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 | 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: C 28 H 38 N 8 O 10 S Mol. Wt. 678.72 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 formula is: 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% Trimethoprim sulfate (Structural formula) Polymyxin B Sulfate, the sulfate salt of polymyxin B1 and B2 (Structural formula)
How Supplied
HOW SUPPLIED Polymyxin B sulfate and trimethoprim ophthalmic solution, USP* containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip and a natural cap in the following size: NDC 24208-315-10 10 mL DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. 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: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: June 2023 9117804 (Folded) 9117904 (Flat)
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.