PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

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