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Beximco Pharmaceuticals LtdProduct Description
**Evo (Levofloxacin) Summary**
**Indications**
* **Respiratory Infections:** Acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia (CAP).
* **Urinary Tract Infections:** Uncomplicated and complicated UTIs, as well as acute pyelonephritis.
* **Skin & Soft Tissue Infections:** Uncomplicated and complicated skin infections (e.g., abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections).
* **Gastrointestinal/Enteric Infections:** Enteric fever (typhoid), diarrhea, cholera, shigellosis, and enteritis.
**Mechanism & Pharmacology**
* **Class:** Broad-spectrum, 3rd-generation fluoroquinolone antibiotic (chiral fluorinated carboxyquinolone).
* **Action:** Inhibits bacterial **DNA gyrase** and **topoisomerase IV**, halting DNA replication, transcription, repair, and recombination in both Gram-positive and Gram-negative bacteria.
**Dosage & Administration**
* **Oral Tablets:** Typically 250 mg, 500 mg, or 750 mg once daily, taken with or without food. *(Oral solution should be taken 1 hour before or 2 hours after meals).*
* **IV Infusion:** Administer via **slow IV infusion only** (250–500 mg over 60 minutes; 750 mg over 90 minutes every 24 hours). Do not give via IM, SC, intrathecal, or IP routes, and do not co-infuse other additives in the same line.
* **Adult Dosing Guidelines (Once Daily):**
* *Sinusitis:* 500 mg for 10–14 days **OR** 750 mg for 5 days.
* *Chronic Bronchitis Exacerbation:* 500 mg for 7 days **OR** 750 mg for 3–5 days.
* *Community-Acquired Pneumonia:* 500 mg for 7–14 days **OR** 750 mg for 5 days.
* *Uncomplicated UTI:* 250 mg for 3 days.
* *Complicated UTI / Pyelonephritis:* 250 mg for 7–10 days.
* *Skin/Soft Tissue:* 500 mg for 7–10 days (uncomplicated) **OR** 750 mg for 7–14 days (complicated).
* *Enteric Infections (Diarrhea/Cholera/Shigellosis):* 500 mg single dose (mild–moderate) **OR** 500 mg daily for 3 days (moderate–severe).
* **Pediatric Dosing:**
* *6 months to <5 years:* 10 mg/kg every 12 hours.
* *>5 years:* 10 mg/kg every 24 hours.
**Drug Interactions**
* **Multivalent Cations / Antacids / Iron / Adsorbents:** Significantly reduce oral absorption; avoid mixing IV infusions with solutions containing multivalent cations (e.g., magnesium).
* **NSAIDs:** May increase the risk of CNS stimulation and seizures.
* **Warfarin:** May enhance anticoagulant effects, increasing bleeding risk.
**Contraindications**
* History of hypersensitivity to levofloxacin, other quinolones, or any formulation components.
**Side Effects & Safety Precautions**
* **Common Side Effects:** Nausea, vomiting, diarrhea, abdominal pain, flatulence.
* **Rare/Severe Side Effects:** Risk of retinal detachment, phototoxicity (sun sensitivity), and CNS effects (tremors, anxiety, confusion, depression).
* **Precautions:** Ensure adequate hydration to prevent concentrated urine/crystalluria. Dose reduction is required in **renal insufficiency**.
* **Pregnancy & Lactation:** Not recommended for use during pregnancy or nursing.
**Storage**
* Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
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