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ERYTHROCIN I.V LACTOBIONATE 1G POWDER FOR SOLUTION FOR INFUSION

Active substance(s): ERYTHROMYCIN LACTOBIONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Erythrocin I.V. Lactobionate 1g Powder for Solution for Infusion
Erythromycin Lactobionate 1g Powder for Solution for Infusion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active: Erythromycin as Erythromycin lactobionate 1 g / vial

3

PHARMACEUTICAL FORM
Powder for solution for infusion

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
This medicine is indicated in severe and immunocompromised cases of
infections caused by sensitive organisms where high blood levels are required
at the earliest opportunity or when the oral route is compromised.
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: peri-operative secondary infection prophylaxis, severe
trauma and burns secondary infection prophylaxis, endocarditis prophylaxis
(dental procedures)
9.
Septicaemia
10.
Endocarditis

11.
Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis,
lymphogranuloma
venereum, diphtheria, prostatitis, scarlet fever.

4.2

Posology and method of administration
Adults: severe and immunocompromised infections, 50mg/kg/day, preferably by
continuous infusion (equivalent to 4g per day for adults).
Mild to moderate infections (oral route compromised) 25mg/kg/day.
Newborn infant (birth to 1 month): 10-15mg/kg 3 times daily.
Children: 12.5mg/kg 4 times daily. Doses can be doubled in severe infections.
Elderly: No special dosage recommendations.
Recommended Administration
Bolus injection (IV) push) is contraindicated
Continuous infusion of this medicine is preferred due to the slower infusion rate and
lower concentration of erythromycin; however, intermittent infusion at intervals not
greater than every six hours is also effective.
Intravenous erythromycin should be replaced by oral erythromycin as soon as
possible.
Preparations for administration:
For Intermittent Infusion of 1 gram dose:
Step 1 - add 20 ml of Water for Injections BP to the 1 g vial.
Step 2 - add 20 ml of Step 1 solution to 200-250 ml of Sodium Chloride Intravenous
Infusion BP (0.9% Saline). This provides a 0.5%-0.4% solution.
If it is decided to administer the daily dose as an intermittent infusion, then the
erythromycin concentration should not exceed 5 mg/ml and the time of each infusion
should be between 20 and 60 minutes.
For Continuous Infusion of 1 gram dose:
Step 1 - add 20 ml of Water for Injections BP to the 1 g vial.
Step 2 - add 20 ml of Step 1 solution to 500-1000 ml of Sodium Chloride Intravenous
Infusion BP (0.9% Saline). This provides a 0.2%-0.1% infusion
The infusion should be completed within eight hours of preparation to ensure
potency.
Alternative Step 2 diluents:
Compound Sodium Lactate Injection BP (Hartmann’s Solution).
Solutions containing glucose may also be used but sodium bicarbonate must first be
added as a buffer to ensure neutrality.
5ml of sterile 8.4% w/v sodium bicarbonate solution will neutralise one litre of:
Glucose Injection BP (5%), or of Sodium Chloride and Glucose Injection BP (usually
0.18% sodium chloride and 4.0% glucose).

The stability of solutions of this medicine is adversely affected below pH 5.5.
For further details please see section 6.6.

4.3

Contraindications
Known hypersensitivity to erythromycin.
Erythromycin is contraindicated in patients taking simvastatin, tolterodine,
mizolastine, amisulpride, astemizole, terfenadine, domperidone, cisapride or
pimozide.
Erythromycin is contraindicated with ergotamine and dihydroergotamine.
Bolus injection ( IV push) is an unacceptable route of administration.
This medicine must be administered by continuous or intermittent intravenous
infusion only.

4.4

Special warnings and precautions for use
Prolonged QTc interval and ventricular arrhythmias have been reported rarely
in patients receiving intravenous erythromycin.
Benzyl alcohol may be added as a preservative. Benzyl alcohol has been
reported to be associated with a fatal ‘Gasping Syndrome’ in premature
infants.
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.
Patients receiving erythromycin concurrently with drugs which can cause
prolongation of the QT interval should be carefully monitored. The
concomitant use of erythromycin with some of these drugs is contraindicated
(See sections 4.3 & 4.5)

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,
domperidone, 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 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 reported rarely 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 dysfunction, 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, pruritus, 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
ATC code: J01FA01
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, 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.

5.2

Pharmacokinetic properties
Following intravenous infusion, erythromycin is widely distributed throughout
body tissues, including lung tissues.

5.3

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
None.

6.2

Incompatibilities
None Stated.

6.3

Shelf life
36 months unopened, use within 1 day of opening.

6.4

Special precautions for storage
Once reconstituted, store in a refrigerator between 2°C and 8°C and use within
24 hours.

6.5

Nature and contents of container
Glass vial with rubber closure.
Size of vial: 1g.

6.6

Special precautions for disposal
Continuous intravenous infusion with an erythromycin concentration of
1mg/ml (0.1% solution) is recommended. The infusion should be completed
within 8 hours of preparation to ensure potency.
If required, solution strengths up to 5mg/ml (0.5% solution) may be used, but
should not be exceeded. Higher concentrations may result in pain along the
vein. Bolus injection is not recommended.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 20072/0038

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/03/2001

10

DATE OF REVISION OF THE TEXT

22/01/2016

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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