FDA Label for Ak-poly-bac
View Indications, Usage & Precautions
Ak-poly-bac Product Label
The following document was submitted to the FDA by the labeler of this product Direct Rx. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description Section
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: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.
Clinical Pharmacology Section
Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species.
Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.
Indications & Usage Section
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 Section
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Warnings Section
Ophthalmic ointments may retard corneal healing.
Precautions Section
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 & Administration Section
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
How Supplied Section
Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.
NDC 17478-238-35
STORAGE:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Akorn
Manufactured By: Akorn, Inc.
Lake Forest, IL 60045
AKP00N
Rev. 11/08
Principal Display Panel Text for Container Label:
NDC 17478-238-35 Akorn
AK-POLY-BAC™
brand of Bacitracin Zinc and Polymyxin B Sulfate
Ophthalmic Ointment USP
For Ophthalmic Use Only. Sterile
Rx only Net Wt. 3.5 g (1/8oz.)
Package Label.Principal Display Panel
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