ERYTHROCIN

Posology Adults and children over 8 years:

For mild to moderate infections 1-2g 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 years, for mild to moderate infections, is 1 gram 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) Not known (cannot be estimated from the available data) System Organ Class Frequency Adverse reactions Infections and infestations Rare *Pseudomembranous colitis Blood and lymphatic system disorders Not known Eosinophilia.

Immune system disorders Not known Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred. Psychiatric disorders Not known Hallucinations Nervous system disorders Not known **Seizures, confusion and vertigo Eye disorders Not known Mitochondrial Optic Neuropathy Ear and labyrinth disorders Not known Deafness, tinnitus ***Reversible hearing loss Cardiac disorders Not known QTc interval prolongation, torsades de pointes, palpitations, and cardiac rhythm disorders including ventricular tachyarrhythmias.

Cardiac arrest, ventricular fibrillation. Vascular disorders Not known Hypotension. Gastrointestinal disorders Not known Infantile hypertrophic pyloric stenosis. 4), hepatomegaly, hepatic dysfunction, cholestatic hepatitis, jaundice. Skin and subcutaneous tissue disorders Not known Acute generalised exanthematous pustulosis (AGEP).

Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioedema, skin eruptions, pruritus, urticaria, exanthema. Renal and urinary Not known Interstitial nephritis disorders General disorders and administration site conditions Not known Chest pain, fever, malaise.

Investigations Not known Increased liver enzyme values. 4). ** There have been isolated reports of transient central nervous system side effects, however, a cause and effect relationship has not been established. *** There have been isolated reports, occurring chiefly in patients with renal insufficiency or high doses.

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)