RxNorm Names
bacitracin zinc and polymyxin b sulfate (Bacitracin Zinc and Polymyxin B Sulfate) ointment
[Bausch & Lomb Incorporated]
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 licheniformis 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:
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:
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 conjunctiva 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
General
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, 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 size:
3.5 gram tube - Prod. No. 07534
DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.
STERILE OPHTHALMIC OINTMENT
Rx only
Storage Conditions
Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED.
KEEP OUT OF REACH OF CHILDREN.
Manufacturing Information
Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated
X051026 (Folded)
XM10096 (Flat)
R.12/03-02
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Revised: 04/2008Bausch & Lomb Incorporated