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.
If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity.
Under such conditions, lower than usual doses are indicated and if therapy is prolonged, tetracycline serum level determinations may be advisable.
Oxytetracycline HCl, which is one of the ingredients of Urobiotic-250, may form a stable calcium complex in any bone-forming tissue with no serious harmful effects reported thus far in humans.
However, use of oxytetracycline during tooth development (last trimester of pregnancy, neonatal period and early childhood) may cause discoloration of the teeth (yellow-grey-brownish).
This effect occurs mostly during long term use of the drug but it also has been observed in usual short treatment courses.
Because of its sulfonamide content, this drug should be used only after critical appraisal in patients with liver damage, renal damage, urinary obstruction, or blood dyscrasias.
Deaths have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood dyscrasias associated with sulfonamide administration.
When used intermittently, or for a prolonged period, blood counts and liver and kidney function tests should be performed.
Certain hypersensitive individuals may develop a photodynamic reaction precipitated by exposure to direct sunlight during the use of this drug.
This reaction is usually of the photoallergic type which may also be produced by other tetracycline derivatives.
Individuals with a history of photosensitivity reactions should be instructed to avoid exposure to direct sunlight while under treatment with this or other tetracycline drugs, and treatment should be discontinued at first evidence of skin discomfort.NOTE: Reactions of a photoallergic nature are exceedingly rare with Terramycin (oxytetracycline HCl).Phototoxic reactions are not believed to occur with Terramycin.