Oxytetracycline hydrochloride indications and usage

Oxytetracycline hydrochloride
UROBIOTIC® FDA Package Insert
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Dosage and Administration
How Supplied

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]

Indications and Usage

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows:

"Lacking substantial evidence of effectiveness as a fixed combination":

Urobiotic-250 is indicated in the therapy of a number of genitourinary infections caused by susceptible organisms. These infections include the following: pyelonephritis, pyelitis, ureteritis, cystitis, prostatitis, and urethritis.

Since both Terramycin and sulfamethizole provide effective levels in blood, tissue, and urine, Urobiotic-250 provides a multiple antimicrobial approach at the site of infection. Both antibacterial components are active against the most common urinary pathogens, including Escherichia coli, Pseudomonas aeruginosa, Aerobacter aerogenes, Streptococcus faecalis, Streptococcus hemolyticus, and Micrococcus pyogenes. Urobiotic-250 is particularly useful in the treatment of infections caused by bacteria more sensitive to the combination than to either component alone. The combination is also of value in those cases with mixed infections, and in those instances where the causative organism is unknown pending laboratory isolation.

Final classification of the less than effective indications requires further investigation. Clinical studies to substantiate the efficacy of Urobiotic 250 are ongoing. Completion of these ongoing studies will provide data for final classification of these indications.

References

Adapted from the FDA Package Insert.