Terramycin

Zoetis Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• INDICATIONS
• ADMINISTRATION
• PRECAUTIONS
• RECOMMENDED STORAGE
• PRINCIPAL DISPLAY PANEL - 3.5 g Tube Label

FULL PRESCRIBING INFORMATION

Antibiotic
Ophthalmic Ointment
with Polymyxin B Sulfate

Terramycin (oxytetracycline HCl) is an antibiotic, bright yellow in color, possessing potent antimicrobial activity. It is one of the most versatile of the broad-spectrum antibiotics, and is effective in the treatment of infections due to gram-positive and gram-negative bacteria, both aerobic and anaerobic, spirochetes, rickettsiae, and certain of the larger viruses.

Polymyxin B sulfate is one of a group of related antibiotics derived from Bacillus polymyxa. The polymyxins are rapidly bactericidal, this action being exclusively against gram-negative bacteria.

The broad-spectrum effectiveness of Terramycin against both gram-positive and gram-negative organisms is enhanced by the particular effectiveness of polymyxin B against infections associated with gram-negative organisms, especially those due to Pseudomonas aeruginosa, where polymyxin B is the antibiotic of choice. In addition, there is evidence to indicate that polymyxin B sulfate possesses some antifungal activity. The combined antibacterial effect of Terramycin plus polymyxin is at least additive and, in many instances, an actual synergistic action is obtained.

Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is a suspension of oxytetracycline hydrochloride and polymyxin B sulfate in a special petrolatum base. Each gram of ointment contains oxytetracycline HCl equivalent to 5 mg of oxytetracycline and 10,000 units of polymyxin B as the sulfate.

INDICATIONS

Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species.

ADMINISTRATION

Terramycin Ophthalmic Ointment with Polymyxin B Sulfate should be administered topically to the eye 2–4 times daily.

PRECAUTIONS

Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe.

Note: The use of oxytetracycline and other antibiotics may result in an overgrowth of resistant organisms such as Monilia, staphylococci, and other species of bacteria. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.

RECOMMENDED STORAGE

Store below 25°C (77°F).

For Animal Use Only

Restricted Drug (California)— Use Only As Directed

Not for Human Use

NADA #8-763, Approved by FDA

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Made in Switzerland

Revised: June 2013

PRINCIPAL DISPLAY PANEL - 3.5 g Tube Label

Terramycin ^®
(oxytetracycline hydrochloride)

Antibiotic Ophthalmic Ointment with Polymyxin B Sulfate

For animal use only

1/8-oz (3.5-g) tube
NADA #8-763, Approved by FDA

zoetis