Erythromycin enteric coated formulations
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of erythromycin.
Drugs List
Therapeutic Indications
Uses
Acne vulgaris
Antibiotic sensitive infections
Genital infections due to chlamydia trachomatis
Pneumococcal infection: prevention
Prevention of a secondary case of group A streptococcal infection
Prevention of rheumatic fever recurrence
Secondary case of diphtheria in non-immune patients: prevention
Syphilis - chancre (initial therapy)
Treatment of rosacea
Treatment of antibiotic sensitive infections including:
Upper respiratory tract infections: Tonsillitis, peritonsillar abscess, pharyngitis, sinusitis, secondary infections in influenza and common colds.
Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis, pneumonia (lobar pneumonia, bronchopneumonia, primary atypical pneumonia), bronchiectasis, legionnaire's disease.
Ear infections: otitis media and otitis externa, mastoiditis
Oral infections: gingivitis, Vincent's angina
Eye infections: blepharitis
Skin and soft tissue infections: boils and carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas, rosacea
Gastrointestinal infections: cholecystitis, staphylococcal enterocolitis
Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis
Prophylaxis against:
Recurrence of streptococcal infections in patients with evidence of rheumatic fever or heart disease
Recurrence of rheumatic fever
Secondary case of diphtheria in non-immune patient
Secondary case of invasive group A streptococcal infection
Bacterial endocarditis in patients with valvular heart disease who are to undergo elective dental or surgical procedures of the upper respiratory tract
Pneumococcal infection in asplenia or in patients with sickle-cell disease
Unlicensed Uses
Control of gastro-intestinal motility
Treatment of gastro-intestinal stasis.
Dosage
Adults
Infection
Mild to moderate
250mg to 500mg every 6 hours or 500mg to 1g every 12 hours.
Severe
4g daily in divided doses.
Acne vulgaris
250mg twice daily for 4 weeks. This may be reduced to 250mg once daily according to response. Alternatively, give 500mg twice a day.
Early syphilis
500mg every 6 hours for fourteen days.
Intestinal amoebiasis
250mg every 6 hours for ten to fourteen days.
Legionnaires' disease
1g to 4 g daily until clinical signs and symptoms indicate a cure.
Pertussis
30 to 50mg/kg daily given in divided doses for five to fourteen days (depending on eradication of a positive culture).
Prophylaxis against recurrence of streptococcal infections in patients with evidence of rheumatic fever or heart disease
250mg twice daily.
Prevention of bacterial endocarditis in patients with valvular heart disease who are to undergo elective dental or surgical procedures of the upper respiratory tract
1g to be taken 2 hours prior to surgery. After surgery, 500mg should be administered every 6 hours for a total of eight doses.
Rosacea
500mg twice daily.
Uncomplicated genital chlamydia or non-gonococcal urethritis
500mg every 12 hours for fourteen days.
Prevention of secondary case of diphtheria in non-immune patient
500mg every 6 hours for seven days. Treat for further ten days if nasopharyngeal swabs positive after first seven days' treatment.
Prevention of secondary case of invasive group A streptococcal infection
250mg to 500mg every 6 hours for ten days.
Prevention of pneumococcal infection in asplenia or in patients with sickle-cell disease
500mg twice a day. Antibiotic prophylaxis is not fully reliable.
Children
General infection
Some manufacturers recommend a dose of 30 to 50mg/kg daily, given in divided doses every 6 or 12 hours (higher doses should be administered every 6 hours). This may be doubled in severe infections.
Intestinal amoebiasis
30 to 50mg/kg daily in divided doses for ten to fourteen days.
Prevention of bacterial endocarditis in patients with valvular heart disease who are to undergo elective dental or surgical procedures of the upper respiratory tract
20mg/kg to be taken 2 hours prior to surgery. After surgery, 10mg/kg should be administered every 6 hours for a total of 8 doses.
Treatment of susceptible infections in patients with penicillin hypersensitivity
Children aged 8 to 18 years
250mg to 500mg every 6 hours. Dose doubled in severe infections. Total daily dose may be given in two divided doses.
Children aged 2 to 8 years
250mg every 6 hours. Dose doubled in severe infections. Total daily dose may be given in two divided doses.
Children aged 1 month to 2 years
125mg every 6 hours. Dose doubled in severe infections. Total daily dose may be given in two divided doses.
Acne vulgaris
Children aged 12 to 18 years
500mg twice a day.
Infantile acne
Children aged 1 month to 2 years
250mg once a day or 125mg twice a day.
Early syphilis
Children aged 12 to 18 years
500mg every 6 hours for fourteen days.
Uncomplicated genital chlamydia or Non-gonococcal urethritis
Children aged 12 to 18 years
500mg every 12 hours for fourteen days.
Children aged 2 to 12 years
250mg every 12 hours for fourteen days.
Children aged 1 month to 2 years
12.5?mg/kg four times a day for fourteen days.
Prevention of pneumococcal infection in asplenia or in patients with sickle-cell disease
Children aged 8 to 18 years
500mg every 12 hours.
Children aged 2 to 8 years
250mg every 12 hours.
Children aged 1 month to 2 years
125mg every 12 hours.
Antibacterial prophylaxis is not fully reliable. Antibacterial prophylaxis may be discontinued in children over 5 years of age with sickle-cell disease who have received pneumococcal immunisation.
