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Bacitracin Ophthalmic Ointment

TABLE OF CONTENTS

1. DESCRIPTION 7. WARNINGS AND PRECAUTIONS
2. INDICATIONS AND USAGE 8. ADVERSE REACTIONS
3. DOSAGE AND ADMINISTRATION 9. OVERDOSAGE
4. CONTRAINDICATIONS 10. DRUG INTERACTIONS
5. MECHANISM OF ACTION 11. PHARMACOKINETICS
6. USE IN SPECIFIC POPULATIONS 12. HOW SUPPLIED/STORAGE AND HANDLING

 

1. DESCRIPTION

Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.

2. INDICATIONS AND USAGE

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.

3. DOSAGE AND ADMINISTRATION

The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.

4. CONTRAINDICATIONS

This product should not be used in patients with a history of hypersensitivity to bacitracin.

5. MECHANISM OF ACTION

The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.

6. USE IN SPECIFIC POPULATIONS

No information is available.

7. WARNINGS AND PRECAUTIONS

PRECAUTIONS

Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.

8. ADVERSE REACTIONS

Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.

9. OVERDOSAGE

No information is available.

10. DRUG INTERACTIONS

No information is available.

11. PHARMACOKINETICS

No information is available.

12. HOW SUPPLIED/STORAGE AND HANDLING

1) How Available:

a) Brand name: None.

b) Generic drugs: BACITRACIN, by various manufacturers.

2) How Supplied:

3.5 g (1/8 Oz) sterile tamper proof tubes (by E. FOUGERA), NDC 0168-0026-38.

3) Storage:

Store at room temperature.

Rx only

Rev 10/07