Application Nr Approved Date Route Status External Links
NDA021926 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Treximet Is Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults And Pediatric Patients 12 Years Of Age And Older. Treximet Is A Combination Of Sumatriptan, A Serotonin (5-Ht) 1b/1d Receptor Agonist (Triptan), And Naproxen Sodium, A Non-Steroidal Anti-Inflammatory Drug, Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults And Pediatric Patients 12 Years Of Age And Older. ( 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 ) 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 Treximet, Reconsider The Diagnosis Of Migraine Before Treximet Is Administered To Treat Any Subsequent Attacks. Treximet Is Not Indicated For The Prevention Of Migraine Attacks. Safety And Effectiveness Of Treximet Have Not Been Established For Cluster Headache.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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