Drug Catalog - Product Detail
POLYMYXIN B-TRIMETHOPRIM OPHTH SOLN 10000 UNIT/ML-0.1% 10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 60758-0908-10 | GREENSTONE | 10 | 10000-0.1UNIT/ML-% | SOLUTION |
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Description
DESCRIPTION Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a sterile antimicrobial solution for topical ophthalmic use. Chemical Names: Trimethoprim sulfate, 2,4-Diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are: Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: purified water; sodium chloride; and sulfuric acid. May also contain sodium hydroxide for pH adjustment. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. structural formula structural formulae
How Supplied
HOW SUPPLIED Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with white high impact polystyrene (HIPS) caps as follows: 10 mL in 10 mL bottle - NDC 60758-908-10 Note: Store at 15° - 25°C (59° - 77°F) and protect from light. Rx only Revised August 2004 © 2004 PACIFIC PHARMA Irvine, CA 92612 U.S.A. Printed in U.S.A. 71756PY10P Repacked by: H.J. Harkins Company, Inc. 513 Sandydale Drive Nipomo, CA 93444 Logo
Indications & 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.