Full Prescribing Info
Each tablet contains: Norfloxacin 400 mg.
Pharmacology: Pharmacodynamics: JANACIN (Norfloxacin) is a fluoroquinolone derivative, which has a broad spectrum bactericidal activity.
Mechanism of actions: 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 absorbed 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 function 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.
*JANACIN should be only used: When Pseudomonas is considered AND the patient is allergic to antipseudomonal penicillins/cephalosporins; For resistant organisms with no other alternative antibiotics available.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage/Direction for Use
RECOMMENDED DOSAGE: Gonorrhoea: 800 mg single dose.
Urinary Tract Infections: Acute uncomplicated: 200 mg twice daily.
Recurrent or complicated: 400 mg twice daily.
Gastro-intestinal tract: 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
The use of Norfloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using fluoroquinolones containing products (see Adverse Reactions). Treatment of these patients with Norfloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment.
In patients with moderate renal impairment, the daily dose should be reduced.
Phototoxicity may occur.
Aortic aneurysm and dissection: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population. Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis). In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
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 persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
Prolonged disabling and potentially irreversible serious adverse drug reactions: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving fluoroquinolones irrespective of their age and pre-existing risk factors. Norfloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.
Tendinitis and tendon rupture: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients (above 60 years of age), with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids*. Therefore, concomitant use of corticosteroids should be avoided.
At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with Norfloxacin should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.
Peripheral neuropathy: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with Norfloxacin should be advised to inform their doctor and pharmacist prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see Adverse Reactions).
Use in Pregnancy & Lactation: Should not be given to pregnant or nursing woman.
Use in Children: Should not be given to prepubertal children.
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
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.
Musculoskeletal and connective tissue disorders*.
Nervous system disorders*.
General disorders and administrative site conditions*.
Psychiatric disorders*.
Eye disorders*.
Ear and labyrinth disorders*.
*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendinitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of fluoroquinolones in some cases irrespective of pre-existing risk factors (see Precautions).
Post Marketing Experience:
Exacerbation of myasthenia gravis.
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 (ovoid, biconvex, white, film-coated, impressed "BIOLAB" on one face and bisect on the obverse) x 25 x 4's.
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