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ERYTHROMYCIN 250 MG / 5 ML ORAL SUSPENSION

Active substance(s): ERYTHROMYCIN ETHYL SUCCINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Erythromycin 250 mg / 5 ml Oral Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted product contains 250 mg of erythromycin as
erythromycin ethyl succinate.
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Granules for Oral Suspension
Yellow granules with a banana odour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Antibiotic for the prophylaxis and treatment of infections caused by
Erythromycin sensitive organisms in a wide variety of clinical indications.
Clinical indications:
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Upper respiratory tract infections.
Lower respiratory tract infections.
Eye infections.
Ear infections.
Oral / dental infections.
Skin and soft tissue infections.
Gastro intestinal infections.
Sexually transmitted diseases.
Prophylaxis.

4.2

Posology and method of administration
To be taken orally
Adults and children over 8 years:
For mild to moderate infections 2 g daily in divided doses up to 4 g daily in
severe infections.
Elderly:
No special dosage recommendations.
Children:
a) Aged 2 to 8 years:
For mild to moderate infections 1 g daily in divided doses.
b) Infants and babies up to 2 years:
For mild to moderate infections 500 mg daily in divided doses.
For severe infections dosage may be doubled. Duration of the dosage regimen
is dependent on the nature of the infection and is at the discretion of the
physician.

4.3

Contraindications
Known sensitivity to erythromycin. Erythromycin is contra-indicated with
astemizole, terfenadine, cisapride and pimozide. It is also contra-indicated
with ergotamine and dihydroergotamine.

4.4

Special warnings and precautions for use
Caution should be exercised in administering this antibiotic to patients with
impaired hepatic function or those receiving concomitantly potentially
hepatotoxic agents since this drug is excreted principally by the liver.
Hepatic dysfunction including increased liver enzymes and/or cholestatic
hepatitis, with or without jaundice, has been infrequently reported with
erythromycin.
This product contains sucrose and therefore caution should be exercised when
administering this antibiotic to patients with diabetes mellitus, hereditary

fructose intolerance, glucose-galactose malabsorption syndrome, or sucraseisomaltase deficiency.

4.5

Interaction with other medicinal products and other forms of interaction
Concomitant use of erythromycin with terfenadine or astemizole is likely to
result in an enhanced risk of cardiotoxicity with these drugs. The concomitant
use of erythromycin with either astemizole or terfenadine is therefore
contraindicated.
Concurrent use of erythromycin and ergotamine or di-hydroergotamine has
been associated in some patients with acute ergot toxicity with the rapid
development of severe peripheral vasospasm and dysesthesia.
With the following drugs an increase in serum concentration may occur when
they are administered concurrently with erythromycin: acenocoumarol,
alfentanil, bromocriptine, cabergoline, carbamazepine, cyclosporin, digoxin,
disopyramide, felodipine, methylprednisolone, midazolam, mizolastine,
phenytoin, sildenafil, tacrolimus, terfenadine, theophylline, triazolam,
valproate, warfarin and zopiclone. Monitoring should be undertaken and
dosage adjusted accordingly.
Elevated levels of cisapride and pimozide may result from concomitant use
with erythromycin, increasing the risk of cardiac arrhythmias.
Concurrent administration of theophylline with oral erythromycin produces a
significant decrease in erythromycin serum concentration which could result in
sub-therapeutic concentrations of erythromycin.
Erythromycin plasma concentrations are increased when taken with cimetidine
increasing risk of toxicity, including deafness. Erythromycin reduces plasma
concentration of zafirlukast. Avoid concomitant use with mizolastine,
reboxetine and tolterodine.
There is an increased risk of myopathy with the lipid-regulating drug,
simvastitin and possibly atorvastatin and cerivastatin.

4.6

Pregnancy and lactation
Animal studies have not shown evidence of teratogenicity or embryo toxicity.
There is no evidence of hazard from erythromycin in human pregnancy, where
it has been in wide use without apparent ill consequence. As with all drugs,
special care should be taken in the treatment of pregnant women.

Erythromycin is readily 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 stated

4.8

Undesirable effects
Side effects are rare and usually mild, nausea, vomiting and diarrhoea occur
infrequently with usual oral doses. Most frequent side effects are gastrointestinal e.g. abdominal discomfort and are dose related. Allergic reactions
are rare and mild, although anaphylaxis has occurred. Skin reactions ranging
from mild eruptions to erythema multiforme, Stevens-Johnson syndrome and
toxic epidermal necrolysis have rarely been reported. Reversible deafness has
occurred after high doses of erythromycin. Super-infection following oral
administration of erythromycin is also rare but should be considered during
prolonged or repeated therapy, especially when other antibacterial agents are
simultaneously employed. Symptoms of hepatitis, hepatic dysfunction and/or
abnormal liver function test results may occur. As with other broad spectrum
antibiotics, pseudomembranous colitis has been reported rarely with
erythromycin.

4.9

Overdose
Symptoms are mainly confined to nausea, vomiting and diarrhoea. Reversible
hearing loss sometimes occurs.
Treatment: Gastric lavage and general supportive measures.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Erythromycin is a macrolide antibiotic, ATC code J01F A, which acts by
interfering with a bacterial protein synthesis and is bacteriostatic or
bactericidal depending on its concentration and the type of organism.
Sensitive organisms include:

(1) Gram positive bacteria such as Staphylococci aureus and epidermis,
Streptococci pyogenes, pneumoniae and viridans, Corynebacterium
diphtheriae and Listeria monocytogenes.
(2) Gram negative bacteria such as Heamophilus influenzae, Neisseria
meningitidis, Neisseria gonorrhoeae, Bordetella pertussis, Campylobacter
strains and Legionella pneumophila.
(3) Treponema pallidum
(4) Mycoplasma pneumoniae
(5) Chlamydia trachomatis

5.2

Pharmacokinetic properties
An ester well absorbed from the gastrointestinal tract, absorption may be
slightly delayed by food and the highest and earliest peak serum levels occur
under fasting conditions.
tmax = 2 to 4 hours
Cmax = approx. 0.5 micrograms/ml (from a 250 mg dose)
t ½ = 1.6 ± 0.7 hours
Erythromycin is excreted in high concentrations in the bile and up to 5% of an
oral dose may appear in the urine; considerable amounts may also be
inactivated by the body.

5.3

Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Carboxymethylcellulose sodium
Sodium citrate
Banana flavour
Quinoline yellow E104
Saccharin sodium

Silica, colloidal anhydrous
Sucrose

6.2

Incompatibilities
Not Applicable

6.3

Shelf life
36 months unopened.
14 days after reconstitution.

6.4

Special precautions for storage
Store in the original container. Do not store above 25°C prior to reconstitution.
After reconstitution, store suspension at 2°C - 8°C. Do not freeze.

6.5

Nature and contents of container
Nature: Amber type III glass bottle with polyethylene screw on cap.
Contents: 60.5 g
Reconstitution of the granules provides 100 ml of suspension.

6.6

Special precautions for disposal
Add 60 ml of water, invert the bottle and shake vigorously for 1 minute.

7

MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia

Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0044

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/02/2009

10

DATE OF REVISION OF THE TEXT
18/02/2009

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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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