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

Levofloxacin Fresenius Kabi

Active Ingredient:
Levofloxacin Hemihydrate
Origin:
EU

Levofloxacin Fresenius Kabi (Levofloxacin Hemihydrate)

Levofloxacin, the active ingredient in Levofloxacin Fresenius Kabi, is a fluoroquinolone antibiotic presented as an injectable solution for intravenous use. It treats a range of serious bacterial infections in adults, including community‑acquired and hospital‑acquired pneumonia, complicated urinary tract infections, skin and soft‑tissue infections, and septicemia.

GNH India supplies Levofloxacin Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Fresenius Kabi Limited

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Indications & Clinical Uses

  • Levofloxacin is a broad‑spectrum fluoroquinolone used for bacterial infections affecting the respiratory, urinary, skin and systemic systems.
  • Community‑acquired pneumonia: achieves bacterial eradication and clinical cure in adult patients.
  • Hospital‑acquired pneumonia: provides effective coverage against common nosocomial pathogens.
  • Complicated urinary tract infections: clears infection and resolves symptoms.
  • Skin and soft‑tissue infections: reduces bacterial load and promotes healing.
  • Septicemia: contributes to rapid bacterial clearance and improves survival outcomes.

How It Works

  • Levofloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA replication, transcription, and repair. By stabilizing the DNA‑enzyme complex, it prevents the resealing of DNA strands, leading to halted bacterial cell division and eventual cell death. This bactericidal action is effective against a wide range of Gram‑positive and Gram‑negative organisms.

Side Effects

Levofloxacin may cause a variety of adverse reactions, ranging from mild to severe.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: loose stools, sometimes watery.
  • Headache: transient cranial discomfort.
  • Dizziness: occasional vertiginous sensation.
  • Rash: mild skin erythema or pruritus.
  • Elevated liver enzymes: transient increase in hepatic transaminases.

Serious or Rare Side Effects

  • Tendon rupture: especially Achilles tendon, may occur without warning.
  • QT interval prolongation: risk of ventricular arrhythmias.
  • Clostridioides difficile infection: severe colitis following dysbiosis.
  • Severe allergic reactions: anaphylaxis, Stevens‑Johnson syndrome.
  • Seizures: particularly in patients with CNS disorders.
  • Hepatic failure: rare but potentially life‑threatening liver injury.

Precautions & Warnings

  • Levofloxacin should be used with caution in specific clinical situations.
  • Renal function: adjust dosing in patients with impaired renal clearance.
  • CNS effects: monitor for seizures, especially in patients with a history of epilepsy.
  • Tendon health: avoid in individuals with prior tendon disorders or those on corticosteroids.
  • QT interval: use cautiously in patients with known cardiac arrhythmias or electrolyte abnormalities.
  • Pregnancy and lactation: risk unknown; prescribe only when benefits outweigh potential risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • Antacids containing magnesium or aluminum: reduce levofloxacin absorption.
  • Warfarin: may increase INR and bleeding risk.
  • Cyclosporine: elevated cyclosporine concentrations.
  • Theophylline: increased theophylline toxicity.
  • NSAIDs: heightened risk of CNS stimulation and seizures.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: reduced hormonal efficacy, consider backup method.
  • Diabetic agents: potential for enhanced hypoglycaemia.
  • Corticosteroids: additive risk of tendon rupture.
  • Diuretics: possible electrolyte disturbances.
  • Rifampin: decreased levofloxacin plasma levels, may reduce effectiveness.

Frequently Asked Questions

Levofloxacin Fresenius Kabi is indicated for the treatment of serious bacterial infections such as community‑acquired and hospital‑acquired pneumonia, complicated urinary tract infections, skin and soft‑tissue infections, and septicemia. It is used in adult patients when a broad‑spectrum fluoroquinolone is appropriate.

Levofloxacin exerts its antibacterial effect by inhibiting the bacterial enzymes DNA gyrase (topoisomerase II) and topoisomerase IV. These enzymes are essential for DNA replication and transcription; their inhibition prevents bacterial cell division and leads to bacterial cell death.

The prescribed dose of Levofloxacin Fresenius Kabi is determined by the treating physician based on the specific infection, severity, patient weight, renal function, and any concomitant medications. Dosage regimens are individualized and should follow the prescriber's instructions.

Safety data for levofloxacin in pregnancy and lactation are limited. It should only be used when the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain if required) and assist with import documentation.

Levofloxacin offers once‑daily dosing and a broad spectrum covering many Gram‑positive and Gram‑negative pathogens, similar to other fluoroquinolones like moxifloxacin. Compared with beta‑lactams, it provides better activity against atypical organisms and some resistant strains, but it carries class‑specific risks such as tendon injury and QT prolongation that must be weighed against benefits.

Levofloxacin Fresenius Kabi should be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect from light, and do not freeze or shake the solution. Maintaining the cold chain preserves product stability and potency.

Levofloxacin Fresenius Kabi is administered by intravenous infusion. The solution is diluted in an appropriate compatible fluid and infused over the period recommended by the prescriber, typically ranging from 30 minutes to 1 hour, depending on the clinical scenario.

Serious adverse events include tendon rupture (especially Achilles), QT interval prolongation leading to arrhythmias, severe allergic reactions such as anaphylaxis, Clostridioides difficile‑associated colitis, and central nervous system effects like seizures. Patients should be instructed to seek immediate medical attention if they experience sudden tendon pain, palpitations, severe rash, or neurological symptoms.

Levofloxacin is contraindicated in individuals with a known hypersensitivity to levofloxacin, other fluoroquinolones, or any component of the formulation. It should also be avoided in patients with a history of tendon disorders related to fluoroquinolone use, those with known prolonged QT interval without correction, and in patients receiving concomitant medications that pose a high risk of serious drug interactions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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