Trimethoprim sulfate and Polymyxin B sulfate

FDA Drug Profile — Trimethoprim sulfate and Polymyxin B sulfate

Drug Details

Generic Name
Trimethoprim sulfate and Polymyxin B sulfate
Brand Names
Trimethoprim sulfate and Polymyxin B sulfate
Application Number
ANDA065006
Sponsor
Proficient Rx LP
NDC Codes
1
Dosage Forms
SOLUTION
Routes
OPHTHALMIC
Active Ingredients
POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE

Indications and Usage

INDICATIONS AND USAGE Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution 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 influenza 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 Trimethoprim and Polymyxin B Sulfate Ophthalmic Solution occurs, discontinue use. Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is not indicated for the prophylaxis or treatment of ophthalmic neonatorum.