Imitrex Warnings
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Imitrex Warnings
Imitrex (sumatriptan succinate) tablets should only be used where a clear diagnosis of migraine headache has been established.
Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events:
Imitrex (sumatriptan succinate) should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD). It is strongly recommended that Imitrex (sumatriptan succinate) not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient's medical history or electrocardiographic investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, Imitrex (sumatriptan succinate) should not be administered.
For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of Imitrex (sumatriptan succinate) take place in the setting of a physician's office or similar medically staffed and equipped facility unless the patient has previously received sumatriptan. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following Imitrex (sumatriptan succinate) tablets, in these patients with risk factors.
It is recommended that patients who are intermittent long-term users of Imitrex (sumatriptan succinate) and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use sumatriptan.
The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to Imitrex (sumatriptan succinate).
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