"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
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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 (oxytetracycline, sulfamethizole and phenazopyridine) -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 (oxytetracycline, sulfamethizole and phenazopyridine) -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 (oxytetracycline, sulfamethizole and phenazopyridine) -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 (oxytetracycline, sulfamethizole and phenazopyridine) -250 are ongoing. Completion of these ongoing studies will provide data for final classification of these indications.
DOSAGE AND ADMINISTRATION
Urobiotic (oxytetracycline, sulfamethizole and phenazopyridine) -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. (See ADVERSE 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 (oxytetracycline, sulfamethizole and phenazopyridine) -250 capsules: bottles of 50 (NDC 0049-0920-50), and unit dose packages of 100 (10 X 10's) (NDC 0049-0920-41).
Revised Dec. 1986.
Last reviewed on RxList: 8/24/2009
This monograph has been modified to include the generic and brand name in many instances.
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