Schedule H

Oral, Intravenous

Form Strengths

Film-coated Tablets 250 mg; 500 mg

Oral Suspension (ready-made) 100 mg per 5 mL; 200 mg per 5 mL

Dry Syrup for Reconstitution 100 mg per 5 mL (15 mL, 30 mL bottles); 200 mg per 5 mL (15 mL, 30 mL bottles)

IV Injection (Lyophilised powder) 500 mg per vial

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Community-Acquired Pneumonia (CAP)

Oral Dosing (Mild–Moderate):

Parameter Recommendation

Starting dose 500 mg once daily

Titration Not applicable

Usual maintenance dose 500 mg once daily (3-day regimen) OR 500 mg Day 1, then 250 mg Days 2–5 (5-day regimen)

Maximum dose 500 mg/day

Duration 3 days (short course) OR 5 days (extended course)

IV Dosing (Moderate–Severe/Hospitalised):

Parameter Recommendation

Starting dose 500 mg IV once daily (infuse over minimum 1 hour)

Titration Not applicable

Usual maintenance dose 500 mg IV once daily for 2 days, then step-down to oral 500 mg once daily

Maximum dose 500 mg/day IV

Duration Total 7–10 days (IV + oral)

Clinical Note: IV infusion must be administered over at least 60 minutes. Never give as IV bolus or IM injection.

1. Acute Bacterial Sinusitis

Parameter Recommendation

Starting dose 500 mg once daily

Titration Not applicable

Usual maintenance dose 500 mg once daily

Maximum dose 500 mg/day

Duration 3 days

Clinical Note: Reserve for patients with confirmed bacterial sinusitis or those allergic to beta-lactams. Amoxicillin-clavulanate preferred as first-line.

1. Acute Pharyngitis/Tonsillitis (Alternative to Penicillin)

Parameter Recommendation

Starting dose 500 mg once daily

Titration Not applicable

Usual maintenance dose 500 mg once daily

Maximum dose 500 mg/day

Duration 3 days

Clinical Note: Second-line agent only. High rates of Group A Streptococcal resistance to macrolides reported in India. Penicillin V or amoxicillin remain first-line for streptococcal pharyngitis.

1. Uncomplicated Skin and Soft Tissue Infections

Parameter Recommendation

Starting dose 500 mg once daily

Titration Not applicable

Usual maintenance dose 500 mg once daily

Maximum dose 500 mg/day

Duration 3 days

1. Uncomplicated Genital Chlamydial Infection (Urethritis/Cervicitis due to Chlamydia trachomatis)

Parameter Recommendation

Starting dose 1 g as single oral dose

Titration Not applicable

Usual maintenance dose Not applicable (single-dose therapy)

Maximum dose 1 g single dose

Duration Single dose

Clinical Note: Recommended first-line for chlamydial infections per NACO STI guidelines. Partner notification and treatment essential. Test-of-cure not routinely required unless pregnancy or persistent symptoms.

1. Typhoid Fever (Uncomplicated, Azithromycin-Sensitive)

Parameter Recommendation

Starting dose 500 mg once daily OR 1 g once daily (for higher-dose regimen)

Titration Not applicable

Usual maintenance dose 500 mg once daily

Maximum dose 1 g/day

Duration 5–7 days

Clinical Note: Preferred oral option for uncomplicated enteric fever when fluoroquinolone resistance suspected or confirmed. Blood culture and sensitivity recommended before initiation where feasible. Higher doses (1 g/day) may be used in areas with reduced susceptibility.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Acute Otitis Media / Pharyngitis / CAP / Skin Infections

Weight-Based Dosing (≥6 months):

3-Day Regimen (Preferred):

Parameter Recommendation

Starting dose 10 mg/kg once daily

Titration Not applicable

Usual maintenance dose 10 mg/kg once daily

Maximum dose 500 mg/day

Duration 3 days

5-Day Regimen (Alternative):

Parameter Recommendation

Starting dose (Day 1) 10 mg/kg once

Days 2–5 5 mg/kg once daily

Maximum dose Day 1: 500 mg; Days 2–5: 250 mg/day

Duration 5 days

Practical Dosing Table by Weight:

Weight (kg) Day 1 Dose Days 2–5 Dose Formulation Guidance

5–7 kg 50 mg 25 mg Use 100 mg/5 mL suspension

8–14 kg 100 mg 50 mg Use 100 mg/5 mL suspension

15–25 kg 200 mg 100 mg Use 200 mg/5 mL suspension

26–35 kg 300 mg 150 mg Use 200 mg/5 mL suspension or tablets

36–45 kg 400 mg 200 mg Tablets preferred

45 kg Adult dosing Adult dosing 500 mg tablets

1. Typhoid Fever (Paediatric)

Parameter Recommendation

Starting dose 10–20 mg/kg once daily

Titration Not applicable

Usual maintenance dose 10–20 mg/kg once daily

Maximum dose 1 g/day

Duration 5–7 days

Clinical Note: Preferred oral agent for enteric fever in children when culture-confirmed azithromycin sensitivity or high local fluoroquinolone resistance. Higher dose range (20 mg/kg) for severe or resistant cases under specialist guidance.

