Drug Facts
Composition & Profile
Identifiers & Packaging
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 in the following size: 10 mL - NDC 63187-631-10 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Storage: Store at 15°-25°C (59°-77°F). PROTECT FROM LIGHT. *Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE. Revised: November 2012 Bausch & Lomb Incorporated Tampa, Florida 33637 ©Bausch & Lomb Incorporated 9117801 (Folded) 9117901 (Flat) Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320; Principal Display Panel NDC 63187-631-10 Polymyxin B Sulfate and Trimethoprim Ophthmalic Solution USP (Sterile) [icon-eye] [icon dropper] [icon 10 mL] 10 ml Rx only 63187-631-10
- 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 in the following size: 10 mL - NDC 63187-631-10 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Storage: Store at 15°-25°C (59°-77°F). PROTECT FROM LIGHT. *Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE. Revised: November 2012 Bausch & Lomb Incorporated Tampa, Florida 33637 ©Bausch & Lomb Incorporated 9117801 (Folded) 9117901 (Flat) Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320
- Principal Display Panel NDC 63187-631-10 Polymyxin B Sulfate and Trimethoprim Ophthmalic Solution USP (Sterile) [icon-eye] [icon dropper] [icon 10 mL] 10 ml Rx only 63187-631-10
Overview
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution USP* is a sterile antimicrobial solution for topical ophthalmic use. It has a pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Trimethoprim sulfate, a white, odorless, crystalline powder, is represented by the following structural formula: C 28 H 38 N 8 O 10 S Mol. Wt. 678.72 Chemical Name: Trimethoprim sulfate, 2,4-diamino-5-(3,4 5-trimethoxybenzyl)pyrimidine sulfate (2:1) 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 – 6.2). PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%. Trimethoprim sulfate (Structural formula) Polymyxin B Sulfate, the sulfate salt of polymyxin Bl and B2 (Structural formula)
Indications & 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 Pseudomonasaeruginosa .** **Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Dosage & 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.
Warnings & Precautions
WARNINGS NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to polymyxin B sulfate and trimethoprim ophthalmic solution occurs, discontinue use. Polymyxin B sulfate and trimethoprim ophthalmic solution is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.
Contraindications
Polymyxin B sulfate and trimethoprim ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions
The most frequent adverse reaction to polymyxin B sulfate and trimethoprim ophthalmic solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Photosensitivity has been reported in patients taking oral trimethoprim.
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