Azithromycin


Generic Medicine Info
Indications and Dosage
Intravenous
Community-acquired pneumonia
Adult: 500 mg once daily for at least 2 consecutive days, followed by oral azithromycin doses to complete 7-10 days of therapy. IV doses are given via infusion over 1 hour (for 2 mg/mL concentration) or over 3 hours (for 1 mg/mL concentration). Timing of transition to oral therapy must be individualised according to the patient's clinical response.

Intravenous
Pelvic inflammatory disease
Adult: 500 mg once daily for 1-2 days, followed by oral azithromycin doses to complete 7 days of therapy. IV doses are given via infusion over 1 hour (for 2 mg/mL concentration) or over 3 hours (for 1 mg/mL concentration). Timing of transition to oral therapy must be individualised according to the patient's clinical response.

Ophthalmic
Trachomatous conjunctivitis
Adult: As 1.5% eye drop solution: Instil 1 drop into the affected eye(s) bid for 3 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As 1.5% eye drop solution: Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Ophthalmic
Bacterial conjunctivitis
Adult: As 1% eye drop solution: Instil 1 drop into the affected eye(s) bid (8-12 hours apart) for the 1st 2 days, then instil 1 drop once daily for the next 5 days. As 1.5% eye drop solution: Instil 1 drop into the affected eye(s) bid for 3 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As 1.5% eye drop solution: Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Uncomplicated gonorrhoea
Adult: 1 g or 2 g as a single dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Prophylaxis of disseminated Mycobacterium avium complex (MAC) infections
Adult: Alone or in combination with rifabutin in patients with advanced HIV infection: 1.2 g once weekly. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Pelvic inflammatory disease
Adult: Following IV therapy: 250 mg once daily to complete 7 days of therapy.