1. Cholera (Paediatric)

Parameter Recommendation

Dose 20 mg/kg as single oral dose

Maximum dose 1 g single dose

Duration Single dose

Clinical Note: Use per outbreak protocols. Ensure adequate oral/IV rehydration as primary therapy.

1. Chlamydial Infections (Adolescents ≥45 kg)

Parameter Recommendation

Dose 1 g single oral dose

Duration Single dose

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

Indication Dose Duration Notes

MAC prophylaxis in HIV (≥6 years) 20 mg/kg once weekly (max 1200 mg/week) Long-term until immune reconstitution OFF-LABEL. Specialist ART centres only. Based on adapted international protocols (PENTA/WHO)

Pertussis (Post-exposure prophylaxis or treatment) 10 mg/kg Day 1, then 5 mg/kg Days 2–5 (max 500 mg Day 1, 250 mg Days 2–5) 5 days OFF-LABEL. Alternative to erythromycin. Better tolerability. Supported by WHO and IAP guidance

Age Restrictions and Safety Monitoring

Age Group Recommendation

<6 months Not recommended except under specialist supervision; limited safety data

6 months–12 years Oral suspension; weight-based dosing

≥12 years Tablets; transition to adult dosing when weight >45 kg

Safety Monitoring in Paediatrics:

• Monitor for diarrhoea (most common)

• Watch for vomiting and abdominal pain

• LFTs if treatment duration >5 days or repeated courses

• Assess hydration status in enteric fever and cholera

10 No dose adjustment required

≤10 Use with caution due to increased systemic exposure; formal dose reduction not established but monitor closely

Haemodialysis Not significantly removed by dialysis; no supplemental dose needed

Peritoneal dialysis No supplemental dose required

Note: Azithromycin is primarily eliminated via hepatic/biliary route. Risk of cholestatic hepatitis reported; discontinue if jaundice or significant transaminase elevation occurs.

• Known hypersensitivity to azithromycin, erythromycin, or any macrolide/ketolide antibiotic

• History of cholestatic jaundice or hepatic dysfunction associated with prior azithromycin use

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

• Pre-existing hepatic disease — increased risk of hepatotoxicity; monitor LFTs

• Known QT prolongation or history of torsades de pointes

• Concomitant use of drugs known to prolong QT interval

• Electrolyte disturbances (hypokalaemia, hypomagnesaemia) — correct before initiating

• Severe renal impairment (CrCl <10 mL/min) — limited data; use cautiously

• Myasthenia gravis — risk of symptom exacerbation reported with macrolides

• Cardiac arrhythmias — baseline ECG recommended in high-risk patients

• Elderly patients with cardiac comorbidities

Parameter Recommendation

Overall safety Generally considered safe; extensive clinical experience

Risk category Category B (US legacy); no formal India classification

Preferred alternatives Amoxicillin or cephalosporins for respiratory infections where appropriate

When to use Acceptable when beta-lactams unsuitable (allergy) or for specific indications (chlamydia, azithromycin-sensitive typhoid)

Monitoring Maternal liver function if prolonged use; standard foetal monitoring

Parameter Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Very low; clinically insignificant amounts excreted

Preferred alternatives None required; azithromycin acceptable during breastfeeding

Infant monitoring Observe for loose stools, feeding difficulties, or oral thrush (rare)

Parameter Recommendation

Starting dose Standard adult dosing unless hepatic or renal concern

Titration Not applicable for short-course therapy

Specific risks Increased QT prolongation risk especially with cardiac comorbidities or polypharmacy; hepatotoxicity risk may be higher

Additional monitoring Baseline ECG if cardiac risk factors; LFTs for courses >3 days; monitor for drug interactions with common geriatric medications

Drug Interaction Recommendation

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

QT-prolonging drugs (amiodarone, sotalol, quinidine, haloperidol, ondansetron) Additive QT prolongation; risk of torsades de pointes Avoid combination; if essential, baseline and follow-up ECG; correct electrolytes

Digoxin Increased digoxin levels via P-glycoprotein inhibition Monitor digoxin levels; watch for toxicity (nausea, arrhythmias)

Cyclosporine Elevated cyclosporine levels Monitor cyclosporine trough levels; may need dose reduction

