenia/fatigue (2%, 2%), headache (1%, 2%), vomiting (1%, <1%), chest pain (<1%, 1%) and paresthesia (<1%, 2%).
Due to the lack of placebo controls in the extension studies, the role of rizatriptan in causation cannot be reliably determined. Other Events Observed in Association with the Administration of Rizatriptan In the section that follows, the frequencies of less commonly reported adverse clinical events are presented.
Because the reports include events observed in open studies, the role of rizatriptan in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc.
limit the Page 12 of 32 value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used rizatriptan 5 mg and 10 mg in Phase II and III studies (n=3716) and reported an event divided by the total number of patients exposed to rizatriptan.
All reported events are included, except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those defined as those occurring in at least 1/100 patients; infrequent adverse experiences are those occurring in 1/100 to […]