This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Bacitracin

Read time: 1 mins
Marketing start date: 12 Jan 2025
...
 

Summary of product characteristics


Indications And Usage

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

Adverse Reactions

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. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications

CONTRAINDICATIONS: This product should not be used in patients with a history of hypersensitivity to Bacitracin.

Description

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

Dosage And Administration

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.

Clinical Pharmacology

CLINICAL PHARMACOLOGY: 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.

Effective Time

20241031

Version

6

Spl Product Data Elements

Bacitracin Bacitracin BACITRACIN BACITRACIN PETROLATUM MINERAL OIL

Application Number

ANDA061212

Brand Name

Bacitracin

Generic Name

Bacitracin

Product Ndc

0574-4022

Product Type

HUMAN PRESCRIPTION DRUG

Route

OPHTHALMIC

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Carton NDC 0574-4022-35 Rx Only Bacitracin Ophthalmic Ointment USP NET WT 3.5 g (1/8 oz) STERILE The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. Bacitracin Ophthalmic Ointment carton serialization-template

Spl Unclassified Section

STERILE Rx Only

How Supplied

HOW SUPPLIED: NDC 0574- 4022 -35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for Padagis ® by Jubilant HollisterStier General Partnership Kirkland, Quebec H9H 4J4 Canada 35F00 RC PH2 Rev 02-23

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.

Drug section

CME banner

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.

Click here to view

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.