Polymyxin B Sulfate and Trimethoprim
Drug Details
- Generic Name
- Polymyxin B Sulfate and Trimethoprim
- Brand Names
- Polymyxin B Sulfate and Trimethoprim
- Application Number
- ANDA064211
- Sponsor
- REMEDYREPACK INC.
- NDC Codes
- 6
- Dosage Forms
- SOLUTION
- Routes
- OPHTHALMIC
- Active Ingredients
- POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE
Indications and Usage
INDICATIONS AND USAGE Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa. * * Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Warnings
WARNINGS NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to polymyxin B sulfate and trimethoprim ophthalmic solution occurs, discontinue use. Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.