EVOX 750/MG FC TAB 7/FC TAB

Indications

Approved Uses

Community-acquired pneumonia, nosocomial pneumonia, acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, complicated urinary tract infections, uncomplicated urinary tract infections, acute pyelonephritis, complicated skin and skin structure infections, uncomplicated skin and skin structure infections, chronic bacterial prostatitis, inhalational anthrax (post-exposure prophylaxis), plague

Off-Label Uses

Off-label examples: multidrug-resistant tuberculosis (as part of combination therapy), certain cases of traveler’s diarrhea, and some sexually transmitted/urogenital infections (e.g., epididymo-orchitis) depending on local resistance; SBP prophylaxis is not a standard off-label role for levofloxacin (norfloxacin/ciprofloxacin are more typical).

Dosage & Administration

Dosing by Condition

For adult regimens that use 750 mg once daily: Community-acquired pneumonia: 750 mg PO daily x 5 days; Nosocomial pneumonia: 750 mg PO daily x 7-14 days; Acute bacterial sinusitis: 750 mg PO daily x 5 days; Complicated UTI/acute pyelonephritis: 750 mg PO daily x 5 days; Complicated skin/skin structure infections: 750 mg PO daily x 7-14 days (where indicated).

Initial Dose

750mg once daily (for most serious infections)

Maintenance Dose

250mg to 750mg once daily depending on indication and severity

Maximum Dose

750 mg per day (usual maximum adult dose for most indications; higher doses are not standard and increase toxicity risk).

Children's Dosage

Approved for children 6 months and older for inhalational anthrax and plague. For children <50 kg and ≥ 6 months: 8 mg/kg every 12 hours (not to exceed 250mg per dose). For children >50 kg: 500 mg every 24 hours.

Dose Adjustment Notes

Dose adjustment is required in renal impairment (typically when CrCl < 50 mL/min); no adjustment is generally needed in hepatic impairment. Use once daily as prescribed and complete the full course.

How to Take

Swallow the 750 mg film‑coated tablet whole with water; may be taken with or without food. Maintain adequate hydration. Separate from polyvalent cations (antacids containing Mg/Al, sucralfate, iron, zinc, calcium/multivitamins, dairy/calcium-fortified products) by at least 2 hours before or 2 hours after.

Side Effects

Common Side Effects

Nausea, diarrhea, headache, dizziness, insomnia (others also common: abdominal pain/dyspepsia, constipation, vomiting, rash).

Side Effect Frequency

Common (1-10%): nausea, diarrhea, headache, insomnia, constipation, dizziness, vomiting, abdominal pain, dyspepsia, rash. Uncommon (<1%): tendinitis, peripheral neuropathy, QT prolongation, hypoglycemia, seizures, psychosis, anaphylaxis, hepatotoxicity, photosensitivity

Safety & Warnings

Contraindications

Contraindicated in patients with hypersensitivity to levofloxacin/other quinolones; avoid use in patients with myasthenia gravis (strong warning/contraindication depending on labeling).

Warnings & Precautions

Key precautions: discontinue for tendon pain/inflammation or neuropathy symptoms; avoid in myasthenia gravis; assess QT-risk (QT prolongation, hypokalemia, interacting drugs); CNS effects/seizure risk; dysglycemia risk in diabetics; aortic aneurysm/dissection risk in susceptible patients; C. difficile diarrhea; photosensitivity; separate from polyvalent cations to avoid treatment failure.

Age Restriction

Not routinely approved for patients <18 years; pediatric use is restricted to specific serious indications (e.g., inhalational anthrax post-exposure, plague) where benefits outweigh risks.

Drug Interactions

Drug Interactions

Chelation interactions reducing absorption: antacids (Mg/Al), sucralfate, iron, zinc/multivitamins (separate dosing); pharmacodynamic risks: QT-prolonging drugs (additive QT), corticosteroids (↑ tendon rupture), warfarin (↑ INR/bleeding), antidiabetic agents (dysglycemia), NSAIDs (↑ CNS stimulation/seizure risk).

