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Erythroped PI SF
Erythromycin Ethylsuccinate SF 125mg/5ml
Erythromycin SF 125mg/5ml
Erythromycin Suspension 125mg/5ml SF
Erythromycin Ethylsuccinate SF Suspension 125mg/5ml


Active: Erythromycin as Erythromycin Ethylsuccinate 125 mg/5ml


Granules for oral suspension.




Therapeutic indications
For the prophylaxis and treatment of infections caused by erythromycinsensitive organisms.
Erythromycin is highly effective in the treatment of a great variety of clinical
infections such as:
1. Upper Respiratory Tract infections: tonsillitis, peritonsillar abscess,
pharyngitis, laryngitis, sinusitis, secondary infections in influenza and
common colds
2. Lower Respiratory Tract infections: tracheitis, acute and chronic bronchitis,
pneumonia (lobar pneumonia, bronchopneumonia, primary atypical
pneumonia), bronchiectasis, Legionnaire's disease
3. Ear infection: otitis media and otitis externa, mastoiditis
4. Oral infections: gingivitis, Vincent's angina
5. Eye infections: blepharitis
6. Skin and soft tissue infections: boils and carbuncles, paronychia, abscesses,
pustular acne, impetigo, cellulitis, erysipelas
7. Gastrointestinal infections: cholecystitis, staphylococcal enterocolitis
8. Prophylaxis: pre- and post-operative trauma, burns, rheumatic fever.
9. Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis,
lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever

Note: Erythromycin has also proved to be of value in endocarditis and
septicaemia, but in these conditions initial administration of erythromycin
lactobionate by the intravenous route is advisable.


Posology and method of administration
Adults and children over 8 years: 2g/day in divided doses. For severe
infections up to 4g/day in divided doses.
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.


Known hypersensitivity to erythromycin.
Erythromycin is contraindicated in patients taking astemizole, terfenadine,
cisapride or pimozide.
Erythromycin is contraindicated with ergotamine and dihydroergotamine.


Special warnings and precautions for use
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.
Pseudomembranous colitis has been reported with nearly all antibacterial
agents, including macrolides, and may range in severity from mild to lifethreatening (see section.4.8). 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.
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
Rhabdomyolysis with or without renal impairment has been reported in
seriously ill patients receiving erythromycin concomitantly with statins.
There have been reports of infantile hypertrophic pyloric stenosis (IHPS)
occurring in infants following erythromycin therapy. In one cohort of 157
newborns who were given erythromycin 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 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.


Interaction with other medicinal products and other forms of interaction
Increases in serum concentrations of the following drugs metabolised by the
cytochrome P450 system may occur when administered concurrently with
erythromycin: acenocoumarol, alfentanil, astemizole, bromocriptine, carbamazepine,
cilostazol, cyclosporin, digoxin, dihydroergotamine, disopyramide, ergotamine,
hexobarbitone, methylprednisolone, midazolam, omeprazole, phenytoin, quinidine,
rifabutin, sildenafil, tacrolimus, terfenadine, theophylline, triazolam, valproate,
vinblastine, and antifungals e.g. fluconazole, ketoconazole and itraconazole.
Appropriate monitoring should be undertaken and dosage should be adjusted as
necessary. Particular care should be taken with medications known to prolong the
QTc interval of the electrocardiogram.
Drugs that induce CYP3A4 (such as rifampicin, phenytoin, carbamazepine,
phenobarbital, St John’s Wort) may induce the metabolism of erythromycin. This
may lead to sub-therapeutic levels of erythromycin and a decreased effect. The
induction decreases gradually during two weeks after discontinued treatment with
CYP3A4 inducers. Erythromycin should not be used during and two weeks after
treatment with CYP3A4 inducers.

HMG-CoA Reductase Inhibitors: erythromycin has been reported to increase
concentrations of HMG-CoA reductase inhibitors (e.g. lovastatin and simvastatin).
Rare reports of rhabdomyolysis have been reported in patients taking these drugs
Contraceptives: some antibiotics may in rare cases decrease the effect of
contraceptive pills by interfering with the bacterial hydrolysis of steroid conjugates in
the intestine and thereby reabsorption of unconjugated steroid. As a result of this
plasma levels of active steroid may decrease.
Antihistamine H1 antagonists: care should be taken in the coadministration of
erythromycin with H1 antagonists such as terfenadine, astemizole and mizolastine
due to the alteration of their metabolism by erythromycin.
Erythromycin significantly alters the metabolism of terfenadine, astemizole and
pimozide when taken concomitantly. Rare cases of serious, potentially fatal,
cardiovascular events including cardiac arrest, torsade de pointes and other
ventricular arrhythmias have been observed (see sections 4.3 and 4.8).
Anti-bacterial agents: an in vitro antagonism exists between erythromycin and the
bactericidal beta-lactam antibiotics (e.g. penicillin, cephalosporin). Erythromycin
antagonises the action of clindamycin, lincomycin and chloramphenicol. The same
applies for streptomycin, tetracyclines and colistin.
Protease inhibitors: in concomitant administration of erythromycin and protease
inhibitors, an inhibition of the decomposition of erythromycin has been observed.
Oral anticoagulants: there have been reports of increased anticoagulant effects when
erythromycin and oral anticoagulants (e.g. warfarin) are used concomitantly.
Triazolobenzodiazepines (such as triazolam and alprazolam) and related
benzodiazepines: erythromycin has been reported to decrease the clearance of
triazolam, midazolam, and related benzodiazepines, and thus may increase the
pharmacological effect of these benzodiazepines.
Post-marketing reports indicate that co-administration of erythromycin with
ergotamine or dihydroergotamine has been associated with acute ergot toxicity
characterised by vasospasm and ischaemia of the central nervous system, extremities
and other tissues (see section 4.3).
Elevated cisapride levels have been reported in patients receiving erythromycin and
cisapride concomitantly. This may result in QTc prolongation and cardiac
arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de
pointes. Similar effects have been observed with concomitant administration of
pimozide and clarithromycin, another macrolide antibiotic.
Erythromycin use in patients who are receiving high doses of theophylline may be
associated with an increase in serum theophylline levels and potential theophylline
toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels,
the dose of theophylline should be reduced while the patient is receiving concomitant
erythromycin therapy. There have been published reports suggesting when oral
erythromycin is given concurrently with theophylline there is a significant decrease in
erythromycin serum concentrations. This decrease could result in sub-therapeutic
concentrations of erythromycin.

There have been post-marketing reports of colchicine toxicity with concomitant use
of erythromycin and colchicine.
Hypotension, bradyarrhythmias and lactic acidosis have been observed in patients
receiving concurrent verapamil, a calcium channel blocker.
Cimetidine may inhibit the metabolism of erythromycin which may lead to an
increased plasma concentration.
Erythromycin has been reported to decrease the clearance of zopiclone and thus may
increase the pharmacodynamic effects of this drug.


Pregnancy and lactation
There are no adequate and well-controlled studies in pregnant women. However,
observational studies in humans have reported cardiovascular malformations after
exposure to medicinal products containing erythromycin during early pregnancy.
Erythromycin has been reported to cross the placental barrier in humans, but foetal
plasma levels are generally low.
Erythromycin is excreted in breast milk, therefore, caution should be exercised when
erythromycin is administered to a nursing mother.


Effects on ability to drive and use machines
None reported


Undesirable effects
Blood and lymphatic system disorders:
Cardiac disorders
QTc interval prolongation, torsades de pointes, palpitations, and cardiac
rhythm disorders including ventricular tachyarrhythmias.
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.
Gastrointestinal disorders

The most frequent side effects of oral erythromycin 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 therapy (see section 4.4).
General disorders and administration site conditions
Chest pain, fever, malaise.
Hepatobiliary disorders
Cholestatic hepatitis, jaundice, hepatic disfunction, hepatomegaly, hepatic
failure, hepatocellular hepatitis (see section 4.4).
Immune system disorders
Allergic reactions ranging from urticaria and mild skin eruptions to
anaphylaxis have occurred.
Increased liver enzyme values.
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.
Psychiatric disorders
Renal and urinary disorders
Interstitial nephritis
Skin and subcutaneous tissue disorders
Skin eruptions, pruritus, urticaria, exanthema, angioedema, Stevens-Johnson
syndrome, toxic epidermal necrolysis, erythema multiforme.
Vascular disorders


Symptoms: hearing loss, severe nausea, vomiting and diarrhoea.
Treatment: gastric lavage, general supportive measures.




Pharmacodynamic properties
Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal
sub-unit of susceptible microorganisms and suppresses protein synthesis.
Erythromycin 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, Lforms, the agents causing trachoma and lymphogranuloma venereum.
Note: The majority of strains of Haemophilus influenzae are susceptible to the
concentrations reached after ordinary doses.


Pharmacokinetic properties
Peak blood levels normally occur within 1 hour of dosing of erythromycin
ethylsuccinate granules. The elimination half life is approximately 2 hours.
Doses may be administered 2, 3 or 4 times a day.
Erythromycin ethylsuccinate is less susceptible than erythromycin 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.


Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.




List of excipients
Sorbitol, xanthan gum, sodium citrate, surfactant poloxamer 188, acesulfame
(K), sodium saccharin, purified water, sodium methylhydroxybenzoate,

sodium propylhydroxybenzoate, colloidal silicon dioxide, imitation banana
flavour entrapped No.2, entrapped artificial cream.

None Stated.


Shelf life
Bottles: 24 months. Once reconstituted Erythroped PI SF should be used
within 7 days.
Sachets:24 months.


Special precautions for storage


Nature and contents of container
High density polyethylene bottles, 100ml or 140ml, with polypropylene cap which
may be a child resistant cap.

Sachet; 44GSM Paper / 12 GSM LDPE / 9μm A1 foil / 34 GSM LDPE


Special precautions for disposal
Not applicable


Amdipharm UK Limited
Capital House, 85 King William Street,
London EC4N 7BL, UK


PL 20072/0041





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Source: Medicines and Healthcare Products Regulatory Agency

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