Sumatriptan Succinate Sumatriptan 100 MG Oral Tablet
1 INDICATIONS AND USAGE 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 )
Mylan Pharmaceuticals Inc.
ROUND WHITE M S12
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16 HOW SUPPLIED/STORAGE AND HANDLING 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.
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