We present a complete, authoritative, and technically accurate overview of Moxifloxacin Tablet 400mg, designed to meet the highest expectations of healthcare professionals, procurement teams, distributors, and regulatory stakeholders. This article consolidates formulation details, therapeutic indications, storage requirements, regulatory documentation, and safety considerations in a single, structured reference to support informed decision-making across pharmaceutical supply chains.
Product Overview: Moxifloxacin Tablet 400mg
Product Name: Moxifloxacin Tablet
Brand Name: Generic
Strength: 400 mg
Dosage Form: Film-coated tablets
Route of Administration: Oral
Therapeutic Class: Antibiotic (Fluoroquinolone)
Moxifloxacin is a broad-spectrum antibacterial agent recognized for its clinical efficacy against a wide range of Gram-positive and Gram-negative organisms. The 400 mg film-coated tablet formulation ensures optimal bioavailability, patient compliance, and consistent therapeutic performance when administered as prescribed.
Qualitative and Quantitative Composition
Each film-coated tablet contains the following:
- Moxifloxacin Hydrochloride IP
Equivalent to Moxifloxacin 400 mg - Excipients: q.s. (quantum satis)
- Colour: Titanium Dioxide IP
The formulation is developed using pharmacopeia-compliant raw materials, ensuring batch-to-batch consistency, stability, and safety in accordance with established quality standards.
Pharmacological Classification and Mechanism
Moxifloxacin belongs to the fluoroquinolone class of antibiotics, characterized by their potent bactericidal activity. It acts by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination. This dual-enzyme inhibition provides robust antibacterial action across susceptible pathogens.
Therapeutic Indications
Moxifloxacin Tablet 400mg is indicated for the treatment of infections caused by susceptible bacterial strains, including:
- Community-acquired pneumonia
- Skin and skin structure infections
- Intra-abdominal infections
- Abdominal (stomach area) infections
- Prevention and treatment of plague, including cases associated with intentional exposure (bioterror-related scenarios)
The breadth of these indications underscores the clinical importance of moxifloxacin as a reliable option in targeted antibacterial therapy.
Dosage and Administration
Dosage: As directed by the Physician
The tablet is intended for oral administration and should be swallowed whole with water. Dosage regimens are determined by the prescribing medical practitioner based on infection type, severity, patient condition, and local treatment guidelines.
Caution, Handling, and Schedule Classification
Important Cautionary Statements
- Swallow whole. Do not chew or crush.
- Read the enclosed Patient Information Leaflet (PIL) before use.
- Keep out of reach of children.
Schedule Classification
- Schedule H Prescription Drug
- Caution: Not to be sold by retail without the prescription of a Registered Medical Practitioner
This classification reinforces the necessity of medical supervision in the use of Moxifloxacin Tablets to ensure appropriate therapy and patient safety.
Storage Conditions and Stability
To maintain product integrity and therapeutic effectiveness, the following storage conditions are recommended:
- Store at 20°C to 25°C (68°F to 77°F)
- Store in a cool, dry, and dark place
- Protect from light and moisture
Adherence to these storage requirements ensures chemical stability throughout the product’s shelf life.
Packaging Configurations
Moxifloxacin Tablet 400mg is available in multiple pack sizes to support diverse market and institutional needs:
- 10 tablets
- 20 tablets
- 30 tablets
- 50 tablets
- 100 tablets
These flexible packaging options facilitate efficient inventory management across hospitals, pharmacies, tenders, and export markets.
Patient Information Leaflet (PIL)
Each pack is accompanied by a Patient Information Leaflet (PIL) that provides clear, structured information on usage, precautions, and storage. The leaflet is designed to improve patient understanding and adherence while aligning with regulatory labeling requirements.
Regulatory and Quality Documentation
To ensure transparency, compliance, and global acceptability, the following regulatory documents are available:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Studies
- Good Manufacturing Practice (GMP) Certification
These documents collectively demonstrate adherence to quality systems, validated manufacturing processes, and stability assurance under defined storage conditions.
Manufacturing and Quality Assurance Standards
The manufacturing of Moxifloxacin Tablet 400mg is carried out in facilities compliant with GMP guidelines, ensuring:
- Controlled production environments
- Validated processes and equipment
- Rigorous in-process and finished product testing
- Traceability and documentation integrity
Quality assurance protocols are implemented at every stage, from raw material procurement to final product release.
Clinical Utility and Market Relevance
Moxifloxacin remains a critical antibacterial agent in modern therapeutic protocols due to its:
- Broad-spectrum antibacterial coverage
- Once-daily dosing convenience
- Proven clinical outcomes in respiratory and systemic infections
- Established role in public health preparedness
Its availability in standardized 400 mg film-coated tablets supports consistent clinical use across varied healthcare settings.
Professional Use and Prescribing Considerations
As a Schedule H prescription medicine, Moxifloxacin Tablet 400mg is intended exclusively for use under medical guidance. Healthcare professionals evaluate patient-specific factors, microbial susceptibility, and treatment protocols prior to prescribing.
A Reliable Antibiotic Formulation with Global Relevance
Moxifloxacin Tablet 400mg represents a well-established, quality-assured oral antibiotic formulation supported by comprehensive regulatory documentation and flexible packaging. With defined therapeutic indications, controlled manufacturing, and strict storage guidelines, it continues to serve as a dependable option in antibacterial therapy across clinical and institutional environments.
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