EMIFLOC 500 MG 7 CAPS

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 and skin structure infections, Inhalational anthrax (post-exposure), Plague.

Off-Label Uses

Potential off-label uses include multidrug-resistant tuberculosis regimens (as a fluoroquinolone option), certain severe Legionella infections, and selected cases of traveler’s diarrhea when alternatives are unsuitable; other proposed uses (e.g., meningitis, endocarditis) are not routine and generally require specialist-directed therapy based on susceptibility and guidelines.

Dosage & Administration

Dosing by Condition

Typical adult dosing (normal renal function) varies by indication; examples from established labeling/guidelines include: Community-acquired pneumonia: 500 mg once daily for 7-14 days OR 750 mg once daily for 5 days; Acute bacterial exacerbation of chronic bronchitis: 500 mg once daily for 7 days; Acute bacterial sinusitis: 500 mg once daily for 10-14 days OR 750 mg once daily for 5 days; Uncomplicated UTI: 250 mg once daily for 3 days; Complicated UTI/acute pyelonephritis: 250 mg once daily for 10 days OR 750 mg once daily for 5 days; Chronic bacterial prostatitis: 500 mg once daily for 28 days; Skin/skin-structure infections: 500 mg once daily for 7-10 days (uncomplicated) or 750 mg once daily for 7-14 days (complicated); Inhalational anthrax (post-exposure): 500 mg once daily for 60 days.

Initial Dose

250mg - 750mg once daily, depending on the infection.

Maintenance Dose

250-750 mg once daily depending on indication and severity

Maximum Dose

750mg per day for most indications

Children's Dosage

Not approved for children under 18 years except for inhalational anthrax and plague: 8 mg/kg (max 250 mg) every 12 hours for patients weighing less than 50 kg; 500 mg every 24 hours for patients weighing 50 kg or more

Dose Adjustment Notes

Dose adjustment is required in renal impairment (typically when CrCl <50 mL/min); no adjustment is generally needed in hepatic impairment; avoid coadministration with antacids/sucralfate/iron/zinc/multivitamins/calcium-separate by ≥2 hours before or after.

How to Take

Swallow the 500 mg film‑coated tablet whole with a full glass of water; may be taken with or without food; take once daily at the same time each day; maintain adequate hydration; separate from polyvalent cations (antacids containing Mg/Al, sucralfate, iron, zinc, multivitamins, calcium supplements) by at least 2 hours before or 2 hours after.

Side Effects

Common Side Effects

Nausea, diarrhea, headache, dizziness, insomnia; may also commonly include abdominal pain/dyspepsia and constipation.

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to levofloxacin/other quinolones or excipients; history of fluoroquinolone-associated tendon disorder/rupture; epilepsy/seizure disorder (per many product labels); myasthenia gravis (avoid/contraindicated in labeling due to exacerbation risk).

Warnings & Precautions

Warnings/precautions: reserve use when alternatives are unsuitable due to risk of disabling/irreversible reactions; stop promptly for tendon pain/swelling, neuropathy, or CNS symptoms; higher tendon-rupture risk in age >60, corticosteroid use, and transplant patients; avoid in myasthenia gravis; caution with QT prolongation risk factors/electrolyte abnormalities and QT-prolonging drugs; risk of C. difficile diarrhea; photosensitivity; dysglycemia in diabetics; aortic aneurysm/dissection risk in susceptible patients.

Age Restriction

Not routinely recommended in patients <18 years; use only when benefits outweigh risks (e.g., post-exposure inhalational anthrax, plague, or other serious infections with no suitable alternatives).

Drug Interactions

Drug Interactions

Key interactions: polyvalent cations (Al/Mg antacids, sucralfate, iron, zinc, calcium) and didanosine-buffered products reduce absorption-separate dosing; warfarin increases INR/bleeding risk; antidiabetic agents may cause dysglycemia; NSAIDs may increase CNS stimulation/seizure risk; QT-prolonging drugs increase arrhythmia risk; probenecid/cimetidine can reduce renal clearance (↑ levels).