Interaction Severity

MAJOR: QT-prolonging drugs (additive QT prolongation/torsades risk); systemic corticosteroids (increased tendinopathy/tendon rupture risk). MODERATE: Warfarin (↑INR/bleeding-monitor); antidiabetic agents/insulin/sulfonylureas (dysglycemia-monitor); NSAIDs (↑CNS stimulation/seizure risk); theophylline (possible ↑levels/CNS effects-monitor). MINOR/CLINICALLY SIGNIFICANT PK: Antacids/sucralfate/iron/zinc/calcium/multivitamins/dairy (↓absorption-separate dosing).

Food Interaction

Tablets may be taken without regard to meals; avoid coadministration with polyvalent cations (including dairy/calcium-fortified products, antacids, iron, zinc, calcium, multivitamins) and separate by at least 2 hours before/after.

Special Populations

Children

Approved for children 6 months and older for inhalational anthrax and plague. For children <50 kg and ≥ 6 months: 8 mg/kg every 12 hours (not to exceed 250mg per dose). For children >50 kg: 500 mg every 24 hours.

Elderly

Standard adult dosing; however, elderly patients are at increased risk of tendon rupture, QT prolongation, and CNS adverse effects. Monitor renal function and adjust dose accordingly

Kidney Impairment

Dose adjustment required when CrCl <50 mL/min; for a 750 mg regimen: CrCl 20-49 mL/min: 750 mg every 48 hours; CrCl 10-19 mL/min (and HD/CAPD): 750 mg once, then 500 mg every 48 hours.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near next dose. Do not double the dose.

Stopping the Medicine

Complete the prescribed course unless serious adverse effects occur; stop immediately and seek care if tendon pain/swelling, neuropathy symptoms, severe hypersensitivity (rash/angioedema), severe CNS effects, or severe/persistent diarrhea occur.

Overdose

Expected overdose effects include CNS toxicity (confusion, dizziness, seizures), GI upset, and QT prolongation/arrhythmias; management is supportive (consider activated charcoal if early), maintain hydration, monitor ECG/electrolytes; hemodialysis does not effectively remove levofloxacin.

Patient Counseling

Take once daily exactly as prescribed and complete the course. May take with or without food; drink fluids. Separate from antacids/iron/zinc/calcium/multivitamins/dairy by ≥2 hours. Stop and seek care urgently for tendon pain/swelling, new numbness/tingling/weakness, severe or bloody diarrhea, severe rash/allergy, or palpitations/fainting. Limit sun/UV exposure and use sunscreen; use caution driving if dizzy; inform clinician about kidney disease, QT issues, seizures, myasthenia gravis, steroid use, and diabetes (monitor glucose).

Monitoring Requirements

Monitor renal function (baseline and during therapy if impaired/prolonged), blood glucose in diabetics, and clinical signs of tendinopathy/tendon rupture, peripheral neuropathy, and severe diarrhea (C. difficile). Consider ECG/electrolytes in patients with QT-risk factors or on QT-prolonging drugs.

Pharmacology

Mechanism of Action

Inhibits bacterial DNA gyrase and topoisomerase IV, which are enzymes required for DNA replication, transcription, repair, and recombination, leading to inhibition of bacterial cell division and death.

Onset of Action

Peak plasma concentration occurs about 1-2 hours after an oral dose; clinical improvement is often seen within 24-72 hours depending on infection.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

6-8 hours

Bioavailability

Approximately 99% (oral bioavailability).

Metabolism

Minimal metabolism (limited hepatic metabolism); largely excreted unchanged.

Excretion

Primarily renal; about 80-87% excreted unchanged in urine within ~48 hours.

Protein Binding

24-38%

Product Information

Available Dosage Forms

For EVOX specifically (per verified API data): Film‑coated tablet for oral use (750 mg).

Composition per Dose

Each film-coated tablet: 750mg levofloxacin

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Broad-spectrum

Antibiotic Class

Fluoroquinolones

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 25-07-2026