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UROMIX
Capsule
COMPOSITION :
Each capsule contains Pipemidic Acid 400 mg.

ACTIONS :
Uromix is an oral, synthetic antibacterial agent useful in the treatment of urinary tract infections, bacillary dysentery and
enteritis. Uromix is effective against some strains of Staphylococcus but is markedly effective against gram-negative
organisms.

MICROBIOLOGY :
Uromix is a structural relative of piromidic acid and nalidixic acid but has a broader spectrum of antibacterial activity than either
piromodic acid or nalidixic acid. It is active against gram – negative bacteria, eg E. coli, Klebseilla, Proteus, Enterobacter,
Citrobacter, Shigella spp, Vibrio parahaemolyticus, Salmonella sp, including Pseudomonas aeruginosa as well as some gram –
positive bacteria ( in vitro ). It is clinically effective for some patients. Uromix shows little antibacterial activity against
anaerobic bacteria. The mode of action of Uromix appears to be the inhibition of bacterial DNA synthesis. The mechanism of
action of Uromix, like other pyridones, is believed to be by DNA – gyrase inhibition. At 2 – 4 times the MIC ( Minimum
Inhibitory Concentration ), Uromix exhibits bactericidal activity which, in solid media, is not effected by the presence of serum,
plasma, red blood cells, heparin or a change in pH from 5 – 9. Incomplete croos – resistance has been observed between
Uromix and piromidic acid and nalidixic acid: most bacteria resistant to piromidic acid and nalidixic acid are susceptible to
Uromix at an MIC of 25 mcg/mL.
Pipemidic acid exhibits MIC values of 1.56-6.25 mcg/mL against almost all of the gram negative bacilli.
Pipemidic acid is generally more potent than nalidixic acid and is active against organism resistant to antibiotics.

INDICATIONS : :
Treatment of acute ( simple ) and chronic ( complicated ) urinary tract infections caused by sensitive gram – negative bacteria.
Uromix is also indicated in the treatment of bacillary dysentery and enteritis caused by gram–negative bacteria.

DOSAGE AND ADMINISTRATION : :
For the treatment of acute urinary infection including cystitis, urethritis, pyelonepheritis and pyelitis, the recommended
daily dosage is 800 mg administered in 2 divided doses for a period of 7 – 10 days.
For the treatment of chronic urinary tract infections, the recommended daily dosage is 800 – 1600 mg administered in 2
– 4 divided doses for a period of at least 2 weeks or longer if required. For the treatment of bacillary dysentery or
enteritis, the recommended daily dosage is 400 mg administered 4 times daily for a period of 3 – 6 days.

CONTRAINDICATION :
Patients with known hypersensitivity to this antibacterial agent.

WARNING :
Uromix is not recommended for  use in patients with severe renal failure ( creatinine clearance below 10 mL/min ) since urinary
levels may not be adequate for therapy and in some patients, in creased drug levels in the blood and carebrospinal fluid may
accur.

PRECAUTIONS :
Cross – resistance between uromix and antibiotic, eg ampicillin, cephalexin, chloramphenicol and streptomycin has not been
observed.
If, however, the clinical response is unsatisfactory or if relapse occurs, cultures and sensitivity tests should be repeated.
Laboratory Test Interference : Uromix interferes with certain measuring methods during determination of urinary protein values
resulting in falsely high values.
It is recommended that the heat coagulation method or reagent strip method be used during therapy with Uromix.
Use In pregnancy & lactation :
The safety or Uromix in pregnant women or nursing mothers with respect to adverse effects upon the fetus newborn has not
been established.
Use in children :
Uromix is not to be used in children under 12 years since its safety has not been established in this age group.

SIDE EFFECTS :
Gastrointestinal Effects :
Gastrointestinal symptoms are the most common side effects observed during therapy with Uromix.
Nausea or anorexia is reported in about 3% of the patients and 1% of the reports are attributed to stomach ache, abdominal
pain or distention, vomiting, diarrhea, constipation or stomatitis.
Since the side effects are most often transient, it is unusual to have to discontinue therapy. By administering Uromix with
meals, these effects can be minimized.

HYPERSENSITIVITY REACTIONS :
Hypersensitivity sign, eg skin eruption, photosensitivity reactions, urticaria, pruritus and fever have been reported.
These occur rarely ( in about 1% of the patients ); the drug therapy must be discontinued if these symptoms occur.

Renal Effects :
Elevations of BUN ( Blood Urea Nitrogen ) and creatinine can occur. A case has been reported in which a patient with chronic
renal insufficiency received Uromix and developed high levels of drug in the blood and cerebrospinal fluid; this was
accompanied by convulsions.
Hepatic Effects :
Elevation of SGOT and SGPT result are sometimes observed, though no causal relationship has been established .
Other Effects :
Fatigue, thirst, leukopenia, headache and dizziness are rarely observed.

PACKING :
Box of 10x10’s. Reg.No. DKL9021004701A1

On medical prescription only.



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Phone: +62-21-536-90112
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