eletriptan hydrobromide
Drug Details
- Generic Name
- eletriptan hydrobromide
- Brand Names
- Relpax, Eletriptan Hydrobromide, eletriptan hydrobromide
- Application Number
- NDA021016
- Sponsor
- Viatris Specialty LLC
- NDC Codes
- 7
- Dosage Forms
- TABLET, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ELETRIPTAN HYDROBROMIDE
Indications and Usage
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 )