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Drug Details

UTINOR Tablets

• Drug Class Description
  Fluoroquinolones
• Generic Name
  Norfloxacin
• Presentation
  'Utinor' is supplied as off-white oval tablets marked 'MSD 705'.
• Description
  'Utinor' contains 400 mg of the active ingredient, norfloxacin.
• Indications
  

  Norfloxacin is a broad-spectrum, quinolone bactericidal agent indicated for the treatment of:

  • Upper and lower, complicated and uncomplicated, acute and chronic urinary tract infections. These infections include cystitis, pyelitis, pyelonephritis, chronic prostatitis and those urinary infections associated with urological surgery, neurogenic bladder or nephrolithiasis caused by bacteria susceptible to 'Utinor'.
  • Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of bacterial agents.
  • Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.
• Adult Dosage
  

  'Utinor' should be taken with a glass of water at least one hour before or two hours after a meal or milk ingestion. Multivitamins, products containing iron or zinc, antacids containing magnesium and aluminium, sucralfate or products containing didanosine should not be taken within 2 hours of administration of norfloxacin.

  Susceptibility of the causative organism to 'Utinor' should be tested. However, therapy may be initiated before obtaining the results of these tests.

  Diagnosis	Dosage	Therapy duration
  Uncomplicated lower urinary tract infections (e.g. cystitis)*	400 mg twice daily	3 days
  Urinary tract infections	400 mg twice daily	7-10 days
  Chronic relapsing urinary tract infection**	400 mg twice daily	Up to 12 weeks

  * Trials in over 600 patients have demonstrated the efficacy and tolerability of 'Utinor' in the threeday treatment of uncomplicated urinary tract infections.

  ** If adequate suppression is obtained within the first four weeks of therapy, the dose of 'Utinor' may be reduced to 400 mg daily.

  Patients with renal impairment

  'Utinor' is suitable for the treatment of patients with renal impairment. In studies involving patients whose creatinine clearance was less than 30 ml/min/1.73m², but who did not require haemodialysis, the plasma halflife of norfloxacin was approximately eight hours. Clinical studies showed there was no difference in the mean halflife of norfloxacin in patients with a creatinine clearance of less than 10 ml/min/1.73m², compared to patients with creatinine clearance of 1030 ml/min/1.73m². Hence, for these patients, the recommended dose is one 400 mg tablet once daily. At this dosage, concentrations in appropriate body tissues or fluids exceed the MICs for most pathogens sensitive to norfloxacin.

• Child Dosage
  As with other quinolones, 'Utinor' has been shown to cause arthropathy in immature animals. The safety of 'Utinor' in children has not been adequately explored and therefore the use of 'Utinor' in prepubertal children or growing adolescents is contraindicated.
• Elderly Dosage
  Pharmacokinetic studies have shown no appreciable changes when compared to younger patients, apart from a slight prolongation of halflife. In the absence of renal impairment, no adjustment of dosage is necessary. Limited clinical studies have shown 'Utinor' to be well tolerated.
• Contra Indications
  

  Hypersensitivity to any component of this product or any chemically related quinolone antibacterials.

  'Utinor' is contraindicated in prepubertal children and growing adolescents.

• Special Precautions
  

  As with other drugs in this class, 'Utinor' should not be used in patients with a history of convulsions or known factors that predispose to seizures unless there is an overwhelming clinical need. Convulsions have been reported rarely with norfloxacin.

  Tendinitis and/or tendon rupture, particularly affecting the Achilles tendon, may occur with quinolone antibiotics. Such reactions have been observed, particularly in older patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue 'Utinor' and rest the affected limbs.

  Photosensitivity reactions have been observed in patients who are exposed to excessive sunlight while receiving some members of this drug class. Excessive sunlight should be avoided. Therapy should be discontinued if photosensitivity occurs.

  Quinolones, including norfloxacin, may exacerbate the signs of myasthenia gravis and lead to life threatening weakness of the respiratory muscles. Caution should be exercised when using quinolones, including 'Utinor', in patients with myasthenia gravis.

  Rarely, haemolytic reactions have been reported in patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity who take quinolone antibacterial agents, including norfloxacin.

  Very rarely, some quinolones have been associated with prolongation of the QTc interval on the electrocardiogram and infrequent cases of arrhythmia (including extremely rare cases of torsade de pointes) have been observed. As with other agents associated with prolongation of the QTc interval, caution should be exercised when using 'Utinor' in patients with hypokalaemia, significant bradycardia or undergoing concurrent treatment with class Ia or class III antiarrhythmics.

