Tobramycin Inhalation Solution
Drug Details
- Generic Name
- Tobramycin Inhalation Solution
- Brand Names
- Tobramycin Inhalation Solution
- Application Number
- ANDA207080
- Sponsor
- Dr. Reddy's Laboratories Inc.
- NDC Codes
- 1
- Dosage Forms
- INHALANT
- Routes
- 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 . ( 1 ) 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. ( 1 )