Azithromycin Uses, Dosage, Side Effects & Price | DrugsAtlas
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Therapeutic Class
Antibacterial
Subclass
Macrolide antibiotic
Speciality
Infectious Disease
Schedule (India)
Schedule H
Routes
Oral, Intravenous
Formulations
| 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 |
Adult indications
NDICATIONS + 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.
2. 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.
3. 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.
4. 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 |
5. 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.
6. 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.
7. Cholera (Alternative Agent)
| 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: Alternative to doxycycline. Particularly useful in pregnant women and children where doxycycline is contraindicated. Use per state/district outbreak protocols.
Secondary Indications — Adults (Off-label, if any)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| MAC (Mycobacterium avium complex) prophylaxis in HIV/AIDS | 1200 mg orally once weekly | Long-term until CD4 count sustained >100 cells/µL for ≥6 months on ART | OFF-LABEL. Specialist only. Used at NACO ART centres and tertiary HIV care facilities. Based on international guidelines adapted in Indian practice |
| Inflammatory Acne (Recalcitrant, moderate–severe) | 500 mg orally 3 times per week (alternate days) | 4–12 weeks | OFF-LABEL. Specialist dermatologist only. Second/third-line option after tetracyclines. Indian dermatology protocols support pulse/intermittent azithromycin use |
| Traveller's Diarrhoea (Bacterial, moderate–severe) | 1 g single dose OR 500 mg once daily for 3 days | 1–3 days | OFF-LABEL. Alternative when fluoroquinolones contraindicated or resistance suspected |
Paediatric indications
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 |
2. 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.
3. 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.
4. 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
Renal Adjustments
| eGFR (mL/min) | Recommendation |
|---|---|
| >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 |
Hepatic adjustment
Contraindications
- 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
Cautions
- 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
Pregnancy
| 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 |
Lactation
| 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) |
Elderly
| 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 |
Major drug interactions
| 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 |
Major drug interactions
Moderate drug interactions
| 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 |
Common Adverse effects
- Diarrhoea (most frequent)
- Nausea
- Abdominal pain/cramps
- Vomiting
- Headache
- Dizziness
- Taste disturbance (dysgeusia)
- Transient elevation of liver transaminases
Serious Adverse effects
| 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 |
Monitoring requirements
| 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 |
Brands in India
| 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):
- ZIFI-AZ, Ceftas-AZ (Cefixime + Azithromycin) — Use with caution; rational FDC use only when both drugs indicated
Price range (INR)
| Formulation | Approximate Price |
|---|---|
| Tablet 250 mg (strip of 6) | ₹50–₹120 |
| Tablet 500 mg (strip of 3) | ₹60–₹150 |
| Tablet 500 mg (single) | ₹8–₹30 |
| Oral suspension 100 mg/5 mL (15 mL) | ₹25–₹50 |
| Oral suspension 200 mg/5 mL (15 mL) | ₹30–₹55 |
| Dry syrup 200 mg/5 mL (30 mL) | ₹45–₹80 |
| IV injection 500 mg vial | ₹120–₹280 |
Regulatory Note: Included in NLEM 2022. Available through Jan Aushadhi outlets at reduced prices. NPPA price-controlled for scheduled formulations.
Clinical pearls
- Once-daily dosing advantage: Single daily dose with short course (3–5 days) improves patient compliance compared to other antibiotics; ideal for outpatient management.
- 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.
- Typhoid utility: Valuable oral option for uncomplicated enteric fever with fluoroquinolone resistance, which is increasingly prevalent in India. Culture-sensitivity guidance preferred.
- 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.
- 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.
- Avoid irrational FDCs: Cefixime-azithromycin combinations should be used only when both drugs are indicated based on clinical/microbiological grounds, not routinely for URTIs.
Version
RxIndia v1.0 — 05 Apr 2025
Reference
-
- 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
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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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