RAFLOX 500/MG FC TAB 5/FC TAB

Indications

Approved Uses

Nosocomial pneumonia, Community-acquired pneumonia, Acute bacterial rhinosinusitis, Acute bacterial exacerbation of chronic bronchitis, Chronic bacterial prostatitis, Acute pyelonephritis, Complicated and uncomplicated urinary tract infections, Complicated and uncomplicated skin or skin structure infections, Inhalational anthrax (post-exposure), Plague.

Off-Label Uses

Multidrug-resistant tuberculosis (as part of combination therapy); traveler’s diarrhea (when a fluoroquinolone is appropriate based on resistance patterns); epididymitis/prostatitis in selected scenarios based on local guidance and susceptibility.

Dosage & Administration

Dosing by Condition

Typical adult regimens (normal renal function): Community-acquired pneumonia: 750 mg once daily x 5 days OR 500 mg once daily x 7-14 days. Acute bacterial sinusitis: 750 mg once daily x 5 days OR 500 mg once daily x 10-14 days. Acute bacterial exacerbation of chronic bronchitis: 500 mg once daily x 7 days.

Initial Dose

250 mg, 500 mg, or 750 mg once daily, depending on the indication.

Maintenance Dose

250mg, 500mg, or 750mg once daily, depending on the indication.

Maximum Dose

750mg per day for most indications; up to 1000mg for tuberculosis.

Children's Dosage

Approved for pediatric patients ≥6 months for inhalational anthrax (post-exposure) and plague. Tablets only for patients ≥30 kg. For inhalational anthrax/plague: Pediatric patients ≥50 kg: 500 mg every 24 hours; Pediatric patients 30-<50 kg: 250 mg every 12 hours (tablets); Pediatric patients <30 kg: alternative formulations required.

Dose Adjustment Notes

Dose adjustment is required in renal impairment (typically when CrCl < 50 mL/min); no adjustment is generally needed in hepatic impairment. Separate dosing from antacids/iron/zinc/sucralfate by ≥2 hours to avoid reduced absorption.

How to Take

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

Side Effects

Common Side Effects

Nausea, diarrhea, headache, dizziness, insomnia (and other GI effects such as abdominal pain/constipation can occur).

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to levofloxacin/other quinolones; history of serious hypersensitivity to fluoroquinolones. (Myasthenia gravis is a strong warning/avoidance, not a strict contraindication in many labels; epilepsy, tendon disorder history, and QT-drug combinations are typically warnings/precautions rather than absolute contraindications.)

Warnings & Precautions

Warnings/precautions: tendonitis/tendon rupture risk (↑ with age >60, corticosteroids, transplant), peripheral neuropathy (stop if symptoms), CNS effects/seizure risk, myasthenia gravis exacerbation (avoid), QT prolongation risk (electrolyte abnormalities, cardiac disease, QT drugs), dysglycemia (monitor diabetics), C. difficile diarrhea, photosensitivity, and aortic aneurysm/dissection risk in at-risk patients.

Age Restriction

Not approved for pediatric patients <6 months or <30 kg (tablets). Approved for pediatric patients ≥6 months and ≥30 kg only for inhalational anthrax (post-exposure) and plague.

Drug Interactions

Drug Interactions

Key interactions: polyvalent cations (Al/Mg antacids, sucralfate, iron, zinc, multivitamins) reduce absorption-separate dosing; warfarin-↑INR/bleeding risk; QT-prolonging drugs-additive QT risk; corticosteroids-↑tendon rupture risk; antidiabetic agents/insulin-dysglycemia risk; NSAIDs-↑CNS stimulation/seizure risk; probenecid/cimetidine-↓renal clearance (↑levels).

Interaction Severity

MAJOR/clinically significant: QT-prolonging drugs (additive QT prolongation/torsades risk); warfarin (may increase anticoagulant effect-bleeding risk); systemic corticosteroids (increased risk of tendinitis/tendon rupture). MODERATE: Antidiabetic agents (dysglycemia); NSAIDs (increased CNS stimulation/seizure risk); probenecid/cimetidine (reduced renal clearance-higher levels). MINOR to MODERATE (management by separation): Antacids, sucralfate, iron, zinc, multivitamins (reduced absorption).

Food Interaction

Can be taken with or without food; avoid co-administration with antacids/sucralfate/iron/zinc/multivitamins-separate by at least 2 hours.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Approved for pediatric patients ≥6 months for inhalational anthrax (post-exposure) and plague. Tablets only for patients ≥30 kg. For inhalational anthrax/plague: Pediatric patients ≥50 kg: 500 mg every 24 hours; Pediatric patients 30-<50 kg: 250 mg every 12 hours (tablets); Pediatric patients <30 kg: alternative formulations required.

Elderly

Standard adult dosing, but adjust for renal function as elderly patients are more likely to have decreased renal function. Use with caution, as the elderly are at increased risk for tendon disorders and QT prolongation.

Kidney Impairment

For regimens equivalent to 500 mg once daily: CrCl 20-49 mL/min: 500 mg once then 250 mg every 24 h; CrCl 10-19 mL/min (including HD/CAPD): 500 mg once then 250 mg every 48 h.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; if it is close to the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

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

Overdose

Overdose may cause GI upset, dizziness/confusion, seizures/CNS effects, and QT prolongation; management is supportive with ECG monitoring and correction of electrolytes, consider decontamination if early; hemodialysis/peritoneal dialysis does not effectively remove levofloxacin.

Patient Counseling

Take exactly as prescribed and complete the course. May take with or without food; separate from antacids/iron/zinc/multivitamins/sucralfate by ≥2 hours. Maintain hydration. Avoid excessive sun/UV exposure and use sunscreen. Stop and seek care for tendon pain/swelling, new numbness/tingling or weakness (neuropathy), severe mood/CNS changes, allergic reaction, or severe/persistent diarrhea. Use caution driving if dizzy; inform clinician about heart rhythm problems, seizure history, myasthenia gravis, diabetes, or warfarin use.

Monitoring Requirements

Monitor renal function when impairment is present (and adjust dose accordingly); monitor blood glucose in diabetics; monitor INR if on warfarin; monitor for tendinopathy/tendon rupture, peripheral neuropathy, CNS effects, and severe/persistent diarrhea (C. difficile). Consider ECG (and electrolytes) in patients with QT-risk factors or on QT-prolonging drugs.

Pharmacology

Onset of Action

Peak plasma concentrations occur about 1-2 hours after an oral dose; clinical improvement is typically assessed within 48-72 hours depending on infection severity.

Duration of Effect

Approximately 24 hours (supports once-daily dosing for most indications).

Product Information

Available Dosage Forms

Film-coated tablet (250 mg, 500 mg, 750 mg); levofloxacin also available as oral solution and IV infusion.

Composition per Dose

Each film-coated tablet: 500mg levofloxacin

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Broad

Antibiotic Class

Fluoroquinolone

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