Schedule H

Oral

• Tablets: 150 mg, 300 mg

• Dispersible Tablets: 50 mg, 100 mg

• Oral Suspension: 50 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

⮞ Upper Respiratory Tract Infections

(Pharyngitis, tonsillitis, sinusitis, otitis media)

Parameter Recommendation

Starting dose 150 mg orally twice daily

Titration Not applicable

Usual maintenance dose 150 mg twice daily OR 300 mg once daily

Maximum dose 300 mg/day

Key Clinical Notes:

• Duration: 5–10 days depending on infection severity

• Administer before meals (1 hour before or 2 hours after) for optimal absorption

• Alternative for patients with beta-lactam allergy

⮞ Lower Respiratory Tract Infections

(Acute bronchitis, acute exacerbation of chronic bronchitis)

Parameter Recommendation

Starting dose 150 mg orally twice daily

Titration Not applicable

Usual maintenance dose 150 mg twice daily OR 300 mg once daily

Maximum dose 300 mg/day

Key Clinical Notes:

• Duration: 7–10 days

• Good coverage for atypical pathogens (Mycoplasma, Chlamydophila)

• Consider culture if no response within 72 hours

⮞ Community-Acquired Pneumonia (Mild to Moderate)

Parameter Recommendation

Starting dose 150 mg orally twice daily

Titration Not applicable

Usual maintenance dose 150 mg twice daily OR 300 mg once daily

Maximum dose 300 mg/day

Key Clinical Notes:

• Duration: 7–10 days

• Preferred alternative in beta-lactam allergy

• Covers typical and atypical respiratory pathogens

• Not suitable for severe CAP requiring hospitalisation

⮞ Skin and Soft Tissue Infections (Mild to Moderate)

(Impetigo, erysipelas, cellulitis — where oral therapy appropriate)

Parameter Recommendation

Starting dose 150 mg orally twice daily

Titration Not applicable

Usual maintenance dose 150 mg twice daily

Maximum dose 300 mg/day

Key Clinical Notes:

• Duration: 5–10 days

• Effective against Streptococcus pyogenes and Staphylococcus aureus (MSSA)

• Not first-line; consider when penicillins contraindicated

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Genital Chlamydia trachomatis infection 300 mg once daily 10 days OFF-LABEL; Alternative when azithromycin not available or contraindicated; Based on international guidelines; Limited Indian data; Specialist supervision recommended

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

⮞ Upper and Lower Respiratory Tract Infections

(Pharyngitis, tonsillitis, otitis media, bronchitis)

Weight-based Dosing:

Body Weight Suspension Dose (50 mg/5 mL) Total Dose per Administration Frequency

6–10 kg 2.5 mL 25 mg Twice daily

11–20 kg 5 mL 50 mg Twice daily

21–40 kg 7.5–10 mL 75–100 mg Twice daily

40 kg Adult dosing 150 mg Twice daily

Dosing Summary:

Parameter Recommendation

Starting dose 5–8 mg/kg/day divided in two doses

Titration Not applicable

Usual maintenance dose 5–8 mg/kg/day in two divided doses

Maximum dose 300 mg/day or adult dose

Key Clinical Notes:

• Duration: 5–10 days

• Administer before meals for optimal absorption

• Shake suspension well before use

Safety Monitoring:

• Monitor for GI upset (nausea, diarrhoea, abdominal pain)

• Watch for skin rash or signs of hypersensitivity

• Baseline LFTs if therapy expected to exceed 10 days

Age Restriction Statement:

Not recommended in infants <2 months of age. Use in children below 1 year requires specialist supervision.

Secondary Indications — Paediatrics (Off-label, if any)

None documented in Indian guidelines.

Mild to moderate impairment (CrCl 30–89 mL/min) No dose adjustment required

Severe impairment (CrCl <30 mL/min) Use with caution; consider extended dosing interval (e.g., once daily dosing); monitor clinical response

Haemodialysis Not significantly dialysed; no supplemental dose required

Peritoneal dialysis No specific data; use with caution

• Known hypersensitivity to roxithromycin or any macrolide antibiotic

• Severe hepatic dysfunction or active liver disease

• Concurrent use with ergot alkaloids (ergotamine, dihydroergotamine) — risk of severe ergotism

• Concurrent use with cisapride or pimozide — risk of life-threatening arrhythmias

• Known history of QT prolongation or congenital long QT syndrome

• History of ventricular arrhythmias including Torsades de Pointes

• Mild to moderate hepatic impairment — monitor LFTs with prolonged therapy

• Pre-existing cardiac disease or electrolyte abnormalities — consider QT prolongation risk

• Myasthenia gravis — may exacerbate muscle weakness

• History of C. difficile-associated diarrhoea

• Concurrent use with other QT-prolonging drugs

• Elderly patients — increased susceptibility to cardiac adverse effects

• Drug interaction potential due to CYP3A4 inhibition (though less potent than erythromycin)

Parameter Information

Risk category Category C (limited human data)

Safety statement Animal studies show no teratogenicity; limited human pregnancy data

Preferred alternatives Azithromycin or Amoxicillin (if not allergic) — preferred in Indian obstetric practice

When to use Only if benefit clearly justifies potential risk; specialist input recommended

Monitoring Monitor fetal growth with prolonged use; routine obstetric surveillance

Parameter Information

Compatibility Compatible with breastfeeding

Drug level in milk Low

Preferred alternatives Azithromycin may be preferred for single-dose regimens; roxithromycin acceptable