  Some quinolones including 'Utinor' should be used with caution in patients using cisapride, erythromycin, antipsychotics, tricyclic antidepressants or who have any personal or family history of QTc prolongation.

  Use in children

  As with other quinolones, 'Utinor' has been shown to cause arthropathy in immature animals. The safety of 'Utinor' in children has not been adequately explored and therefore the use of 'Utinor' in prepubertal children or growing adolescents is contraindicated.

• Interactions
  

  Coadministration of probenecid does not affect serum concentrations of norfloxacin, but urinary excretion of the drug diminishes.

  As with other organic acid antibacterials, antagonism has been demonstrated in vitro between 'Utinor' and nitrofurantoin.

  Elevated plasma levels of theophylline have been reported with concomitant quinolone use. There have been rare reports of theophyllinerelated side effects in patients on concomitant therapy with norfloxacin and theophylline. Therefore, monitoring of theophylline plasma levels should be considered and dosage of theophylline adjusted as required.

  Elevated serum levels of cyclosporin have been reported with concomitant use of norfloxacin. Cyclosporin serum levels should be monitored and appropriate cyclosporin dosage adjustments made when these drugs are used concomitantly.

  Quinolones, including norfloxacin, may enhance the effects of the anticoagulant warfarin, or its derivatives, by displacing significant amounts from serum albuminbinding sites. When concomitant administration of these products cannot be avoided, measurements of prothrombin time or other suitable coagulation tests should be carried out.

  The concomitant administration of quinolones including norfloxacin with glibenclamide (a sulfonylurea agent) has, on occasions, resulted in severe hypoglycaemia. Therefore monitoring of blood glucose is recommended when these agents are co-administered.

  Multivitamins, products containing iron or zinc, antacids or sucralfate should not be administered concomitantly with, or within two hours of, the administration of norfloxacin because they may interfere with absorption, resulting in lower serum and urine levels of norfloxacin.

  Products containing didanosine should not be administered concomitantly with, or within 2 hours of the administration of norfloxacin, because the products may interfere with absorption resulting in lower serum and urine levels of norfloxacin.

  Some quinolones, including norfloxacin, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of its plasma halflife.

  Animal data have shown that quinolones in combination with fenbufen can lead to convulsions. Therefore, concomitant administration of quinolones and fenbufen should be avoided.

• Adverse Drug Reactions
  

  The overall incidence of drugrelated side effects reported during clinical trials was approximately 3%.

  The most common side effects have been gastrointestinal, neuropsychiatric and skin reactions, and include nausea, headache, dizziness, rash, heartburn, abdominal pain/cramps, and diarrhoea.

  Less commonly, other side effects such as anorexia, sleep disturbances, depression, anxiety/nervousness, irritability, euphoria, disorientation, hallucination, tinnitus, and epiphora have been reported.

  Abnormal laboratory side effects observed during clinical trials included:

  leucopenia, elevation of ALAT (SGPT), ASAT (SGOT), eosinophilia, neutropenia, thrombocytopenia.

  With more widespread use the following additional side effects have been reported:

  Hypersensitivity reactions

  Hypersensitivity reactions including anaphylaxis, angioedema, dyspnoea, vasculitis, urticaria, arthritis, myalgia, arthralgia and interstitial nephritis.

  Skin

  Photosensitivity, StevensJohnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, pruritus.

  Gastrointestinal

  Pseudomembranous colitis, pancreatitis (rare), hepatitis, jaundice including cholestatic jaundice and elevated liver-function tests.

  Musculoskeletal

  Tendinitis, tendon rupture, exacerbation of myasthenia gravis, elevated creatinine kinase (CK).

  Nervous system/psychiatric

  Polyneuropathy including Guillaine-Barré syndrome, confusion, paraesthesia, psychic disturbances including psychotic reactions, convulsions, tremors, myoclonus.

  Haematological

  Haemolytic anaemia, sometimes associated with glucose-6-phosphate dehydrogenase deficiency.

  Genito-urinary

  Vaginal candidiasis.

  Renal function

  Renal failure.

  Special senses

  Dysgeusia, visual disturbances.

  Cardiovascular

  Very rarely: prolonged QTc interval and ventricular arrhythmia (including torsade de pointes) may occur with some quinolones including norfloxacin.