In the pharmaceutical industry, Ofloxacin 200 mg is a widely utilized second-generation fluoroquinolone antibiotic. As a pharmacist and manufacturer, I view it as a highly effective broad-spectrum agent, though its safety profile is “context-dependent”—it is safe for most adults but requires strict adherence to clinical contraindications.
At your WHO-GMP facility in Mumbai, Ofloxacin 200 mg and 400 mg tablets are likely core products for your anti-infective portfolio, particularly for export to markets requiring cost-effective, stable antibiotics.
Clinical Safety & Indications
Ofloxacin is generally safe and highly effective for treating:
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Urinary Tract Infections (UTIs): Including both complicated and uncomplicated cases.
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Respiratory Infections: Such as chronic bronchitis and community-acquired pneumonia.
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Skin and Soft Tissue Infections: Managing various bacterial skin conditions.
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Enteric Fevers: Often used in the management of typhoid in specific regions.
Mechanism: DNA Gyrase Inhibition
Ofloxacin does not just slow bacteria down; it destroys their ability to replicate.
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Enzyme Targeting: It binds to and inhibits two essential bacterial enzymes: DNA gyrase and topoisomerase IV.
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Replication Blockade: These enzymes are responsible for uncoiling and repairing bacterial DNA during replication. By blocking them, Ofloxacin causes the DNA strands to break and prevent the bacteria from multiplying.
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Bactericidal Effect: This process results in rapid bacterial cell death.
The Pharmacist’s “Technical Warning”
As you promote your firm on digital platforms, providing these “Black Box” warnings is essential for clinical authority:
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Tendon Rupture Risk: Fluoroquinolones carry a rare but serious risk of tendonitis and tendon rupture, especially the Achilles tendon. This risk is higher in patients over 60 or those taking corticosteroids.
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Central Nervous System (CNS) Effects: It can cause dizziness, tremors, and in rare cases, seizures. It should be used with caution in patients with known CNS disorders.
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The “Divalent Cation” Interaction: Advise patients to avoid taking Antacids, Iron, or Calcium supplements within 2 hours of Ofloxacin, as these minerals bind to the drug and prevent its absorption.
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Strict Contraindication: Generally avoided in children, adolescents, and during pregnancy/breastfeeding due to theoretical risks to developing cartilage.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “OZ” Combination USP: On your marketplace, highlight your Ofloxacin + Ornidazole Fixed-Dose Combination. This is an extremely popular product in India and Southeast Asia for managing mixed “diarrhea and dysentery” infections.
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Stability for Export: Ofloxacin is stable but highly light-sensitive. Utilizing Alu-Alu blister packaging is the gold standard for maintaining a 36-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for private B2B pharmacy networks.