Drug Catalog - Product Detail
TRIMETHOPRIM SULF/POLYMYXIN B SULF OPHTH SOL 1MG/10M/ML 10ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 17478-0703-11 | AKORN | 10 | 10000-0.1UNIT/ML-% | SOLUTION |
PACKAGE FILES
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate (2:1), occurs as a white, odorless, crystalline powder with a molecular weight of 678.72. The structural formula is as follows: Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 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 as follows: Each mL contains: Actives: Trimethoprim Sulfate equivalent to Trimethoprim 1 mg (0.1%) and Polymyxin B Sulfate 10,000 units. Preservative: Benzalkonium Chloride 0.04 mg (0.004%). Inactives: Sodium Chloride, Sulfuric Acid and Sodium Hydroxide may be added to adjust pH (3.0 to 5.5), and Water for Injection. Structural Formula Structural Formula
How Supplied
HOW SUPPLIED Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is supplied as a sterile solution in plastic dropper bottles in the following size: 10 mL in a 10 mL bottle NDC 17478-703-11 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. WARNING – KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Akorn Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 ATP00N Rev. 03/22
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 influenza and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Dosage and Administration
DOSAGE AND ADMINISTRATION Adults: 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. Pediatric Use: Clinical studies have shown Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution to be safe and effective for use in pediatric patients over two months of age. The dosage regimen is the same as for adults.