Norfloxacin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Susceptible infections 400 mg bid. Duration: Uncomplicated UTI caused by susceptible E. coli, Klebsiella pneumoniae, Proteus mirabilis spp: 3 days; uncomplicated UTI caused by other susceptible bacteria: 7-10 days; complicated UTI: 10-21 days; chronic bacterial prostatitis: 28 days. Chronic relapsing UTI 400 mg bid, up to 12 wk, may reduce to once daily if adequate suppression w/in 1st 4 wk.
Dosage Details
Oral
Chronic bacterial prostatitis
Adult: 400 mg bid for 28 days.

Oral
Chronic relapsing urinary tract infections
Adult: 400 mg bid, up to 12 wk, may be reduced to once daily if adequate suppression w/in 1st 4 wk.

Oral
Complicated urinary tract infections
Adult: 400 mg bid for 10-21 days.

Oral
Uncomplicated urinary tract infections
Adult: Infections caused by susceptible E. coli, Klebsiella pneumoniae, Proteus mirabilis spp: 400 mg bid for 3 days. Infections caused by other susceptible bacteria: 400 mg bid for 7-10 days.
Renal Impairment
Oral:
Chronic relapsing urinary tract infections:
CrCl (mL/min) Dosage
≤30 400 mg once daily.
Uncomplicated gonorrhoea:
CrCl (mL/min) Dosage
≤30 400 mg as a single dose.
Complicated urinary tract infections:
CrCl (mL/min) Dosage
≤30 400 mg once daily
Chronic bacterial prostatitis:
CrCl (mL/min) Dosage
≤30 400 mg once daily.
Uncomplicated urinary tract infections:
CrCl (mL/min) Dosage
≤30 400 mg once daily.
Administration
Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals, w/ a glass of water. Ensure adequate hydration. Do not take w/ dairy products.
Contraindications
Hypersensitivity to norfloxacin or any other quinolone. Patients w/ known myasthenia gravis, history of tendonitis or tendon rupture associated w/ the use of quinolone.
Special Precautions
Patient w/ known prolongation of QT interval, uncorrected hypokalaemia, known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis) or other factors that predispose to seizures. Kidney, heart or lung transplant recipients. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Dizziness, headache, nausea, abdominal cramping, diarrhoea, vomiting, anorexia, constipation, flatulence, dyspepsia, asthenia, anal/rectal pain, peripheral neuropathy (reversible), tingling of the fingers, hyperhidrosis, arthralgia, arthritis, convulsions, muscle spasms, drug rash w/ eosinophilia and systemic symptoms syndrome (DRESS), leukocytoclastic vasculitis, tendon rupture or tendinitis, photosensitivity/phototoxicity, hepatitis, jaundice, QT interval prolongation, hypoglycaemia. Decreased Hb, WBC, hematocrit and platelet count, increased creatine kinase, urine protein and eosinophils.
Potentially Fatal: Anaphylaxis, Clostridium difficile-associated diarrhoea and colitis, hepatic or acute renal failure.
Patient Counseling Information
This drug may cause dizziness and lightheadedness, if affected do not drive or operate machinery. Avoid unnecessary or excessive exposure to sunlight or artificial UV light (e.g. tanning beds, UVA/UVB treatment). If staying outdoors is necessary, use protective measures (e.g. sunscreen, wear loose-fitting clothes). Rest and refrain from exercise as it may increase risk of tendon rupture.
MonitoringParameters
Periodically monitor CBC, renal and hepatic function during prolonged therapy.
Drug Interactions
Additive effect on QT interval prolongation w/ class IA (e.g. quinidine) or class III (e.g. amiodarone) antiarrhythmics and other drugs that prolong QT interval (e.g. erythromycin, TCAs, antipsychotic agents). Increased serum concentrations of theophylline. Reduced absorption w/ oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn) and antacids containing Al or Mg, sucralfate, buffered didanosine. Prolonged prothrombin time w/ concomitant coumarin anticoagulant. Increased risk of severe tendon disorders w/ corticosteroids. Concurrent use w/ NSAIDs may increase the risk of CNS stimulation and convulsive seizures.
Food Interaction
Food may decrease rate and/or extent of absorption.
Action
Description: Norfloxacin is a fluoroquinolone anti-infective agent which inhibits DNA synthesis in susceptible organisms via inhibition of DNA gyrase and topoisomerase IV.
Pharmacokinetics:
Absorption: Rapidly but incompletely absorbed from the GI tract (approx 30-40%). Food may delay rate and/or extent of absorption. Time to peak plasma concentration: Approx 1-2 hr.
Distribution: Penetrates well into tissues of genito-urinary tract; crosses the placenta and distributed into cord blood and amniotic fluid; relatively high concentrations occur in bile. Plasma protein binding: Approx 14%.
Metabolism: Undergoes partial hepatic metabolism to several metabolites.
Excretion: Via urine by tubular secretion and glomerular filtration w/in 24 hr (approx 30% as unchanged drug); faeces (approx 39%). Plasma half-life: 3-4 hr.
Chemical Structure

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Storage
Store between 15-30°C.
Disclaimer: This information is independently developed by MIMS based on Norfloxacin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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