In the pharmaceutical industry, Norfloxacin 400 mg is a synthetic, broad-spectrum antibacterial agent belonging to the fluoroquinolone class. As a pharmacist and manufacturer, I view Norfloxacin as the “standard-bearer” for urinary tract infections. It was the first of the fluoroquinolones to gain widespread clinical use and remains a high-volume product in international trade.
Primary Clinical Uses
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Urinary Tract Infections (UTIs): It is primarily indicated for complicated and uncomplicated UTIs (cystitis, pyelitis, cystopyelitis) caused by susceptible bacteria like E. coli, Klebsiella, and Proteus.
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Prostatic Infections: Treatment of chronic bacterial prostatitis.
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Infectious Diarrhea: Effective against enterotoxigenic E. coli and other pathogens causing “traveler’s diarrhea” or gastroenteritis.
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Gonorrhea: Traditionally used for uncomplicated urethral and cervical gonorrhea, though local resistance patterns should be monitored.
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Prophylaxis in Neutropenic Patients: Used to prevent bacterial infections in patients with compromised immune systems.
Mechanism of Action: Inhibiting DNA Replication
Norfloxacin is bactericidal. It targets the “machinery” that bacteria use to replicate their genetic material.
Enzyme Targeting: It inhibits bacterial DNA gyrase (Topoisomerase II) and Topoisomerase IV.
Supercoiling Interference: These enzymes are essential for the supercoiling, uncoiling, and repair of bacterial DNA.
DNA Fragmentation: By blocking these enzymes, Norfloxacin causes the DNA to become unstable and break, preventing the bacteria from multiplying and leading to rapid cell death.
The Manufacturer’s Perspective: Formulation & Export
From a production and global trade standpoint at our WHO-GMP facility, Norfloxacin 400 mg involves specific technical considerations:
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Bioavailability & Absorption: Norfloxacin is best taken on an empty stomach (1 hour before or 2 hours after a meal) for maximum absorption. As a manufacturer, ensuring this is clear in the Product Information Leaflet (PIL) is a professional priority.
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Photosensitivity: Like all quinolones, Norfloxacin is light-sensitive. We utilize opaque PVC/PVDC or Alu-Alu blister packaging to ensure a 36-month shelf life, especially for export to Zone IVb regions.
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Chelation Warning: Norfloxacin binds with multivalent ions (like Calcium, Aluminum, or Iron in antacids/supplements), which significantly reduces its absorption. Highlighting this “drug-mineral interaction” is a key technical USP for your digital platform.
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B2B & Dossier Support: This is a staple for government tenders and institutional supplies. Our Mumbai facility provides full CTD/eCTD Dossiers to support international registration against the innovator (Noroxin).