Product image of Levofloxacin Actavis (Levofloxacin Hemihydrate) supplied by GNH India

Levofloxacin Actavis

Active Ingredient:
Levofloxacin Hemihydrate
Origin:
EU

Levofloxacin Actavis (Levofloxacin Hemihydrate)

Levofloxacin, the active ingredient in Levofloxacin Actavis, is a fluoroquinolone antibiotic presented as an oral dosage form for systemic use. It treats a range of bacterial infections, including respiratory, urinary, and skin infections, in adult patients. The drug is approved in the European Union and is supplied under a prescription‑only status.

GNH India supplies Levofloxacin Actavis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. Our distribution network ensures reliable delivery to healthcare providers across multiple continents.

Manufacturer / TM Owner

Actavis Group Ptc Ehf.

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Indications & Clinical Uses

Levofloxacin Actavis is a fluoroquinolone antibiotic indicated for several bacterial infection categories.

  • Community‑acquired respiratory tract infections: effective in eradicating the causative bacteria and improving respiratory symptoms.
  • Acute bacterial sinusitis: reduces sinus inflammation by eliminating the infecting organisms.
  • Acute exacerbations of chronic bronchitis: shortens the duration of exacerbation and aids recovery.
  • Uncomplicated urinary tract infections: clears the infection and relieves urinary symptoms.
  • Skin and soft tissue infections: treats bacterial skin infections and promotes healing.
  • Prostatitis: eliminates bacterial pathogens in the prostate and alleviates associated discomfort.

How It Works

  • Levofloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA supercoiling and replication. By binding to the quinolone‑resistance‑determining region of these enzymes, the drug prevents DNA strand separation, halting bacterial replication and transcription, which leads to bacterial cell death. This bactericidal action is broad‑spectrum against Gram‑negative and Gram‑positive organisms. The inhibition is concentration‑dependent and remains effective even against many resistant strains.

Side Effects

Levofloxacin may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: mild stomach upset that may resolve without treatment.
  • Diarrhea: loose stools, sometimes accompanied by abdominal cramping.
  • Headache: transient head pain that usually improves with rest.
  • Dizziness: sensation of light‑headedness, especially when standing quickly.

Serious or Rare Side Effects

  • Tendon rupture: sudden tendon pain or rupture, most often in the Achilles tendon.
  • QT interval prolongation: cardiac rhythm changes that can lead to serious arrhythmias.
  • Severe allergic reaction: rash, swelling, breathing difficulty, or anaphylaxis requiring immediate medical attention.

Precautions & Warnings

Before prescribing Levofloxacin, clinicians should consider several safety precautions.

  • Renal impairment: adjust therapy based on kidney function to avoid drug accumulation.
  • History of tendon disorders: avoid use in patients with prior tendon inflammation or rupture.
  • Cardiac risk factors: monitor QT interval in patients with known cardiac arrhythmias or electrolyte disturbances.
  • Concomitant CNS active drugs: use caution with medications that may lower seizure threshold.
  • Pregnancy and lactation: assess risk versus benefit, as safety data are limited.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Avoid Interactions

Levofloxacin can interact with other medicines, altering its efficacy or safety.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: reduce levofloxacin absorption; separate dosing by at least 2 hours.
  • Warfarin: may increase anticoagulant effect, requiring closer INR monitoring.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): increase risk of central nervous system stimulation and seizures.

Moderate Interactions (Monitor Closely)

  • Theophylline: levofloxacin can raise plasma theophylline levels, necessitating dosage adjustment.
  • Diabetic agents (e.g., insulin, sulfonylureas): may cause hypoglycemia; monitor blood glucose.

Frequently Asked Questions

Levofloxacin Actavis is a prescription‑only fluoroquinolone antibiotic used to treat a variety of bacterial infections, including community‑acquired respiratory tract infections, acute bacterial sinusitis, exacerbations of chronic bronchitis, uncomplicated and complicated urinary tract infections, skin and soft‑tissue infections, and prostatitis.

Levofloxacin works by binding to bacterial DNA gyrase and topoisomerase IV, enzymes that control DNA supercoiling and replication. This binding blocks DNA strand separation, halting bacterial replication and transcription, which results in bacterial cell death. The action is bactericidal and covers many Gram‑negative and Gram‑positive organisms.

The dosage of Levofloxacin Actavis is determined by the prescribing clinician based on the specific infection, patient age, renal function, and other clinical factors. Healthcare professionals should follow local prescribing guidelines and adjust the regimen as needed for each individual patient.

Safety data for levofloxacin during pregnancy and lactation are limited. The drug should only be used when the potential benefit justifies any potential risk to the fetus or infant. Clinicians must evaluate each case carefully and discuss possible risks with the patient.

To place an order, submit an enquiry on the Levofloxacin Actavis 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 and respond with pricing, availability, shipping details (including any cold‑chain requirements) and required import documentation.

Levofloxacin offers broad‑spectrum coverage against many Gram‑negative and Gram‑positive bacteria and has the advantage of once‑daily oral dosing for many indications. Compared with older fluoroquinolones, it provides higher potency and better tissue penetration, but it shares class‑related safety considerations such as tendon toxicity and QT prolongation, which must be weighed against alternatives.

Levofloxacin Actavis should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability throughout its shelf life.

Levofloxacin Actavis is administered orally, typically as a tablet or oral suspension, depending on the marketed dosage form. Patients should swallow tablets whole with water and follow any specific instructions regarding food intake provided by the prescriber.

Serious risks include tendon rupture or inflammation, especially in the Achilles tendon, QT interval prolongation that can lead to arrhythmias, severe hypersensitivity reactions such as anaphylaxis, and Clostridioides difficile‑associated diarrhea. Patients should seek immediate medical attention if they experience sudden tendon pain, palpitations, severe rash, or persistent diarrhea.

Levofloxacin should be avoided in patients with a known hypersensitivity to fluoroquinolones, a history of tendon disorders related to quinolone use, or those with significant cardiac arrhythmias that predispose to QT prolongation. Caution is also advised for individuals with severe renal impairment, pregnant or breastfeeding women, and patients taking interacting medications without proper monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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