LEVAQUIN 500/MG FC TAB 5/FC TAB

Indications

Off-Label Uses

Off-label examples: multidrug-resistant tuberculosis (second-line), traveler’s diarrhea, epididymitis/epididymo-orchitis (pathogen-directed), and some cases of pelvic inflammatory disease as part of combination therapy where appropriate.

Dosage & Administration

Dosing by Condition

Community-acquired pneumonia: 500mg once daily for 7-14 days or 750mg once daily for 5 days. Nosocomial pneumonia: 750mg once daily for 7-14 days. Acute bacterial sinusitis: 500mg once daily for 10-14 days or 750mg once daily for 5 days. Acute bacterial exacerbation of chronic bronchitis: 500mg once daily for 7 days.

Initial Dose

500mg once daily (most indications)

Maintenance Dose

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

Maximum Dose

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

Children's Dosage

Not approved for children under 18 years for most indications. Exception: inhalational anthrax and plague in pediatric patients - dosing based on weight (8mg/kg every 12 hours, max 250mg per dose) for children under 50kg

Dose Adjustment Notes

Dose adjustment is required in renal impairment (typically when CrCl <50 mL/min); no routine hepatic dose adjustment. Avoid coadministration with antacids/sucralfate/iron/zinc-separate by ≥2 hours.

How to Take

Swallow the 500 mg film‑coated tablet whole with a full glass of water; may be taken with or without food. Maintain adequate hydration. Separate from polyvalent cations/chelators (antacids containing Mg/Al, sucralfate, iron, zinc, multivitamins) by at least 2 hours before or 2 hours after.

Side Effects

Common Side Effects

Nausea, diarrhea, headache, dizziness, insomnia (and other common GI effects such as abdominal pain/dyspepsia may occur).

Side Effect Frequency

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

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to levofloxacin or other quinolones/any component. (Other items listed by the models-e.g., myasthenia gravis, tendon disorder history, epilepsy, pregnancy/breastfeeding, QT-risk drug combinations-are generally warnings/precautions or use-not-recommended situations rather than absolute contraindications in most labeling.)

Warnings & Precautions

Warnings/precautions: reserve use when benefits outweigh risks due to disabling adverse reactions; tendinopathy/tendon rupture risk (higher age >60, corticosteroids, transplant); peripheral neuropathy-stop immediately if symptoms; CNS effects/seizure risk; QT prolongation risk (electrolyte abnormalities, congenital QT, interacting drugs); myasthenia gravis exacerbation-avoid; C. difficile diarrhea; severe hypersensitivity; dysglycemia in diabetics; photosensitivity; aortic aneurysm/dissection risk in susceptible patients.

Age Restriction

Not routinely approved/recommended in patients <18 years; may be used in pediatrics only for limited indications (e.g., inhalational anthrax post-exposure and plague) per product labeling, with pediatric use permitted from 6 months of age for these indications.

Driving Warning

Caution advised; may cause dizziness, CNS effects

Drug Interactions

Drug Interactions

Key interactions: polyvalent cations (Al/Mg antacids, sucralfate, iron, zinc, calcium) reduce absorption-separate dosing; warfarin-may increase INR/bleeding; antidiabetic agents/insulin-dysglycemia risk; QT-prolonging drugs-additive QT prolongation; NSAIDs-may increase CNS stimulation/seizure risk; probenecid/cimetidine-reduce renal clearance (↑ levels). (Theophylline/cyclosporine interactions are not typically clinically significant with levofloxacin compared with some other fluoroquinolones but CNS-seizure risk is a consideration.)

Interaction Severity

MAJOR: QT‑prolonging drugs (additive QT prolongation/torsades risk); warfarin (↑INR/bleeding-monitor closely). MODERATE: Antidiabetic agents (dysglycemia), NSAIDs (↑CNS stimulation/seizure risk), theophylline (CNS/toxicity risk), probenecid/cimetidine (↓renal clearance → ↑levels). MINOR/ADMINISTRATION: Antacids, sucralfate, iron, zinc, calcium/dairy (↓absorption-separate dosing).

Food Interaction

Can be taken with or without food; avoid taking concurrently with dairy products or calcium-fortified juices and with antacids/iron/zinc/sucralfate-separate by ≥2 hours.

Special Populations

Pregnancy

Not Assigned (Risk Summary: Limited human data)

Breastfeeding

Use with caution; potential for serious adverse effects

Children

Not approved for children under 18 years for most indications. Exception: inhalational anthrax and plague in pediatric patients - dosing based on weight (8mg/kg every 12 hours, max 250mg per dose) for children under 50kg

Elderly

Standard adult dosing; however, elderly patients are at increased risk of tendon rupture, QT prolongation, and CNS effects. Monitor renal function and adjust dose accordingly. Use with caution in patients on corticosteroids

Liver Impairment

No hepatic dose adjustment needed.

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

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

Overdose

Overdose may cause CNS effects (confusion, dizziness, seizures), GI upset (nausea/vomiting), and QT prolongation; management is supportive with ECG monitoring and seizure control as needed; no specific antidote and levofloxacin is not effectively removed by hemodialysis/peritoneal dialysis.

Patient Counseling

Take exactly as prescribed and complete the full course. Swallow whole with water; stay well hydrated. Separate from antacids, sucralfate, iron, zinc, multivitamins, and dairy/calcium products by ≥2 hours. Stop and seek care urgently for tendon pain/swelling, sudden joint pain, numbness/tingling/weakness (neuropathy), severe mood/CNS changes, severe rash, or severe/persistent diarrhea. Use sun protection (photosensitivity). If diabetic, monitor glucose closely. Use caution driving if dizzy/confused.

Monitoring Requirements

Monitor renal function (especially if elderly/renal impairment) and adjust dose accordingly; monitor for tendinopathy/tendon rupture, peripheral neuropathy, CNS effects, and severe diarrhea (C. difficile). In diabetics, monitor blood glucose; consider ECG/electrolytes if at risk for QT prolongation; during prolonged therapy consider periodic CBC and hepatic/renal function.

Pharmacology

Mechanism of Action

Inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, blocking DNA replication/transcription/repair and leading to bacterial cell death.

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.

Half-Life

Approximately 6-8 hours in adults with normal renal function (prolonged in renal impairment).

Bioavailability

>99%.

Metabolism

Minimal hepatic metabolism; primarily eliminated unchanged via renal excretion (urine).

Product Information

Available Dosage Forms

For this SFDA-registered product: film‑coated tablet (oral). (Levofloxacin also exists in other markets as IV infusion and oral solution, but those are not this specific product’s dosage form.)

Composition per Dose

Each film-coated tablet: 500mg levofloxacin as hemihydrate.

OTC Alternatives

No OTC alternative

Spectrum

Broad-spectrum

Antibiotic Class

Fluoroquinolone

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