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NAT-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: , 1.1 Pediatrics 12/2024 7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics 12/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF…
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. • NAT-ZOLMITRIPTAN should only be used where a clear diagnosis of migraine has been established. • NAT-ZOLMITRIPTAN is not indicated for prophylaxis of migraine.
• Lactose is a non-medicinal ingredient in NAT-ZOLMITRIPTAN tablets. Patients with hereditary problems of galactose intolerance should not use NAT-ZOLMITRIPTAN (see
1 Adverse Reaction Overview 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 Pr NAT-ZOLMITRIPTAN zolmitriptan tablets Page 14 of 40 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.
3 Pediatrics 12/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
5 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 5 OVERDOSAGE..............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 13 8 ADVERSE REACTIONS ................................................................................................
20 9 DRUG INTERACTIONS ................................................................................................ 23 10 CLINICAL PHARMACOLOGY .......................................................................................
25 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 27 12 SPECIAL HANDLING INSTRUCTIONS […]
). 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 NAT-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 NAT-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 NAT-ZOLMITRIPTAN can give rise to increases in blood pressure (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular). 4 Drug-Drug Interaction). • in patients with hemiplegic, basilar or ophthalmoplegic migraine.
4 Drug-Drug Interactions). Pr NAT-ZOLMITRIPTAN zolmitriptan tablets Page 6 of 40 • 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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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 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 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%, […]