Description

Levofloxacin Tablets (250mg / 500mg / 750mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Levofloxacin Tablets in India. Levofloxacin is a third-generation Fluoroquinolone Antibiotic and the biologically active L-isomer of Ofloxacin. It is widely regarded as the “Respiratory Fluoroquinolone” due to its excellent activity against lung pathogens, making it a first-line treatment for Community-Acquired Pneumonia (CAP), acute sinusitis, and severe Urinary Tract Infections (UTIs).

We offer Contract Manufacturing (Third Party) services for this high-volume antibiotic. Levofloxacin is photosensitive and has a bitter taste. Our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating technology to provide a light barrier and taste-masking, ensuring the tablet remains stable and palatable. Healthy Inc manages the export logistics, supplying hospitals and pharmacy chains across the USA, Europe, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Chiral purity is the key to potency.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Enantiomeric Purity: Levofloxacin is the pure L-isomer. We strictly source API with >99% Chiral Purity and use validated manufacturing processes to ensure no racemization (conversion back to the inactive D-isomer) occurs during granulation or compression, guaranteeing maximum potency.

  • High Solubility Formulation: Unlike Ciprofloxacin, Levofloxacin is highly soluble. We formulate the tablet to dissolve rapidly but use specific binders to prevent “dose dumping” or capping during high-speed compression.

  • Light Stability: The drug degrades in strong light. We apply a titanium dioxide-based Opaque Film Coating to protect the core from photodegradation.

• The Exporter: Healthy Inc

  • High-Dose Packs: We offer the 750mg strength (often used for short-course 5-day therapy) in specialized 5-tablet blister packs, optimizing compliance for “High-Dose Short-Course” regimens.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for the N-oxide impurity and other degradation products.

5. Why Use Levofloxacin?

It hits the lungs and kidneys hard.

• Mechanism: It is a broad-spectrum bactericidal agent. It enters the bacterial cell and inhibits two essential enzymes: DNA Gyrase (Topoisomerase II) and Topoisomerase IV. These enzymes are required for bacterial DNA replication, transcription, and repair. By blocking them, Levofloxacin causes the bacterial DNA to break, killing the bacteria.

• Key Indications:

  • Respiratory: Pneumonia (CAP), Acute Bacterial Sinusitis, Chronic Bronchitis exacerbations.

  • Urinary: Complicated UTIs, Pyelonephritis (Kidney infection).

  • Skin: Complicated skin and soft tissue infections.

  • Prostatitis: Bacterial infection of the prostate.

     

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Levofloxacin Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Levaquin?

  A: Levaquin is the brand name (Janssen). We manufacture the Generic Equivalent (Levofloxacin), which is bioequivalent.

• Q: Can I take it with milk or antacids?

  A: NO. Calcium, Magnesium, Aluminum, and Iron bind to the antibiotic and stop it from working. Take Levofloxacin 2 hours before or 2 hours after dairy products, antacids, or multivitamins.

• Q: Does it hurt tendons?

  A: Yes. Fluoroquinolones carry a Black Box Warning for Tendinitis and Tendon Rupture (especially the Achilles heel), particularly in elderly patients or those on steroids.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Pneumonia / Sinusitis: 500mg once daily for 7-14 days OR 750mg once daily for 5 days.

• UTI / Pyelonephritis: 250mg or 750mg once daily.

• Renal Impairment: Dose adjustment is strictly required if Creatinine Clearance is < 50 mL/min.

• Administration: Swallow whole with plenty of water to prevent crystalluria.

9. Side Effects and Precautions

• Black Box Warnings: Tendinitis/Rupture, Peripheral Neuropathy (nerve damage), and CNS effects (anxiety, confusion, hallucinations).

• QT Prolongation: Can disrupt heart rhythm. Caution in patients with known QT issues or on anti-arrhythmics.

• Photosensitivity: Skin becomes very sensitive to sunlight. Use sunscreen and avoid tanning beds.

• Hypoglycemia: Can cause low blood sugar, especially in diabetics taking insulin/sulfonylureas.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.