Azithromycin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Respiratory tract infections; Skin and soft tissue infections As tab/cap/immediate release suspension: 500 mg/day for 3 days, or 500 mg as single dose on day 1 then 250 mg/day on days 2-5. Uncomplicated genital infections due to Chlamydia trachomatis; Chancroid 1 g as a single dose. Uncomplicated gonorrhoea 1 g or 2 g as a single dose, combined with ceftriaxone. Community-acquired pneumonia As tab/cap/immediate release suspension: 500 mg on day 1, then 250 mg once daily on days 2-5. As extended release suspension: 2 g as a single dose. Acute bacterial sinusitis As tab/cap/ immediate release suspension: 500 mg once daily for 3 days. As extended release suspension: 2 g as a single dose. Prophylaxis of disseminated Mycobacterium avium complex (MAC) infections 1.2 g once weekly. IV Community-acquired pneumonia 500 mg as a single daily dose for at least 2 days followed by oral dose of 500 mg daily to complete 7-10 days. Pelvic inflammatory disease 500 mg daily as a single dose for 1 or 2 days followed by oral dose of 250 mg daily to complete 7 days. Ophthalmic Bacterial conjunctivitis As 1% solution: Instill 1 drop into affected eye(s) bid (8-12 hours apart) for 2 days then 1 drop once daily for the next 5 days. As 1.5% (as dihydrate) solution: Instill 1 drop into the conjunctival fornix bid (morning and evening) for 3 days.
Dosage Details
Intravenous
Community-acquired pneumonia
Adult: 500 mg as a single daily dose for at least 2 days, given at a rate of 1 mg/mL over 3 hours or 2 mg/mL over 1 hour, followed by oral dose of 500 mg daily to complete 7-10 days.

Intravenous
Pelvic inflammatory disease
Adult: 500 mg daily as a single dose for 1 or 2 days, given at a rate of 1 mg/mL over 3 hours or 2 mg/mL over 1 hour, followed by oral dose of 250 mg daily to complete 7 days.

Ophthalmic
Bacterial conjunctivitis
Adult: As 1% solution: Instill 1 drop into affected eye(s) bid (8-12 hours apart) for 2 days then 1 drop once daily for the next 5 days. As 1.5% (as dihydrate) solution: Instill 1 drop into the conjunctival fornix bid (morning and evening) for 3 days.
Child: As 1% solution: ≥1 year Same as adult dose. As 1.5% solution: Same as adult dose.

Oral
Chancroid, Uncomplicated genital infections due to Chlamydia trachomatis
Adult: 1 g as a single dose.

Oral
Prophylaxis of disseminated Mycobacterium avium complex (MAC) infections
Adult: 1.2 g once weekly.

Oral
Acute otitis media
Child: ≥6 months As immediate release suspension: 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose in day 1, followed by 5 mg/kg/day on days 2-5.

Oral
Acute bacterial sinusitis
Adult: As tab, cap or immediate release suspension: 500 mg once daily for 3 days. As extended release suspension: 2 g as a single dose.
Child: As immediate release suspension: 10 mg/kg once daily for 3 days.

Oral
Respiratory tract infections, Skin and soft tissue infections
Adult: As tab, cap, or immediate release suspension: 500 mg daily for 3 days. Alternatively, 500 mg as single dose on day 1 followed by 250 mg daily on days 2-5.
Child: ≥6 months As immediate release suspension: 10 mg/kg daily for 3 days or 10 mg/kg on day 1, followed by 5 mg/kg/day on days 2-5. >45 kg: Same as adult dose.

Oral
Uncomplicated gonorrhoea
Adult: 1 g or 2 g as a single dose, in combination with ceftriaxone.

Oral
Pharyngitis, Tonsillitis
Child: >2 years As immediate release preparation: 12 mg/kg/day for 5 days.

Oral
Community-acquired pneumonia
Adult: As tab, cap, or immediate release suspension: 500 mg on day 1, followed by 250 mg once daily on days 2-5. As extended release suspension: 2 g as a single dose.
Child: ≥6 months As immediate release suspension: 10 mg/kg as single dose on day 1 followed by 5 mg/kg/day on days 2-5. As extended release suspension: 60 mg/kg as a single dose. Max: 2 g.
Administration
Tab & Susp: May be taken with or without food. May be taken w/ meals to reduce GI discomfort.
Cap &Amp; Extended Release Microspheres: Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.
Reconstitution
Intravenous:
Powder for inj: Add 4.8 mL of sterile water for inj to the 500 mg vial. Further diluted to a concentration of 1 mg/mL (500 mL) to 2 mg/mL (250 mL) in normal saline, 5% dextrose in water or lactated ringer solution.
Contraindications
Hypersensitivity to macrolide antibiotics. History of hepatic dysfunction/cholestatic jaundice following previous antibiotic use.
Special Precautions
Patients with myasthenia gravis, electrolyte disturbance particularly hypokalaemia and hypomagnesaemia; bradycardia, cardiac arrhythmia, severe cardiac insufficiency, congenital or documented QT prolongation, history of torsades de pointes. Severe renal (GFR <10 mL/min) and hepatic impairment. Children. Pregnancy and lactation. Azithromycin should not be given long-term to prevent bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a hematopoietic stem cell transplant.
Adverse Reactions
Significant: Myasthenia gravis.
Ear and labyrinth disorders: Deafness.
Eye disorders: Pruritus, burning, stinging of the eye or ocular discomfort, sticky eye sensation, foreign body sensation (ophthalmic).
Gastrointestinal disorders: Diarrhoea, vomiting, abdominal pain, nausea, flatulence, dyspepsia, dysgeusia.
General disorders and admin site conditions: Injection site pain, fatigue.
Investigations: Decreased lymphocyte count and blood bicarbonate; increased eosinophil count, basophils, monocytes and neutrophils.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia.
Nervous system disorders: Headache, dizziness, paraesthesia.
Skin and subcutaneous tissue disorders: Pruritus, rash.
Potentially Fatal: Rarely, serious hypersensitivity reactions (e.g. anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis drug reaction with eosinophilia and systemic symptoms), fulminant hepatitis leading to liver failure, prolonged cardiac repolarisation and QT interval, cardiac arrhythmia, torsades de pointes, Clostridium difficile associated diarrhea (CDAD).
IV/Ophth/Parenteral/PO: B
Patient Counseling Information
Ophthalmic: Avoid using contact lenses during treatment. This drug may cause blurred vision, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor liver function values and blood count with differential. Perform culture and susceptibility testing before initiating therapy.
Overdosage
Symptoms: Diarrhoea, reversible hearing loss, severe nausea and vomiting. Management: Initiate symptomatic and supportive measures as necessary.
Drug Interactions
Increased risk of prolonged QT interval with class IA (e.g. quinidine, procainamide) and class III (e.g. dofetilide, amiodarone, sotalol) antiarrhythmics; pimozide cisapride and terfenadine. Increased serum concentrations of digoxin, colchicine, and ciclosporin. May potentiate the effects of oral anticoagulants (e.g. warfarin).
Action
Description: Azithromycin is a macrolide antibiotic under the azalide group. It inhibits RNA-dependent protein synthesis by binding to the 50s ribosomal subunit, preventing the translocation of peptide chains.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: Approx 37%. Time to peak plasma concentration: Approx 2-3 hours (oral, immediate release).
Distribution: Extensively distributed in the tissues (skin, lungs, tonsils, cervix) and sputum. Present in breastmilk. Volume of distribution: 31-33 L/kg. Plasma protein-binding: 7-51%.
Metabolism: Metabolised in the liver to inactive metabolites.
Excretion: Via bile (50%, as unchanged drug); urine (6-14%, as unchanged drug). Terminal elimination half-life: 68-72 hours (conventional preparations); 59 hours (extended release).
Chemical Structure

Click on icon to see table/diagram/image
Storage
Tab/Immediate release suspension/Inj: Store below 30°C. Cap/Eye drop (1.5%): Store below 25°C. Protect from light. Eye drop (1%): Store between 2-8°C.
MIMS Class
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.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Azee
  • Azimax
  • Azithromycin Winthrop
  • Binozyt
  • Imexa
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in