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M-ZOLMITRIPTAN is a brand name for Zolmitriptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: M-ZOLMITRIPTAN (zolmitriptan tablets) is indicated for: • the acute treatment of migraine attacks with or without aura, in adults. M-ZOLMITRIPTAN is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar, or ophthalmoplegic migraine (see
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The following general statements apply to all dosage formulations of zolmitriptan. • M-ZOLMITRIPTAN should only be used where a clear diagnosis of migraine has been established. M-ZOLMITRIPTAN (Zolmitriptan Tablets) Page 7 of 44 • M-ZOLMITRIPTAN is not indicated for prophylaxis of migraine.
• Lactose is a non-medicinal ingredient in M-ZOLMITRIPTAN tablets. Patients with hereditary problems of galactose intolerance should not take M-ZOLMITRIPTAN tablets(see
1 Adverse Reaction Overview M-ZOLMITRIPTAN (Zolmitriptan Tablets) Page 16 of 44 Zolmitriptan is generally well tolerated. Across all doses, most adverse reactions were mild to moderate in severity as well as transient and self-limiting.
The incidence of adverse events in controlled clinical trials was not affected by gender, weight, or age of patients; use of prophylactic medications; or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse events.
Serious cardiac events, including some that have been fatal, have occurred following the use of 5-HT1 agonists. These events are very rare and most have been reported in patients with risk factors predictive of coronary artery disease.
Events reported have included coronary artery vasospasm, transient myocardial ischemia, angina pectoris, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. (see 2 CONTRAINDICATIONS; 3 SERIOUS WARNINGS AND PRECAUTIONS BOX; 7 WARNINGS AND PRECAUTIONS - Cardiovascular).
As with other 5HT1 agonists, transient increases in systemic blood pressure have been reported in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events.
Isolated reports of chest pain, pulmonary edema, coronary vasospasm, transient cerebral ischemia, angina and subarachnoid hemorrhage have been received (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular). As with other 5-HT1 agonists, zolmitriptan 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. There have been rare reports of hypersensitivity reactions including urticaria and angioedema (see 7 WARNINGS AND PRECAUTIONS - Immune). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
Cardiovascular). • in patients with uncontrolled or severe hypertension, as M-ZOLMITRIPTAN can give rise to increases in blood pressure (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular). 4 Drug-Drug Interactions). • in patients with hemiplegic, basilar or ophthalmoplegic migraine.
4 Drug-Drug Interactions). • in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Risk of Myocardial Ischemia and/or Myocardial Infarction: Serious adverse cardiac events, including acute myocardial infarction, have been reported to occur within a few hours of zolmitriptan administration.
M-ZOLMITRIPTAN is contraindicated for use in patients who have documented ischemic or vasospastic coronary artery disease (see 2 CONTRAINDICATIONS). M-ZOLMITRIPTAN should not be given to patients who have risk factors for coronary artery disease (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular).
• Cardiac Arrythmias: Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours of zolmitriptan administration (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular).
• Angina Pectoris: M-ZOLMITRIPTAN may cause coronary artery vasospasm (Prinzmetal angina), even in patients without a history of coronary artery disease (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular). • Cerebrovascular Events: Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5-HT1 agonists, and some have resulted in fatalities (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular).
). Safety and efficacy have not been established for cluster headache, which is present in an older, predominantly male population. 3 Pediatrics). 3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS M-ZOLMITRIPTAN (zolmitriptan) 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 M- ZOLMITRIPTAN. , 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 7 WARNINGS AND PRECAUTIONS - Cardiovascular).
• in patients with uncontrolled or severe hypertension, as M-ZOLMITRIPTAN can give rise to increases in blood pressure (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular). 4 Drug-Drug Interactions). • in patients with hemiplegic, basilar or ophthalmoplegic migraine.
4 Drug-Drug Interactions). • in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Experience in Controlled Clinical Trials with Zolmitriptan Tablets Acute Safety:
In placebo-controlled migraine trials, 1,673 patients received at least one dose of zolmitriptan. The following table (Table 2) lists adverse events that occurred in five placebo- controlled clinical trials in migraine patients. 5 mg or 5 mg dose groups and that occurred at a higher incidence than in the placebo group are included.
