TERRAMYCIN- oxytetracycline hydrochloride and polymyxin b sulfate ointment

Terramycin by

Drug Labeling and Warnings

Terramycin by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

(Oxytetracycline Hydrochloride and

Polymyxin B Sulfate Ophthalmic Ointment)

Antibiotic

Ophthalmic Ointment

DESCRIPTION

Terramycin (Oxytetracycline Hydrochloride and
Polymyxin B Sulfate Ophthalmic Ointment) 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 is an ointment 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 AND USAGE

Terramycin 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.

WARNING

Serious, life threatening, hypersensitivity
(anaphylactic) reactions have been reported in some cats
following application of antibiotic ophthalmic preparations.
If your cat has swelling of the face, itching, appears weak,
vomits, or has difficulty breathing within 4 hours of application
you should discontinue treatment and contact your veterinarian
immediately.

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.

DOSAGE AND ADMINISTRATION

Terramycin (Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment)

should be administered topically to the eye 2–4 times daily.

RECOMMENDED STORAGE

Store at controlled room temperature between 20° to 25°C (68° to 77°F), with excursions

between 15° to 30°C (59° to 86°F).

HOW SUPPLIED

1/8-oz (3.5-g) tube

SPL UNCLASSIFIED SECTION

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 2017

23288602

PRINCIPAL DISPLAY PANEL - 3.5 g Tube Label

Terramycin®

(Oxytetracycline Hydrochloride and

Polymyxin B Sulfate Ophthalmic Ointment)

Antibiotic Ophthalmic Ointment

For animal use only

1/8-oz (3.5-g) tube

NADA #8-763, Approved by FDA

zoetis

25317402

INGREDIENTS AND APPEARANCE

TERRAMYCIN 
oxytetracycline hydrochloride and polymyxin b sulfate ointment

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-1096
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S)	OXYTETRACYCLINE HYDROCHLORIDE	5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-1096-1	3.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA008763	01/02/1953

Labeler - Zoetis Inc. (828851555)