eletriptan 40 MG Oral Tablet
1 INDICATIONS AND USAGE Eletriptan hydrobromide 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 has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. • Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. • Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache. Eletriptan hydrobromide 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 )
Mylan Pharmaceuticals Inc.
ROUND ORANGE M EL5
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eletriptan 20 MG Oral Tablet
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ELETRIPtan HYDROBROMIDE Tablets are available containing
ELETRIPtan HYDROBROMIDE equivalent to 20 mg or 40 mg eletriptan (base), respectively. The 20 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and EL4 on the other side. They are available as follows: NDC 0378-4287-85 carton of 6 unit-dose tablets (1 x 6) The 40 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and EL5 on the other side. They are available as follows: NDC 0378-4288-85 carton of 6 unit-dose tablets (1 x 6) NDC 0378-4288-08 carton of 12 unit-dose tablets (2 x 6) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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