Prevention of secondary case of diphtheria in non-immune patient
Children aged 8 to 18 years
500mg every 6 hours for seven days.
Children aged 2 to 8 years
250 mg every 6 hours for seven days.
Children aged 1 month to 2 years
125mg every 6 hours for seven days.
Treat for further ten days if nasopharyngeal swabs positive after first seven days' treatment.
Prevention of recurrence of rheumatic fever
Children aged 2 to 18 years
250mg twice daily.
Children aged 1 month to 2 years
125mg twice daily.
Prevention of secondary case of invasive group A streptococcal infection
Children aged 8 to 18 years
250mg to 500mg every 6 hours for ten days.
Children aged 2 to 8 years
250mg every 6 hours for ten days.
Children aged 1 month to 2 years
125mg every 6 hours for ten days.
Gastrointestinal stasis (unlicensed)
Children aged 1 month to 18 years
3mg/kg four times daily.
Patients with Renal Impairment
A maximum dose of 1.5g daily is recommended in patients with severe renal impairment due to risk of ototoxicity.
Contraindications
Acute porphyria
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Neonates under 14 days old
Predisposition to long QT syndrome
Breastfeeding
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of torsade de pointes
Lactose intolerance
Myasthenia gravis
Pregnancy
Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Reduce dose in patients with severe renal impairment
Some formulations contain lactose
Some formulations contain propylene glycol
Perform ECG before and during treatment
Increased risk of infantile hypertrophic pyloric stenosis
Monitor liver function on prolonged therapy
Monitor serum electrolytes
Consider C. difficile if diarrhoea occurs within 2 months of treatment
Consider pseudomembranous colitis if patient presents with diarrhoea
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Prolonged use may result in superinfection with non-susceptible organisms
May interfere with certain laboratory measurements
Discontinue at once if pseudomembranous colitis occurs
Discontinue if severe hepatic changes occur
Discontinue permanently if AGEP is diagnosed
Advise patient not to take St John's wort concurrently
Erythromycin should not be used during and for two weeks after treatment with CYP3A4 inducers.
There have been reports suggesting that erythromycin does not reach the fetus in adequate concentrations to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate treatment for congenital syphilis.
The Drug Database for Acute Porphyria classifies erythromycin lactobionate as porphyrinogenic and should only be prescribed on urgent indications.
Infantile hypertrophic pyloric stenosis (IHPS) has been reported in infants receiving erythromycin. The benefits of therapy must be carefully weighed against the risks of developing IHPS. If the infant experiences vomiting or irritability, patients should be advised to contact their physician immediately. The risk of IHPS is increased in the first two weeks after birth. Parents or carers should seek medical advice if vomiting or irritability with feeding occurs in infants during treatment with erythromycin.
Pregnancy and Lactation
Pregnancy
Use erythromycin with caution during pregnancy.
The manufacturer advises caution if erythromycin is used during pregnancy. Use only if potential benefit outweighs the risk. Observational human studies have reported cardiovascular malformations after exposure to erythromycin during early pregnancy. Erythromycin crosses the placental barrier. Infants born to women treated during pregnancy for early syphilis should receive appropriate treatment for congenital syphilis. Maternal macrolide exposure within 7 weeks of delivery has been reported to result in an increased risk of infantile hypertrophic pyloric stenosis.
Lactation
Use erythromycin with caution during breastfeeding.
The manufacturer advises erythromycin may be used with caution during breastfeeding. The small amounts of erythromycin in milk are unlikely to cause adverse effects in the infant. However, the infant should be monitored for irritability and possible effects on the gastrointestinal flora (e.g. diarrhoea, candidiasis). A greater risk of infantile hypertrophic pyloric stenosis has been reported in breastfed infants when a macrolide antibiotic has been administered to the mother.
Side Effects
Abdominal discomfort
Acute generalised exanthematous pustulosis
Allergic reaction
Altered liver function tests
Anaphylaxis
Antibiotic-associated colitis
Cardiac arrhythmias
Chest pain
Cholestatic hepatitis
CNS effects
Confusion
Diarrhoea
Dizziness
Eosinophilia
Erythema multiforme
Fever
Hallucinations
Hearing disturbances
Hearing loss
Hepatic impairment
Hepatitis
Hepatocellular hepatitis
Hypotension
Infantile hypertrophic pyloric stenosis
Interstitial nephritis
Jaundice
Myasthenia gravis-like syndrome
Nausea
Optic neuropathy
Palpitations
Pancreatitis
Prolongation of QT interval
Pruritus
Pseudomembranous colitis
Rash
Seizures
Skin eruption
Stevens-Johnson syndrome
Superinfections
Toxic epidermal necrolysis
Urticaria
Vertigo
Vomiting
Effects on Laboratory Tests
Erythromycin may interfere with measurements of urinary catecholamines and 17-hydroxycorticosteroids.
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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Further Information
Last Full Review Date: October 2019
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
Summary of Product Characteristics: Erythromycin 250mg Gastro-resistant Tablets. Brown & Burk UK Ltd. Revised December 2017.
Summary of Product Characteristics: Erythromycin 250mg Capsules. Titan Laboratories UK Ltd. Revised August 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 October 2021
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last accessed: 04 October 2019
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Erythromycin. Last revised: 01 April 2019
Last accessed: 04 October 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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