PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

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INDICATIONS AND CLINICAL USEAdultsIMITREX DF ® (sumatriptan succinate) and IMITREX ® (sumatriptansuccinate/sumatriptan hemisulphate) are indicated for the acute treatment of migraineattacks with or without aura.IMITREX DF ® and IMITREX ® are not intended for the prophylactic therapy of migraineor for use in the management of hemiplegic, basilar, or ophthalmoplegic migraine (seeCONTRAINDICATIONS). Safety and efficacy have not been established for clusterheadache, which is present in an older, predominantly male population.Pediatrics (< 18 years of age)The safety and efficacy of IMITREX DF ® and IMITREX ® in children have not beenestablished and their use in this age group is not recommended. (See WARNINGS andPRECAUTIONS).Geriatrics (> 65 years of age)Experience of the use of IMITREX DF ® and IMITREX ® in patients aged over 65 years islimited. Therefore the use of IMITREX DF ® and IMITREX ® in patients over 65 years isnot recommended. (See WARNINGS and PRECAUTIONS).CONTRAINDICATIONSIMITREX DF ® and IMITREX ® are contraindicated in patients with history,symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascularsyndromes, valvular heart disease or cardiac arrhythmias (especially tachycardias).In addition, patients with other significant underlying cardiovascular diseases (e.g.,atherosclerotic disease, congenital heart disease) should not receiveIMITREX DF ® or IMITREX ® . Ischemic cardiac syndromes include, but are notlimited to, angina pectoris of any type (e.g., stable angina of effort and vasospasticforms of angina such as the Prinzmetal’s variant), all forms of myocardialinfarction, and silent myocardial ischemia. Cerebrovascular syndromes include, butare 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, orRaynaud’s syndrome (see WARNINGS AND PRECAUTIONS).Because IMITREX DF ® and IMITREX ® may increase blood pressure, they arecontraindicated in patients with uncontrolled or severe hypertension.Concurrent administration of MAO inhibitors or use within 2 weeks ofdiscontinuation of MAO inhibitor therapy is contraindicated (see ACTION ANDCLINICAL PHARMACOLOGY and DRUG INTERACTIONS).October 21, 2014Page 4 of 58
Ergot-containing drugs have been reported to cause prolonged vasospasticreactions. Because IMITREX DF ® and IMITREX ® may also cause coronaryvasospasm and these effects may be additive, the use of IMITREX DF ® andIMITREX ® within 24 hours before or after treatment with other 5-HT 1 receptoragonists, or ergotamine-containing drugs or their derivatives (e.g.dihydroergotamine, methysergide) is contraindicated.IMITREX DF ® and IMITREX ® should not be administered to patients with severehepatic impairment (see WARNINGS AND PRECAUTIONS, Special Populationsand DOSAGE AND ADMINISTRATION).IMITREX DF ® and IMITREX ® are contraindicated in patients with hemiplegic,basilar, or ophthalmoplegic migraine.IMITREX DF ® and IMITREX ® are contraindicated in patients withhypersensitivity to sumatriptan or to any of the ingredients of the formulations, orcomponent of the container. For a complete listing, see the DOSAGE FORMS,COMPOSITION AND PACKAGING section of the product monograph.IMITREX ® Injection should not be given intravenously because of its potential tocause coronary vasospasm.WARNINGS AND PRECAUTIONSGeneralIMITREX DF ® and IMITREX ® should only be used where a clear diagnosis ofmigraine has been established.Cluster Headache: There is insufficient information on the efficacy and safety ofIMITREX DF ® and IMITREX ® in the treatment of cluster headache, which is present inan older, predominantly male population. The need for prolonged use and the demandfor repeated medication in this condition renders the dosing information inapplicable forcluster headache.Psychomotor Impairment: Patients should be cautioned that drowsiness may occur as aresult of treatment with IMITREX DF ® and IMITREX ® . They should be advised not toperform skilled tasks (e.g. driving or operating machinery) if drowsiness occurs.Medication Overuse Headache: Overuse of acute headache treatments has beenassociated with the exacerbation of headache (medication overuse headache, MOH) insusceptible patients. Withdrawal of the treatment may be necessary.October 21, 2014Page 5 of 58
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Page 11 and 12: Special PopulationsPregnant Women:
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Page 15 and 16: Table 4Treatment-Emergent Adverse E
Page 17 and 18: unaltered when preceded by a single
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Page 23 and 24: STORAGE AND STABILITYIMITREX DF ®
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Page 37 and 38: MutagenicitySumatriptan produced no
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PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

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