TERRAMYCIN- oxytetracycline hydrochloride and polymyxin b sulfate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)

Available from:

Zoetis Inc.

INN (International Name):

OXYTETRACYCLINE HYDROCHLORIDE

Composition:

OXYTETRACYCLINE HYDROCHLORIDE 5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC

Therapeutic indications:

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.

Product summary:

1/8-oz (3.5-g) tube

Authorization status:

New Animal Drug Application

Summary of Product characteristics

TERRAMYCIN- OXYTETRACYCLINE HYDROCHLORIDE AND POLYMYXIN B
SULFATE OINTMENT
ZOETIS INC.
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TERRAMYCIN®
(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;
ocula