Each gram of sterile ointment contains oxytetracycline HCl equivalent to 5 mg oxytetracycline, 10,000 units of polymyxin B sulfate, white petrolatum, and liquid petrolatum.
Terramycin is a widely used antibiotic with clinically proved activity against gram-positive and gram-negative bacteria, rickettsiae, spirochetes, large viruses, and certain protozoa.
Polymyxin B Sulfate, one of a group of related antibiotics derived from Bacillus polymyxa, is rapidly bactericidal. This action is exclusively against gram-negative organisms. It is particularly effective against Pseudomonas aeruginosa (B. pyocyaneus) and Koch-Weeks bacillus, frequently found in local infections of the eye.
There is thus made available a particularly effective antimicrobial combination of the broad-spectrum antibiotic Terramycin as well as polymyxin B sulfate against primarily causative or secondarily infecting organisms.
The sterile preparation, Terramycin with Polymyxin B Sulfate Ophthalmic Ointment, is indicated for the treatment of superficial ocular infections involving the conjunctiva and/ or cornea caused by Terramycin with Polymyxin B Sulfate-susceptible organisms.
It may be administered topically alone, or as an adjunct to systemic therapy.
It is effective in infections caused by susceptible strains of staphylococci, streptococci, pneumococci, Haemophilus influenzae, Pseudomonas aeruginosa, Koch-Weeks bacillus, and Proteus.
This drug is contraindicated in individuals who have shown hypersensitivity to any of its components.
As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate specific therapy should be instituted.
Terramycin with Polymyxin B Sulfate Ophthalmic Ointment is well tolerated by the epithelial membranes and other tissues of the eye. Allergic or inflammatory reactions due to individual hypersensitivity are rare.
Approximately 1 / 2 inch of the ointment is squeezed from the tube onto the lower lid of the affected eye two to four times daily.
The patient should be instructed to avoid contamination of the tip of the tube when applying the ointment.
Terramycin with Polymyxin B Sulfate Ophthalmic Ointment is supplied in 1 / 8 oz (3.5 g) tubes (NDC 0049-0801-08).
August 1987 60-2324-00-1