Symptoms: hearing loss, severe nausea, vomiting and diarrhoea.
Treatment: gastric lavage, general supportive measures.
Erythromycin tablets enterosoluble is not dialysable.
Erythromycin tablets enterosoluble is contraindicated in patients taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine, domperidone, cisapride or pimozide.
Erythromycin tablets enterosoluble is contraindicated with ergotamine and dihydroergotamine.
None know
Blood and lymphatic system disorders
Eosinophilia.
Immune system disorders
Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred.
Psychiatric disorders
Hallucinations
Nervous system disorders
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.
Eye disorders
Mitochondrial Optic Neuropathy
Ear and labyrinth disorders
Deafness, tinnitus
There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency or taking high doses.
Cardiac disorders
QTc interval prolongation, torsades de pointes, palpitations, and cardiac rhythm disorders including ventricular tachyarrhythmias.
Vascular disorders
Hypotension.
Gastrointestinal disorders
The most frequent side effects of oral Erythromycin tablets enterosoluble preparations are gastrointestinal and are dose-related. The following have been reported:
upper abdominal discomfort, nausea, vomiting, diarrhoea, pancreatitis, anorexia, infantile hypertrophic pyloric stenosis.
Pseudomembranous colitis has been rarely reported in association with Erythromycin tablets enterosoluble therapy.
Hepatobiliary disorders
Cholestatic hepatitis, jaundice, hepatic diysfunction, hepatomegaly, hepatic failure, hepatocellular hepatitis.
Skin and subcutaneous tissue disorders
Skin eruptions, pruritus, urticaria, exanthema, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
Not known: acute generalised exanthematous pustulosis (AGEP).
Renal and urinary disorders
Interstitial nephritis
General disorders and administration site conditions
Chest pain, fever, malaise.
Investigations
Increased liver enzyme values.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There are no preclinical data of relevance to the prescriber, which are additional to that already included in the other sections of the SPC
Erythromycin tablets enterosoluble is indicated for the treatment / prophylaxis of infections caused by Erythromycin tablets enterosoluble-sensitive organisms:-
- upper and lower respiratory tract infections
- Skin and soft tissue infections
- bone infections
- gastro -intestinal infections
- oral/dental infections
- eye infections
- sexually transmitted diseases
- prophylaxis of whooping cough and diphtheria
- as an alternative to penicillin for staphylococcal infections in sensitive patients
Consideration should be given to official guidance on the appropriate use of antimicrobial agents
Pharmacotherapeutic group: Macrolides, Lincosamides and Streptogramins, Macrolides, ATC code: J01F A01
Mechanism of action
Erythromycin tablets enterosoluble exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis. Erythromycin tablets enterosoluble is usually active against most strains of the following organisms both in vitro and in clinical infections.
Gram positive bacteria - Listeria monocytogenes, Corynebacterium diphtheriae (as an adjunct to antitoxin), Staphylococci spp, Streptococci spp (including Enterococci).
Gram negative bacteria - Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Campylobacter spp.
Mycoplasma - Mycoplasma pneumoniae, Ureaplasma urealyticum.
Other organisms - Treponema pallidum, Chlamydia spp, Clostridia spp, L-forms, the agents causing trachoma and lymphogranuloma venereum.
Note: The majority of strains of Haemophilus influenzae are susceptible to the concentrations reached after ordinary doses.
Absorption is facilitated if the stomach is empty.
Peak blood levels normally occur within 1 hour of dosing of Erythromycin tablets enterosoluble ethylsuccinate granules. The elimination half life is approximately 2 hours. Doses may be administered 2, 3 or 4 times a day.
Erythromycin tablets enterosoluble ethylsuccinate is less susceptible than Erythromycin tablets enterosoluble to the adverse effect of gastric acid. It is absorbed from the small intestine. It is widely distributed throughout body tissues. Little metabolism occurs and only about 5% is excreted in the urine. It is excreted principally by the liver.
The drug is not removed by either peritoneal dialysis or haemodialysis. It diffuses readily into intracellular fluids and antibacterial activity can be achieved at essentially all sites. There is some retention on liver and spleen. Only low concentrations are achieved in cerebrospinal fluid, unless the meninges are inflamed. Diffusion into the aqueous humour, but not the vitreous humour of the eye is good. A significant proportion is bound to serum proteins.
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.
Erythromycin tablets enterosoluble 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 tablets enterosoluble.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Clostridium difficile-associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including Erythromycin tablets enterosoluble, 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.
Patients receiving Erythromycin tablets enterosoluble concurrently with drugs which can cause prolongation of the QT interval should be carefully monitored. The concomitant use of Erythromycin tablets enterosoluble with some of these drugs is contraindicated.
There have been reports suggesting Erythromycin tablets enterosoluble does not reach the foetus in adequate concentrations to prevent congenital syphilis. Infants born to women treated during pregnancy with oral Erythromycin tablets enterosoluble for early syphilis should be treated with an appropriate penicillin regimen.
There have been reports that Erythromycin tablets enterosoluble may aggravate the weakness of patients with myasthenia gravis.
Erythromycin tablets enterosoluble interferes with the fluorometric determination of urinary catecholamines.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving Erythromycin tablets enterosoluble concomitantly with statins.
There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following Erythromycin tablets enterosoluble therapy. In one cohort of 157 newborns who were given Erythromycin tablets enterosoluble for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. Since Erythromycin tablets enterosoluble 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 tablets enterosoluble 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 1193 mg sorbitol in each 5 ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium free'.
None known
Method of Administration
For oral administration only
Posology
Adults, including elderly, and children over 8 years:
250 - 500 mg every six hours, up to 4 g daily for more severe infections.
For acne vulgaris the usual dose is 250 mg three times daily before meals for one to four weeks and then reduced to twice daily until improvement occurs.
Children 2 to 8 years:
250 mg every six hours, doubled for severe infections.
30 mg/kg/day in divided doses. For severe infections up to 50 mg/kg/day in divided doses.
Children up to 2 years:
125 mg every six hours, doubled for severe infections.
30 mg/kg/day in divided doses. For severe infections up to 50 mg/kg/day in divided doses.
Renal Impairment
If impairment is severe (GFR< 10 ml/min), the daily dose should not exceed 1.5 g due to risk of ototoxicity.
60 ml suspension: to reconstitute add 48 ml water and shake the bottle vigorously. The resulting suspension is yellow in colour.
100 ml suspension: to reconstitute add 80 ml water and shake the bottle vigorously. The resulting suspension is yellow in colour
140 ml suspension: to reconstitute add 112 ml water and shake the bottle vigorously. The resulting suspension is yellow in colour
