Full Prescribing Info
Each tablet contains: Norfloxacin 400 mg.
Pharmacology: JANACIN (Norfloxacin) is a fluoroquinolone derivative, which has a broad spectrum bactericidal activity. Its antibacterial activity is against Pseudomonas aeruginosa, E. coli, Klebsiella, indole-positive Proteus, penicillinase-producing Neisseria gonorrhoea, etc.
Mechanism of Action: Norfloxacin inhibits DNA topoisomerase (ATP-hydrolyzing), a type II DNA topoisomerase commonly referred to as DNA-gyrase, in susceptible organisms, DNA-gyrase is necessary for bacterial DNA replication and some aspects of transcription, repair, recombination and transposition. The target of the drug appears to be the subunit of the enzyme. Inhibition of DNA gyrase in susceptible organisms resulting in inhibition of ATP-depending negative supercoiling DNA, inhibition of ATP-dependent relaxation of supercoiled DNA and promotion of double-stranded DNA breakage.
Pharmacokinetics: Absorption: Norfloxacin is rapidly but incompletely absorbed from the GI tract following oral administration. In healthy, fasting adults, at least 30-50% of and oral dose of norfloxacin is adsorbed from the GI tract, peak plasma concentrations of the drug are generally attained within 1-2 hours.
Following oral administration of 800 mg single dose in healthy, fasting adults, peak serum concentration average 2.4 μg/ml.
Distribution: Norfloxacin has been detected in bile, prostatic fluid, amniotic fluid. It is 10-15% bound to serum proteins.
Elimination: Serum half-life of norfloxacin in adults with normal renal functions is 2.3-4 hours. In patients with impaired renal function, serum concentration of the drug is higher and its half-life is prolonged.
It is eliminated by renal and nonrenal mechanisms. Norfloxacin and its metabolites are excreted in urine, with unchanged form being excreted by both glomerular filtration and tubular secretion.
For the treatment of Acute and Chronic Urinary Tract Infections, Gastro-Intestinal Infections, and Gonorrhoea.
Dosage/Direction for Use
Gonorrhoea: 800 mg. single dose
Urinary Tract Infections: Acute uncomplicated: 200 mg. twice daily
Recurrent or complicated: 400 mg. twice daily
Gastro-Intestinal Infections: 400 mg. twice daily
If acute overdosage of norfloxacin occurs, the stomach should be emptied by inducing emesis or by gastric lavage. Supportive and symptomatic treatment should be applied. The patients should be observed carefully.
Patients hypersensitive to Norfloxacin or quinolone compound.
Patients with renal insufficiency.
Special Precautions
Exacerbation of myasthenia gravis: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in person with myasthenia gravis. Post marketing serious adverse events, including deaths and requirement for ventilator support have been associated with fluoroquinolones use in patients with myasthenia gravis.
Avoid fluoroquinolones in patients with known history of myasthenia gravis.
Should not be given to pregnant or nursing woman or prepubertal children.
In patients with moderate renal impairment, the daily dose should be reduced.
Phototoxicity may occur.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate and well controlled studies in pregnant women. Norfloxacin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Nursing mother: It is not known whether norfloxacin is excreted in human milk. Norfloxacin should be used only if the potential benefit outweighs the potential risk to the fetus.
Adverse Reactions
Post Marketing Experience: Exacerbation of myasthenia gravis.
Side Effects
Norfloxacin is generally well tolerated at dosage used in the treatment of urinary tract infections.
The most frequent adverse effects of norfloxacin involve the GI tract or CNS such as nausea, vomiting, abdominal pain, headache, dizziness. Crystalluria has occurred with high doses.
Drug Interactions
Antacids containing magnesium hydroxide or aluminum hydroxide may decrease absorption of oral norfloxacin.
Oral multivitamin and mineral supplements containing divalent or trivalent cations such as iron or zinc may interfere with oral absorption of norfloxacin resulting in decreased serum and urine concentrations of the quinolone.
Concomitant administration of probenecid substantially decreases urinary excretion of norfloxacin.
Concomitant use of norfloxacin in patients receiving theophylline has resulted in increased plasma theophylline concentrations and decreased clearance of the drug and may increase the risk of theophylline-related adverse effects.
MIMS Class
ATC Classification
J01MA06 - norfloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Tab 400 mg x 25 x 4's.
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