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RELPAX is a brand name for Eletriptan, 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 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 the use of other 5-HT1 agonists. These events are extremely rare and most have been reported in patients with risk factors of CAD.
Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). Typical 5-HT1 Agonist Adverse Reactions As with other 5-HT1 agonists, RELPAX 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 limbs. Increases in Blood Pressure Significant elevations in systemic blood pressure, including hypertensive crisis, have been reported on rare occasions in patients with and without a history of hypertension treated with other 5-HT1 agonists.
RELPAX is contraindicated in patients with uncontrolled hypertension (see CONTRAINDICATIONS). Clinical Trial Adverse Drug Reactions In the clinical program, 7,483 subjects have received RELPAX (eletriptan hydrobromide) tablets and 1,595 have received placebo.
In Phase 2/3 clinical trials for the treatment of migraine, safety data were obtained for 6,954 subjects treated with eletriptan and 1,376 subjects treated with placebo. In the clinical pharmacology program, 529 subjects received eletriptan and 219 received placebo.
2%). Table 1 lists the most common adverse events that occurred in the subset of 7,131 patients with migraine who received eletriptan doses of 20 mg, 40 mg, 80 mg or placebo in worldwide, placebo-controlled clinical trials. Adverse events that were more frequent in a RELPAX treatment group compared to the placebo group with an incidence greater than 1% are included in Table 1.
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, those frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.
RELPAX tablets are generally well tolerated. Across all doses, most adverse reactions were mild and transient. The frequency of adverse events in clinical trials did not increase when up to 2 doses of RELPAX tablets were taken within 24 hours.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Eletriptan in Canada.
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The incidence of adverse events in RELPAX (eletriptan hydrobromide) – Product Monograph Page 12 of 32 controlled clinical trials was not affected by gender, age, or race of patients. Adverse event frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis, (eg, beta-blockers, calcium channel blockers, tricyclic antidepressants), estrogen replacement therapy and oral contraceptives.
6 *The term “sensations” encompasses adverse events described as pain & discomfort, pressure, heaviness, constriction, tightness, heat/burning sensation, paresthesia, numbness, tingling and strange sensations. Other Events Observed in Association with the Administration of RELPAX Tablets The frequencies of less commonly reported adverse clinical events are listed below by body system in order of decreasing frequency.
Because the reports include events observed in open studies, the role of RELPAX tablets in their causation cannot be reliably determined. , limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients reporting an event divided by the total number of patients (N=4,719) exposed to RELPAX.
All reported events are included except those already listed in Table 1, those too general to be informative, and those not reasonably associated with the use of the drug. Frequent adverse events are those occurring in at least 1/100 RELPAX (eletriptan hydrobromide) – Product Monograph Page 13 of 32 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.
General:
Frequent: back pain, chills and pain. Infrequent: face edema and malaise. Rare: abdomen enlarged, abscess, accidental injury, allergic reaction, fever, flu syndrome, halitosis, hernia, hypothermia, lab test abnormal, moniliasis, rheumatoid arthritis and shock.
Cardiovascular:
Frequent: […]