Ibuprofen and famotidine
Drug Details
- Generic Name
- Ibuprofen and famotidine
- Brand Names
- Ibuprofen and famotidine, IBUPROFEN AND FAMOTIDINE
- Application Number
- ANDA203658
- Sponsor
- ENDO USA, Inc.
- NDC Codes
- 15
- Dosage Forms
- TABLET, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- FAMOTIDINE, IBUPROFEN
Indications and Usage
1 INDICATIONS AND USAGE Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14 ), Use in Specific Populations ( 8.5 )] . Ibuprofen and famotidine tablet, a combination of a nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months. ( 1 )