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azithromycin
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MODEL LIST INFORMATION
SECTION FORMULATION DISEASE/INDICATION RATIONALE FOR INCLUSION
06.02.02.00 Other antibacterials Dosage form and strength

Capsule: 250 mg or 500 mg.

Oral liquid: 200 mg/5 ml.



ATC Code
J01FA10

Type of List
Core List

Only listed for single-dose treatment of genital Chlamydia trachomatis and of trachoma.

Trachoma is the world’s leading cause of preventable blindness.

92 million genital Chlamydia infections worldwide per year.

A major advantage is the clinical efficacy of single-dose azithromycin.

Azithromycin, as a single dose, is as effective as multiple dose regimens of tetracycline, doxycycline and erythromycin in the treatment of C. trachomatis infections.

Date added: 2003.

MODEL FORMULARY INFORMATION
GENERAL INFORMATION

Macrolides

 

Azithromycin is more active than erythromycin against some Gram-negative organisms such as Chlamydia trachomatis. The concentration and persistance of azithromycin is much higher in the tissue than in plasma; a single dose of azithromycin is used in the treatment of uncomplicated genital chlamydia and trachoma. Azithromycin is not recommended if there is a possibility of gonorrhoea because macrolide resistance emerges rapidly when it is used in this setting.

 

Uses: uncomplicated genital chlamydial infections and trachoma

 

Contraindications: hepatic impairment (Appendix 5)

 

Precautions: pregnancy (Appendix 2) and breastfeeding (Appendix 3); prolongation of QT interval (ventricular tachycardia reported); interactions: Appendix 1

 

Dose: Uncomplicated genital chlamydial infections or trachoma, by mouth, ADULT over 45 kg 1 g as a single dose; under 45 kg 20 mg/kg as a single dose

 

PATIENT ADVICE. Not to be taken at the same time as aluminium- or magnesium-containing indigestion remedies. Capsules should be taken at least 1 hour before or 2 hours after food; oral suspension can be taken with food

 

Adverse effects: see under Erythromycin (but fewer gastrointestinal effects); also anorexia, dyspepsia, flatulence, constipation, pancreatitis; syncope, dizziness, headache, drowsiness, agitation, anxiety, hyperactivity; photosensitivity; hepatitis, interstitial nephritis, acute renal failure, asthenia, paraesthesia, arthralgia, convulsions, mild neutropenia, thrombocytopenia, tinnitus, hepatic necrosis, hepatic failure, tongue discoloration, and taste disturbances

 



MEDICINE REFERENCES
Applications to the Expert Committee (2003)
http://mednet3.who.int/EML/expcom/expcom13/expcom03add.htm
WHO Technical Report Series 920: The selection and use of essential medicines.
http://whqlibdoc.who.int/trs/WHO_TRS_920.pdf
WHO Guidelines: Guidelines for the management of sexually transmitted infections.
http://whqlibdoc.who.int/publications/2003/9241546263.pdf
WHO Guidelines: Sexually transmitted and other reproductive tract infections: a guide to essential practice.
http://www.who.int/reproductive-health/publications/rtis_gep/
WHO Guidelines: Trachoma control: a guide for programme managers.
http://whqlibdoc.who.int/publications/2006/9241546905_eng.pdf
Cochrane review: Antibiotics for trachoma.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001860/frame.html
Cochrane review: Interventions for treating genital chlamydia trachomatis infection in pregnancy.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD000054/frame.html
Trials: Randomized Controlled Study of a Single Dose Azithromycin in the Treatment of Trachoma.
http://www.mrw.interscience.wiley.com/cochrane/clcentral/articles/091/CN-00486091/frame.html
Trials: A randomized controlled trial comparing amoxicillin and azithromycin for the treatment of Chlamydia trachomatis in pregnancy.
http://www.mrw.interscience.wiley.com/cochrane/clcentral/articles/693/CN-00348693/frame.html