Azithromycin parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder for solution for infusion containing azithromycin
Drugs List
Therapeutic Indications
Uses
Community acquired pneumonia
Pelvic inflammatory disease
Dosage
Adults
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.
Administration
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.
Contraindications
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
Bradycardia
Breastfeeding
Cardiac arrhythmias
Congenital long QT syndrome
Electrolyte imbalance
History of hepatic impairment
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Myasthenia gravis
Pregnancy
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
Pregnancy
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.
Lactation
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.
Side Effects
Abdominal pain
Acute generalised exanthematous pustulosis
Acute renal failure
Ageusia
Aggression
Agitation
Alanine aminotransferase increased
Anaphylactic reaction
Angioedema
Anorexia
Anosmia
Anxiety
Arrhythmias
Arthralgia
Aspartate aminotransferase increased
Asthenia
Blood urea increased
Candidiasis
Chest pain
Cholestatic jaundice
Constipation
Convulsions
Deafness
Decrease in blood bicarbonate
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dysgeusia
Dyspepsia
Erythema multiforme
Exacerbation of myasthenia gravis
Fatigue
Flatulence
Fluctuating serum potassium levels
Fulminant hepatitis
Gastritis
Haemolytic anaemia
Headache
Hearing loss
Hepatic failure
Hepatic impairment
Hepatic necrosis
Hepatitis
Hypereosinophilia
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Inflammation (injection site)
Insomnia
Interstitial nephritis
Leucopenia
Local pain (injection site)
Malaise
Nausea
Nervousness
Neutropenia
Oedema
Palpitations
Pancreatitis
Paraesthesia
Parosmia
Photosensitivity
Prolongation of QT interval
Pruritus
Pseudomembranous colitis
Psychomotor excitation
Rash
Reduced lymphocyte count
Serum bilirubin increased
Serum creatinine increased
Somnolence
Stevens-Johnson syndrome
Syncope
Thrombocytopenia
Tinnitus
Tongue discolouration
Torsades de pointes
Toxic epidermal necrolysis
Urticaria
Vaginitis
Ventricular tachycardia
Vertigo
Visual disturbances
Vomiting
Overdosage
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 ).
Further Information
Last Full Review Date: April 2020
Reference Sources
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
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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