Product Description

Indications (Uses)

Respiratory Infections: Acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, and community-acquired pneumonia.

Urinary Tract Infections: Uncomplicated and complicated urinary tract infections (UTI), as well as acute pyelonephritis.

Skin and Soft Tissue Infections: Uncomplicated and complicated infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, and wound infections.

Enteric/Gastrointestinal Infections: Enteric fever (typhoid), diarrhea, cholera, shigellosis, and enteritis.

2. Description & Pharmacology

Class: Synthetic, broad-spectrum, third-generation fluoroquinolone antibacterial agent.

Mechanism of Action: Inhibits bacterial topoisomerase IV and DNA gyrase—essential enzymes required for bacterial DNA replication, transcription, repair, and recombination. Active against a wide range of Gram-positive and Gram-negative bacteria.

3. Dosage & Administration

Oral Administration: Tablets can be taken without regard to food. Oral solutions should be taken 1 hour before or 2 hours after meals.

Intravenous (IV) Infusion: Administered only by slow IV infusion over 60 minutes (for 250 mg or 500 mg) or 90 minutes (for 750 mg) every 24 hours. Must not be given via IM, intrathecal, intraperitoneal, or subcutaneous routes. Do not mix with other additives/medications.

Adult Dosage:

Acute Sinusitis: 500 mg once daily for 10–14 days, or 750 mg once daily for 5 days.
Chronic Bronchitis Exacerbation: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (uncomplicated) / 5 days (complicated).
Community-Acquired Pneumonia: 500 mg once daily for 7–14 days, or 750 mg once daily for 5 days.
UTI & Pyelonephritis: 250 mg once daily for 3 days (uncomplicated) or 7–10 days (complicated/pyelonephritis).
Skin & Soft Tissue Infections: 500 mg once daily for 7–10 days (uncomplicated) or 750 mg once daily for 7–14 days (complicated).
Enteric Fever: 500 mg once daily for 7–14 days.
Diarrhea / Cholera / Shigellosis: Mild-to-moderate: 500 mg single dose. Moderate-to-severe: 500 mg once daily for 3 days.

Pediatric Dosage:
6 months to <5 years: 10 mg/kg every 12 hours.
>5 years: 10 mg/kg every 24 hours.

4. Infusion Administration Instructions
Check the inner bag for leaks by squeezing firmly; discard if leaking, seal is broken, or solution is cloudy/precipitated.

Clear air from the tubing before starting, adjust flow rate with the clamp, and never connect flexible containers in series.

5. Drug Interactions
Multivalent Cations: Do not co-administer solutions containing multivalent cations (e.g., magnesium) in the same IV line.

Absorption Inhibitors: Antacids, iron, and adsorbents reduce oral absorption.
Other Drugs: NSAIDs may increase the risk of CNS stimulation; Warfarin may increase bleeding risk.

6. Contraindications
Known hypersensitivity to levofloxacin, quinolone antimicrobials, or any inactive component of the product.

7. Side Effects
Common: Nausea, vomiting, diarrhea, abdominal pain, and flatulence.
Rare/Serious: Retinal detachment, photoxicity (0.1%), tremors, depression, anxiety, and confusion.

8. Special Precautions & Pregnancy
Pregnancy & Lactation: Not recommended, as potential risks to unborn or nursing infants are unknown.
Precautions: Ensure adequate fluid intake/hydration to prevent concentrated urine. Adjust dosage in patients with renal impairment. Must be infused slowly over 60–90 minutes.

9. Overdose & Storage
Overdose: Low acute toxicity potential. Management involves emptying the stomach, supportive care, and maintaining proper hydration.

Storage: Store below 30°C away from light and moisture. Keep out of reach of children.

Note: Take medication only as prescribed by a registered physician.