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Erythromycin stearate oral

Presentation

Oral formulations of erythromycin stearate (250mg and 500mg).

Drugs List

  • ERYTHROCIN 250 250mg tablets
  • ERYTHROCIN 500 500mg tablets
  • erythromycin stearate 250mg tablets
  • erythromycin stearate 500mg tablets
  • 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 infections caused by erythromycin-sensitive organisms, including:
    Upper respiratory tract infections: tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, 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 infection: 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.

    Gastrointestinal infections: cholecystitis, staphylococcal enterocolitis.

    Other infections: diphtheria, syphilis, gonorrhoea, pelvic inflammatory disease, osteomyelitis, urethritis, lymphogranuloma venereum, prostatitis, scarlet fever.

    Prophylaxis of infections caused by erythromycin-sensitive organisms
    Pre-operative trauma.
    Post-operative trauma.
    Burns.
    Rheumatic fever.
    Secondary case of invasive group A streptococcal infection.
    Secondary case of diphtheria in non-immune patient.
    Pneumococcal infection in asplenia or in patients with sickle-cell disease.

    Unlicensed Uses

    Control of gastro-intestinal motility

    Gastrointestinal stasis.

    Dosage

    Adults

    Treatment of infection
    1g to 2g per day in divided doses every 6, 8 or 12 hours.
    In severe infections, up to 4g daily in divided doses.

    Distinct doses for the following indications can be found in other sources:

    Early syphilis
    500mg four times daily for 14 days.

    Uncomplicated genital chlamydia
    500mg twice daily for 14 days.

    Non-gonococcal urethritis
    500mg twice daily for 14 days.

    Acne vulgaris
    500mg twice daily.

    Rosacea
    500mg twice daily.

    Prophylaxis of secondary cases of invasive group A streptococcal infection
    250mg to 500mg every 6 hours for 10 days.

    Prophylaxis of secondary case of diphtheria in non-immune patients
    500mg every 6 hours for 7 days.
    If nasopharyngeal swabs are positive after the first 7 days of therapy, treat for a further 10 days.

    Prevention of pneumococcal infection in asplenia or in patients with sickle-cell disease
    500mg twice a day.
    Note: antibiotic prophylaxis is not fully reliable.

    Children

    Treatment of infection
    Children 8 to 18 years
    See Dosage; Adult.

    Children 2 to 8 years
    1g daily in divided doses. This may given as 250mg every 6 hours or 500mg every 12 hours. The dose may be doubled for severe infections.

    Children under 2 years
    500mg in divided doses. This may be given as 125mg every 6 hours or 250mg every 12 hours. The dose may be doubled for severe infections.

    Distinct doses for the following indications can be found in other sources:

    Acne vulgaris
    Children 12 to 18 years
    500mg twice a day.

    Infantile acne
    Children 1 month to 2 years
    250mg once daily or 125mg twice daily.

    Early syphilis
    Children 12 to 18 years
    500mg every 6 hours for 14 days.

    Uncomplicated genital chlamydia, non-gonococcal urethritis, pelvic inflammatory disease
    Children 12 to 18 years
    500mg twice daily for 14 days.

    Children 2 to 12 years
    250mg twice daily for 14 days.

    Children 1 month to 2 years
    12.5mg/kg four times daily for 14 days.

    Prevention of pneumococcal infection in asplenia or in patients with sickle-cell disease
    Children 8 to 18 years
    500mg twice daily.

    Children 2 to 8 years
    250mg twice daily.

    Children 1 month to 2 years
    125mg twice daily.
    Note: antibiotic 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 8 to 18 years
    500mg every 6 hours for 7 days.

    Children 2 to 8 years
    250 mg every 6 hours for 7 days.

    Children 1 month to 2 years
    125mg every 6 hours for 7 days.
    Treat for further 10 days if nasopharyngeal swabs positive after first 7 days' treatment.

    Prevention of recurrence of rheumatic fever
    Children 2 to 18 years
    250mg twice daily.

    Children 1 month to 2 years
    125mg twice daily.

    Prevention of secondary case of invasive group A streptococcal infection
    Children 8 to 18 years
    250 to 500mg every 6 hours for 10 days.

    Children 2 to 8 years
    250mg every 6 hours for 10 days.

    Children 1 month to 2 years
    125mg every 6 hours for 10 days.

    Gastro-intestinal stasis (Under specialist supervision)
    Children 1 month to 18 years
    3mg/kg four times daily.

    Erythrolar
    Children under 18 years old
    For treatment using tablets, the dose is to be calculated on the basis of 30mg erythromycin stearate activity/kg per day in divided doses throughout the day. In cases of severe infections the dose may be increased to 50mg/kg daily in divided doses throughout the day.

    Additional Dosage Information

    Some manufacturers recommend to avoid erythromycin stearate during and for two weeks after treatment with CYP3A4 inducers.

    Contraindications

    Long QT syndrome
    Porphyria
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Neonates under 14 days old
    Breastfeeding
    Electrolyte imbalance
    Hepatic impairment
    History of torsade de pointes
    Myasthenia gravis
    Pregnancy

    Correct electrolyte disorders before treatment
    May exacerbate myasthenia gravis
    Reduce dose in patients with severe renal impairment
    Some brands contain tartrazine
    Perform ECG before and during treatment
    Increased risk of infantile hypertrophic pyloric stenosis
    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 affect results of some laboratory tests
    Discontinue at once if pseudomembranous colitis occurs
    Discontinue permanently if AGEP is diagnosed
    Advise patient not to take St John's wort concurrently

    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 stearate with caution during pregnancy.

    Manufacturer advises caution if erythromycin stearate is used during pregnancy. Use only if potential benefit outweighs the risk. 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 stearate with caution during breastfeeding.

    The manufacturer advise erythromycin stearate 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
    Anaphylaxis
    Angioneurotic oedema
    Anorexia
    Cardiac symptoms
    Chest pain
    Cholestatic hepatitis
    Clostridium difficile diarrhoea
    CNS disturbances
    Diarrhoea
    Dizziness
    Eosinophilia
    Erythema multiforme
    Exanthema
    Fever
    Hallucinations
    Hearing loss
    Hepatic failure
    Hepatic impairment
    Hepatitis
    Hepatomegaly
    Hypersensitivity reactions
    Hypotension
    Increases in hepatic enzymes
    Infantile hypertrophic pyloric stenosis
    Interstitial nephritis
    Jaundice
    Malaise
    Myasthenia gravis-like syndrome
    Nausea
    Optic neuropathy
    Palpitations
    Pancreatitis
    Prolongation of QT interval
    Pruritus
    Pseudomembranous colitis
    Rash
    Seizures
    Skin eruption
    Stevens-Johnson syndrome
    Tinnitus
    Torsades de pointes
    Toxic epidermal necrolysis
    Urticaria
    Ventricular tachycardia
    Vomiting

    Effects on Laboratory Tests

    Erythromycin interferes with the fluorometric determination of urinary catecholamines.

    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: 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.

    Summary of Product Characteristics: Erythrocin 250 tablets. ADVANZ Pharma. Revised February 2018.

    Summary of Product Characteristics: Erythrocin 500 tablets. ADVANZ Pharma. Revised February 2018.

    Summary of Product Characteristics: Erythrolar (Erythromycin) Tablets 250mg. Ennogen Pharma Limited. Revised July 2022.

    Summary of Product Characteristics: Erythrolar (Erythromycin) Tablets 500mg. Ennogen Pharma Limited. Revised July 2022.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 August 2022.

    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 September 2019

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