The events cited reflect experience gained under closely monitored conditions in clinical trials, in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may M-ZOLMITRIPTAN (Zolmitriptan Tablets) Page 17 of 44 not apply, as the conditions of use, reporting behaviour, and the kinds of patients treated may differ.
Several of the adverse events appear dose related, notably paresthesia, sensation of heaviness or tightness in chest, neck, jaw and throat, dizziness, somnolence, and possibly asthenia and nausea. 7 *The term sensation encompasses adverse events described as pain, discomfort, pressure, heaviness, tightness, heat/burning sensations, tingling and paresthesia Zolmitriptan is generally well tolerated.
Across all doses, most adverse events were mild to moderate in severity as well as transient and self-limiting. The incidence of adverse events in controlled clinical trials was not affected by gender, weight, or age of patients; use of prophylactic medications; or presence of aura.
There were insufficient data to assess the impact of race on the incidence of adverse events.
Long Term Safety:
In a long-term open label study in which patients were allowed to treat multiple migraine attacks for up to one year, 8% (167 of 2,058) of patients withdrew from the study due to an adverse experience. In this study, migraine headaches could be treated with either a single 5 mg dose of zolmitriptan, or an initial 5 mg dose followed by a second 5 mg dose if necessary (5+5 mg).
The most common adverse events (defined as occurring at an incidence of at least 5%) recorded for the 5 mg and 5+5 mg doses, respectively, comprised, in descending order of frequency: neck/throat sensations* (16%, […]
1 Dosing Considerations The following general statements apply to all dosage formulations of zolmitriptan. • M-ZOLMITRIPTAN should only be used where a clear diagnosis of migraine has been established. M-ZOLMITRIPTAN (Zolmitriptan Tablets) Page 7 of 44 • M-ZOLMITRIPTAN is not indicated for prophylaxis of migraine.
• Lactose is a non-medicinal ingredient in M-ZOLMITRIPTAN tablets. Patients with hereditary problems of galactose intolerance should not take M-ZOLMITRIPTAN tablets(see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING; 7 WARNINGS AND PRECAUTIONS - Endocrine and Metabolism).
5 mg. The maximum recommended single dose is 5 mg. • If the headache returns, the dose may be repeated after 2 hours. A dose should not be repeated, regardless of dosage form, within 2 hours. A total cumulative dose of 10 mg should not be exceeded in any 24 hour period.
• Controlled trials have not established the effectiveness of a second dose, should the initial dose be ineffective. • The safety of treating more than 3 migraine headaches with zolmitriptan in a one- month period has not been established.
• Patients with mild to moderate hypertension should be treated cautiously at the lowest effective dose. M-ZOLMITRIPTAN is contraindicated in patients with severe or uncontrolled hypertension (see 2 CONTRAINDICATIONS). • Hepatic impairment reduces zolmitriptan clearance.
3 Pharmacokinetics). 4 Drug-Drug Interactions). 2 Recommended Dose and Dosage Adjustment Adults (≥ 18 years of age): M-ZOLMITRIPTAN (zolmitriptan tablets): The minimal effective single adult dose of M- ZOLMITRIPTAN is 1 mg. 5 mg. 5 mg tablet in half.
1 Clinical Trials By Indication).
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use. 4 Geriatrics).
Hepatic Insufficiency:
Zolmitriptan is metabolized primarily in the liver. Patients with moderate to severe hepatic impairment have decreased clearance of zolmitriptan and significant elevation in blood pressure was observed in some patients. 5 mg. Total dose should not exceed 5 mg in 24 hours.
3 Pharmacokinetics).
Renal Insufficiency:
No dosage adjustment is required in patients with a creatinine clearance ≥15 ml/min. M-ZOLMITRIPTAN should not be used in patients with end-stage renal disease (CrCl <15 mL/min). 3 Administration M-ZOLMITRIPTAN (zolmitriptan tablets): The tablet should be swallowed with water.
5 mg tablet in half. 5 OVERDOSAGE There is no experience with clinical overdose. Volunteers receiving single 50 mg oral doses of zolmitriptan commonly experienced sedation. 3 […]