ERYTHROMYCIN 125MG/5ML ORAL SUSPENSION
Active substance(s): ERYTHROMYCIN ETHYL SUCCINATE
NAME OF THE MEDICINAL PRODUCT
Erythromycin 125 mg / 5 ml Oral Suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted product contains 125 mg of erythromycin as
erythromycin ethyl succinate.
For excipients, see 6.1.
Granules for Oral Suspension
Yellow granules with a banana odour.
Antibiotic for the prophylaxis and treatment of infections caused by
Erythromycin sensitive organisms in a wide variety of clinical indications.
Upper respiratory tract infections.
Lower respiratory tract infections.
Oral / dental infections.
Skin and soft tissue infections.
Gastro intestinal infections.
Sexually transmitted diseases.
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
No special dosage recommendations.
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
Known sensitivity to erythromycin. Erythromycin is contra-indicated with
astemizole, terfenadine, cisapride and pimozide. It is also contra-indicated
with ergotamine and dihydroergotamine.
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
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.
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
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.
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.
Effects on ability to drive and use machines
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
Symptoms are mainly confined to nausea, vomiting and diarrhoea. Reversible
hearing loss sometimes occurs.
Treatment: Gastric lavage and general supportive measures.
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
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.
Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
List of excipients
Quinoline yellow E104
Silica, colloidal anhydrous
36 months unopened.
14 days after reconstitution.
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.
Nature and contents of container
Nature: Amber type III glass bottle with polyethylene screw on cap.
Contents: 62.5 g
Reconstitution of the granules provides 100 ml of suspension.
Special precautions for disposal
Add 60 ml of water, invert the bottle and shake vigorously for 1 minute.
MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT