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Azithromycin Uses, Dosage, Side Effects & Price | DrugsAtlas

Authoritative Clinical Reference

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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Clinical Responsibility

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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