ZOMIG NASAL SPRAY 2.5 MG — DIN 02248992

What is ZOMIG NASAL SPRAY?

ZOMIG NASAL SPRAY 2.5 MG contains ZOLMITRIPTAN : 2.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02248992, held by XEDITON PHARMACEUTICALS INC, supplied as SPRAY for NASAL ; ORAL administration. Health Canada currently lists it as marketed, status dated 12-Jan-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ZOMIG NASAL SPRAY used for?

ZOMIG (zolmitriptan; tablets, orally disintegrating tablets, nasal spray) is indicated for the acute treatment of migraine attacks with or without aura, in adults. ZOMIG is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar, or ophthalmoplegic migraine. Safety and efficacy have not been established for cluster headache.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The following general statements apply to all dosage formulations of ZOMIG: - ZOMIG should only be used where a clear diagnosis of migraine has been established. - ZOMIG is not indicated for prophylaxis of migraine. - Regardless of formulation, the recommended adult starting dose for ZOMIG is 2.5 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. ZOMIG Tablets: - The tablet should be swallowed with water. The 1 mg dose can be approximated by manually breaking a 2.5 mg conventional tablet in half. ZOMIG RAPIMELT (orally disintegrating tablets): - The tablet should be placed on the tongue, where it will dissolve with the saliva. Water is not needed for the dispersible tablet. The 2.5 mg orally dispersible tablet cannot be broken in half to approximate a 1 mg dose. ZOMIG NASAL SPRAY: - The nasal spray should be administered into one nostril only. The device is a single dose unit and must not be primed before use. Patients should be advised to read the consumer information leaflet regarding the use of the nasal spray device prior to administration. The recommended initial starting dose is 2.5 mg. For patients for whom a 2.5 mg dose of zolmitriptan is not optimally effective, a 5 mg dose of ZOMIG NASAL SPRAY is recommended. Hepatic Insufficiency: ZOMIG should be administered with caution to patients with moderate or severe hepatic impairment, using a dose lower than 2.5 mg. Total dose should not exceed 5 mg in 24 hours. Blood pressure monitoring is recommended. Renal Insufficiency: No dosage adjustment is required in patients with a creatinine clearance ≥15 ml/min. ZOMIG should not be used in patients with end-stage renal disease (CrCl <15 mL/min).

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

ZOMIG (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). Patients with other significant underlying cardiovascular diseases (e.g., atherosclerotic disease, congenital heart disease) should not receive ZOMIG. Ischemic cardiac syndromes include, but are not restricted to, angina pectoris of any type, 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. - in patients with uncontrolled or severe hypertension, as ZOMIG can give rise to increases in blood pressure. - within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide. - in patients with hemiplegic, basilar or ophthalmoplegic migraine. - concurrent administration of MAO inhibitors or use of zolmitriptan within 2 weeks of discontinuation of MAO inhibitor therapy. - 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.

Warnings and precautions

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 ZOMIG administration. ZOMIG is contraindicated for use in patients who have documented ischemic or vasospastic coronary artery disease. ZOMIG should not be given to patients who have risk factors for coronary artery disease. - Cardiac Arrhythmias: Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours of ZOMIG administration. - Angina Pectoris: ZOMIG may cause coronary artery vasospasm (Prinzmetal angina), even in patients without a history of coronary artery disease. - 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. General Warnings: - ZOMIG should only be used where a clear diagnosis of migraine has been established. - Patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders should not receive ZOMIG. - Other Vasospasm-Related Events: 5-HT1 agonists may cause vasospastic reactions other than coronary artery vasospasm. Peripheral vascular ischemia has been reported. Very rare reports of splenic infarction and gastrointestinal ischemic events including ischemic colitis, gastrointestinal infarction or necrosis, which may present as bloody diarrhea or abdominal pain, have been received. - Increased Blood Pressure: Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients receiving other 5-HT1 agonists with and without a history of hypertension. ZOMIG is contraindicated in patients with uncontrolled or severe hypertension. - Dependence, Tolerance and/or Abuse Liability: ZOMIG has not been studied for its potential to cause dependence, tolerance and/or abuse. Overuse of analgesics or other medications, such as triptans, can result in the worsening of headache symptoms (medication overuse headache). - Driving and Operating Machinery: Although ZOMIG did not interfere with psychomotor performance in healthy volunteers, some patients in clinical trials experienced sedation with ZOMIG. Patients should be cautioned not to drive, operate dangerous machinery or engage in activities that require alertness or physical coordination until they are reasonably certain that ZOMIG does not affect them adversely. - Neurologic: Care should be taken to exclude other potentially serious neurologic conditions before treating headache in patients not previously diagnosed with migraine or who experience a headache that is atypical for them. Serotonin toxicity / Serotonin syndrome is a potentially life-threatening condition and has been reported with triptans, including ZOMIG, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs).