Product image of Levofloxacine Fresenius Kabi (Levofloxacin Hemihydrate) supplied by GNH India

Levofloxacine Fresenius Kabi

Active Ingredient:
Levofloxacin Hemihydrate
Origin:
EU

Levofloxacine Fresenius Kabi (Levofloxacin Hemihydrate)

Levofloxacin, the active ingredient in Levofloxacine Fresenius Kabi, is a fluoroquinolone presented as an intravenous solution for injection use. It treats a range of serious bacterial infections in adult patients, including pneumonia, urinary‑tract and intra‑abdominal infections.
GNH India supplies Levofloxacine Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

Manufacturer / TM Owner

Fresenius Kabi Nederland B.V.

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Indications & Clinical Uses

Levofloxacin is a broad‑spectrum fluoroquinolone antibiotic indicated for several bacterial infections.

  • Community‑acquired pneumonia: effective eradication of the causative pathogens in the lungs.
  • Complicated urinary tract infections: eradicates resistant Gram‑negative organisms in the urinary system.
  • Complicated intra‑abdominal infections: provides coverage against mixed aerobic and anaerobic bacteria.
  • Skin and soft tissue infections: treats serious bacterial skin infections, including those caused by Staphylococcus aureus.
  • Acute bacterial sinusitis: resolves infection of the sinus mucosa caused by susceptible bacteria.

How It Works

  • Levofloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA supercoiling and replication. By binding to these enzymes, it prevents DNA strand separation and transcription, leading to bacterial cell death. The drug exhibits concentration‑dependent bactericidal activity against a wide spectrum of Gram‑positive and Gram‑negative organisms.

Side Effects

Levofloxacin may cause a range of adverse reactions, most of which are dose‑related and reversible.

Common Side Effects

  • Nausea or vomiting: mild gastrointestinal upset.
  • Diarrhea: loose stools, occasionally watery.
  • Headache: transient cranial discomfort.
  • Rash: mild skin erythema or pruritus.

Serious or Rare Side Effects

  • Tendon rupture: especially Achilles tendon, often linked to sudden activity.
  • QT interval prolongation: may predispose to ventricular arrhythmias.
  • Severe hypersensitivity: anaphylaxis or Stevens‑Johnson syndrome.
  • Clostridioides difficile colitis: severe diarrhea due to gut flora disruption.

Precautions & Warnings

Levofloxacin requires careful assessment before use to minimise risks.

  • Renal function assessment: adjust therapy in patients with impaired clearance.
  • QT interval monitoring: avoid in patients with known prolongation or concurrent QT‑prolonging drugs.
  • Tendon health evaluation: counsel patients to report tendon pain or swelling promptly.
  • Pregnancy and lactation: avoid unless benefits outweigh potential fetal risk.
  • Store at ambient temperature below 25°C: keep in the original container, protect from moisture and light.

Avoid Interactions

Levofloxacin can interact with several medicines, altering efficacy or safety.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: reduce levofloxacin absorption.
  • Warfarin: may increase anticoagulant effect and bleeding risk.
  • Theophylline: potentiates central nervous system stimulation and seizures.

Moderate Interactions (Monitor Closely)

  • NSAIDs: increase risk of central nervous system adverse events.
  • Corticosteroids: may heighten tendon toxicity.
  • Diabetic agents: monitor blood glucose as levofloxacin can cause dysglycaemia.

Frequently Asked Questions

Levofloxacine Fresenius Kabi is indicated for serious bacterial infections such as community‑acquired pneumonia, complicated urinary tract infections, complicated intra‑abdominal infections, skin and soft tissue infections, and acute bacterial sinusitis. It is administered intravenously and is reserved for cases where oral therapy is unsuitable or rapid bacterial eradication is required.

Levofloxacin blocks bacterial DNA gyrase and topoisomerase IV, enzymes that control DNA supercoiling and replication. By binding to these targets, the drug prevents DNA synthesis and transcription, leading to bacterial cell death. This mechanism provides broad‑spectrum, concentration‑dependent bactericidal activity against many Gram‑positive and Gram‑negative organisms.

The specific dose and duration of therapy are determined by the prescribing clinician based on the infection type, severity, patient weight, renal function, and local resistance patterns. Healthcare professionals should follow institutional guidelines and product labeling when selecting the appropriate regimen.

The safety of levofloxacin in pregnancy and lactation has not been established. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians are advised to discuss alternatives and consider fetal monitoring when prescribing to pregnant or nursing patients.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

Levofloxacin is a third‑generation fluoroquinolone with enhanced activity against Gram‑positive organisms compared with earlier agents like ciprofloxacin. It offers once‑daily dosing for many indications and has a favorable pharmacokinetic profile, but shares class‑related risks such as tendon toxicity and QT prolongation, which must be weighed against alternative antibiotics.

The product should be stored at ambient temperature below 25 °C, protected from moisture and direct light. Keep the vial in its original packaging until use and avoid freezing. If reconstituted, follow the manufacturer’s guidance on stability and discard any unused solution after the specified period.

Levofloxacine Fresenius Kabi is supplied as an intravenous solution for infusion. It is administered by a qualified healthcare professional through a peripheral or central line, typically over 30–60 minutes depending on the dose and clinical protocol. Infusion rates and dilution volumes should follow the product’s prescribing information.

Serious adverse events include tendon rupture (especially the Achilles tendon), QT interval prolongation leading to arrhythmias, severe hypersensitivity reactions such as anaphylaxis or Stevens‑Johnson syndrome, and Clostridioides difficile‑associated colitis. Patients should be monitored closely for musculoskeletal pain, cardiac symptoms, or any signs of allergic reaction during treatment.

Levofloxacine Fresenius Kabi is contraindicated in patients with a known hypersensitivity to levofloxacin, other fluoroquinolones, or any component of the formulation. Caution is also advised for individuals with a history of tendon disorders, prolonged QT interval, or severe renal impairment where dose adjustment is required.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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