Description

Ofloxacin & Ornidazole Film-Coated Tablets (200 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced anti-infective, gastroenterological, and syndromic-management therapeutics. We provide ultra-high-purity, kinetically synchronized Ofloxacin & Ornidazole Film-Coated Tablets (200 mg / 500 mg), manufactured in WHO–GMP certified, high-precision multi-particulate oral solid dosage facilities. This “Dual-Spectrum Antimicrobial & Antiprotozoal Synergy” is a massive-volume, highly lucrative export to gastroenterology clinics, rural health NGOs, surgical centers, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally trusted intervention for severe mixed gastrointestinal infections, pelvic inflammatory disease (PID), and acute amoebic dysentery.

Product Overview

This highly advanced Fixed-Dose Combination masterfully synchronizes a second-generation fluoroquinolone with a premium nitroimidazole, delivering a devastating, two-pronged attack that completely eradicates aerobic bacteria, anaerobic bacteria, and protozoal parasites simultaneously.

The “Syndromic Management & Mixed-Infection” Specialist:

• Mechanism 1 (The Aerobic Assassin – Ofloxacin): Ofloxacin aggressively targets Gram-negative and Gram-positive aerobic bacteria (like E. coli, Salmonella, and Shigella). It physically enters the bacterial cell and binds to DNA gyrase and topoisomerase IV—the essential enzymes bacteria use to unwind and copy their DNA. By locking these enzymes, Ofloxacin forcefully breaks the bacterial DNA strands, causing rapid, bactericidal cell death.
• Mechanism 2 (The Anaerobic/Protozoal Shredder – Ornidazole): While Ofloxacin kills the oxygen-breathing pathogens, Ornidazole hunts the pathogens that thrive without oxygen (like Bacteroides, Giardia, and Entamoeba histolytica). Once inside an anaerobic cell, Ornidazole is chemically reduced into highly toxic, reactive radicals that violently shred the organism’s DNA from the inside out.
• The “Blind Therapy” Advantage: In acute, life-threatening diarrheal diseases or severe pelvic infections, waiting days for laboratory results is not an option. This synergistic combination provides complete, overlapping “blind” coverage, guaranteeing that whatever pathogen is causing the infection is eradicated quickly and efficiently, making it a massive staple in global health tenders.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Infectious Disease Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Intensive Taste-Masking & Segregation Engineering: Fluoroquinolones and Nitroimidazoles are two of the most bitter, unpalatable chemical classes in pharmacology. If the tablet dissolves even slightly on the tongue, the patient will immediately vomit it back up, ruining the therapy. Our facilities utilize advanced high-shear wet granulation to safely blend the APIs, followed immediately by a heavy-gauge, multi-layer Hypromellose (HPMC) film-coating process. This locks the lethal payload inside a perfectly smooth, tasteless shell, ensuring complete therapeutic delivery into the stomach.

Therapeutic Indications (Human Use)

Indicated for the targeted, broad-spectrum eradication of severe mixed intra-abdominal and pelvic infections:

• Acute Diarrhea & Dysentery: Syndromic treatment of severe, complicated gastroenteritis of mixed bacterial and amoebic/protozoal origin.
• Pelvic Inflammatory Disease (PID): Treatment of complex gynecological infections, including endometritis and tubo-ovarian abscesses.
• Surgical Prophylaxis & Treatment: Management of severe intra-abdominal infections, peritonitis, and post-operative surgical site infections.
• Severe Dental Infections: Management of acute, refractory periodontitis and peri-apical abscesses where mixed aerobic/anaerobic flora is suspected.

Dosage & Administration

Recommended Dosage (Strictly as per Physician Guidelines):

• Standard Adult Dosing: One tablet taken orally twice daily (every 12 hours) for 3 to 5 days, depending on the severity of the infection.
• Administration (THE MEALTIME RULE): To drastically reduce the risk of severe gastric irritation and nausea, the tablets MUST be taken immediately after meals with a full glass of water.
• Dairy & Antacid Warning: Ofloxacin binds to calcium, magnesium, and iron. Tablets must not be taken within 2 hours of dairy products, antacids, or iron supplements, as this will completely block the antibiotic’s absorption into the blood.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Tendon Rupture & Neuropathy): Fluoroquinolones (Ofloxacin) are associated with disabling and potentially irreversible serious adverse reactions, including spontaneous tendon rupture (especially the Achilles tendon), peripheral neuropathy, and severe central nervous system effects (hallucinations, extreme anxiety). Discontinue immediately at the first sign of tendon pain.
• Alcohol Interaction (Disulfiram-Like Reaction): Patients must be heavily warned to avoid all alcohol consumption during therapy and for at least 3 days after the last dose to prevent violent nausea, vomiting, flushing, and tachycardia caused by the Ornidazole component.
• QT Prolongation: Ofloxacin can dangerously prolong the QT interval on an ECG, potentially leading to fatal cardiac arrhythmias. Avoid use in patients with a history of long QT syndrome or severe hypokalemia.
• Pregnancy & Pediatrics: Strictly contraindicated in pregnant women, nursing mothers, and children/adolescents under 18 years of age due to severe risks of cartilage damage in developing weight-bearing joints.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Anti-Infective and FDC Formulations. Whether you are looking for a reliable Government Tender Supplier for dysentery outbreak control in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.