Interaction Severity

MAJOR: Other QT‑prolonging drugs (e.g., class IA/III antiarrhythmics such as amiodarone/sotalol; some antipsychotics) due to torsades risk. MODERATE: Warfarin (↑INR/bleeding-monitor), antidiabetic agents including insulin/sulfonylureas (dysglycemia), NSAIDs (↑CNS stimulation/seizure risk, especially predisposed). MINOR/PHARMACOKINETIC: Antacids/sucralfate/iron/zinc/multivitamins/calcium (↓absorption-manage by separation); probenecid/cimetidine (↑levofloxacin levels via reduced renal tubular secretion-usually not clinically significant but consider in renal impairment).

Food Interaction

Can be taken with or without food; avoid taking at the same time as products containing polyvalent cations (antacids with Mg/Al, sucralfate, iron, zinc, multivitamins, calcium supplements, and calcium-fortified products) and separate by at least 2 hours before or 2 hours after.

Special Populations

Children

Not approved for children under 18 years except for inhalational anthrax and plague: 8 mg/kg (max 250 mg) every 12 hours for patients weighing less than 50 kg; 500 mg every 24 hours for patients weighing 50 kg or more

Elderly

Use with caution, especially in patients over 60, those on corticosteroids, or with renal impairment, due to increased risk of tendon disorders and QT prolongation. Dose adjustment may be necessary based on renal function.

Kidney Impairment

Dose adjustment required in renal impairment (example for 500 mg once-daily regimen): CrCl 20-49 mL/min: 500 mg once then 250 mg every 24 h; CrCl 10-19 mL/min (or HD/CAPD): 500 mg once then 250 mg every 48 h.

Liver Impairment

No hepatic dose adjustment required.

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Do not stop early without prescriber advice; complete the prescribed course unless serious adverse effects occur (e.g., tendon pain/swelling, neuropathy symptoms, severe rash, severe diarrhea), in which case stop and seek urgent medical care.

Overdose

Overdose may cause CNS toxicity (confusion, dizziness, seizures), GI upset, and QT prolongation/arrhythmias; management is supportive (airway/ventilation as needed, seizure control, ECG monitoring), consider decontamination if early, and hemodialysis does not effectively remove levofloxacin.

Patient Counseling

Take exactly as prescribed and complete the full course; take once daily with a full glass of water and maintain hydration; may take with or without food; separate from antacids/sucralfate/iron/zinc/multivitamins/calcium by ≥2 hours before/after; limit sun/UV exposure and use protection (photosensitivity); stop and seek care urgently for tendon pain/swelling, new numbness/tingling/weakness (neuropathy), severe rash, palpitations/syncope, or severe/persistent diarrhea; if diabetic, monitor glucose closely; use caution driving if dizzy.

Monitoring Requirements

Monitor renal function (especially if elderly or renally impaired) for dose adjustment; monitor blood glucose in patients with diabetes or on hypoglycemics; consider ECG/QT risk assessment in patients with QT prolongation risk or on QT‑prolonging drugs; counsel/monitor for tendinopathy/tendon rupture and peripheral neuropathy; monitor for severe diarrhea/C. difficile; consider LFTs if prolonged therapy or hepatic symptoms.

Pharmacology

Mechanism of Action

Inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination, leading to bacterial cell death

Onset of Action

Peak plasma concentration occurs about 1-2 hours after an oral dose; clinical improvement is typically assessed within 48-72 hours depending on infection and source control.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

Mean terminal plasma elimination half-life is approximately 6.1 hours in females and 7.5 hours in males following a 500 mg oral dose

Bioavailability

>99%.

Metabolism

Levofloxacin undergoes minimal hepatic metabolism (approximately <5%); it is eliminated primarily as unchanged drug in the urine, with minor metabolites including desmethyl-levofloxacin and levofloxacin N-oxide.

Excretion

Primarily renal elimination: ~80-87% excreted unchanged in urine (within ~48 hours); minor fecal excretion (~<5%).

Protein Binding

24-38%.

Product Information

Available Dosage Forms

For EMIFLOC specifically (per verified SFDA data): oral film‑coated tablet, 500 mg (blister pack of 7).

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative (levofloxacin is prescription-only).

Spectrum

Broad

Antibiotic Class

Fluoroquinolone

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