- Home
- /
- Drugs
- /
- B
- /
- Bacitracin Zinc and Polymyxin B Sulfate
- /
- Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC 500 [USP'U]/g A-S Medication Solutions
Bacitracin Zinc and Polymyxin B Sulfate
- Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC 500 [USP'U]/g NuCare Pharmaceuticals,Inc.
- Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC 500 [USP'U]/g Preferred Pharmaceuticals Inc.
- Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC 500 [USP'U]/g Bausch & Lomb Incorporated
- Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC 500 [USP'U]/g NuCare Pharmaceuticals,Inc.
- Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC 500 [USP'U]/g A-S Medication Solutions
- Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC 500 [USP'U]/g A-S Medication Solutions
- Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC 500 [USP'U]/g RPK Pharmaceuticals, Inc.
- Polycin BACITRACIN ZINC 500 [USP'U]/g Padagis US LLC
- Polycin BACITRACIN ZINC 500 [USP'U]/g RPK Pharmaceuticals, Inc.
Summary of product characteristics
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Contraindications
CONTRAINDICATIONS This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Description
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/mg. The structural formula for bacitracin A is: 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/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: mineral oil and white petrolatum. bacitracinchemstructure polychemstructure
Dosage And Administration
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
Indications And Usage
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.
Warnings
WARNINGS Ophthalmic ointments may retard corneal healing.
Clinical Pharmacology
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.
Effective Time
20230724
Version
14
Spl Product Data Elements
Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM MINERAL OIL
Application Number
ANDA064046
Brand Name
Bacitracin Zinc and Polymyxin B Sulfate
Generic Name
Bacitracin Zinc and Polymyxin B Sulfate
Product Ndc
50090-3274
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Package Label Principal Display Panel
Bacitracin Zinc and Polymyxin B Sulfate Label Image
Spl Unclassified Section
PRECAUTIONS As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.
How Supplied
HOW SUPPLIED Product: 50090-3274 NDC: 50090-3274-0 3.5 g in a TUBE / 1 in a CARTON
Storage And Handling
Storage Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED. Keep out of reach of children Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
Disclaimer
The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).
Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.
Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.