Zolmitriptan - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors Arrhythmias: Discontinue dosing if occurs Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs Medication Overuse Headache: Detoxification may be necessary Serotonin syndrome: Discontinue dosing if occurs (5.7 , 7.5) Increase in blood pressure: very rarely associated with significant events 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Zolmitriptan is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD).

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of zolmitriptan.

Some of these reactions occurred in patients without known CAD.

5-HT 1 agonists including zolmitriptan may cause coronary artery vasospasm (Prinzmetal's Angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving zolmitriptan.

Do not administer zolmitriptan if there is evidence of CAD or coronary artery vasospasm [see Contraindications ] .

For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first zolmitriptan dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following zolmitriptan administration.

For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of zolmitriptan.

5.2 Arrhythmias Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT 1 agonists.

Discontinue zolmitriptan if these disturbances occur.

Patients with Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders should not receive zolmitriptan [see Contraindications ] .

5.3 Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure As with other 5-HT 1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with zolmitriptan and is usually non-cardiac in origin.

However, if a cardiac origin is suspected, patients should be evaluated.

Patients shown to have CAD and those with Prinzmetal's variant angina should not receive 5-HT 1 agonists [see Contraindications ] .

5.4 Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities.

In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not.

Discontinue zolmitriptan if a cerebrovascular event occurs.

As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine, other potentially serious neurological conditions should be excluded.

Zolmitriptan should not be administered to patients with a history of stroke or transient ischemic attack [see Contraindications ] .

5.5 Other Vasospasm Reactions 5-HT 1 agonists, including zolmitriptan, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome.

In patients who experience symptoms or signs suggestive of vasospasm reaction following the use of any 5-HT 1 agonist, the suspected vasospasm reaction should be ruled out before receiving additional zolmitriptan doses [see Contraindications ] .

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT 1 agonists.

Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT 1 agonists have not been clearly established.

5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g. ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache).

Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks.