DURAMYCIN 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:

Durvet, Inc.

INN (International Name):

oxytetracycline hydrochloride

Composition:

oxytetracycline anhydrous 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

OTC

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 Duramycin-100 solution can be determined in advance.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

DURAMYCIN 100- OXYTETRACYCLINE HYDROCHLORIDE INJECTION, SOLUTION
DURVET, INC.
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DURAMYCIN-100
OXYTETRACYCLINE HYDROCHLORIDE INJECTION
ANADA 200-452, APPROVED BY FDA
ANTIBIOTIC
Each mL contains:
100 MG OXYTETRACYCLINE HCL
For use in Beef Cattle, Beef Calves, Non-lactating Dairy Cattle and
Dairy Calves Only
DESCRIPTION
Duramycin-100 [oxytetracycline hydrochloride] 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 Duramycin-100 at least 22 days prior to
slaughter of the animal. Not for use
in lactating dairy animals.
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 animal collapse.
Oxytetracycline should be administered
intravenously slowly over a period of at least 5 minutes.
If no improvement occurs within 24 to 48 hours, consult a
veterinarian. Do not use the drug for more
than 4 consecutive days. Use beyond 4 days or doses higher than
maximum recommended dose may
result in antibiotic tissue residues beyond the withdrawal period.
PRECAUTIONS
The improper or accidental injection of the drug outside of the vein
wi