Eletriptan HBR

FDA Drug Profile — Eletriptan HBR

Drug Details

Generic Name
Eletriptan HBR
Brand Names
Eletriptan HBR
Application Number
ANDA210708
Sponsor
Direct_Rx
NDC Codes
2
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ELETRIPTAN HYDROBROMIDE

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.