In the pharmaceutical industry, Ciplox TZ is a potent, fixed-dose combination (FDC) of Ciprofloxacin (500 mg) and Tinidazole (600 mg). As a pharmacist and manufacturer, I view this pairing as a “Dual-Action Anti-Infective”—it combines a broad-spectrum fluoroquinolone with a powerful nitroimidazole to cover both aerobic and anaerobic pathogens simultaneously.
At your WHO-GMP facility in Mumbai, this FDC is a high-demand SKU, particularly for the treatment of mixed gastrointestinal and gynecological infections in international export markets.
Primary Clinical Indications
Ciplox TZ is specifically indicated for “Mixed Infections” where both bacteria and protozoa are suspected:
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Infectious Diarrhea & Dysentery: The most common use. It treats bacterial causes (like E. coli or Salmonella) and protozoal causes (like Amoebiasis or Giardiasis) at the same time.
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Gynecological Infections: Highly effective for Pelvic Inflammatory Disease (PID) and bacterial vaginosis, where anaerobic bacteria are often present alongside common pathogens.
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Intra-abdominal Infections: Used for complicated infections following abdominal surgery or trauma where a mix of gut flora has escaped into the cavity.
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Dental Infections: Used for severe periodontitis or dental abscesses involving anaerobic bacteria.
Mechanism: The “Double-Kill” Strategy
The synergy of these two APIs ensures that no “blind spots” are left in the infection:
Ciprofloxacin (Aerobic Coverage): Inhibits DNA Gyrase and Topoisomerase IV. This prevents bacterial DNA from replicating and repairing, leading to the death of aerobic Gram-negative and Gram-positive bacteria.
Tinidazole (Anaerobic & Protozoal Coverage): This prodrug is activated inside anaerobic cells. It creates free radicals that cause direct DNA strand breakage, killing anaerobic bacteria and protozoal parasites (like Entamoeba histolytica).
The Pharmacist’s “Technical Warning”
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The “Alcohol” Danger: Patients must avoid alcohol during and for 72 hours after finishing Ciplox TZ. Tinidazole causes a Disulfiram-like reaction, leading to severe nausea, vomiting, palpitations, and flushing.
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The “Black Box” Tendon Risk: Because it contains Ciprofloxacin, there is a risk of tendonitis or tendon rupture, especially in patients over 60 or those on corticosteroids.
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Metallic Taste: Tinidazole frequently causes a bitter or metallic taste in the mouth. This is a common side effect and not a reason to stop the medication.
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No Dairy/Antacids: Calcium and Magnesium bind to Ciprofloxacin. Advise a 2-hour gap between the tablet and milk or antacids.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “FDC Compliance” USP: On your digital platform, highlight that Ciplox TZ improves patient compliance by reducing the “pill burden” from 4 tablets a day (if taken separately) to just 2.
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Stability for Export: Tinidazole is slightly more moisture-sensitive than Ciprofloxacin. For export to Zone IVb tropical regions, Alu-Alu blister packaging is the industry standard to ensure a 36-month shelf life.
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Dossier Support: We provide full CTD/eCTD Dossiers for this combination to support your firm’s registration in international tenders focused on infectious diseases.