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Urobiotic
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  • FDA PI

Urobiotic

Generic name: oxytetracycline hydrochloride, sulfamethizole and phenazopyridine hydrochloride
Dosage form: Capsules
Drug class:Urinary anti-infectives

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Each capsule contains

Oxytetracycline hydrochloride equivalent to. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 mg
oxytetracycline

Sulfamethizole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 mg

Phenazopyridine hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mg

Inert ingredients in the formulation are: hard gelatin capsules (which may contain Green 3, Yellow 6, Yellow 10 and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch.

ACTIONS

Urobiotic-250 is a product designed for use specifically in urinary tract infections.

Terramycin® (oxytetracycline HCl) is a widely used antibiotic with clinically proved activity against gram-positive and gram-negative bacteria, rickettsiae, spirochetes, large viruses, and certain protozoa. Terramycin is well tolerated and well absorbed after oral administration. It diffuses readily through the placenta and is present in the fetal circulation. It diffuses into the pleural fluid, and under some circumstances, into the cerebrospinal fluid. Oxytetracycline HCl appears to be concentrated in the hepatic system and is excreted in the bile. It is excreted in the urine and in the feces, in high concentrations, in a biologically active form.

Sulfamethizole is a chemotherapeutic agent active against a number of important gram-positive and gram-negative bacteria. This sulfonamide is well absorbed, has a low degree of acetylation, and is extremely soluble. Because of these features and its rapid renal excretion, sulfamethizole has a low order of toxicity and provides prompt and high concentrations of the active drug in the urinary tract.

Phenazopyridine is an orally absorbed agent which produces prompt and effective local analgesia and relief of urinary symptoms by virtue of its rapid excretion in the urinary tract. These effects are confined to the genitourinary system and are not accompanied by generalized sedation or narcosis.

INDICATIONS

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 inc..