Sumatriptan

Brand names: IMITREX, Migraine Pack, Migranow, ONZETRA, Onzetra Xsail, SUMATRIPTAN SUCCINATE, SumaChip, Sumatriptan Succinate, sumatriptan succinate, Sumatriptan, SUMATRIPTAN, sumatriptan, Tosymra, TOSYMRA

Warnings

No boxed warning. Contraindicated in patients with "history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes," "uncontrolled hypertension," recent use of ergotamine-type medications within 24 hours, concurrent or recent (within 2 weeks) MAO-A inhibitor use, and hemiplegic or basilar migraine. Key warnings address risk of myocardial ischemia/infarction, Prinzmetal's angina, and other serious cardiac events even in patients without known coronary disease; cerebrovascular events such as stroke; and serotonin syndrome when combined with SSRIs or SNRIs.

Contraindications

4 CONTRAINDICATIONS 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 [s ee 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 inhibitor (4) • Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) (4) • Severe hepatic impairment (4)

Overdose

10 OVERDOSAGE Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mg without serious adverse reactions. Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation. The elimination half-life of sumatriptan is approximately 2.5 hours [see Clinical Pharmacology (12.3)] , and therefore monitoring of patients after overdose with sumatriptan tablets should continue for at least 12 hours or while symptoms or signs persist. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

Drug interactions

7 DRUG INTERACTIONS 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. 7.4 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7)] .

Uses

"Indicated for the acute treatment of migraine with or without aura in adults." The label specifies it is "not indicated for the prevention of migraine attacks" and should not be used for "hemiplegic or basilar migraine" because efficacy has not been established and there is theoretical concern about vasospasm.

Dosage forms & strengths

Capsule Tablet Tablet, Coated Tablet, Film Coated TABLET, FILM COATED INJECTION, SOLUTION POWDER SPRAY TABLET INJECTION

SUMATRIPTAN 100 mg SUMATRIPTAN SUCCINATE 100 mg SUMATRIPTAN SUCCINATE 11 mg SUMATRIPTAN SUCCINATE 25 mg SUMATRIPTAN SUCCINATE 50 mg sumatriptan succinate 100 mg sumatriptan succinate 25 mg sumatriptan succinate 50 mg SUMATRIPTAN SUCCINATE 50 mg/1 SUMATRIPTAN SUCCINATE 6 mg/.5mL SUMATRIPTAN 1 kg/kg SUMATRIPTAN 20 mg/.1mL SUMATRIPTAN SUCCINATE 25 mg/1 SUMATRIPTAN 10 mg/.1mL SUMATRIPTAN SUCCINATE 100 mg/1 SUMATRIPTAN SUCCINATE 4 mg/.5mL SUMATRIPTAN 5 mg/.1mL SUMATRIPTAN 5 mg/1 SUMATRIPTAN 20 mg/1 SUMATRIPTAN 5 mg/100uL SUMATRIPTAN 20 mg/100uL

2 DOSAGE AND ADMINISTRATION • Single dose of 50 mg tablet. (2.1) • A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. (2.1) • Maximum dose in a 24 hour period: 200 mg. (2.1) • Maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment. (2.2) 2.1 Dosing Information The recommended dose of sumatriptan tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25 mg dose, but doses of 100 mg may not provide a greater effect than the 50 mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14)] . If the migraine has not resolved by 2 hours after taking sumatriptan tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24 hour period. Use after sumatriptan injection If the migraine returns following an initial treatment with sumatriptan injection, additional single sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30 day period has not been established. 2.2 Dosing in Patients with Hepatic Impairment If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].