azithromycin reference
Reference image
(azithromycin · DailyMed)
Registered Kenya · PPB

AZI-BIO TABLETS

AZITHROMYCIN USP

H2010/19537/041 500MG GENERIC/BIOSIMILARS antiinfectives for systemic use INN generic

What it does

Azithromycin is an antibiotic that helps treat infections caused by bacteria.

Commonly used for: bacterial infections, chest infections (pneumonia), throat infections (pharyngitis), skin infections …

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Hard to find? We help patients in Kenya source rare medicines. We don't sell or dispense medicines - licensed pharmacies do.

Source this medicine

Registration & product details

Registration no.
H2010/19537/041
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
AZITHROMYCIN USP
Dosage form
500MG
Strength
-
Pack size
1X3
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
J01FA - Macrolides
RxNorm RxCUI
18631
Manufacturer / MAH
Knvm Medicare
Country of origin
FOREIGN
Manufacturer location
Level- 7, 8, 13, 14 [Lift] Nasir Trade Centre 89, Old Sonargaon Road, ঢাকা 1205, Bangladesh

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:36:47 · updated 2026-08-03 02:23:33

Drug Interactions

43
Check interactions

Severe (5)

Ergometrine - increases risk of ergotism

Macrolides (clarithromycin) are predicted to increase the risk of ergotism when given with ergometrine. Avoid.

Severe Theoretical

Ergotamine - increases risk of ergotism

Macrolides (clarithromycin) are predicted to increase the risk of ergotism when given with ergotamine. Avoid.

Severe Theoretical

Fidaxomicin - increases exposure

Macrolides are predicted to increase the exposure to fidaxomicin. Avoid.

Severe Study

Irinotecan - increases risk of toxicity

Macrolides (clarithromycin) are predicted to increase the risk of toxicity when given with irinotecan. Avoid.

Severe Study

Tepotinib - increases exposure

Macrolides(clarithromycin)mightincreasetheexposureto tepotinib.Avoid.rTheoretical

Severe Theoretical

Moderate (6)

Bictegravir - increases exposure

Macrolides are predicted to increase the exposure to bictegravir. Use with caution or avoid.

Moderate Theoretical

Macrolides - decreases exposure

Aminophylline is predicted to decrease the exposure to macrolides (erythromycin). Adjust dose.

Moderate Study

Macrolides - increases exposure

Atazanavir is predicted to increase the exposure to macrolides (clarithromycin). Adjust dose in renal impairment.

Moderate Study

Macrolides - increases exposure

Ritonavir increases the exposure to macrolides (clarithromycin). Adjust dose in renal impairment.

Moderate Study

Macrolides - decreases concentration

Rifabutin decreases the concentration of macrolides (clarithromycin) and macrolides (clarithromycin) increase the concentration of rifabutin. Monitor and adjust dose.

Moderate Study

Ticagrelor - increases exposure

Azithromycin is predicted to increase the exposure to ticagrelor. Use with caution or avoid.

Moderate Study

Unknown (32)

Afatinib - increases exposure

Macrolides are predicted to increase the exposure to afatinib.

Unknown Study

Aliskiren - increases exposure

Azithromycinispredictedtoincreasetheexposuretoaliskiren. oTheoretical

Unknown Theoretical

Aminophylline - increases exposure

Azithromycinispredictedtoincreasetheexposureto aminophylline.oTheoretical

Unknown Theoretical

Antimalarials - increases risk of serious cardiovascular adverse effects

Macrolides might increase the risk of serious cardiovascular adverse effects when given with antimalarials (chloroquine).

Unknown Theoretical

Berotralstat - increases exposure

Macrolides are predicted to increase the exposure to berotralstat.

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Azithromycin is an antibiotic that helps treat infections caused by bacteria.

What it treats

  • bacterial infections
  • chest infections (pneumonia)
  • throat infections (pharyngitis)
  • skin infections
  • ear infections (otitis media)

How it works

It works by stopping the growth of bacteria, helping your body fight off infections.

Who it's for

It is for people with certain bacterial infections as prescribed by a healthcare professional.

Drug class

Macrolides

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Azithromycin

BNF-referenced

Azithromycin is a macrolide antibiotic used to treat various bacterial infections, including respiratory tract infections, skin and soft tissue infections, and certain sexually transmitted infections. It works by inhibiting bacterial protein synthesis.

Indications

  • Bacterial infections
  • Mild to moderate typhoid due to multiple-antibacterial resistant organisms
  • Respiratory-tract infections
  • Otitis media
  • Skin and soft tissue infections
  • Chlamydia trachomatis genital infection
  • Chronic Pseudomonas aeruginosa infection in cystic fibrosis
  • Prevention of group A streptococcal infection in patients allergic to penicillin

Dosage

Children: Child 6 months–17 years: 10 mg/kg once daily (max. per dose 500 mg) for 3 days, repeated after 1 week if necessary. Refer to BNF for Children for specific dosing based on age and weight.

Adults: 500 mg once daily for 3 to 5 days depending on the infection being treated. For certain cases, doses may be adjusted based on clinical judgment.

Mechanism of action

Azithromycin binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis and thus preventing bacterial growth.

Pharmacodynamics

Azithromycin exhibits bacteriostatic activity against susceptible bacteria. It has a long half-life, allowing for once-daily dosing and effective treatment of infections.

Pharmacokinetics

Azithromycin is well-absorbed after oral administration, with a bioavailability of approximately 37%. It penetrates well into tissues, with a half-life of about 68 hours, and is primarily excreted in bile, with minimal renal excretion.

Adverse effects

  • Appetite decreased
  • Diarrhoea
  • Dizziness
  • Gastrointestinal discomfort
  • Headache
  • Hearing impairment
  • Insomnia
  • Nausea
  • Pancreatitis
  • Paraesthesia
  • Skin reactions
  • Taste altered
  • Vomiting
  • Angioedema
  • Anxiety
  • Arrhythmias
  • Chest pain
  • Constipation
  • Drowsiness
  • Eosinophilia
  • Hepatic disorders
  • Leucopenia
  • Neutropenia
  • Palpitations
  • QT interval prolongation
  • Severe cutaneous adverse reactions (SCARs)
  • Tinnitus
  • Vertigo
  • Antibiotic associated colitis
  • Myasthenia gravis
  • Nephritis tubulointerstitial
  • Hallucination
  • Hypotension
  • Seizure
  • Acute kidney injury
  • Aggression
  • Akathisia
  • Hemolytic anemia
  • Syncope

Interactions

  • Azithromycin + ticagrelor: Moderate (increases exposure)
  • Azithromycin + aliskiren: Unknown (increases exposure)
  • Azithromycin + aminophylline: Unknown (increases exposure)
  • Azithromycin + colchicine: Unknown (increases exposure)
  • Azithromycin + erlotinib: Unknown (increases exposure)
  • Azithromycin + lomitapide: Unknown (increases exposure)
  • Azithromycin + rimegepant: Unknown (increases exposure)
  • Azithromycin + taxanes: Unknown (increases exposure)
  • Azithromycin + docetaxel: Unknown (increases exposure)
  • Azithromycin + paclitaxel: Unknown (increases exposure)

Precautions

  • Use with caution in patients with electrolyte disturbances
  • Use with caution if estimated glomerular filtration rate is less than 10 mL/minute/1.73 m2
  • Predisposition to QT interval prolongation may be aggravated
BNF for Children 2019-2020 p.361 BNF for Children 2019-2020 p.722 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Azithromycin

PubChem CID 447043

Molecular formula: C38H72N2O12

Mechanism of action

In order to replicate, bacteria require a specific process of protein synthesis, enabled by ribosomal proteins. Azithromycin binds to the 23S rRNA of the bacterial 50S ribosomal subunit. It stops bacterial protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit,. This results in the control of various bacterial infections,. The strong affinity of macrolides, including azithromycin, for bacterial ribosomes, is consistent with their broad‐spectrum antibacterial activities. Azithromycin is highly stable at a low pH, giving it a longer serum half-life and increasing its concentrations in tissues compared to erythromycin. Azithromycin usually is bacteriostatic, although the drug may be bactericidal in high concentrations against selected organisms. Bactericidal activity has been observed in vitro against Streptococcus pyogenes, S. pneumoniae, and Haemophilus influenzae. Azithromycin inhibits protein synthesis in susceptible organisms by penetrating the cell wall and binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. The site of action of azithromycin appears to be the same as that of the macrolides (i.e., erythromycin, clarithromycin), clindamycin, lincomycin, and chloramphenicol. The antimicrobial activity of azithromycin is reduced at low pH. Azithromycin concentrates in phagocytes, including polymorphonuclear leukocytes, monocytes, macrophages, and fibroblasts. Penetration of the drug into phagocytic cells is necessary for activity against intracellular pathogens (e.g., Staphylococcus aureus, Legionella pneumophila, Chlamydia trachomatis, Salmonella typhi).

Pharmacodynamics

Macrolides stop bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections. Azithromycin has additional immunomodulatory effects and has been used in chronic respiratory inflammatory diseases for this purpose.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.