Polymyxin B Sulfate And Trimethoprim

Description

DESCRIPTION Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. 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 formula are: Contains : Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to trimethoprim 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: sodium chloride; sulfuric acid; and purified water. May also contain sodium hydroxide for pH adjustment. trimethoprim-chemical polymyxin

What Is Polymyxin B Sulfate And Trimethoprim Used For?

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. * *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.

Side Effects (Adverse Reactions)

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. Stevens- Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) and anaphylaxis have been reported. Photosensitivity has been reported in patients taking oral trimethoprim. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications

CONTRAINDICATIONS Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

Pregnancy and Breastfeeding

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with polymyxin B sulfate. It is not known whether polymyxin B sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Trimethoprim has been shown to be teratogenic in the rat when given in oral doses 40 times the human dose. In some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with oral doses 6 times the human therapeutic dose. While there are no large well-controlled studies on the use of trimethoprim in pregnant women, Brumfitt and Pursell, in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or oral trimethoprim in combination with sulfamethoxazole. The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving trimethoprim and sulfamethoxazole. There were no abnormalities in the 10 children whose mothers received the drug during the first trimester. In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received oral trimethoprim and sulfamethoxazole at the time of conception or shortly thereafter. Because trimethoprim may interfere with folic acid metabolism, trimethoprim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects The oral administration of trimethoprim to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is administered to a nursing woman.

How Supplied

HOW SUPPLIED Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is a sterile solution. Each mL contains trimethoprim sulfate equivalent to 1 mg trimethoprim and polymyxin B sulfate 10,000 units in NDC: 70518-1735-00 PACKAGING: 10 mL in 1 BOTTLE PLASTIC TYPE 0 Storage: Store at 15° to 25°C (59° to 77°F) and protect from light. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762