Azithromycin

Mechanism of Action:

Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected.

 

Drug Label Information | Brands:

Brands of Azithromycin in Kenya

Agycin, Bliss GVS Pharma Ltd.
ATM, Indoco Remedies Limited
Azal, Medox Pharmaceuticals Ltd
Azaltic , Nirpo Jmi Pharma Ltd
Azar, Ochoa
Azbact , Globela Pharma Pvt. Ltd
Azi-Agio, Agio
Azi-bio , Sava Healthcare Ltd
Azibru , Brawn Laboratories Limited
Azic ,Cian Health Care Pvt. Ltd.
Azicin, Opsonin
Azicip, Cipla Ltd
Azicure , Macleods Pharmaceuticals Limited
Azidawa ,Dawa Limited
Azidoc ,Doctor Pharma Manufacturing UK Ltd
Azifast, Ipca Laboratories Limited
Aziflam, Flamigo
Azflor, Stallion Laboratories Ltd
Azifred, Fredun Pharmaceuticals Ltd
Azik, Medox Pharmaceuticals Ltd
Azileb, Leben Laboratories Ltd
Azilide ,Micro Labs Ltd
Azilin , Lincoln Pharmaceuticals Ltd
Azimax, Cipla
Azimed , Zest pharma
Azimet, Metro
Azimol ,Mol Chem Limited
Azin , The ACME Laboratories Ltd
Azines, Nestor Pharmaceuticals Limited
Azinowel, Unosource Pharma Ltd
Azipar, Plethico
Azisara, Sarabhai
Azita, Zawadi Healthcare Ltd
Azitcor, Signature Healthcare Ltd
Azitec , Europa Healthcare Limited
Azithrax , Eskayef Bangladesh Ltd.
Azithrocin, Beximco Pharmaceuticals Ltd.
Azithral, Alembic
Azithrin , Theon Pharmaceuticals Ltd
Azitro, Pharmaco Healthcare Limited
Azito , Zim Laboratories Limited
Azique , Questa Care Inc.
Aziwin , Orange Pharma Limited
Aziwok , Wockhardt Limited
Azix, Bottu S.A Laboratories
Azuma, Shelys Pharmaceuticals Limited
Azy , Opera Pharma (K) Ltd
Binozyt , Sandoz GmbH Kundl
Enaz , Twokay Chemicals Ltd.
Macrosafe , MSN Laboratories Private Limited.
Maczith , Tempharma Solutions Ltd
Mazit , Neopharma L.L.C.
Ortiza, Medopharm
Plazo ,Dinlas Pharma EPZ Limited
Romycin , Tempharma Solutions Ltd
Sazro , Krishna Chemists Ltd
Shalzin , Shalina Laboratories Pvt. Ltd
Swazi , Ind-Swift Limited
Threomycin , National Pharmacy Ltd
Throza, Universal Corporation Limited
Unozit, Alkem Laboratories
Xolide , Radiant Pharmaceuticals Limited
Zaha, Ajanta Pharma Limited
Zerocin,Laboratory & Allied Ltd
Zetro, Getz Pharma (Pvt) Limited
Zibac, Popular Pharmaceuticals Ltd.
Zicith , Psm Pharmaceuticals Ltd
Zithrocare, Meyer Organic Pvt Ltd
Zithrocin , Unique Pharmaceutical Laboratories
Zithrolite , Skylight Chemical Industries
Zithromax,Pfizer Laboratories Limited
Zithromax IV , Pfizer Laboratories Limited
Zithroriv, Riva Pharma S.A.E
Zomax , Hikma pharmaceuticals Ltd
Zithrox, Cosmos Limited
Zimax, Square Pharmaceuticals Ltd.
Zimycin, Saga Laboratories
Zmax Granules, Pfizer (formulated as a single dose release microsphere)
Zocin, Advanced pharm
ZTM , Shambhuprasad And Sons
Zymcin , Gufic Stridden Biopharma Private Ltd.

INDICATIONS:

Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:

  • Acute bacterial exacerbations of chronic bronchitis in adults
  • Acute bacterial sinusitis in adults
  • Uncomplicated skin and skin structure infections in adults
  • Urethritis and cervicitis in adults
  • Genital ulcer disease in men
  • Acute otitis media in pediatric patients (6 months of age and older)
  • Community-acquired pneumonia in adults and pediatric patients (6 months of age and older)
  • Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older)

Limitation of Use:

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

DOSAGE AND ADMINISTRATION

Adults

  • Community-acquired pneumonia (mild severity)
    Pharyngitis/tonsillitis (second-line therapy)
    Skin/skin structure (uncomplicated)
    500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
  • Acute bacterial exacerbations of chronic bronchitis
    (mild to moderate)
    500 mg as a single dose on Day 1, followed by
    250 mg once daily on Days 2 through 5 or 500 mg
    once daily for 3 days.
  • Acute bacterial sinusitis
    500 mg once daily for 3 days.
  • Genital ulcer disease (chancroid) Non-gonococcal
    urethritis and cervicitis
    One single 1 gram dose.
  • Gonococcal urethritis and cervicitis
    One single 2 gram dose.

Pediatric Patients

  • Acute otitis media
    30 mg/kg as a single dose or 10 mg/kg once daily for 3 days
    or 10 mg/kg as a single dose on Day 1 followed by
    5 mg/kg/day on Days 2 through 5.
  • Acute bacterial sinusitis
    10 mg/kg once daily for 3 days.
  • Community-acquired pneumonia
    10 mg/kg as a single dose on Day 1 followed by 5 mg/kg
    once daily on Days 2 through 5.
  • Pharyngitis/tonsillitis
    12 mg/kg once daily for 5 days.

CONTRAINDICATIONS:

Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibacterial drug.
Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

WARNINGS AND PRECAUTIONS

Serious (including fatal) allergic reactions and skin reactions. Discontinue azithromycin for injection and initiate appropriate therapy if reaction occurs.

Hepatotoxicity: Severe and sometimes fatal, hepatoxicity has been reported. Discontinue azithromycin for injection immediately if signs and symptoms of hepatitis occur.

Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.

Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval.

Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs.

Azithromycin for injection may exacerbate muscle weakness in persons with myasthenia gravis.

ADVERSE REACTIONS

Most common adverse reactions are nausea (4%), diarrhea (4%), abdominal pain (3%), or vomiting (1%).

DRUG INTERACTIONS

Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted .

Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time

USE IN SPECIFIC POPULATIONS

Pediatric Use: Safety and effectiveness in the treatment of patients under 16 years of age have not been established

Geriatric Use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias.

DOSAGE FORMS AND STRENGTHS

Azithromycin tablets, 250 mg and 500 mg

Azithromycin oral Suspension 200mg/5ml


Prescription Category:
DDA Schedule:
Dosage Forms:
Routes of Administration:
Protein Binding:
Metabolosim:
Bioavailability:
Elimination Half life:
Drug Indentifiers:

References/ Citation:

Prescription Category:
DDA Schedule:
Dosage Forms:
Routes of Administration:
Protein Binding:
Metabolosim:
Bioavailability:
Elimination Half life:
Drug Indentifiers:

References/ Citation: