Azithromycin oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing azithromycin
Drugs List
Therapeutic Indications
Uses
Antibiotic sensitive infections
Chronic pulmonary infection caused by P.aeruginosa in cystic fibrosis
Genital infections due to chlamydia trachomatis
Treatment of non-gonococcal urethritis
Uncomplicated gonorrhoea
Treatment of infections caused by susceptible organisms including:
Bronchitis
Community acquired pneumonia
Sinusitis
Pharyngitis/tonsillitis
Skin and soft tissue infections
Otitis media
Uncomplicated genital infections due to chlamydia trachomatis, neisseria gonorrhoeae and non-gonococcal urethritis
When being sold to the public as a 'P' medicine
Treatment of confirmed asymptomatic Chlamydia trachomatis genital infection in individuals aged 16 years and over and the epidemiological treatment of their sexual partners.
Unlicensed Uses
Lyme disease
Prevention of a secondary case of group A streptococcal infection
Trachoma: treatment
Typhoid: treatment
Treatment of trachoma
Treatment of mild to moderate typhoid due to multiple antibacterial resistant organisms
Prevention of secondary case of group A streptococcal infection
Treatment of early Lyme disease when doxycycline, amoxicillin or cefuroxime axetil are contraindicated
Dosage
Adults
500mg once daily for three days.
OR
500mg as a single dose on the first day, followed by 250mg once daily for the following four days.
The following dose recommendations are suitable for specific infections:
Uncomplicated genital infections due to Chlamydia trachomatis and non-gonococcal urethritis
1g as a single dose.
Uncomplicated genital infections due to Neisseria gonorrhoeae
1g or 2g in combination with ceftriaxone.
Antibacterial prophylaxis for insertion of intra-uterine device (unlicensed)
1g as a single dose.
Prevention of secondary case of group A streptococcal infection (unlicensed)
500mg once daily for five days.
Treatment of Lyme disease (unlicensed)
500mg once daily for seven to ten days.
Treatment of mild to moderate typhoid due to multiple antibacterial resistant organisms (unlicensed)
500mg once daily for seven days.
Children
Children weighing over 45kg
(See Dosage; Adult)
Children weighing under 45kg
Use the oral suspension for children under 45kg. The measuring device within each pack should be used for precise dosing according to the following schedule:
Three day schedule
Children weighing 36kg to 45kg: 10ml (400mg) once daily for three days.
Children weighing 26kg to 35kg: 7.5ml (300mg) once daily for three days.
Children weighing 17kg to 25kg: 5ml (200mg) once daily for three days.
Children weighing under 17kg: 10mg/kg once daily for three days.
Five day schedule
Day one: Dose as per the above schedule.
Days two to five: Give half of the above scheduled dose.
Children aged 6 months to 1 year
Unlicensed.
The following dose recommendations are suitable for specific infections:
Streptococcus pyogenes infection
Children aged 1 year to 18 years
10mg/kg or 20mg/kg daily for three days (maximum 500mg daily).
Eradication of the bacteria is more significant at a daily dose of 20mg/kg.
Infection in cystic fibrosis (unlicensed)
Children aged 6 months to 18 years
10mg/kg once daily for three days (maximum 500mg once daily). Repeat after one week.
Chronic Pseudomonas aeruginosa in cystic fibrosis (unlicensed)
Children aged 6 to 18 years
Children weighing over 40kg: 500mg three times weekly.
Children weighing 25kg to 40kg: 250mg three times weekly.
Uncomplicated genital chlamydial infections and non-gonococcal urethritis
Children aged 12 to 18 years
1g as a single dose.
Lyme disease (unlicensed)
Children aged 6 months to 18 years
10mg/kg once daily for seven to ten days (maximum 500mg once daily).
Prevention of secondary case of group A streptococcal infection (unlicensed)
Children aged 12 to 18 years
500mg once daily for five days.
Children aged 6 months to 12 years
12mg/kg once daily for five days (maximum 500mg once daily).
Treatment of mild to moderate typhoid due to multiple antibacterial resistant organisms (unlicensed)
Children aged 6 months to 18 years
10mg/kg once daily for seven days (maximum 500mg once daily).
Patients with Renal Impairment
Mild to moderate renal impairment (GFR 10 to 80ml/minute)
No dosage adjustment is necessary
Severe renal impairment (GFR less than 10ml/minute)
Use with caution.
A 33% increase in systemic exposure to azithromycin has been observed in these patients.
Contraindications
Children under 6 months
Long QT syndrome
Severe hepatic impairment
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
History of progenitor cell transplantation
Bradycardia
Breastfeeding
Cardiac arrhythmias
Congenital long QT syndrome
Diabetes mellitus
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Lactose intolerance
Mild hepatic impairment
Myasthenia gravis
Neurological disorder
Phenylketonuria
Pregnancy
Psychiatric disorder
Renal impairment - glomerular filtration rate below 10ml/minute
Severe cardiac dysfunction
Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Consider prevalence of resistance when prescribing
Consult national/regional policy on the use of anti-infectives
Not all available brands are licensed for all indications
Some products may have a pharmacy only legal classification
Some formulations contain lactose
Some formulations contain sucrose
Some products may contain soya or soya derivative
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 hepatic function in patients with hepatic impairment
Monitor liver function if fatigue or dark urine occurs
Monitor serum electrolytes
Advise patient to inform doctor if vomiting occurs after administration
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 hepatic function deteriorates
Discontinue therapy if marked diarrhoea occurs
Avoid antacids within 2 hours of dose
In case of sexually transmitted diseases, concomitant infection by T. pallidum should be excluded.
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 during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking azithromycin.
Limited information from published literature indicates that azithromycin is present in human breast milk at an estimated highest median daily dose of 0.1 to 0.7mg/kg/day, no serious effects on breastfed infants were observed. Drugs and Lactation Database (LactMed) suggests azithromycin is not expected to cause adverse effects in breastfed infants due to the low levels excreted in breast milk and use of azithromycin in infants in higher doses. However, the infant should be monitored for possible effects on the gastrointestinal flora, such as diarrhoea, thrush or nappy rash. Unconfirmed epidemiologic evidence indicates that the risk of hypertrophic pyloric stenosis in infants might be increased by maternal use of macrolide antibiotics during breastfeeding.
Counselling
Advise patients to contact their G.P. or Pharmacist if vomiting occurs after taking a dose.
Advise patients to report signs of hepatic damage (e.g. malaise, jaundice, dark urine).
Advise patients ability to drive and operate machinery may be affected by side effects such as dizziness, somnolence and convulsions.
Capsules
Advise patients capsules should be swallowed whole and taken at least 1 hour before or 2 hours after food.
Suspension
When dispensing a pack of oral suspension, advice should be given on the correct usage of the multi-dosing syringe or spoon provided by the manufacturer.
Advise patients the oral suspension can be taken with food.
Tablets
Advise patients tablets can be taken with or without food.
Side Effects
Abdominal distension
Abdominal pain
Acute generalised exanthematous pustulosis
Acute renal failure
Aggression
Agitation
Allergic reaction
Alterations in haematological function tests
Altered liver function tests
Anaphylaxis
Angioedema
Anorexia
Antibiotic-associated colitis
Anxiety
Arrhythmias
Arthralgia
Asthenia
Candidiasis
Chest pain
Cholestatic jaundice
Constipation
Convulsions
Deafness
Delirium
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dyspepsia
Dyspnoea
Dysuria
Eosinophilia
Epistaxis
Erythema multiforme
Fatigue
Flatulence
Gastritis
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hearing loss
Hepatic failure
Hepatic impairment
Hepatic necrosis
Hepatitis
Hot flushes
Hyperactivity
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Infections
Insomnia
Interstitial nephritis
Leukopenia
Malaise
Metrorrhagia
Myalgia
Myasthenia
Nausea
Nervousness
Neutropenia
Oedema
Osteoarthritis
Pain
Palpitations
Pancreatitis
Paraesthesia
Photosensitivity
Prolongation of QT interval
Pruritus
Pseudomembranous colitis
Pyrexia
Rash
Respiratory disorders
Salivation changes
Skin reactions
Smelling disturbances
Somnolence
Stevens-Johnson syndrome
Superficial tooth discolouration
Syncope
Taste disturbances
Testicular disorders
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.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Azithromycin 250 mg tablets. Teva UK Ltd. Revised June 2019.
Summary of Product Characteristics: Azithromycin 250 mg capsules. Teva UK Ltd. Revised July 2019.
Summary of Product Characteristics: Azithromycin 500 mg tablets. Teva UK Ltd. Revised June 2019.
Summary of Product Characteristics: Azithromycin 500 mg tablets. Sandoz Ltd. Revised September 2019.
Summary of Product Characteristics: Azithromycin 200 mg/5ml powder for oral suspension. Teva UK Ltd. Revised March 2018.
Summary of Product Characteristics: Zithromax 200 mg powder for oral suspension. Pfizer Ltd. Revised December 2020.
Summary of Product Characteristics: Zithromax 250 mg capsules. Pfizer Ltd. Revised December 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
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.