ERYTHROPED SF, ERYTHROMYCIN

Posology Adults and children over 8 years: 2g/day in divided doses. For severe infections up to 4g/day in divided doses. Paediatric population Children 2-8 years: 30 mg/kg/day in divided doses. For severe infections up to 50 mg/kg/day in divided doses.

Normal dose: 250mg four times a day or 500mg twice daily. Children up to 2 years: 30mg/kg/day in divided doses. For severe infections up to 50mg/kg/day in divided doses. Normal dose: 125mg four times a day or 250mg twice daily. Presentations are available for adults and children over 8 years, children aged 2-8 years, and for children under 2 years.

Method of administration For oral administrations.

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. The list of undesirable effects shown below is presented by system organ class, MedDRA preferred term, and frequency using the following frequency category: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) 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 Blood and lymphatic system disorders Not known Eosinophilia. Immune system disorders Not known Hypersensitivity ranging from urticaria and mild rash to anaphylaxis have occurred. Psychiatric disorders Not known Hallucinations Nervous system disorders Not known Confusion, seizures and vertigo* Eye disorders Not known Optic Neuropathy Ear and labyrinth disorders Not known Deafness**, tinnitus Cardiac disorders Not known Torsades de pointes, palpitations, and cardiac rhythm disorders including ventricular tachyarrhythmias.

Cardiac arrest, ventricular fibrillation. Electrocardiogram QT prolonged Vascular disorders Not known Hypotension. 4)***. Not known Upper abdominal discomfort, nausea, vomiting, diarrhoea, pancreatitis, anorexia, infantile hypertrophic pyloric stenosis.

4). Skin and subcutaneous tissue disorders Not known Rash, pruritis, urticaria, exanthema, angioedema, Stevens- Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. Acute generalised exanthematous pustulosis (AGEP). Renal and urinary disorders Not known Tubulointerstitial nephritis General disorders and administration site conditions Not known Chest pain, fever, malaise.

Investigations Not known Hepatic enzyme increased *There have been isolated reports of transient central nervous system side effects including confusion, seizures and vertigo; however, a cause and effect relationship has not been established.

**There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency or high doses. 4). 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.

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). 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. 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. 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.

There have been reports suggesting erythromycin does not reach the foetus 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 penicillin regimen.

There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis. Erythromycin interferes with the fluorometric determination of urinary catecholamines. Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with statins.

Paediatric population There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. Epidemiological studies including data from meta-analyses suggest a 2-3-fold increase in the risk of IHPS following exposure to erythromycin in infancy.

This risk is highest following exposure to erythromycin during the first 14 days of life. 2%) following exposure to erythromycin during this time period. 2%. Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or chlamydia), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS.

Parents should be informed to contact their physician if vomiting or irritability with feeding occurs. This medicine contains sorbitol (E420). 2 g of sorbitol. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect. This medicine contains parahydroxybenzoates. May cause allergic reactions (possibly delayed). 47% of the WHO recommended maximum daily intake of 2g sodium for an adult.

73% of the WHO recommended maximum daily intake for sodium. This medicine is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

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).