Bacitracin - Bacitracin ointment prescribing information
INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
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.
CONTRAINDICATIONS:
This product should not be used in patients with a history of hypersensitivity to Bacitracin.
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.
DESCRIPTION:
Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.
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.
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