Infant monitoring Watch for diarrhoea, oral thrush, or skin rash in nursing infant

• Starting dose: 150 mg once daily initially; increase to twice daily if tolerated

• Titration: Gradual increase based on clinical response and tolerance

• Additional considerations:

• Assess baseline hepatic and renal function before initiation

• Increased susceptibility to QT prolongation — consider baseline ECG if cardiac history

• Higher risk of drug interactions due to polypharmacy

• Monitor for hypotension and dehydration from GI adverse effects

• Fall risk if GI upset causes weakness or dehydration

Interacting Drug Effect Management

Ergot alkaloids (ergotamine, dihydroergotamine) Risk of severe vasospasm and ergotism CONTRAINDICATED — do not co-administer

Cisapride QT prolongation; risk of Torsades de Pointes CONTRAINDICATED — avoid combination

Pimozide QT prolongation; risk of fatal arrhythmias CONTRAINDICATED — avoid combination

Warfarin Enhanced anticoagulant effect; increased bleeding risk Monitor INR frequently; adjust warfarin dose as needed

Theophylline Increased theophylline serum levels; risk of toxicity Monitor theophylline levels; reduce dose if necessary

Cyclosporine Increased cyclosporine levels; nephrotoxicity risk Monitor cyclosporine trough levels closely

Disopyramide Increased disopyramide levels; QT prolongation Avoid combination or monitor ECG and drug levels

Interacting Drug Effect Management

Digoxin Increased digoxin bioavailability due to altered gut flora Monitor digoxin levels and clinical response; adjust dose if needed

Statins (simvastatin, atorvastatin) Increased statin levels; risk of myopathy/rhabdomyolysis Monitor for muscle pain, weakness; check CK if symptomatic

Antacids (aluminium/magnesium) Reduced roxithromycin absorption Separate administration by at least 2 hours

Rifampicin CYP3A4 induction; reduced roxithromycin efficacy Avoid combination if possible; consider alternative macrolide

Carbamazepine Increased carbamazepine levels; toxicity risk Monitor carbamazepine levels; watch for signs of toxicity

Midazolam/Triazolam Increased sedation due to reduced benzodiazepine clearance Use lower benzodiazepine doses; monitor sedation

• Nausea

• Vomiting

• Abdominal pain/discomfort

• Diarrhoea

• Dyspepsia

• Headache

• Dizziness

• Taste disturbance (metallic taste)

• Mild transient elevation of liver enzymes

Adverse Effect Clinical Notes

QT prolongation / Torsades de Pointes Rare but potentially fatal; discontinue immediately if palpitations, syncope, or ECG changes occur

Hepatotoxicity Elevated transaminases, cholestatic hepatitis; monitor LFTs; discontinue if symptomatic liver injury

Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis Rare; discontinue immediately and refer urgently

Pseudomembranous colitis (C. difficile) Suspect with severe or persistent diarrhoea; discontinue and treat appropriately

Anaphylaxis / Angioedema Immediate hypersensitivity; discontinue and provide emergency care

Exacerbation of myasthenia gravis Monitor closely in patients with MG

Phase Parameters

Baseline LFTs (if prolonged therapy anticipated or hepatic disease); ECG (if cardiac history or concurrent QT-prolonging drugs); allergy history

During therapy (>7 days) LFTs; clinical assessment for GI tolerance and hypersensitivity

High-risk patients ECG monitoring in elderly, those with cardiac disease, or concurrent QT-prolonging medications

Long-term use Not recommended due to resistance risk; if essential, monitor LFTs and CBC periodically

• Roxid (Dr Reddy's)

• Roxee (Cipla)

• Roxibid (Sun Pharma)

• Roxithral (Alkem)

• Rulide (Aventis) — if available

• Macrozid

• Multiple generic preparations available

Note: Not included in NLEM; not NPPA price-controlled; variable pricing in private sector.

1. Better GI tolerance: Roxithromycin has improved gastrointestinal tolerability compared to erythromycin due to less motilin receptor activity — preferred when erythromycin causes intolerable GI upset.

1. Once-daily option: The 300 mg once-daily regimen offers equivalent efficacy to 150 mg twice daily and may improve patient adherence.

1. Food interaction: Administer on empty stomach (1 hour before or 2 hours after meals) for optimal absorption; food reduces bioavailability.

1. Not first-line for streptococcal pharyngitis: Penicillins remain first-line for GAS pharyngitis; use roxithromycin only if penicillin allergy exists.

1. QT prolongation screening: Obtain baseline ECG in patients with cardiac history, electrolyte abnormalities, or concurrent QT-prolonging medications before initiating therapy.

1. Antacid separation: Avoid concurrent administration with aluminium/magnesium antacids — separate doses by at least 2 hours to prevent reduced absorption.

Roxithromycin; macrolide; antibiotic; respiratory infections; skin infections; atypical pneumonia; QT prolongation; hepatic metabolism; pregnancy-caution; CYP3A4 inhibitor; Schedule H

RxIndia v1.0 — 10 Jan 2025

• CDSCO Drug Formulations List

• Indian Pharmacopoeia / National Formulary of India 2021

• API Textbook of Medicine

• AIIMS Adult Treatment Guidelines

• IAP Paediatric Drug Formulary

• ICMR Treatment Guidelines for Antimicrobial Use in Common Syndromes

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's: The Pharmacological Basis of Therapeutics

• Select Indian brand product inserts (Dr Reddy's, Cipla)