Prulifloxacin Film-Coated Tablets (600 mg)
Healthy Inc is a specialized global supplier and exporter of advanced anti-infective, urological, and pulmonology therapeutics. We provide ultra-high-purity, kinetically optimized Prulifloxacin Film-Coated Tablets (600 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Broad-Spectrum Prodrug Fluoroquinolone” is a highly lucrative, premium export to urology centers, infectious disease NGOs, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally trusted, once-daily intervention for the rapid eradication of complex lower urinary tract infections and severe respiratory exacerbations.
Product Overview
This highly advanced formulation contains Prulifloxacin, a sophisticated lipophilic prodrug that safely bypasses initial gastric degradation, absorbing deeply into the system before deploying a lethal, broad-spectrum attack against resistant bacterial pathogens.
The “Ulifloxacin Prodrug & Once-Daily” Specialist:
- Mechanism 1 (The Prodrug Activation): When swallowed, Prulifloxacin is inactive. As it absorbs through the gastrointestinal tract, enzymes (esterases) naturally present in the body cleave the molecule, rapidly converting it into its highly lethal, active metabolite: Ulifloxacin.
- Mechanism 2 (The Dual Enzyme Blockade): Once activated, Ulifloxacin acts as a potent bactericidal agent. It aggressively targets and paralyzes two essential bacterial enzymes: DNA Gyrase and Topoisomerase IV. By destroying these enzymes, the bacteria physically cannot unwind, repair, or copy their DNA, resulting in immediate, violent bacterial cell death across both Gram-negative and Gram-positive spectrums.
- The “Once-Daily” Compliance & Tissue Penetration Advantage: Ciprofloxacin and Ofloxacin typically require strict twice-daily (every 12 hours) dosing, which leads to massive patient dropout and subsequent antibiotic resistance. Ulifloxacin has an exceptionally long half-life and achieves massive, sustained concentrations specifically in the prostate, bladder tissue, and bronchial mucosa. This allows for a highly convenient, single 600 mg daily dose, guaranteeing complete clinical eradication.
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/Fluoroquinolones) |
| CAS Number | 109525-31-1 |
| Dosage Form | Film-Coated Tablet (Immediate Release Prodrug) |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Fluoroquinolones and their ester prodrugs are highly sensitive to UV light and hydrolytic degradation. Heavy-gauge Alu-Alu packaging guarantees absolute chemical stability and prevents premature breakdown across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily 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.
- Prodrug Hydrolysis Shield Engineering: Prulifloxacin is an ester-based prodrug. If the formulation absorbs ambient moisture during the tableting process, the ester bond will prematurely hydrolyze (break down) inside the blister pack, rendering the tablet completely clinically useless before the patient even swallows it. Our facilities utilize strictly controlled, low-humidity environmental suites during granulation and compression, ensuring the prodrug remains 100% intact until it meets the patient’s internal enzymes.
Therapeutic Indications (Human Use)
Indicated for the targeted eradication of susceptible bacterial pathogens in severe localized infections:
- Acute Lower Urinary Tract Infections: Treatment of acute uncomplicated lower UTIs (simple cystitis).
- Complicated Lower UTIs: Treatment of complex urinary tract infections where once-daily high tissue penetration is clinically mandated.
- Respiratory Tract Infections (RTIs): Acute exacerbation of chronic bronchitis caused by susceptible Gram-negative and Gram-positive strains.
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Standard Adult Dosing: 600 mg taken orally once daily. (Duration depends on the infection: typically 3 to 10 days).
- Administration (THE DAIRY & ANTACID RULE – CRITICAL): The tablet must be swallowed whole with water. It MUST NOT be taken with milk, dairy products, iron supplements, calcium supplements, or magnesium/aluminum antacids. These heavy metals physically bind (chelate) to the fluoroquinolone in the stomach, completely destroying its absorption. The tablet must be taken at least 2 hours before or 4 hours after consuming any of these products.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Tendon Rupture & Neuropathy): All fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions, including tendinitis, tendon rupture (especially the Achilles tendon in elderly patients or those on corticosteroids), peripheral neuropathy, and severe central nervous system effects (hallucinations, anxiety, seizures).
- BLACK BOX WARNING (Myasthenia Gravis): Fluoroquinolones may violently exacerbate muscle weakness in patients with myasthenia gravis, potentially leading to fatal respiratory failure. Strictly contraindicated in these patients.
- Phototoxicity (Severe Sunburn): Prulifloxacin causes extreme sensitivity to ultraviolet light. Patients must be warned to strictly avoid direct sunlight or tanning beds during therapy and for 48 hours after the last dose, as severe, blistering sunburns can occur rapidly.
- QT Prolongation Risk: Can prolong the QT interval on an ECG, increasing the risk of fatal cardiac arrhythmias. Avoid use in patients with uncorrected hypokalemia or those taking Class IA or III antiarrhythmics.
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 Formulations. Whether you need a reliable Hospital Tender Supplier for urology clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery of WHO-GMP certified products.