Label: TERRAMYCIN- oxytetracycline hydrochloride and polymyxin b sulfate ointment
- NDC Code(s): 54771-1096-1
- Packager: Zoetis Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated October 17, 2024
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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 Pseudomonasaeruginosa, 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.
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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
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INGREDIENTS AND APPEARANCE
TERRAMYCIN
oxytetracycline hydrochloride and polymyxin b sulfate ointmentProduct Information Product Type PRESCRIPTION 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)