BACITRACIN ZINC AND POLYMYXIN B SULFATE description, usages, side effects, indications, overdosage, supplying and lots more!

BACITRACIN ZINC AND POLYMYXIN B SULFATE

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BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment [Akorn, Inc.]

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx only

DESCRIPTION

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is a sterile antimicrobial ointment 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:


DESCRIPTION

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:


DESCRIPTION

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

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 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

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.

HOW SUPPLIED

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].

Manufactured By: Akorn, Inc.
Lake Forest, IL 60045

AKP00N
Rev. 11/08


PACKAGE LABEL - AK - POLY-BAC OPHTHALMIC OINTMENT 3.5 GRAMS


PACKAGE LABEL - AK - POLY-BAC OPHTHALMIC OINTMENT  3.5 GRAMS



BACITRACIN ZINC AND POLYMYXIN B SULFATE

BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16590-989(NDC:17478-238)
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BACITRACIN ZINC BACITRACIN 500 [USP'U]
Polymyxin B Sulfate POLYMYXIN B 10000 [USP'U]

Inactive Ingredients

Ingredient Name Strength
petrolatum
Mineral Oil

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 3.5 in 1 TUBE
2 NDC:16590-989-35 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064028 1995-01-30


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