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Authoritative Clinical Reference
Schedule H
Oral, Intravenous, Ophthalmic
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Parameter Recommendation
Starting dose 500 mg once daily orally or IV
Titration Not applicable
Usual maintenance dose 500 mg once daily
Maximum dose 750 mg once daily
Duration: 7–14 days (standard regimen) OR 750 mg once daily for 5 days (high-dose short-course for uncomplicated CAP)
Clinical Notes:
Parameter Recommendation
Starting dose 500 mg once daily orally
Titration Not applicable
Usual maintenance dose 500 mg once daily
Maximum dose 750 mg once daily
Duration: 10–14 days (standard) OR 750 mg once daily for 5 days (short-course)
Clinical Notes:
Parameter Recommendation
Starting dose 500 mg once daily orally
Titration Not applicable
Usual maintenance dose 500 mg once daily
Maximum dose 500 mg once daily
Duration: 7 days
Clinical Notes:
Parameter Recommendation
Starting dose 250 mg once daily orally
Titration Not applicable
Usual maintenance dose 250 mg once daily
Maximum dose 250 mg once daily
Duration: 3 days
Clinical Notes:
Parameter Recommendation
Starting dose 250–500 mg once daily orally or IV
Titration Not applicable
Usual maintenance dose 250–500 mg once daily (mild); 750 mg once daily (severe)
Maximum dose 750 mg once daily
Duration: 7–14 days (complicated UTI); 5–7 days for 750 mg regimen in pyelonephritis
Clinical Notes:
Uncomplicated:
Parameter Recommendation
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
General Statement: Systemic levofloxacin is NOT routinely recommended in children and adolescents due to risk of musculoskeletal adverse effects (arthropathy, tendinopathy) observed in juvenile animal studies. Use is restricted to situations where no safer alternative exists and benefits outweigh risks.
Use under NTEP/paediatric pulmonologist supervision only.
Weight-based Dosing:
Body Weight Daily Dose
<15 kg 15–20 mg/kg once daily (max 500 mg)
15–19.9 kg 250–375 mg once daily
20–29.9 kg 500 mg once daily
30–39.9 kg 500–750 mg once daily
≥40 kg 750–1000 mg once daily
Duration: As per NTEP paediatric MDR-TB regimen
Safety Monitoring:
Age ≥1 year:
Parameter Recommendation
Starting dose 1–2 drops in affected eye(s) every 2 hours while awake (Days 1–2)
Titration Reduce frequency after Day 2
Usual maintenance dose 1–2 drops every 4 hours while awake (Days 3–5)
Maximum dose 8 times daily
Duration: 5–7 days
Clinical Notes:
Secondary Indications — Paediatrics (Off-label)
Indication Age Dose Notes
Complicated UTI / Pyelonephritis (when no alternative) ≥6 months 10 mg/kg once daily (max 500 mg) orally or IV OFF-LABEL — Specialist only. Use only when first-line agents (cephalosporins, aminoglycosides) contraindicated or resistant. Duration: 10–14 days. Based on international paediatric ID guidelines.
Typhoid Fever (fluoroquinolone-sensitive) ≥1 year 10–15 mg/kg once daily (max 500 mg) orally OFF-LABEL — Specialist only. Use only when susceptibility confirmed. Duration: 7–10 days. Based on Indian paediatric ID practice.
Anthrax (post-exposure prophylaxis/treatment) ≥6 months 8 mg/kg every 12 hours (max 250 mg per dose) OFF-LABEL — Use in bioterrorism or confirmed exposure only. Duration: 60 days for prophylaxis. CDC/emergency guidelines.
