- Drugs List
- Therapeutic Indications
- Precautions and Warnings
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Powder for solution for infusion containing azithromycin
Community acquired pneumonia
Pelvic inflammatory disease
Community acquired pneumonia
500 mg daily for at least 2 consecutive days. Intravenous therapy should be followed by 500 mg daily of oral azithromycin for 7 to 10 days. Transition to oral therapy should be carried out when indicated by the doctor and according to clinical response.
Pelvic inflammatory disease (PID)
500 mg daily for 1 or 2 days. Intravenous therapy should be followed by 250 mg daily of oral azithromycin for up to 7 days. Transition to oral therapy should be carried out when indicated by the doctor and according to clinical response.
To be administered by intravenous infusion.
The concentration of the solution for infusion and the infusion rate should be 1 mg/ml for 3 hours or 2 mg/ml for 1 hour.
Children under 18 years
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
History of progenitor cell transplantation
Restricted sodium intake
Congenital long QT syndrome
History of hepatic impairment
History of torsade de pointes
Renal impairment - glomerular filtration rate below 10ml/minute
Severe cardiac dysfunction
Severe hepatic impairment
Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Sodium content of formulation may be significant
Consult national/regional policy on the use of anti-infectives
Perform ECG before and during treatment
Allergic symptoms may recur and require long treatment and observation
Monitor for signs of superinfection with non-susceptible organisms
Monitor liver function if fatigue or dark urine occurs
Monitor serum electrolytes
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Consider pseudomembranous colitis if patient presents with diarrhoea
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue if allergic reaction occurs
Discontinue if hepatic function deteriorates
Discontinue therapy if marked diarrhoea occurs
Breastfeeding: Do not breastfeed & discard milk for 48 hours after therapy
Pregnancy and Lactation
Use azithromycin with caution during pregnancy.
The manufacturer suggests azithromycin should only be used during pregnancy if definitely indicated.
Azithromycin crosses the human placenta. There are no adequate and well controlled studies in human pregnancy. Although macrolide antibiotics are not considered to be major human teratogens (Briggs 2011), the data available are too limited to fully assess the safety of azithromycin in pregnancy. Animal studies in rats and mice have shown no evidence of harm to the foetus.
Use azithromycin with caution in breastfeeding.
The manufacturer suggests to discard the milk during treatment and up until 2 days after discontinuation of treatment. Breastfeeding may be resumed thereafter.
Azithromycin passes into breast milk.
Acute generalised exanthematous pustulosis
Acute renal failure
Alanine aminotransferase increased
Aspartate aminotransferase increased
Blood urea increased
Decrease in blood bicarbonate
Drug rash with eosinophilia and systemic symptoms (DRESS)
Exacerbation of myasthenia gravis
Fluctuating serum potassium levels
Inflammation (injection site)
Local pain (injection site)
Prolongation of QT interval
Reduced lymphocyte count
Serum bilirubin increased
Serum creatinine increased
Torsades de pointes
Toxic epidermal necrolysis
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: April 2020
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Zedbac 500 mg powder for solution for infusion. Aspire Pharma. Revised January 2020
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 24 April 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Azithromycin Last revised: 01 May 2019
Last accessed: 27 April 2020
HPRA Safety Notice May 2018
Available at: https://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---azithromycin.pdf?sfvrsn=0
Last accessed: 23 October 2018
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.