Polymyxin B Sulfate and Trimethoprim

FDA Drug Profile — Polymyxin B Sulfate and Trimethoprim

Polymyxin B Sulfate and Trimethoprim is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including Polymyxin B Sulfate and Trimethoprim. Available dosage form: solution.

Drug Details

Generic Name
Polymyxin B Sulfate and Trimethoprim
Brand Names
Polymyxin B Sulfate and Trimethoprim
Application Number
ANDA064211
Sponsor
A-S Medication Solutions
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.