Minimum Age Statement: Systemic levofloxacin not recommended in children below 6 months of age except in life-threatening infections with no alternative (specialist supervision mandatory). Ophthalmic use not recommended below 1 year of age.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| ≥50 | No adjustment: 500 mg every 24 hours No adjustment: 750 mg every 24 hours |
| 20–49 | Initial: 500 mg, then 250 mg every 24 hours Initial: 750 mg, then 500 mg every 24 hours |
| 10–19 | Initial: 500 mg, then 250 mg every 48 hours Initial: 750 mg, then 500 mg every 48 hours |
| <10 | (not on dialysis) Initial: 500 mg, then 250 mg every 48 hours Initial: 750 mg, then 500 mg every 48 hours |
| Haemodialysis | Initial: 500 mg, then 250 mg every 48 hours (no supplemental dose post-dialysis needed) Initial: 750 mg, then 500 mg every 48 hours |
CAPD Initial: 500 mg, then 250 mg every 48 hours Initial: 750 mg, then 500 mg every 48 hours
Note: For uncomplicated UTI (250 mg regimen), reduce to 250 mg every 48 hours if CrCl <20 mL/min.
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | No dose adjustment required; monitor for CNS and QT effects |
| Severe impairment (Child-Pugh C) | Limited data; use with caution; no specific dose adjustment but monitor closely for adverse effects including CNS toxicity and QT prolongation |
Parameter Recommendation
Safety Category Generally contraindicated for systemic use; potential risk of cartilage damage in developing fetus (animal studies); limited human data
Preferred Alternatives Beta-lactams (penicillins, cephalosporins), macrolides (azithromycin for atypicals) for respiratory infections; nitrofurantoin (1st/2nd trimester) for UTI
When to Use Only in life-threatening infections where no safer alternative exists; requires specialist input and informed consent
Monitoring Fetal growth surveillance; joint development assessment if exposed
Ophthalmic Use: May be used if benefits outweigh risks; minimal systemic absorption.
Parameter Recommendation
Breastfeeding Compatibility Generally not recommended for systemic use; excreted in breast milk; theoretical risk of arthropathy in nursing infant
Drug Levels in Milk Moderate (similar to maternal plasma levels)
Preferred Alternatives Beta-lactams (amoxicillin, cephalosporins), macrolides for respiratory infections; nitrofurantoin for UTI
Infant Monitoring If used: monitor for diarrhoea, candidiasis, feeding difficulties; observe for any signs of joint problems
Ophthalmic Use: Compatible with breastfeeding; negligible systemic absorption.
Parameter Recommendation
Starting dose Standard dose initially; adjust for renal function (calculate CrCl)
Titration Not applicable
Maximum dose As per renal function; use lower doses in impaired renal function
Additional Risks Tendon rupture (Achilles tendon especially) — risk increases significantly in elderly and with corticosteroid use; QT prolongation; CNS effects (confusion, agitation, hallucinations, insomnia); hypoglycaemia (especially with concurrent antidiabetics); C. difficile colitis
Monitoring Baseline ECG if cardiac risk factors; renal function; mental status; blood glucose in diabetics; monitor for tendon pain
Note: Warn elderly patients about tendon pain — discontinue immediately if occurs. Avoid concurrent corticosteroids if possible.
Interacting Drug Mechanism/Effect Management
Tizanidine Levofloxacin inhibits CYP1A2; massively increased tizanidine levels causing severe hypotension, sedation, bradycardia Contraindicated — avoid concurrent use
Class IA antiarrhythmics (quinidine, procainamide) Additive QT prolongation; risk of torsades de pointes Avoid combination; if essential, ECG monitoring and electrolyte correction
Class III antiarrhythmics (amiodarone, sotalol) Additive QT prolongation; significant arrhythmia risk Avoid combination; if essential, close ECG monitoring
NSAIDs Increased CNS stimulation and seizure risk (synergistic effect on GABA inhibition) Use with caution; avoid in patients with seizure history
Systemic corticosteroids Significantly increased risk of tendon rupture Avoid concurrent use if possible; if essential, warn patient; discontinue at first sign of tendon pain
Theophylline Increased theophylline levels; risk of theophylline toxicity (seizures, arrhythmias) Monitor theophylline levels; may need dose reduction
Warfarin Enhanced anticoagulant effect; increased INR; bleeding risk Monitor INR closely; adjust warfarin dose as needed
Multivalent cations (aluminium/magnesium antacids, calcium, iron, zinc supplements, sucralfate) Chelation significantly reduces levofloxacin absorption Administer levofloxacin at least 2 hours before or 6 hours after these products
Insulin, sulfonylureas Dysglycaemia (both hypoglycaemia and hyperglycaemia); may be severe Monitor blood glucose closely; adjust antidiabetic doses as needed
Interacting Drug Effect Management
Other QT-prolonging drugs (macrolides, antipsychotics, ondansetron, TCAs) Additive QT prolongation risk ECG monitoring if co-prescribed; correct electrolytes
Methotrexate (high-dose) Reduced methotrexate clearance; increased toxicity Monitor for methotrexate toxicity; may need leucovorin
Cyclosporine Possible increased cyclosporine levels; nephrotoxicity Monitor renal function and cyclosporine levels
Probenecid Reduced renal clearance of levofloxacin; increased plasma levels Usually clinically insignificant; monitor for adverse effects
Rifampicin May reduce levofloxacin levels (induction) Monitor clinical response; generally not a major concern for TB regimens
Phenytoin Altered phenytoin levels (may increase or decrease) Monitor phenytoin levels
Didanosine (buffered formulation) Contains aluminium/magnesium; reduced levofloxacin absorption Separate administration by 2 hours before or 6 hours after
Adverse Effect Clinical Significance
Tendinitis and tendon rupture May occur during or after treatment (up to months); Achilles tendon most commonly affected; risk increased in elderly, corticosteroid users, renal transplant recipients; discontinue immediately if tendon pain occurs
QT prolongation and torsades de pointes Risk increased with concurrent QT-prolonging drugs, electrolyte abnormalities, cardiac disease; ECG monitoring in high-risk patients
Clostridioides difficile-associated diarrhoea (CDAD) May range from mild diarrhoea to fatal colitis; can occur during or weeks after treatment; discontinue if significant diarrhoea develops
CNS effects Seizures, psychosis, toxic psychosis, hallucinations, anxiety, confusion, depression, suicidal ideation; discontinue if neuropsychiatric symptoms occur
Peripheral neuropathy May be irreversible; presents with pain, burning, tingling, numbness; discontinue immediately if symptoms occur
Hypersensitivity reactions Anaphylaxis, Stevens-Johnson syndrome/TEN, DRESS syndrome; discontinue immediately
Hepatotoxicity Hepatitis, hepatic failure (rare); monitor if prolonged therapy
Severe hypoglycaemia Including hypoglycaemic coma; especially in elderly diabetics on antidiabetic agents
Haemolytic anaemia In G6PD deficiency
Aortic aneurysm/dissection Emerging signal; increased risk with prolonged use, especially in elderly and those with risk factors
Baseline:
After Initiation/During Therapy:
Long-term (MDR-TB regimens):
Fixed-Dose Combinations (use judiciously):
| Brand Name | Composition | Manufacturer |
|---|---|---|
| * | Levofloxacin + Ornidazole (for mixed aerobic-anaerobic | infections) |
| * | Levofloxacin + Ambroxol (not recommended — irrational | FDC) |
Ophthalmic:
| Formulation | Approximate Price (per tablet) |
|---|---|
| Levofloxacin 250 mg tablet ₹3–₹8 per tablet | |
| Levofloxacin 500 mg tablet ₹5–₹15 per tablet | |
| Levofloxacin 750 mg tablet ₹10–₹25 per tablet | |
| Levofloxacin 500 mg/100 mL IV infusion ₹50–₹150 per unit | |
| Levofloxacin 750 mg/150 mL IV infusion ₹80–₹200 per unit | |
| Levofloxacin 0.5% eye drops (5 mL) ₹30–₹80 per bottle |
levofloxacin; fluoroquinolone; respiratory infection; CAP; UTI; MDR-TB; NTEP; ophthalmic antibiotic; QT-prolongation; tendon-rupture; renal-adjustment; NLEM; pregnancy-avoid
RxIndia v1.0 — 10 Jan 2025
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