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ERYTHROMYCIN 250MG TABLETS BP

Active substance(s): ERYTHROMYCIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Erythromycin Tablets BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active: Erythromycin BP 250 mg per tablet

3.

Pharmaceutical Form
Enteric coated tablet

4.

CLINICAL PARTICULARS

4.1.

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.

4.2

Posology and method of administration
For oral administration.
Adults and older children: For mild to moderate infections 2g daily in divided
doses. Up to 4g daily in severe infections.
Elderly: No special dosage recommendations.
Note: For younger children, infants and babies, Erythroped, erythromycin
ethylsuccinate suspensions, are 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.

4.3

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

4.4

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
catecholamines.
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.

4.5

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 concomitantly.
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.
4.6

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.

4.7

Effects on ability to drive and use machines
None reported

4.8

Undesirable effects
Blood and lymphatic system disorders
Eosinophilia.
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 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.
Investigations
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
Hallucinations
Renal and urinary disorders
Interstitial nephritis
Skin and subcutaneous tissue disorders
Skin eruptions, prurituls, urticaria, exanthema, angioedema, Stevens-Johnson
syndrome, toxic epidermal necrolysis, erythema multiforme.
Vascular disorders
Hypotension.
4.9

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

5

PHARMACOLOGICAL PROPERTIES
5.1.

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.

5.2

Pharmacokinetic particulars
Peak blood levels normally occur within one hour of dosing of erythromycin
ethylsuccinate granules. The elimination half life is approximately two hours.
Doses may be administered two, three or four times a day.

5.3

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 eliminated 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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium carboxymethylcellulose
Microcrystalline cellulose
Povidone
Polacrilin potassium
Talc
Magnesium stearate
Hypromellose

Hydroxypropyl cellulose
Propylene glycol
Sorbitan oleate
Methacrylic acid - ethyl acrylate copolymer
Titanium dioxide
Triethyl citrate
Antifoam emulsion

6.2

Incompatibilities
None Stated.

6.3

Shelf life
24 months.

6.4

Special precautions for storage
Protect from light, store below 25°C.

6.5

Nature and contents of container
Glass bottles, type III EP amber glass with a urea outer / aluminium liner cap,
of 100 tablets.
Polypropylene bottles with either an LDPE or an HDPE closure, of 50, 100,
500 and 1000 tablets.
Blisters, clear or opaque PVC/PVDC 300μm / 60gsm film and 20μm hard
tamper aluminium foil with 5 - 8gsm PVC/PVDC compatible heat seal lacquer
on one side, of 28, 40 and 56 tablets.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Amdipharm UK Limited
Regency House
Miles Gray Road
Basildon
Essex
SS14 3AF
United Kingdom.

8

MARKETING AUTHORISATION NUMBER(S)
PL 20072/0039

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/08/2006

10

DATE OF REVISION OF THE TEXT
10/09/2013

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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