AK-Poly-Bac

Name: AK-Poly-Bac

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What do I need to tell my doctor BEFORE I take AK-Poly-Bac?

  • If you have an allergy to bacitracin, polymyxin B, or any other part of AK-Poly-Bac (bacitracin and polymyxin B (ophthalmic)).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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:

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

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.

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.)

Principal Display Panel Text for Carton Label:

NDC 17478-238-35

AK-POLY-BAC™

brand of Bacitracin Zinc and Polymyxin B Sulfate

Ophthalmic Ointment, USP

Net Wt. 3.5 g (1/8oz.) Sterile Rx only Akorn Logo

AK-POLY-BAC 
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-238
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bacitracin Zinc (Bacitracin) Bacitracin 500 [USP'U]  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B 10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient Name Strength
Mineral Oil  
Petrolatum  
Packaging
# Item Code Package Description
1 NDC:17478-238-35 1 TUBE (1 TUBE) in 1 CARTON
1 3.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064028 05/08/2006
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Operations
Akorn, Inc 603980319 MANUFACTURE(17478-238), ANALYSIS(17478-238), STERILIZE(17478-238), PACK(17478-238), LABEL(17478-238)
Revised: 07/2012   Akorn, Inc.
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