Description
Ofloxacin & Satranidazole Tablets (200 mg / 300 mg)
Healthy Inc is a specialized global supplier and exporter of advanced anti-infective, gastrointestinal, and critical-care therapeutics. We provide ultra-high-purity, kinetically synchronized Ofloxacin (200 mg) & Satranidazole (300 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Broad-Spectrum Aerobic, Anaerobic & Antiprotozoal FDC” is a massive-volume, premium export to gastroenterology clinics, infectious disease NGOs, retail pharmacy networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally trusted, highly tolerable intervention for severe mixed gastrointestinal, pelvic, and dental infections.
Product Overview
This highly advanced Dual-FDC masterfully synchronizes a potent 2nd-generation fluoroquinolone with a premium, next-generation nitroimidazole, delivering a lethal, two-pronged strike against complex mixed infections that involve both oxygen-breathing (aerobic) and non-oxygen-breathing (anaerobic) pathogens, as well as destructive protozoa.
The “Mixed-Infection & Dysentery” Eradication Specialist:
- Mechanism 1 (The Aerobic Terminator – Ofloxacin 200mg): Ofloxacin is a powerful bactericidal fluoroquinolone. It aggressively targets and inhibits two essential bacterial enzymes: DNA Gyrase and Topoisomerase IV. By paralyzing these enzymes, the bacteria cannot unwind or copy their DNA, resulting in the rapid death of Gram-negative and Gram-positive aerobic bacteria (such as E. coli, Salmonella, and Shigella responsible for severe food poisoning and dysentery).
- Mechanism 2 (The Anaerobic & Protozoal Destroyer – Satranidazole 300mg): Satranidazole attacks the pathogens that thrive in oxygen-deprived environments (like the deep gut or pelvic cavity). Once inside the anaerobic bacterium or protozoan (like Amoeba or Giardia), the drug is chemically reduced, creating highly reactive, toxic free radicals. These radicals violently shatter the pathogen’s DNA strands, instantly killing it.
- The Premium Compliance Advantage: Older nitroimidazoles (like Metronidazole and Tinidazole) cause a highly unpleasant, lingering metallic taste in the mouth and induce severe nausea, leading to massive patient drop-off and subsequent antibiotic resistance. Satranidazole is uniquely structured to bypass these side effects, offering superior gastrointestinal tolerability and guaranteeing patients actually finish their full antibiotic course.
Product Composition & Strength
We supply this product as a Precision-Engineered Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute stability of the fluoroquinolone and nitroimidazole APIs.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Ofloxacin USP/Ph.Eur. | 200 mg | Broad-spectrum fluoroquinolone for the eradication of aerobic bacterial pathogens. |
| Satranidazole INN/Ph.Eur. | 300 mg | Premium nitroimidazole for the eradication of anaerobic bacteria and protozoa. |
| Excipients | Microcrystalline Cellulose / Crospovidone / Magnesium Stearate / Hypromellose | Diluent / Superdisintegrant / Lubricant / Premium Film-Coating (Engineered to mask bitterness and ensure immediate gastric dissolution) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for standard 3-to-5 day acute gastrointestinal and pelvic infection regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Infectious Disease Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antibacterials/Antiprotozoals) |
| CAS Numbers | 82419-36-1 (Ofloxacin) / 79660-72-3 (Satranidazole) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Fluoroquinolones are highly sensitive to UV light and moisture degradation. Heavy-gauge Alu-Alu packaging guarantees absolute chemical stability and full therapeutic potency across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dual-API Dissolution Engineering: Formulating a fluoroquinolone alongside a highly insoluble nitroimidazole requires advanced superdisintegrant technology (like Crospovidone) to ensure both active ingredients release synchronously within the gastric fluid, providing an immediate, combined plasma spike necessary to overwhelm rapidly dividing pathogens.
Therapeutic Indications (Human Use)
Indicated for the comprehensive eradication of complex, mixed aerobic/anaerobic and protozoal infections:
- Gastrointestinal Infections: Acute diarrhea of mixed etiology, severe amoebic dysentery, giardiasis, and enteric bacterial infections.
- Pelvic Inflammatory Disease (PID): Treatment of polymicrobial infections of the female upper genital tract.
- Surgical & Dental Prophylaxis: Treatment of severe mixed dental infections (periodontitis, dental abscesses) and prophylaxis against infection following intra-abdominal or gynecological surgery.
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. (Pelvic or intra-abdominal infections may require up to 14 days of therapy).
- Administration (THE MEALTIME RULE): Tablets must be swallowed whole with a full glass of water. They should be taken after meals to minimize potential gastrointestinal irritation.
- The Dairy & Antacid Warning (CRITICAL): Dairy products (milk, yogurt), calcium supplements, iron pills, and magnesium/aluminum antacids physically bind to Ofloxacin in the stomach, completely destroying its absorption. The tablet must be taken at least 2 hours before or 2 hours after consuming any of these products.
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 tendinitis, tendon rupture (especially the Achilles tendon), peripheral neuropathy, and severe central nervous system effects (hallucinations, anxiety, seizures). Treatment must be discontinued immediately at the first sign of tendon pain or nerve tingling.
- BLACK BOX WARNING (Myasthenia Gravis): Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis, potentially leading to fatal respiratory failure. Strictly contraindicated in these patients.
- QT Prolongation Risk: Ofloxacin can prolong the QT interval on an ECG, increasing the risk of fatal cardiac arrhythmias. Avoid use in patients with a history of QT prolongation or those taking Class IA or III antiarrhythmics.
- Alcohol Consumption: While Satranidazole is uniquely formulated to drastically reduce the risk of a disulfiram-like reaction (severe vomiting and palpitations) compared to Metronidazole, patients are still strongly advised to avoid heavy alcohol consumption during therapy to prevent undue hepatic stress.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of 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 Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Government Tender Supplier for dysentery eradication programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.









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