Product Information:

LEFLOX 500mg Tablets contain Levofloxacin 500mg, a broad-spectrum fluoroquinolone antibiotic. Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV—enzymes critical for DNA replication, transcription, and repair—resulting in rapid bactericidal activity.

This standard-strength formulation is widely used for moderate to severe community-acquired infections requiring reliable oral therapy with once-daily dosing.

⚠️ Important Safety Note: Fluoroquinolones like levofloxacin carry Black Box Warnings (FDA/DRAP) for:

1. Tendonitis and tendon rupture (especially in elderly or corticosteroid users)
2. Irreversible peripheral neuropathy
3. Exacerbation of myasthenia gravis
4. CNS effects (anxiety, insomnia, seizures)
5. Reserve for infections where benefits outweigh risks and no safer alternatives exist.

Uses of (LEFLOX 500MG TABLETS):

1. Community-acquired pneumonia
2. Acute bacterial sinusitis (when other options are unsuitable)
3. Acute exacerbations of chronic bronchitis
4. Complicated and uncomplicated urinary tract infections (including pyelonephritis)
5. Chronic bacterial prostatitis
6. Complicated skin and skin structure infections

Key Benefits of (LEFLOX 500MG TABLETS):

1. Once-daily dosing improves adherence
2. Excellent penetration into lungs, urine, prostate, and soft tissues
3. Activity against Gram-positive, Gram-negative, and atypical pathogens (Legionella, Mycoplasma, Chlamydia)
4. Short-course regimens possible (e.g., 7 days for pneumonia)

How To Use (LEFLOX 500MG TABLETS):

1. Take once daily with or without food.
2. Swallow whole with water—do not crush or chew.
3. Avoid taking within 2 hours of dairy products, antacids, iron, calcium, or zinc supplements (they significantly reduce absorption).
4. Complete the full prescribed course—even if symptoms improve early.
5. Stay well-hydrated to prevent crystalluria.

When Not to Use (LEFLOX 500MG TABLETS):

Do not use if you have:

1. Hypersensitivity to levofloxacin or other fluoroquinolones
2. History of fluoroquinolone-associated tendon disorders
3. Myasthenia gravis
4. Pregnancy, breastfeeding, or children/adolescents (risk of cartilage/joint damage)
5. Known QT prolongation or concurrent use of QT-prolonging drugs (e.g., amiodarone, erythromycin)

Side Effects of (LEFLOX 500MG TABLETS):

Common: Nausea, headache, diarrhea, dizziness, insomnia.

Serious (discontinue immediately and seek medical help):

1. Tendon pain, swelling, or rupture (Achilles tendon most common)—stop at first sign
2. Numbness, tingling, burning pain (peripheral neuropathy—may be permanent)
3. Worsening muscle weakness or breathing difficulty (myasthenia gravis exacerbation)
4. Severe watery or bloody diarrhea (Clostridioides difficile-associated colitis)
5. Photosensitivity, hepatotoxicity, QT prolongation, seizures
6. Seek emergency care for signs of anaphylaxis or tendon rupture.

Dosage: (LEFLOX 500MG TABLETS):

1. Community-acquired pneumonia: 500mg once daily for 7–14 days
2. Acute bacterial sinusitis: 500mg once daily for 10–14 days
3. Uncomplicated UTI: 500mg once daily for 3 days
4. Complicated UTI/pyelonephritis: 500mg once daily for 7–10 days
5. Chronic bacterial prostatitis: 500mg once daily for 28 days
6. Renal impairment (CrCl <50 mL/min): Dose adjustment required

Who It’s For (LEFLOX 500MG TABLETS):

Adults with moderate to severe bacterial infections where oral fluoroquinolone therapy is clinically justified. Not for viral infections, mild sinusitis, or first-line uncomplicated UTI treatment in areas with high resistance.

Warnings & Precautions:

1. Avoid direct sunlight—use sunscreen and protective clothing (risk of phototoxicity)
2. Discontinue immediately at first sign of tendon pain or neurological symptoms
3. Use extreme caution in elderly patients and those on corticosteroids
4. Do not combine with NSAIDs (↑ risk of seizures) or QT-prolonging medications
5. Monitor for mood changes, sleep disturbances, or new-onset joint pain

Drug Interactions:

1. Antacids, iron, zinc, calcium, sucralfate: ↓ Absorption—administer ≥2 hours apart
2. Warfarin: May increase INR—monitor closely
3. NSAIDs (e.g., ibuprofen, diclofenac): ↑ Risk of CNS stimulation and seizures
4. QT-prolonging drugs: ↑ Risk of torsades de pointes
5. Always inform your doctor about all medications and supplements.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiration date on the blister pack. Available by prescription only in Pakistan.