OXYTET 100- oxytetracycline hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

oxytetracycline hydrochloride (UNII: 4U7K4N52ZM) (oxytetracycline anhydrous - UNII:SLF0D9077S)

Available from:

Norbrook Laboratories Limited

INN (International Name):

oxytetracycline hydrochloride

Composition:

oxytetracycline hydrochloride 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

A great many of the pathogens involved in cattle diseases are known to be susceptible to oxytetracycline hydrochloride therapy. Many strains of organisms, however, have shown resistance to oxytetracycline. In the case of certain coliforms, streptococci and staphylococci, it may be advisable to conduct culture and sensitivity testing to determine susceptibility of the infecting organism to oxytetracycline. In this manner, the likelihood of successful treatment with Oxytet 100 solution can be determined in advance.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

OXYTET 100- OXYTETRACYCLINE HYDROCHLORIDE INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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OXYTET 100
(OXYTETRACYCLINE INJECTION)
ANTIBIOTIC
EACH ML CONTAINS 100 MG
OXYTETRACYCLINE HCL
For use in Beef Cattle, Beef Calves, Non-lactating Dairy Cattle and
Dairy Calves Only
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A
LICENSED VETERINARIAN.
Each mL Contains: 100 mg oxytetracycline HCl,5.75% w/v magnesium
chloride • 6 H2O,
17% v/v water for injection, 1.3% w/v sodium formaldehyde Sulfoxylate
as a
preservative and q.s. with propylene glycol. pH adjusted with
monoethanolamine.
DESCRIPTION
Oxytet 100 (oxytetracycline injection) is a sterile ready-to-use
preparation containing
100 mg/mL oxytetracycline HCl, for administration of the broad
spectrum antibiotic,
oxytetracycline, by injection.
ANTIBIOTIC ACTION OF OXYTETRACYCLINE
Oxytetracycline is effective against a wide range of gram-negative and
gram-positive
organisms that are pathogenic for cattle. The antibiotic is primarily
bacteriostatic in
effect, and is believed to exert its antimicrobial action by the
inhibition of microbial
protein synthesis. The antibiotic activity of oxytetracycline is not
appreciably diminished
in the presence of body fluids, serum or exudates. Since the drugs in
the tetracycline
class have similar antimicrobial spectra, organisms can develop cross
resistance among
them. Oxytetracycline is concentrated by the liver in the bile and
excreted in the urine
and feces at high concentrations and in a biologically active form.
WARNING
Discontinue treatment with Oxytet 100 at least 22 days prior to
slaughter of the animal.
This drug product is not approved for use in female dairy cattle 20
months of age or
older, including dry dairy cows. Use in these cattle may cause drug
residues in milk
and/or in calves born to these cows. A withdrawal period has not been
established for
this product in pre-ruminating calves. Do not use in calves to be
processed for veal.
CAUTION
Rapid intravenous administration may result in