Oral
Acute otitis media
Adult: 500 mg once daily for 3 days. Alternatively, 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2-5. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: ≥6 months As oral susp: 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days. Alternatively, 10 mg/kg as a single dose on day 1, followed by 5 mg/kg once daily on days 2-5. For patients weighing >45 kg: Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Pharyngitis, Tonsillitis
Adult: 500 mg once daily for 3 days. Alternatively, 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2-5. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: ≥2 years As oral susp: 12 mg/kg once daily for 5 days. Alternatively, 20 mg/kg once daily for 3 days. Max: 500 mg daily. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Chancroid, Uncomplicated genital infections due to Chlamydia trachomatis
Adult: 1 g as a single dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Skin and soft tissue infections
Adult: 500 mg once daily for 3 days. Alternatively, 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2-5. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: As oral susp: 10 mg/kg once daily for 3 days. Alternatively, 10 mg/kg as a single dose on day 1, followed by 5 mg/kg once daily on days 2-5. For patients weighing >45 kg: Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Community-acquired pneumonia
Adult: 500 mg once daily for 3 days. Alternatively, 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2-5. Following IV therapy: 500 mg once daily to complete 7-10 days of therapy. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: ≥6 months As oral susp: 10 mg/kg (Max: 500 mg) as a single dose on day 1, followed by 5 mg/kg once daily on days 2-5 (Max: 250 mg daily). Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Acute bacterial sinusitis
Adult: 500 mg once daily for 3 days. Alternatively, 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2-5. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: ≥6 months As oral susp: 10 mg/kg once daily for 3 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Oral
Acute bacterial exacerbation of chronic bronchitis
Adult: 500 mg once daily for 3 days. Alternatively, 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2-5. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
What are the brands available for Azithromycin in Indonesia?
Other Known Brands
  • Aziwin
  • Azomax
  • Azomep
  • Azyter
  • Ethrimax
  • Maxmor
  • Sohomac
  • Trozin
  • Zarom
  • Zibramax
  • Zicho
  • Zistic
  • Zithrax
  • Zithrolic
  • Zithromax
  • Zitrolin
  • Zitromed
  • Zymed
See more
Administration
tab & susp: May be taken with or without food. May be taken w/ meals to reduce GI discomfort.
cap & extended release microspheres: Should be taken on an empty stomach.
Reconstitution
Powder for oral susp: Reconstitute with the appropriate volume of water as indicated on the label. Shake well until suspended and before each use. Powder for solution for IV infusion: Reconstitute vial labelled as 500 mg with 4.8 mL of sterile water for inj to achieve a concentration of 100 mg/mL. Further dilute the reconstituted solution with either 500 mL or 250 mL of compatible diluent (e.g. NaCl 0.9%, dextrose 5% in water, lactated Ringer's solution) to make a final concentration of 1 mg/mL or 2 mg/mL, respectively.
Contraindications
Hypersensitivity to azithromycin or any other macrolide or ketolide antibiotics. History of cholestatic jaundice or hepatic dysfunction associated with previous azithromycin therapy.
Special Precautions
Patient with congenital or documented QT prolongation, electrolyte disturbance (particularly hypokalaemia and hypomagnesaemia), clinically relevant bradycardia, cardiac arrhythmia, severe cardiac insufficiency; myasthenia gravis. Patient taking other agents known to prolong QT interval (e.g. class IA or class III antiarrhythmic agents, antipsychotics, antidepressants, fluoroquinolones). Concomitant administration with ergot derivatives is not recommended. May delay or mask symptoms of incubating gonorrhoea or syphilis. Hepatic and severe renal (GFR <10 mL/min) impairment. Neonates, children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Hearing loss, tinnitus; new onset and exacerbation of myasthenia gravis; fungal superinfection (prolonged use); infantile hypertrophic pyloric stenosis (neonates and infants <6 weeks).
Eye disorders: Visual impairment; ocular discomfort (e.g. pruritus, burning, stinging), blurred vision, sticky eye or foreign body sensation (ophthalmic).
Gastrointestinal disorders: Nausea, diarrhoea, abdominal pain, flatulence, vomiting, dyspepsia, dysgeusia.
General disorders and administration site conditions: Fatigue; pain and inflammation at the inj site (IV).
Investigations: Decreased lymphocyte count and blood bicarbonate; increased eosinophils, monocytes, basophils, and neutrophils.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia.
Nervous system disorders: Dizziness, headache, paraesthesia, somnolence.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Potentially Fatal: Hepatotoxicity (e.g. cholestatic jaundice, hepatic necrosis, fulminant hepatitis leading to liver failure); prolonged cardiac repolarisation and QT interval; Clostridioides difficile-associated diarrhoea or pseudomembranous colitis. Rarely, serious allergic reactions (e.g. angioneurotic oedema, anaphylaxis, acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
IV/Ophth/Parenteral/PO: B
Patient Counseling Information
Ophthalmic: Avoid wearing contact lenses during treatment. This drug may cause temporary blurred vision after administration, if affected, do not drive or operate machinery.
Monitoring Parameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor LFTs, CBC with differential, and ECG (for QT prolongation). Perform audiogram during prolonged use. Assess for signs and symptoms of hepatitis (e.g. nausea, vomiting, fever, abdominal colic).
Overdosage
Symptoms: Reversible loss of hearing, severe nausea, diarrhoea, and vomiting. Management: Symptomatic and supportive treatment. May give medicinal charcoal.
Drug Interactions
Concomitant administration with ergot derivatives (e.g. ergotamine) may result in ergotism. Increased risk of QT interval prolongation with class IA (e.g. procainamide, quinidine) and class III (e.g. amiodarone, dofetilide, sotalol) antiarrhythmic agents, antipsychotics (e.g. pimozide), antidepressants (e.g. citalopram), fluoroquinolones (e.g. levofloxacin, moxifloxacin), hydroxychloroquine, and cisapride. Increased risk of rhabdomyolysis when used concomitantly with statins (e.g. lovastatin). May elevate the serum concentrations of P-gp substrates (e.g. digoxin, colchicine) and ciclosporin. Increased serum concentration with nelfinavir. May potentiate the effect of oral anticoagulants (e.g. warfarin). Reduced rate, but not the extent, of oral absorption with Al- and Mg-containing antacids.
Action
Description:
Mechanism of Action: Azithromycin is a macrolide antibiotic under the azalide group. It inhibits the RNA-dependent protein synthesis in susceptible bacteria by binding to the 50S ribosomal subunit and preventing peptide translocation.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: 34-52% (oral). Time to peak plasma concentration: Approx 2-3 hours (oral).
Distribution: Extensively distributed into tissues (skin, lungs, tonsils, cervix) and sputum; poor penetration into CSF. Crosses the placenta and enters breast milk. Volume of distribution: 31-33 L/kg. Plasma protein binding: 7-51%.
Metabolism: Metabolised in the liver into inactive metabolites.
Excretion: Mainly via bile (50%; as unchanged drug); urine (6-14% as unchanged drug). Terminal elimination half-life: 68-72 hours.
Chemical Structure