Colchicine Increased colchicine toxicity risk (especially in renal/hepatic impairment) Reduce colchicine dose or avoid; monitor for myopathy, GI toxicity

Nelfinavir Significantly increased azithromycin levels Monitor for azithromycin adverse effects; dose adjustment may be needed

Drug Interaction Recommendation

Warfarin Potential enhancement of anticoagulant effect Monitor INR during and shortly after azithromycin course; adjust warfarin if needed

Antacids (aluminium/magnesium hydroxide) Reduced azithromycin peak concentration Administer azithromycin at least 1 hour before or 2 hours after antacids

Rifampicin/Rifabutin May reduce azithromycin efficacy via enhanced metabolism Monitor clinical response; consider alternative antibiotic if needed

Theophylline Possible increased theophylline levels (less than with other macrolides) Monitor theophylline levels if symptoms of toxicity appear

Atorvastatin Potential increased statin exposure Monitor for myopathy; azithromycin interaction less significant than clarithromycin

• Diarrhoea (most frequent)

• Nausea

• Abdominal pain/cramps

• Vomiting

• Headache

• Dizziness

• Taste disturbance (dysgeusia)

• Transient elevation of liver transaminases

Adverse Effect Clinical Notes

Hepatotoxicity (including fulminant hepatitis, cholestatic jaundice) May occur during or after treatment; discontinue immediately if jaundice or significant LFT elevation

QT prolongation / Torsades de pointes Rare; higher risk with pre-existing cardiac disease, electrolyte imbalance, or concurrent QT-prolonging drugs

Anaphylaxis / Severe allergic reactions Discontinue and provide emergency treatment

Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis Very rare; discontinue immediately; hospitalisation required

Clostridioides difficile-associated diarrhoea (CDAD) May occur during or weeks after therapy; discontinue if confirmed

Hearing impairment (reversible) Reported with prolonged high-dose use; usually reversible on discontinuation

Myasthenia gravis exacerbation Worsening muscle weakness; use alternative antibiotic if possible

Phase Parameters

Baseline LFTs (if hepatic risk factors or prolonged course planned); ECG (if cardiac risk factors or concurrent QT-prolonging drugs); renal function in severe CKD

During treatment Clinical response; signs of hepatotoxicity (jaundice, RUQ pain); GI tolerance; cardiac symptoms in at-risk patients

Long-term use (e.g., MAC prophylaxis) LFTs every 1–3 months; periodic ECG if indicated; hearing assessment if high-dose prolonged use

Brand Name Manufacturer

Azithral Alembic

Azee Cipla

Azicip Cipla

Zithromax Pfizer

ATM Zydus

Azibact Intas

Azifast Sun Pharma

Trulimax Mankind

Azithromycin (Generic) Multiple manufacturers

Fixed-Dose Combinations (FDCs):

Regulatory Note: Included in NLEM 2022. Available through Jan Aushadhi outlets at reduced prices. NPPA price-controlled for scheduled formulations.

1. Once-daily dosing advantage: Single daily dose with short course (3–5 days) improves patient compliance compared to other antibiotics; ideal for outpatient management.

1. Resistance awareness: Significant macrolide resistance exists in India for Streptococcus pyogenes and Streptococcus pneumoniae. Avoid empiric use for pharyngitis; not first-line for CAP unless beta-lactam allergy.

1. Typhoid utility: Valuable oral option for uncomplicated enteric fever with fluoroquinolone resistance, which is increasingly prevalent in India. Culture-sensitivity guidance preferred.

1. QT risk in elderly: Screen for cardiac history and concurrent medications before prescribing in elderly. Avoid combination with other QT-prolonging drugs commonly used in this population.

1. Single-dose STI treatment: 1 g single dose for chlamydial infections offers excellent compliance. Ensure partner treatment and consider co-treatment for gonorrhoea if risk factors present.

1. Avoid irrational FDCs: Cefixime-azithromycin combinations should be used only when both drugs are indicated based on clinical/microbiological grounds, not routinely for URTIs.

azithromycin; macrolide; antibiotic; CAP; typhoid; chlamydia; STI; QT-prolongation; hepatotoxicity-risk; once-daily; NLEM-India; Schedule-H; paediatric-use

RxIndia v1.0 — 05 Apr 2025

• CDSCO Drug Database and Product Inserts

• Indian Pharmacopoeia 2022

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine (11th Edition)

• ICMR Guidelines for Diagnosis and Management of Enteric Fever (2021)

• IAP Guidelines on Fever and Infectious Disease Management

• AIIMS Standard Treatment Protocols (CAP, Enteric Fever)

• NACO STI/RTI Treatment Guidelines

• National HIV Programme (NACO) — ART Guidelines

• Indian Association of Dermatologists (IADVL) Protocols (for off-label acne use)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics