ERYTHROPED A

Posology Adults and children over 8 years:

For mild to moderate infections 2g daily in divided doses. Up to 4g daily in severe infections.

Elderly:

No special dosage recommendations.

Paediatric population Note:

For younger children, infants and babies, erythromycin suspensions is normally recommended. The recommended dose for children age 2 – 8, for mild to moderate infections, is 1 g daily in divided doses. The recommended dose for infants and babies, for mild to moderate infections, is 500 mg daily in divided doses.

For severe infections doses may be doubled. Method of administration For oral administration

The list of undesirable effects shown below is presented by system organ class, MedDRA preferred term, and frequency using the following frequency conventions: Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) System Organ Class Frequency Adverse reactions Immune system disorders Not known Allergic reactions (rare and mild) although anaphylaxis has occurred.

Eye disorders Not known Mitochondrial optic neuropathy Ear and labyrinth disorders Not known *Reversible hearing loss Very rare **Cardiac arrhythmiasCardiac disorders Not known Cardiac arrest, ventricular fibrillation Gastrointestinal disorders Not known Infantile hypertrophic pyloric stenosis Nausea, abdominal discomfort, vomiting and diarrhoea Hepatobiliary disorders Not known Hepatic dysfunction, hepatitis Rare Stevens-Johnson syndrome, toxic epidermal necrolysis, mild eruptions to erythema multiforme Skin and subcutaneous tissue disorders Not known Acute generalised exanthematous pustulosis (AGEP) Investigations Not known Abnormal liver function tests * Associated with doses of erythromycin usually greater than 4g per day has been reported.

** There have been isolated reports of chest pain, dizziness and palpitations, however, a cause and effect relationship has not been established. There are no reports implicating erythromycin products with abnormal tooth development, and only rare reports of damage to the blood, kidneys or central nervous system.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Erythromycin is excreted principally by the liver, so caution should be exercised in administering the antibiotic to patients with impaired hepatic function or concomitantly receiving potentially hepatotoxic agents. Hepatic dysfunction including increased liver enzymes and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin.

8). Clostridium difficile-associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including erythromycin and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, which may lead to overgrowth of C.

difficile. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued, and appropriate therapy should be instituted.

Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. 8). Fatalities have been reported. Erythromycin should be used with caution in the following; - Patients with coronary artery disease, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia.

5). 8). Epidemiological studies investigating the risk of adverse cardiovascular outcomes with macrolides have shown variable results. Some observational studies have identified a rare short term risk of arrhythmia, myocardial infarction and cardiovascular mortality associated with macrolides including erythromycin.

Consideration of these findings should be balanced with treatment benefits when prescribing erythromycin. 5). There have been reports suggesting erythromycin does not reach the foetus in adequate concentrations to prevent congenital syphilis.

1. Erythromycin is contraindicated in patients taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine, domperidone, cisapride or pimozide. 5). Erythromycin should not be given to patients with electrolyte disturbances (hypokalaemia, hypomagnesaemia due to the risk of prolongation of QT interval).

Erythromycin is contraindicated with ergotamine and dihydroergotamine. 5)