졸미트립탄

Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks. Zolmitriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache. Zolmitriptan tablets are a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only after a clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 )

Zolmitriptan tablets are contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or c oronary artery vasospasm including Prinzmetal’s angina [see Warnings and Precautions ( 5.1 ) ] Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 ) ] History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4 ) ] Peripheral vascular disease (PVD) [see Warnings and Precautions ( 5.5 ) ] Ischemic bowel disease [see Warnings and Precautions ( 5.5 ) ] Uncontrolled hypertension [see Warnings and Precautions ( 5.8 ) ] Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication …

Myocardial Ischemia/Infarction, and Prinzmetal Angina : Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) Arrhythmias : Discontinue zolmitriptan if occurs ( 5.2 ) Chest/Throat/Neck/Jaw Pain, Tightness, and Pressure : Generally not associated with myocardial ischemia; evaluate for CAD in patients at high risk ( 5.3 ) Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke : Discontinue zolmitriptan if occurs ( 5.4 ) Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions : Discontinue zolmitriptan if occurs ( 5.5 ) Medication Overuse Headache : Detoxification may be necessary ( 5.6 ) Serotonin Syndrome : Discontinue zolmitriptan if occurs ( 5.7 , 7.4 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal 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 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 …

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of zolmitriptan in pregnant women. In reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures (see Data). In the U.S general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. The estimated rates of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates …