Schedule H

Oral, Intravenous, Ophthalmic

• Tablets: 400 mg (film-coated)

• Injection: 400 mg/250 mL (IV infusion solution)

• Ophthalmic solution: 0.5% w/v (5 mg/mL) in 5 mL bottle

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

▶ 1. Community-Acquired Pneumonia (CAP) — Moderate to Severe

Parameter Recommendation

Starting dose 400 mg once daily (oral or IV)

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg once daily

Duration: 7–14 days (typically 7–10 days for uncomplicated cases)

Key Clinical Notes:

• Oral and IV formulations are bioequivalent (~90% oral bioavailability)

• IV-to-oral switch feasible once patient is clinically stable and tolerating oral intake

• Covers typical pathogens (S. pneumoniae, H. influenzae, M. catarrhalis) and atypicals (Mycoplasma, Chlamydophila, Legionella)

• Reserve for patients with risk factors for resistant organisms or when beta-lactam/macrolide regimens are unsuitable

▶ 2. Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) / COPD

Parameter Recommendation

Starting dose 400 mg once daily orally

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg once daily

Duration: 5–7 days

Key Clinical Notes:

• Reserve for patients with risk factors for Gram-negative or resistant organisms

• Not first-line therapy; consider amoxicillin-clavulanate or azithromycin first

• Assess local resistance patterns before prescribing

▶ 3. Acute Bacterial Sinusitis

Parameter Recommendation

Starting dose 400 mg once daily orally

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg once daily

Duration: 7–10 days

Key Clinical Notes:

• Third-line agent; reserve for treatment failure with amoxicillin-clavulanate or in penicillin-allergic patients

• Consider local antibiogram and resistance patterns

▶ 4. Complicated Skin and Soft Tissue Infections

Parameter Recommendation

Starting dose 400 mg once daily (oral or IV)

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg once daily

Duration: 7–21 days (based on clinical response)

Key Clinical Notes:

• Not first-line for most skin infections

• Consider when anaerobic coverage required and beta-lactams unsuitable

• IV initiation for severe infections; switch to oral when clinically appropriate

▶ 5. Multidrug-Resistant Tuberculosis (MDR-TB) — As Part of Combination Regimen

Parameter Recommendation

Starting dose 400 mg once daily orally

Titration Not applicable

Usual maintenance dose 400 mg once daily

Maximum dose 400 mg once daily

Duration: As per ICMR-PMDT protocol (typically 9–20 months as part of full regimen)

Key Clinical Notes:

• Specialist use only under RNTCP/PMDT guidelines

• Part of Group A drugs in WHO classification for MDR-TB

• Must be used in combination with other anti-TB drugs; never as monotherapy

• Baseline and periodic ECG monitoring mandatory (QTc prolongation risk)

• Do not use for drug-sensitive TB to preserve efficacy for resistant strains

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

⚠️ Moxifloxacin is NOT routinely recommended in children <18 years due to risk of cartilage and tendon toxicity in growing individuals.

Secondary Indications — Paediatrics (Off-label)

▶ Multidrug-Resistant Tuberculosis (MDR-TB) — OFF-LABEL

≥6 years 10–15 mg/kg once daily orally (maximum 400 mg/day) As per ICMR-PMDT paediatric guidelines

<6 years 10–15 mg/kg once daily orally (maximum 400 mg/day) Only if no alternative; paediatric TB specialist supervision mandatory

Duration: As per full MDR-TB treatment regimen (9–20 months)

Key Clinical Notes:

• Use only under paediatric infectious disease or TB specialist supervision

• Part of combination regimen; never as monotherapy

• Benefits may outweigh risks in life-threatening MDR-TB when alternatives are limited

▶ Serious Life-Threatening Infections (Plague, Anthrax, Tularaemia) — OFF-LABEL

All ages 10 mg/kg once daily (oral or IV); maximum 400 mg/day Only for bioterrorism-related emergencies or confirmed severe infections

Duration: Based on specific indication and clinical response

Safety Monitoring (All Paediatric Use):

• Joint pain or swelling — discontinue immediately if occurs

• Tendon symptoms — immediate cessation required

• ECG for QTc interval — baseline and periodic monitoring

• Liver function tests — baseline and periodically

• Visual assessment in prolonged use

⚠️ Not recommended in children <18 years for routine infections. Off-label paediatric use only for MDR-TB or life-threatening infections where no safer alternative exists, under specialist supervision.

Note: Moxifloxacin is primarily metabolised hepatically with minimal renal excretion (~20% unchanged in urine).

• Known hypersensitivity to moxifloxacin or any other fluoroquinolone

• History of tendon disorders (tendinitis, tendon rupture) associated with fluoroquinolone use

• Congenital or documented acquired QT prolongation

• Concurrent use with Class IA antiarrhythmics (quinidine, procainamide, disopyramide)

• Concurrent use with Class III antiarrhythmics (amiodarone, sotalol, dofetilide)

• Uncorrected hypokalaemia or hypomagnesaemia

• Clinically significant bradycardia

• Acute decompensated heart failure with reduced LVEF

• Children and adolescents <18 years (routine use)

• History of QTc prolongation or risk factors (elderly, female sex, cardiac disease)

• Electrolyte disturbances — correct hypokalaemia and hypomagnesaemia before initiation

• Concurrent use of other QT-prolonging medications

• History of seizures or conditions predisposing to seizures (CNS lesions, epilepsy)

• Myasthenia gravis — may exacerbate muscle weakness; avoid if possible

• Elderly patients — increased risk of tendinopathy, QT prolongation, CNS effects

• Concurrent corticosteroid use — significantly increases tendon rupture risk

• Diabetes mellitus — risk of both hypoglycaemia and hyperglycaemia; monitor glucose

• G6PD deficiency — potential for haemolytic reactions

• Aortic aneurysm or dissection history — fluoroquinolones associated with increased risk

• Peripheral neuropathy history — may worsen or precipitate symptoms

Aspect Details

Risk category Not recommended; animal studies show cartilage toxicity in developing fetus

Safety statement Avoid during pregnancy; fluoroquinolones cross placenta

Preferred alternatives Beta-lactams (amoxicillin-clavulanate, ceftriaxone); macrolides (azithromycin) for atypical coverage

When to use Only if life-threatening infection with no safer alternative; specialist input essential

Monitoring Fetal ultrasound for musculoskeletal assessment if used; maternal ECG for QTc

Aspect Details

Compatibility Not routinely recommended during breastfeeding

Drug levels in milk Low — excreted in small amounts

Preferred alternatives Azithromycin, cefixime, amoxicillin-clavulanate

When to use If essential and no alternative; short-term use may be considered with monitoring

Infant monitoring Observe for diarrhoea, oral thrush, rash, feeding difficulties

Aspect Recommendation

Starting dose 400 mg once daily (same as younger adults)

Titration Not applicable

Extra risks Increased susceptibility to QTc prolongation and torsades de pointes; higher tendon rupture risk (especially with concurrent corticosteroids); CNS effects (confusion, delirium, seizures) more common; increased aortic aneurysm/dissection risk

Special considerations ECG before initiation in patients with cardiac risk factors; avoid concurrent QT-prolonging drugs; discontinue immediately if tendon pain or CNS symptoms develop; monitor blood glucose in diabetics

Class IA antiarrhythmics (quinidine, procainamide, disopyramide) Additive QT prolongation; risk of torsades de pointes CONTRAINDICATED — avoid concurrent use

Class III antiarrhythmics (amiodarone, sotalol, dofetilide) Additive QT prolongation,risk of ventricular arrhythmias CONTRAINDICATED — avoid concurrent use

Antipsychotics (haloperidol, ziprasidone, pimozide, droperidol) Additive QT prolongation Avoid combination; if essential, ECG monitoring mandatory

Tricyclic antidepressants (amitriptyline, imipramine) QT prolongation risk Avoid or use with ECG monitoring

Cisapride, domperidone (high-dose) QT prolongation risk Avoid concurrent use

Erythromycin (IV), clarithromycin Additive QT prolongation Avoid concurrent use

Ondansetron (IV, high-dose) QT prolongation risk Use with caution; ECG monitoring

Interacting Drug Mechanism / Effect Management

Antacids (aluminium, magnesium), calcium supplements Chelation reduces moxifloxacin absorption Administer moxifloxacin ≥4 hours before or ≥6 hours after

Iron preparations, zinc supplements Chelation reduces absorption Administer moxifloxacin ≥4 hours before or ≥6 hours after

Sucralfate Chelation reduces absorption Administer moxifloxacin ≥4 hours before or ≥6 hours after

Didanosine (buffered formulation) Reduced moxifloxacin absorption Separate administration by at least 2 hours

NSAIDs May increase CNS stimulation and seizure risk Use with caution; monitor for CNS effects

Warfarin May enhance anticoagulant effect; INR fluctuations Monitor INR closely; adjust warfarin dose as needed

Insulin, sulfonylureas Risk of dysglycaemia (both hypoglycaemia and hyperglycaemia) Monitor blood glucose closely; educate patient on symptoms

Corticosteroids (systemic) Significantly increased tendon rupture risk Avoid combination if possible; if essential, close monitoring for tendon symptoms

Rifampicin May reduce moxifloxacin plasma concentrations (enzyme induction) Avoid if possible; if combined, monitor for clinical efficacy

Theophylline May increase theophylline levels (less than other fluoroquinolones) Monitor theophylline levels

• Nausea

• Diarrhoea

• Dizziness

• Headache

• Vomiting

• Abdominal pain

• Dyspepsia

• Transient elevation of liver enzymes (ALT, AST)

• QTc prolongation (dose-dependent; usually clinically silent)

• Taste disturbance (dysgeusia)

Ophthalmic use:

• Conjunctival irritation

• Transient ocular discomfort

• Dry eye sensation

• Blurred vision (transient)

Adverse Effect Clinical Action

Tendinitis / Tendon rupture (especially Achilles tendon) Discontinue immediately; rest affected limb; orthopaedic referral; do not rechallenge with any fluoroquinolone

QTc prolongation / Torsades de pointes Discontinue immediately; cardiac monitoring; correct electrolytes; avoid all QT-prolonging drugs

Severe hepatotoxicity (hepatitis, hepatic failure) Discontinue; supportive care; liver function monitoring

Clostridioides difficile-associated diarrhoea (CDAD) Discontinue; stool testing; treat with oral vancomycin or fidaxomicin

CNS toxicity (seizures, toxic psychosis, delirium, hallucinations) Discontinue immediately; supportive care; more common in elderly

Severe hypersensitivity reactions (anaphylaxis, SJS/TEN, DRESS) Discontinue immediately; never rechallenge; emergency management

Peripheral neuropathy (may be irreversible) Discontinue if symptoms develop; may persist after stopping drug

Aortic aneurysm / dissection Rare but life-threatening; discontinue; surgical evaluation

Severe dysglycaemia (hypoglycaemia, hyperglycaemic coma) Monitor glucose; adjust antidiabetic therapy; discontinue if severe

Phototoxicity Advise sun protection; less common than with other fluoroquinolones

During treatment Monitor for tendon pain or swelling; CNS symptoms (dizziness, confusion, seizures); gastrointestinal symptoms; blood glucose in diabetics

ECG monitoring Repeat if symptoms suggestive of arrhythmia; in high-risk patients at 48–72 hours

Long-term use (MDR-TB) Monthly LFTs; periodic ECG (every 1–2 months); visual assessment; monitor for peripheral neuropathy

Avelox Tablet 400 mg, Injection Bayer

Moxicip Tablet 400 mg,Eye drops 0.5% Cipla

Moxiford Tablet 400 mg Lupin

Milflox Tablet 400 mg,Eye drops 0.5% Sun Pharma

Moxif Tablet 400 mg,Injection Mankind

Vigamox Eye drops 0.5% Novartis/Alcon

Moxigram Tablet 400 mg Dr. Reddy's

NLEM Status Not included in NLEM 2022 Not price-controlled

Government Supply Available through RNTCP for MDR-TB Free under PMDT programme

• QTc awareness is critical: Always assess cardiac risk factors and review concomitant medications for QT-prolonging potential before prescribing; ECG recommended in elderly and cardiac patients

• Oral bioavailability is excellent (~90%): IV-to-oral switch can be made early when patient is stable and tolerating oral intake; no dose adjustment needed

• Not appropriate for UTIs: Poor urinary concentration despite high serum levels; use ciprofloxacin or levofloxacin for urinary tract infections

• Tendon rupture risk: Higher in elderly (>60 years), concurrent corticosteroid users, and renal transplant recipients; educate patients to report any tendon pain immediately

• Reserve for appropriate indications: Avoid use for uncomplicated respiratory infections where beta-lactams or macrolides are effective; helps preserve fluoroquinolone efficacy and reduce resistance

• MDR-TB use requires specialist oversight: Never use as monotherapy; follow ICMR-PMDT protocols strictly

Moxifloxacin; respiratory infections; fluoroquinolone; community-acquired pneumonia; MDR-TB; QTc prolongation risk; hepatically cleared; antimicrobial stewardship; Schedule H

RxIndia v1.0 — 13 Jun 2025

• CDSCO approved drug database and product inserts

• Indian Pharmacopoeia 2018

• AIIMS Antimicrobial Guidelines 2022

• ICMR Guidelines for Programmatic Management of Drug-resistant TB (PMDT) 2021

• API Textbook of Medicine, 11th Edition

• NLEM 2022 (Moxifloxacin not included)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Indian hospital prescribing protocols (AIIMS, PGIMER)