Urobiotic

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.

Glossitis, stomatitis, proctitis, nausea, diarrhea, vaginitis, and dermatitis, as well as reactions of an allergic nature, may occur during oxytetracycline HCl therapy, but are rare. If adverse reactions, individual idiosyncrasy, or allergy occur, discontinue medication. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule forms of drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See Dosage and Administration.)

With oxytetracycline therapy bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving full therapeutic dosages. These conditions disappeared rapidly when the drug was discontinued.

As in all sulfonamide therapy, the following reactions may occur: nausea, vomiting, diarrhea, hepatitis, pancreatitis, blood dyscrasias, neuropathy, drug fever, skin rash, injection of the conjunctiva and sclera, petechiae, purpura, hematuria and crystalluria. The dosage should be decreased or the drug withdrawn, depending upon the severity of the reaction.

Urobiotic-250 is recommended in adults only. A dose of 1 capsule four times daily is suggested. In refractory cases 2 capsules four times a day may be used.

Therapy should be continued for a minimum of seven days or until bacteriologic cure in acute urinary tract infections.

Administration of adequate amounts of fluid along with capsule forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (SeeAdverse Reactions.)

To aid absorption of the drug, it should be given at least one hour before or two hours after eating. Aluminum hydroxide gel given with antibiotics has been shown to decrease their absorption and is contraindicated.

Urobiotic-250 capsules: bottles of 50 (NDC 0049-0920-50), and unit dose packages of 100 (10 × 10's) (NDC 0049-0920-41).

Rx only

70-1636-00-9
December 1986