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POLYTRIM®
(polymyxin B sulfate and trimethoprim ophthalmic solution, USP)

Sterile

DESCRIPTION

POLYTRIM® (polymyxin B sulfate and trimethoprim ophthalmic solution, USP) 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, 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 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 formulae are:

CLINICAL PHARMACOLOGY

Trimethoprim is a synthetic antibacterial drug active against a wide variety of aerobic gram-positive and gram-negative ophthalmic pathogens. Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the enzyme dihydrofolate reductase. This binding is stronger for the bacterial enzyme than for the corresponding mammalian enzyme and therefore selectively interferes with bacterial biosynthesis of nucleic acids and proteins.

Polymyxin B, a cyclic lipopeptide antibiotic, is bactericidal for a variety of gram-negative organisms, especially Pseudomonas aeruginosa. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Blood samples were obtained from 11 human volunteers at 20 minutes, 1 hour and 3 hours following instillation in the eye of 2 drops of ophthalmic solution containing 1 mg trimethoprim and 10,000 units polymyxin B per mL. Peak serum concentrations were approximately 0.03μg/mL trimethoprim and 1 unit/mL polymyxin B.

INDICATIONS AND USAGE

POLYTRIM® 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.

CONTRAINDICATIONS

POLYTRIM® Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to POLYTRIM® occurs, discontinue use. POLYTRIM® Ophthalmic Solution is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.

PRECAUTIONS

General:

As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Information for Patients:

Avoid contaminating the applicator tip with material from the eye, fingers, or other source. This precaution is necessary if the sterility of the drops is to be maintained.

If redness, irritation, swelling or pain persists or increases, discontinue use immediately and contact your physician. Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular bacterial infections.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy:

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 POLYTRIM® Ophthalmic Solution is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children below the age of 2 months have not been established (see WARNINGS).

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

ADVERSE REACTIONS

The most frequent adverse reaction to POLYTRIM® 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.

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.

HOW SUPPLIED

POLYTRIM® (polymyxin B sulfate and trimethoprim ophthalmic solution, USP) is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with white high impact polystyrene (HIPS) caps as follows:

10 mL in 10 mL bottle - NDC 0023-7824-10

Note: Store at 15˚ - 25˚ C (59˚ - 77˚ F) and protect from light.

Rx only

Revised August 2004

© 2004 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® Marks owned by Allergan, Inc.

8317X
71756US10P

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