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TERRAMYCIN Label and TERRAMYCIN General Information

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terramycin (Oxytetracycline Hydrochloride and Polymyxin B Sulfate)  ointment 
[Roerig]

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Terramycin® and other antibacterial drugs, Terramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

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.

ACTIONS

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.

INDICATIONS

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, Hemophilus influenzae, Pseudomonas aeruginosa, Koch-Weeks bacillus, and Proteus.

To reduce the development of drug-resistant bacteria and maintain effectiveness of Terramycin and other antibacterial drugs, Terramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CONTRAINDICATIONS

This drug is contraindicated in individuals who have shown hypersensitivity to any of its components.

PRECAUTIONS

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.

Prescribing Terramycin in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information For Patients

Patients should be counseled that antibacterial drugs including Terramycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Terramycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Terramycin or other antibacterial drugs in the future.

ADVERSE REACTIONS

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.

DOSAGE AND ADMINISTRATION

Approximately ½ 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.

HOW SUPPLIED

Terramycin with Polymyxin B Sulfate Ophthalmic Ointment is supplied in 1/8 oz (3.5 g) tubes (NDC 0049-0801-08).

Rx only

LAB-0193-3.0

Terramycin (Oxytetracycline Hydrochloride and Polymyxin B Sulfate)

PRODUCT INFO Product Code 0049-0801 Dosage Form OINTMENT Route Of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Oxytetracycline Hydrochloride (Oxytetracycline) Active 5 MILLIGRAM  In 1 GRAM Polymyxin B Sulfate (Polymyxin) Active 10000 UNITS  In 1 GRAM white petrolatum Inactive   liquid petrolatum Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 0049-0801-08 3.5 GRAM In 1 TUBE None

Revised: 04/2006