Sumatriptan: uses, appearance and warnings

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

Sumatriptan Tablets, USP are available containing 35 mg, 70 mg or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg or 100 mg of sumatriptan, respectively. • The 25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and S4 on the other side. • The 50 mg tablets are white, film-coated, round, unscored tablets debossed with M over S7 on one side of the tablet and blank on the other side. • The 100 mg tablets are white, film-coated, round, unscored tablets debossed with M over S12 on one side of the tablet and blank on the other side. Tablets: 25 mg, 50 mg, and 100 mg ( 3 )

Sumatriptan Tablets, USP are available containing 35 mg, 70 mg or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg or 100 mg of sumatriptan, respectively. The 25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and S4 on the other side. They are available as follows: NDC 0378-5630-59 bottles of 9 tablets The 50 mg tablets are white, film-coated, round, unscored tablets debossed with M over S7 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5631-59 bottles of 9 tablets The 100 mg tablets are white, film-coated, round, unscored tablets debossed with M over S12 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5632-59 bottles of 9 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.

Sumatriptan tablets are contraindicated in patients with: • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary 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 or 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 [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 ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions (7.1 , 7.3) ] • Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [ see Drug Interactions (7.2) , Clinical Pharmacology (12.3) ] • Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9) ] • Severe hepatic impairment [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] • History of coronary artery disease or coronary artery vasospasm ( 4 ) • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 ) • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 ) • Peripheral vascular disease ( 4 ) • Ischemic bowel disease ( 4 ) • Uncontrolled hypertension ( 4 ) • Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan) or of an ergotamine-containing medication ( 4 ) • Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibi …

• Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. ( 5.1 ) • Arrhythmias: Discontinue sumatriptan if occurs. ( 5.2 ) • 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. ( 5.3 ) • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue sumatriptan if occurs. ( 5.4 ) • Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan if occurs. ( 5.5 ) • Medication overuse headache: Detoxification may be necessary. ( 5.6 ) • Serotonin syndrome: Discontinue sumatriptan if occurs. ( 5.7 ) • Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. ( 5.10 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina The use of sumatriptan tablets is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan tablets. Some of these reactions occurred in patients without known CAD. Sumatriptan tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan tablets. If there is evidence of CAD or coronary artery vasospasm, sumatriptan tablets are contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan tablets in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of sumatriptan tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan tablets. 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 sumatriptan tablets if these disturbances occur. Sumatriptan tablets are contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. 5.3 Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan tablets and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of sumatriptan tablets is contraindicated in patients with CAD and those with Prinzmetal’s variant angina. 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. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA). Discontinue sumatriptan tablets if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Sumatriptan tablets are contraindicated in patients with a history of stroke or TIA. 5.5 Other Vasospasm Reactions Sumatriptan tablets 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 non-coronary vasospasm reaction following the use of any 5-HT 1 agonist, rule out a vasospastic reaction before receiving additional sumatriptan tablets. 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 agonist has not been clearly established. 5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these 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. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.7 Serotonin Syndrome Serotonin syndrome may occur with sumatriptan tablets, particularly during coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions (7.4) ] . Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). …

The following adverse reactions are discussed in more detail in other sections of the prescribing information: • Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1) ] • Arrhythmias [see Warnings and Precautions (5.2) ] • Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3) ] • Cerebrovascular events [see Warnings and Precautions (5.4) ] • Other vasospasm reactions [see Warnings and Precautions (5.5) ] • Medication overuse headache [see Warnings and Precautions (5.6) ] • Serotonin syndrome [see Warnings and Precautions (5.7) ] • Increase in blood pressure [see Warnings and Precautions (5.8) ] • Hypersensitivity reactions [see Contraindications (4) , Warnings and Precautions (5.9) ] • Seizures [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥ 2% and > placebo) were paresthesia, …

7.1 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and sumatriptan tablets within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 7-fold. Therefore, the use of sumatriptan tablets in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3) ] . 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, coadministration of sumatriptan tablets and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. …