tobramycin inhalation
Drug Details
- Generic Name
- tobramycin inhalation
- Brand Names
- Tobramycin Inhalation
- Application Number
- NDA201820
- Sponsor
- Prasco, LLC
- NDC Codes
- 1
- Dosage Forms
- SOLUTION
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- TOBRAMYCIN
Indications and Usage
1 INDICATIONS AND USAGE Tobramycin Inhalation Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )] . Tobramycin Inhalation Solution is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . ( 1 ) Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume in one second (FEV 1 ) less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia . ( 1 )