Drug Catalog - Product Detail
TRIMETHOPRIM SULF/POLYMYXIN B SULF OPHTH SOL SOL 1MG/10M/ML 10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 24208-0315-10 | BAUSCH HEALTH US | 10 | 10000-0.1UNIT/ML-% | SOLUTION |
PACKAGE FILES
Generic Name
POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
Substance Name
POLYMYXIN B SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA064120
Description
DESCRIPTION Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 5.5 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate, 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: Each mL contains: Actives: polymyxin B sulfate equal to 10,000 polymyxin B units, trimethoprim sulfate (equivalent to trimethoprim 1 mg); Inactives: purified water, sodium chloride. Sulfuric acid and, if necessary, sodium hydroxide may be added to adjust pH (4.0 – 5.5). Preservative: benzalkonium chloride 0.004%. Chem structure chemical structure 2
How Supplied
HOW SUPPLIED Polymyxin B sulfate and trimethoprim ophthalmic solution, USP* is supplied in a plastic bottle with a controlled drop tip in the following size: NDC 85766-141-10 10 mL (relabeled from NDC 24208-315-10) Storage: Store at 15°C to 25°C (59°F to 77°F). PROTECT FROM LIGHT. *Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE. Distributed by: Sportpharm LLC 379 Van Ness Ave 1401, Torrance, CA 90501 Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501 do not use
Indications & Usage
INDICATIONS AND USAGE Polymyxin B sulfate and trimethoprim 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 influenzae and Pseudomonas aeruginosa. 1 1 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 3 hours (maximum of 6 doses per day) for a period of 7 to 10 days.