(and dosage form):
Each coated tablet contains 400 mg Norfloxacin
A20.1.1 Broad and medium spectrum antibiotics
Norfloxacin is a fluorinated 4-quinolone or fluoroquinolone antibacterial agent structurally related to nalidixic acid. Fluoroquinolones are bactericidal acting intracellularly by inhibiting DNA gyrase DNA gyrase is an essential bacterial enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.
Fluoroquinolones are active against a wide range of aerobic gram-positive and gram-negative organisms. They are active in-vitro against the following bacteria found in urinary tract infections. (In-vitro activity does not necessarily imply in-vivo efficacy).
Proteus spp. (indole positive)
Klebsiella - Enterobacter - Serratia
Gram positive cocci:
Fluoroquinolones also have in-vitro activity against Shigella spp., Salmonella spp., Campylobacter spp., Yersinia enterocolitica, Vibrio parahemolyticus, Bacillus cereus, Neisseria gonorrhoea, Ureaplasma urelyticum and Haemophilus influenzae.
Pharmacokinetics: Fluoroquinolones are widely distributed to most body fluids and tissues; high concentrations are attained in the kidneys, gall bladder, liver, lungs, gynaecological tissue, prostatic tissue, phagocytic cells, urine, sputum and bile. Fluoroquinolones are primarily excreted via the renal tract.
Utin-400 is indicated for the treatment of complicated and uncomplicated upper and lower urinary tract infections including cystitis, pyelitis, cystopyelitis and pyelonephritis caused by bacteria susceptible to Utin-400.
In the treatment of infections caused by Pseudomonas aeruginosa, an aminoglycoside must be administered concomitantly.
Utin-400 is contra-indicated in patients who are hypersensitive to any of the ingredients or any chemically related quinolone antibacterials. The product should not be used in patients with a creatinine clearance of less than 30 mL per minute.
Utin-400 should not be used in children and adolescents up to the age of 18 because fluoroquinolones caused lameness in immature dogs due to permanent lesions of the cartilage of weight bearing joints. This medication and other related quinolones have been reported to cause arthropathy in immature animals of various species.
The safe use of Utin-400 in pregnant women has not been established and should therefore not be used in pregnancy. The safety in breast feeding has not been established.
DOSAGE AND DIRECTIONS FOR USE
Uncomplicated urinary tract infections: One tablet (400 mg) every twelve hours for three days.
Complicated urinary tract infections: One tablet (400 mg) every twelve hours for 7 to 10 days. Treatment may need to be extended from 21 days to 12 weeks in chronic relapsing urinary - tract infections.
Children: Use is not recommended in infants and children since Norfloxacin causes arthropathy in immature animals (see contra-indications).
Geriatrics: No geriatric-specific problems have been demonstrated. However, elderly patients are more likely to have an age-related decrease in renal function, which may require an adjustment in dosage.
Renal impairment: Doses may need to be reduced in renal impairment; 400 mg once daily has been suggested when creatinine clearance is 30 mL per minute.
The presence of food in the stomach may slightly decrease or delay the absorption of Norfloxacin. Therefore, Norfloxacin should preferably be taken with a full glass (240 mL) of water on an empty stomach (either 1 hour before or 2 hours after meals).
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects: The most common side effects reported are gastro-intestinal effects (abdominal or stomach pain, nausea, anorexia, vomiting, diarrhoea and heartburn), central nervous system toxicity (dizziness, headache, nervousness, drowsiness, insomnia). Others which are less common include central nervous stimulation (psychosis, depression, convulsions, agitation, confusion, hallucinations, visual disturbances and tremors), hypersensitivity reactions (skin rash, photosensitivity, itching or redness, Stevens-Johnson syndrome, shortness of breath, swelling of face or neck, vasculitis), interstitial nephritis (bloody or cloudy urine, fever, rash, swelling of feet or lower legs). Very rarely photosensitivity has been reported. Pseudomembranous colitis has been reported. Peripheral neuropathy has occurred.
Abnormal laboratory values observed include: leucopenia, thrombocytopenia, eosinophilia, neutropenia and elevation of ALT (SGPT), AST (SGOT), alkaline phosphatase, bilirubin, blood urea and creatinine. Crystalluria has been reported especially when dosage has exceeded the recommended dosage. The maximum recommended dosage of 400 mg twice daily should not be exceeded and the patient should drink sufficient fluids to ensure a proper state of hydration and adequate urinary output. Care is necessary in patients with impaired hepatic or renal function, glucose-6-phosphate dehydrogenase deficiency.
As fluoroquinolones may cause central nervous system (CNS) stimulation or toxicity, Utin-400 should be used cautiously in patients with CNS disorders including cerebral arteriosclerosis or epilepsy or a history of convulsions. Exposure to strong sunlight or sun lamps should be avoided. The ability to drive or operate machinery may be impaired by Norfloxacin, especially when alcohol is also taken. Exacerbation of Myasthenia Gravis has been reported with Norfloxacin.
Interactions: Antagonism has been demonstrated between Utin-400 and nitrofurantoin and they should not be prescribed together.
Urinary alkalizers such as citrates, sodium bicarbonate may reduce solubility of Norfloxacin in the urine. Patients should be observed for signs of crystalluria and nephrotoxicity.
Antacids, ferrous sulfate, zinc and sucralfate, may reduce the absorption of fluoroquinolones by chelation, resulting in lower serum and urine concentrations. Utin-400 should be taken at least 2 hours before or after any of these medications.
Concurrent use with Cyclosporin has been reported to elevate serum creatinine and serum cyclosporin concentrations.
Didanosine should not be administered concurrently with Utin-400. Concurrent use with Probenecid decreases the renal tubular secretion of Utin-400, resulting in decreased urinary excretion of the Utin-400, prolonged elimination half-life, and increased risk of toxicity. Concurrent use with Warfarin has been reported to increase the anticoagulant effect of warfarin, increasing the chance of bleeding. The prothrombin time of patients receiving warfarin should be carefully monitored in all patients receiving Utin-400.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the event of acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage and the patient carefully observed and given symptomatic and supportive treatment. Adequate hydration must be maintained.
Orange, oval, biconvex film-coated tablets.
Utin-400 tablets are available in blister packs of 6 and 20 tablets.
Store below 25°C in a dry place. Protect from light.
Keep well closed.
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF APPLICANT
CIPLA-MEDPRO (Pty.) Ltd
Rosen Heights, Pasita Street
DATE OF PUBLICATION OF THIS PACKAGE INSERT
Updated on this site: October 2001
Current: January 2004
Source: Community Pharmacy
SAEPI HOME PAGE
TRADE NAME INDEX
GENERIC NAME INDEX
Information presented by Malahyde Information Systems © Copyright 1996-2004