PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline
PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline
spontaneously from worldwide postmarketing experience, the frequency of such eventsand the role of sumatriptan in their causation cannot be reliably determined.Cardiac Disorders: Bradycardia, tachycardia, palpitations, cardiac arrhythmias,transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardialinfarction (see CONTRAINDICATIONS, and WARNINGS and PRECAUTIONS).Ophthalmologic Disorders: Patients treated with IMITREX ® rarely exhibit visualdisorders like flickering and diplopia. Additionally, cases of reduced vision have beenobserved. Very rarely, both transient and permanent loss of vision have occurred. Theseoccurrences have included reports of retinal vascular occlusion, ocular venousthrombosis, vasospasm of the eye and ischemic optic neuropathy. Visual disorders mayalso occur during a migraine attack itself.Gastrointestinal Disorders: Colonic ischemia (see WARNINGS and PRECAUTIONS,Cardiovascular, Other Vasospasm Related Events).Immune System Disorders: Hypersensitivity reactions ranging from cutaneoushypersensitivity to anaphylaxis (see WARNINGS and PRECAUTIONS, Immune).Nervous System Disorders: Seizures, although some have occurred in patients witheither a history of seizures or concurrent conditions predisposing to seizures there arealso reports in patients where no such predisposing factors are apparent (seeWARNINGS and PRECAUTIONS, Neurologic).There have been very rare reports of dystonia and related extrapyramidal disorders, suchas choreoathetoid movement, akathisia, parkinsonism and akinesia following bothsubcutaneous and oral treatments of IMITREX. Patients with previous history of drugrelated dystonia and patients taking medications recognised to be associated withmovement disorders such as SSRIs, may be at higher risk.Nystagmus, scotoma.Vascular Disorders: Hypotension, Raynaud’s phenomenon, peripheral vascularischemia (see CONTRAINDICATIONS and WARNINGS and PRECAUTIONS,Increases in Blood Pressure; Cardiovascular; and Other Vasospasm Related Events).DRUG INTERACTIONSDrug - Drug InteractionsSingle-dose pharmacokinetic drug interaction studies have not shown evidence ofinteractions with propranolol, flunarizine, pizotifen or alcohol. Multiple-dose interactionstudies have not been performed. The pharmacokinetics of sumatriptan nasal spray wereOctober 21, 2014Page 16 of 58
unaltered when preceded by a single clinical dose of the nasal decongestantxylometazoline (Otrivin ®2 ).Ergot-Containing Drugs: Ergot-containing drugs have been reported to cause prolongedvasospastic reactions. Because there is a theoretical basis for these effects being additive,ergot-containing or ergot-type medications (like dihydroergotamine or methysergide) arecontraindicated within 24 hours of IMITREX DF ® or IMITREX ® administration (seeCONTRAINDICATIONS).MAO Inhibitors: In studies conducted in a limited number of patients, MAO inhibitorsreduce sumatriptan clearance, significantly increasing systemic exposure. Therefore, theuse of IMITREX DF ® or IMITREX ® in patients receiving MAO inhibitors iscontraindicated (see CONTRAINDICATIONS and ACTION AND CLINICALPHARMACOLOGY).Selective Serotonin Reuptake Inhibitors (SSRIs)/Serotonin Norepinephrine ReuptakeInhibitors (SNRIs): Cases of life-threatening serotonin syndrome have been reportedduring combined use of selective serotonin reuptake inhibitors (SSRIs) or serotoninnorepinephrine reuptake inhibitors (SNRIs) and triptans (see WARNINGS ANDPRECAUTIONS).Other 5-HT 1 agonists: The administration of IMITREX DF ® or IMITREX ® with other5-HT 1 agonists has not been evaluated in migraine patients. As an increased risk ofcoronary vasospasm is a theoretical possibility with coadministration of 5-HT 1 agonists,use of these drugs within 24 hours of each other is contraindicated.Drug - Laboratory InteractionsIMITREX DF ® and IMITREX ® are not known to interfere with commonly employedclinical laboratory tests.DOSAGE AND ADMINISTRATIONDosing ConsiderationsAdults:IMITREX DF ® and IMITREX ® are indicated for the acute treatment of migraineheadache with or without aura. Sumatriptan should not be used prophylactically.Sumatriptan may be given orally, subcutaneously or as a nasal spray. The safety oftreating an average of more than four headaches in a 30-day period has not beenestablished. The recommended dose of IMITREX DF ® and IMITREX ® should notbe exceeded.2 Trademark Ciba Self MedicationOctober 21, 2014Page 17 of 58
- Page 3 and 4: IMITREX DF ®(sumatriptan succinate
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- Page 31 and 32: Sumatriptan (1-1000 μg/kg, iv) pro
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spontaneously from worldwide postmarketing experience, the frequency of such eventsand the role of sumatriptan in their causation cannot be reliably determined.Cardiac Disorders: Bradycardia, tachycardia, palpitations, cardiac arrhythmias,transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardialinfarction (see CONTRAINDICATIONS, and WARNINGS and PRECAUTIONS).Ophthalmologic Disorders: Patients treated with <strong>IMITREX</strong> ® rarely exhibit visualdisorders like flickering and diplopia. Additionally, cases of reduced vision have beenobserved. Very rarely, both transient and permanent loss of vision have occurred. Theseoccurrences have included reports of retinal vascular occlusion, ocular venousthrombosis, vasospasm of the eye and ischemic optic neuropathy. Visual disorders mayalso occur during a migraine attack itself.Gastrointestinal Disorders: Colonic ischemia (see WARNINGS and PRECAUTIONS,Cardiovascular, Other Vasospasm Related Events).Immune System Disorders: Hypersensitivity reactions ranging from cutaneoushypersensitivity to anaphylaxis (see WARNINGS and PRECAUTIONS, Immune).Nervous System Disorders: Seizures, although some have occurred in patients witheither a history of seizures or concurrent conditions predisposing to seizures there arealso reports in patients where no such predisposing factors are apparent (seeWARNINGS and PRECAUTIONS, Neurologic).There have been very rare reports of dystonia and related extrapyramidal disorders, suchas choreoathetoid movement, akathisia, parkinsonism and akinesia following bothsubcutaneous and oral treatments of <strong>IMITREX</strong>. Patients with previous history of drugrelated dystonia and patients taking medications recognised to be associated withmovement disorders such as SSRIs, may be at higher risk.Nystagmus, scotoma.Vascular Disorders: Hypotension, Raynaud’s phenomenon, peripheral vascularischemia (see CONTRAINDICATIONS and WARNINGS and PRECAUTIONS,Increases in Blood Pressure; Cardiovascular; and Other Vasospasm Related Events).DRUG INTERACTIONSDrug - Drug InteractionsSingle-dose pharmacokinetic drug interaction studies have not shown evidence ofinteractions with propranolol, flunarizine, pizotifen or alcohol. Multiple-dose interactionstudies have not been performed. The pharmacokinetics of sumatriptan nasal spray wereOctober 21, 2014Page 16 of 58
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