tobramycin
Drug Details
- Generic Name
- tobramycin
- Brand Names
- TOBREX, tobramycin, BETHKIS
- Application Number
- NDA050555
- Sponsor
- Novartis Pharmaceuticals Corporation
- NDC Codes
- 3
- Dosage Forms
- OINTMENT, INJECTION, POWDER, FOR SOLUTION, SOLUTION
- Routes
- OPHTHALMIC, INTRAVENOUS, RESPIRATORY (INHALATION)
- Active Ingredients
- TOBRAMYCIN
Indications and Usage
1 INDICATIONS AND USAGE Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ]. Tobramycin inhalation solution is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia .