A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Urobiotic Indications, Dosage, Storage, Stability - Oxytetracycline,Sulfamethizole and Phenazopyridine
Urobiotic Indications, Dosage, Storage, Stability - Oxytetracycline,Sulfamethizole and Phenazopyridine
INDICATIONS
AND USES
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 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.
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DOSAGE AND ADMINISTRATION
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. (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.
HOW SUPPLIED
Urobiotic-250 capsules: bottles of 50 (NDC 0049-0920-50), and unit dose packages
of 100 (10 × 10's) (NDC 0049-0920-41).
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