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Drug Details

URIBEN

• Drug Class Description
  Quinolones.
• Generic Name
  Nalidixic acid - urinary tract infections
• Presentation
  Suspension for oral administration
• Description
  Uriben 300mg/5ml Oral Suspension
• Indications
  Uriben is recommended for the treatment of acute or chronic infections, especially those of the urinary tract caused by Gram-negative organisms, other than Pseudomonas species, sensitive to nalidixic acid. It may also be used for the treatment of selective cases of gastro-intestinal Gram-negative infections sensitive to nalidixic acid.
• Adult Dosage
  

  Adults including the elderly: Three 5ml spoonfuls four times daily for at least seven days reducing to two 5ml spoonfuls four times daily for chronic infections.

• Child Dosage
  

  For those over the age of three months, the recommended dose is 1ml of suspension per Kilogram body weight daily. The neonate does not tolerate nalidixic acid suspension well owing to immaturity of the liver enzymes.

• Contra Indications
  

  Nalidixic acid is contra-indicated for patients with a history of convulsive disorder, porphyria and severe renal impairment. It should be used with caution in patients with liver disease.

  Contra-indicated for those with a hypersensitivity to hydroxybenzoate esters or nalidixic acid.

  Use in infants under the age of three months is not recommended.

• Special Precautions
  

  Nalidixic acid may precipitate a haemolytic reaction in Glucose-6-phosphate dehydrogenase deficient individuals. Recent toxicological studies have shown that high doses of oxyquinoline antibacterial agents can produce erosion of the cartilage in weight – bearing joints in immature animals of some species. No such lesions have been reported in man to date, nevertheless, until significance of this finding is clarified, care should be exercised when prescribing nalidixic acid for children.

  Although care should be exercised when treating patients with renal failure, the full dosage of nalidixic acid may be administered in patients with creatinine clearance of more than 20ml/min.

  Nalidixic acid in therapeutic doses can interfere with the estimation of urinary 17-ketosteroids and may cause high results in the assay of urinary vanilmandelic acid (Pisano method).

  Active proliferation of the organisms is a necessary condition for the antibacterial action of nalidixic acid and the action of the suspension may therefore be inhibited by the presence of other antibacterial substances.

  When testing for glycosuria in patients receiving nalidixic acid, “Clinistix” or “Tes-tape” should be used since other reagents give a false positive result.

  Patients should avoid excessive exposure to sunlight.

   Excipient warnings

  This product contains the following:

  Parahydroxybenzoates: may cause allergic reactions (possibly delayed).

  Sucrose: contains 0.45g sucrose per 5ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. May be harmful to teeth.

  Sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.

  Ponceau 4R E124 and carmoisine E122: may cause allergic reactions.

• Interactions
  

  1. . Anticoagulants (coumarin-or-indandione-derivative):

  Due to competition for protein binding sites between nalidixic acid and anti-coagulants, it may be necessary to reduce the anti-coagulant dosage and monitor the prothrombin time until a satisfactory prothrombin ratio is achieved.

  2. Probenecid:

  May be associated with reduced efficacy against urinary pathogens and an increased incidence of side effects.

  3. NSAID's:

  An increased likelihood of convulsions has been reported.

  4. Melphalan:

  Serious GI toxicity has been reported.

  5. Ciclosporin:

  Increased nephrotoxicity may result.

• Adverse Drug Reactions
  

  Gastro intestinal effects including nausea, diarrhoea, abdominal pain and cholestasis have been reported. Visual disturbances may occur but are readily reversible on reduction of or discontinuation of therapy. Skin reactions including urticaria and photosensitivity have been reported. Arthralgia, myalgia and muscular weakness.

  Blood disorders, including eosinophilia, leucopenia, thrombocytopenia and altered prothrombin concentrations have been reported. Headache, dizziness, sleep disorders, depression, hallucinations, confusion and disorders of taste and smell have been reported. Raised intra-cranial pressure may occur in infants. Convulsions have been reported, sometimes associated with overdosage and in individuals with a post history of convulsions.