Chemical Structure Image
Azithromycin

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 447043, Azithromycin. https://pubchem.ncbi.nlm.nih.gov/compound/Azithromycin. Accessed July 29, 2024.

Storage
Tab: Store between 15-30°C. Cap: Store below 25°C. Powder for oral susp: Store below 30°C. After reconstitution, store between 5-30°C and use within 10 days. Powder for solution for IV infusion: Store intact vials below 30°C. Reconstituted IV solution: Store at or below 30°C within 24 hours. Diluted solution for IV infusion: Store below 30°C for 24 hours or under refrigeration (5°C) for 7 days. As 1% eye drop solution: Store the unopened bottle between 2-8°C. Once opened, store between 2-25°C for up to 14 days. As 1.5% eye drop solution: Store below 25°C. Storage and stability recommendations may vary among countries and individual products (refer to specific product guidelines).
MIMS Class
Macrolides
ATC Classification
S01AA26 - azithromycin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
References
Tiwari T, Murphy T, Moran J; National Immunization Program, CDC. Recommended Antimicrobial Agents for the Treatment and Postexposure Prophylaxis of Pertussis: 2005 CDC Guidelines. MMWR Recomm Rep.. 2005 Dec;54(RR-14):1-16. Accessed 26/06/2024. PMID: 16340941

Anon. Azithromycin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 04/04/2024.

AzaSite Solution/Drops (Akorn). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/04/2024.

Azithromycin (Ophthalmic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 05/04/2024.

Azithromycin (Systemic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 17/05/2024.

Azithromycin (Systemic). UpToDate Lexidrug, Pediatric and Neonatal Lexi-Drugs Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 26/06/2024.

Azithromycin 200 mg/5 mL Powder for Oral Suspension (Teva UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/04/2024.

Azithromycin 250 mg Capsules (Crescent Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/04/2024.

Azithromycin 250 mg Film-coated Tablets (SNIGD [UK Limited]). MHRA. https://products.mhra.gov.uk. Accessed 04/04/2024.

Azithromycin Dihydrate Injection, Powder, Lyophilized, for Solution (Slate Run Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/04/2024.

Azithromycin Monohydrate Injection, Powder, Lyophilized, for Solution (Athenex Pharmaceutical Division, LLC.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/04/2024.

Azithromycin Monohydrate Powder, for Suspension (Amneal Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/04/2024.

Azithromycin Monohydrate Tablet, Film Coated (Lannett Company, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/04/2024.

Azithromycin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 26/06/2024.

Azyter 15 mg/g Eye Drops, Solution in Single-dose Container (HK Medical Supplies/Health Express). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 24/06/2024.

Azyter 15 mg/g, Eye Drops, Solution in Single-dose Container (Laboratoires Thea). MHRA. https://products.mhra.gov.uk. Accessed 04/04/2024.

Buckingham R (ed). Azithromycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/04/2024.

Joint Formulary Committee. Azithromycin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/04/2024.

Pfizer New Zealand Limited. Zithromax 250 mg, 500 mg, 600 mg Tablets, Film-coated; Zithromax 40 mg/mL Powder for Oral Suspension data sheet 16 September 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 04/04/2024.

Zedbac 500 mg Powder for Solution for Infusion (Aspire Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 04/04/2024.

Zithromax (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/04/2024.

Zithromax Tablet, Film Coated; Powder, for Suspension (Pfizer Laboratories Div Pfizer Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/04/2024.

Disclaimer: This information is independently developed by MIMS based on Azithromycin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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