eletriptan hydrobromide 20 mg
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 is 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)
Aurobindo Pharma Limited
ROUND ORANGE EL 20
EL 20 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ELETRIPtan HYDROBROMIDE tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt.
ELETRIPtan HYDROBROMIDE Tablets 20 mg are orange colored, round, biconvex, film-coated tablets debossed with ‘EL’ on one side and ‘20’ on the other side. They are supplied as follows: Carton of 6 (1 X 6) Unit-dose Tablets NDC 59651-104-69
ELETRIPtan HYDROBROMIDE Tablets 40 mg are orange colored, round, biconvex, film-coated tablets debossed with ‘EL’ on one side and ‘40’ on the other side. They are supplied as follows: Carton of 6 (1 X 6) Unit-dose Tablets NDC 59651-105-69 Carton of 12 (2 X 6) Unit-dose Tablets NDC 59651-105-93 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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