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SANDOZ ZOLMITRIPTAN ODT is a brand name for Zolmitriptan, supplied as a tablet (orally disintegrating). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 11/2024 7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE…
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. • Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT should only be used where a clear diagnosis of migraine has been established.
• Sandoz Zolmitriptan / Sandoz Zolmitriptan ODT is not indicated for prophylaxis of migraine. • Lactose is a non-medicinal ingredient in Sandoz Zolmitriptan (zolmitriptan tablets). Patients with hereditary problems of galactose intolerance should use another zolmitriptan formulation: Sandoz Zolmitriptan ODT (orally disintegrating tablets) (see
1 Adverse Reaction Overview The adverse experience profile seen with zolmitriptan nasal spray is similar to that seen with zolmitriptan conventional tablets and zolmitriptan orally disintegrating tablets, except for localized adverse events related to intranasal dosing.
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; and 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 Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT Page 19 of 63 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.
3 Pediatrics 11/2024 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 ................................................................................................................ 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 5 2 CONTRAINDICATIONS ..................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 6 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ..........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 8 5 OVERDOSAGE...............................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations..............................................................................................
). 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 Sandoz Zolmitriptan (zolmitriptan tablets) / Sandoz Zolmitriptan ODT (zolmitriptan orally disintegrating tablets) are contraindicated under the following conditions: • 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 zolmitriptan. , stable angina of effort and vasospastic forms of angina such as Sandoz Zolmitriptan and Sandoz Zolmitriptan ODT Page 6 of 63 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 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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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.
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 reactions in real- word use.
Experience in Controlled Clinical Trials with Zolmitriptan Tablets Acute Safety:
In placebo-controlled migraine trials, 1673 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 2058) of patients withdrew from the study due to an adverse experience. In this study, migraine headaches could be treated with […]
1 Pregnant Women ............................................................................................ 2 Breastfeeding .................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ......................................................................................................... 18 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ........................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ....................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 1 Less Common Clinical Trial Adverse Reactions - Pediatrics .............................. 5 Post-Market Adverse Reactions ..........................................................................
28 9 DRUG INTERACTIONS ................................................................................................. 1 Serious Drug Interactions ....................................................................................
2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions............................................................................. 4 Drug-Drug Interactions ........................................................................................
5 Drug-Food Interactions........................................................................................ 6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions.......................................................................
34 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics .........................................................................................
3 Pharmacokinetics ............................................................................................ 36 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 40 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
40 PART II: SCIENTIFIC INFORMATION ........................................................................................ 41 13 PHARMACEUTICAL INFORMATION .............................................................................
41 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication .................................................................................
2 Comparative Bioavailability Studies.................................................................... 50 15 MICROBIOLOGY ......................................................................................................... 53 16 NON-CLINICAL TOXICOLOGY ......................................................................................
53 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 55 PATIENT […]