POLYSPORIN
(Monarch)
OPHTHALMIC OINTMENT STERILE
(Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP)
STERILE OPHTHALMIC OINTMENT

Description

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP is a sterile antimicrobial ointment formulated for ophthalmic use.

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the llchenlformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula for bacitracin A is:

images/05/56538001.jpg

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 formulae are:

images/05/56538002.jpg

Each Gram Contains:   ACTIVES: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; INACTIVES: White Petrolatum and Mineral Oil.

Clinical Pharmacology

Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and Haemophilus influenzae species.

Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

Indications and Usage

For the treatment of superficial ocular infections involving the conjunctive and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

Contraindications

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Warnings

Ophthalmic ointments may retard corneal healing.

Precautions:   As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible orgamisms, including fungi. Appropriate measures should be taken if this occurs.

Dosage and Administration

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

FOR OPHTHALMIC USE ONLY.

How Supplied

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP is available in tubes with an ophthalmic tip applicator in the following sizes:

3.5 gram tube--NDC# 61570-049-35

DO NOT USE IF BOTTOM RIDGE OF CAP IS EXPOSED.

Storage:

Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED.

KEEP OUT OF REACH OF CHILDREN.

Rx only

Mfg. for. Monarch Pharmaceuticals, Inc., Bristol, TN 37620

XO51008   R.5/99-9E

By: Bausch & Lomb Pharmaceuticals, Inc, Tampa, FL 33637

GTD7534

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