M-Floxsel Infusion 400mg/250ml – Intravenous Fluoroquinolone Antibacterial Solution

Product Overview

M-Floxsel Infusion 400mg/250ml is a high-potency, ready-to-use parenteral fourth-generation fluoroquinolone formulation containing Moxifloxacin Hydrochloride (400mg in 250ml saline/aqueous solution). Formulated for Intravenous (IV) infusion, M-Floxsel Infusion provides immediate systemic bioavailability for hospitalized or critically ill patients unable to tolerate oral administration. It is indicated for severe community-acquired pneumonia (CAP), complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and acute severe exacerbations of chronic bronchitis caused by multi-drug resistant bacterial pathogens.

Key Benefits

• Immediate Systemic Availability: Provides rapid 100% systemic bioequivalent drug concentrations required for inpatient critical care settings.

• Broad-Spectrum Bactericidal Coverage: Active against resistant Gram-positive pathogens (including penicillin-resistant Streptococcus pneumoniae), Gram-negative bacilli, atypicals, and anaerobic isolates.

• Ready-to-Use Premixed Solution: Supplied in a pre-formulated 250ml infusion bottle/bag, reducing preparation time and contamination risk in clinical environments.

• Targeted Respiratory & Tissue Penetration: Demonstrates high concentration ratios in lung tissue, alveolar macrophages, bronchial mucosa, and skin structures.

• Smooth Step-Down Therapy: Enables seamless transition to oral M-Floxsel 400mg tablets once the patient stabilizes clinically.

How It Works

M-Floxsel Infusion 400mg/250ml (Moxifloxacin) exerts rapid bactericidal action by concurrently inhibiting two essential bacterial enzymes necessary for chromosome replication and cell division: DNA gyrase (topoisomerase II) and topoisomerase IV. By binding to these targets during bacterial DNA transcription and replication, M-Floxsel induces double-stranded DNA cleavage, prevents repair mechanisms, and triggers rapid microbial cell lysis.

Key Active Ingredients

• Moxifloxacin Hydrochloride (400mg per 250ml solution): Synthetic 8-methoxyfluoroquinolone antibacterial agent in an isotonic aqueous vehicle for intravenous administration.

Directions for Use

1. Administration Route: Strictly for Intravenous (IV) Infusion. Do not administer via intramuscular, subcutaneous, or rapid bolus injection.

2. Infusion Rate: Administer the 250ml premixed solution as a slow intravenous infusion over a period of 60 minutes.

3. Dosing Schedule: Typically 400mg (250ml) administered once every 24 hours as determined by an attending infectious disease specialist or clinical physician.

4. Professional Healthcare Use: Must be administered exclusively by qualified medical personnel in a hospital, clinic, or emergency department.

Precautions

• Prescription-Only Parenteral: For clinical and inpatient hospital administration only; strictly prohibited for self-administration.

• Serious Fluoroquinolone Warnings: Associated with severe risks including tendonitis, tendon rupture, peripheral neuropathy, central nervous system toxicity, and aortic aneurysm/dissection. Discontinue at the first sign of tendon pain or neurological disturbance.

• QT Prolongation: Avoid in patients with known prolongation of the QTc interval, uncorrected hypokalemia, or co-administration with Class IA/Class III antiarrhythmics.

• Infusion Site Care: Administer slowly over 60 minutes to minimize venous irritation, phlebitis, and local pain.

• Consult an attending physician prior to use during pregnancy or lactation.

• Keep out of reach of children.

Storage Instructions

Store in a cool, dry place below 30°C. Protect from direct sunlight, excessive heat, and freezing. Retain in original protective packaging until administration; inspect for clarity and absence of particulate matter prior to use.

Manufacturer Information

Formulated and manufactured in strict compliance with international pharmaceutical quality standards, committed to advancing parenteral anti-infective therapies that effectively combat antimicrobial resistance and support critical inpatient recovery.