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ERYTHROMYCIN LACTOBIONATE 1G POWDER FOR SOLUTION FOR INFUSION

Active substance(s): ERYTHROMYCIN LACTOBIONATE / ERYTHROMYCIN LACTOBIONATE / ERYTHROMYCIN LACTOBIONATE

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102503/LF/156/02

• fluconazole, ketoconazole and itraconazole (medicines
used to treat fungal infections);
• digoxin, quinidine or disopyramide (used to treat heart
problems);
• cilostazol (a medicine used to treat peripheral circulation
problems);
• hexobarbitone, phenobarbital or midazolam (used as
sedatives);
• warfarin and acenocoumarol (used to help thin the blood);
• valproate, carbamazepine or phenytoin (used to control
epilepsy);
• theophylline (used to treat asthma and other breathing
problems);
• ciclosporin or tacrolimus (used following organ
transplants);
• bromocriptine (used to treat Parkinson’s disease);
• zopiclone or triazolam/alprazolam (used to help you sleep
or relieve states of anxiety);
• alfentanil (a medicine used to provide pain relief);
• methylprednisolone (used to help suppress the body's
immune system – this is useful in treating a wide range of
conditions);
• St John’s Wort (a herbal medicine used to treat depression);
• verapamil (used to treat high blood pressure and chest
pain);
• vinblastine (used to treat certain types of cancer);
• sildenafil (used to treat erectile dysfunction).
If you or your child goes for any medical tests, tell your doctor
that you are receiving Erythrocin I.V. Lactobionate, as this
may interfere with some test results.
Pregnancy and breast-feeding
Erythromycin should be used by women during pregnancy
only if clearly needed.
If you are pregnant or think you may be pregnant, or if you
are breast-feeding please consult your doctor before taking
this medicine.
3. HOW YOU WILL BE GIVEN ERYTHROCIN I.V.
LACTOBIONATE
For patients with severe infections or those who are at
particular risk of developing infections, the usual dose of
Erythrocin I.V. Lactobionate is:
For adults:
50 mg per kg of body weight per day.
For patients with mild to moderate infections who cannot swallow
tablets, the usual dose is 25 mg per kg of bodyweight per day.
For Children:
12.5 mg per kg of body weight four times daily
For newborn infants (birth to 1 month):
10-15 mg per kg of body weight three times daily.
Doses can be doubled in severe infections. Your doctor will
calculate the correct dose for you.
Erythrocin I.V. Lactobionate will be given either in divided
doses throughout the day or as a continuous slow infusion.
You should not receive Erythrocin I.V. Lactobionate as an
injection directly into your vein via a syringe.
If you have any further questions on the use of this product
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Erythrocin I.V. Lactobionate can cause
side effects, although not everybody gets them.
If you notice any of the following, contact your doctor
immediately:
• difficulty breathing;
• fainting;
• swelling of the face, lips or throat;
• skin rashes;

• severe skin reactions including large fluid-filled blisters,
sores and ulcers;
• ulcers in the mouth and throat;
as these may be signs of an allergic reaction.
Other side effects of Erythrocin I.V. Lactobionate include:
• diarrhoea which may be severe or prolonged and may
contain blood or mucus;
• feeling sick or being sick;
• increase in a particular type of white blood cells (eosinophilia);
• stomach pains; these may be a symptom of an inflamed
pancreas (pancreatitis);
• ringing in the ears (tinnitus);
• reversible loss of hearing (usually associated with high
doses or in patients with kidney problems);
• various liver or gall-bladder problems, which can cause
yellowing of the skin and/or eyes (jaundice) or pale stools
with dark urine;
• chest pains;
• abnormal heart rhythms (including palpitations);
• fever;
• anorexia;
• confusion;
• fits (seizures);
• vertigo (problems with balance that can result in feelings
of dizziness or sickness – particularly on standing);
• hallucinations (seeing or hearing things that aren’t there);
• feeling generally unwell (malaise);
• inflammation of the kidneys (a condition known as
interstitial nephritis);
• low blood pressure;
• serious skin rashes that may involve blistering and can
cover large areas of the torso, face and limbs (conditions
known as Stevens Johnson syndrome, toxic epidermal
necrolysis and erythema multiforme).
If any of the side effects becomes severe, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE ERYTHROCIN I.V. LACTOBIONATE
Your medicine will be stored by the hospital or clinic. Once the
vial of Erythrocin I.V. Lactobionate has been mixed ready for
use it should be used immediately.
This medication should not be used after the expiry date
shown on the label.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
6. FURTHER INFORMATION
What Erythrocin I.V. Lactobionate contains
Each vial of Erythrocin I.V. Lactobionate Injection contains 1 g
of the active ingredient erythromycin lactobionate.
When made up with 20 ml of Water for Injections, each ml of
solution contains 50 mg of erythromycin lactobionate.
This solution must be further diluted prior to use.
There are no other ingredients in the product.
Erythrocin I.V. Lactobionate is available as single 1g vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL, UK
Manufacturer:
Famar L’Aigle,
BP No 103, 28380 Saint Remy Sur Avre, France.
Erythrocin is a registered trademark of
Amdipharm Mercury International Limited

This leaflet applies only to Erythrocin I.V. Lactobionate
and This leaflet was last revised in February 2015.

31 01160 00

TECHNICAL LEAFLET
ON

ERYTHROCIN® I.V. LACTOBIONATE 1G POWDER
FOR SOLUTION FOR INFUSION
(Erythromycin Lactobionate)

Intravenous therapy effective in serious bacterial infections
Presentation
Erythrocin I.V. Lactobionate is a sterile presentation of erythromycin. It is not suitable for intramuscular
use or intravenous bolus administration. It is available in vials of 1 g of erythromycin.
Preparation of suitable solutions is detailed in the section on administration.
Uses
For the treatment of infections due to organisms susceptible to erythromycin in patients who cannot
take oral medicine or in whom immediate high levels of erythromycin are important.
IT IS NOT FOR I.M. OR I.V. BOLUS USE. FOR I.V. INFUSION USE ONLY.
Microbiological Indications
Erythromycin has been shown to be active in vitro against the following organisms:
Staphylococci, Streptococci, Haemophilus influenzae, L-forms, Mycoplasma pneumoniae, Legionella
pneumophila, Branhamella catarrhalis, Bordetella pertussis, Corynebacterium diphtheriae (as an adjunct to
antitoxin), Neisseria, Treponema pallidum, Chlamydia trachomatis, Clostridia, Ureaplasma urealytica,
Campylobacter.
Administration
The product must be reconstituted (step 1) and then further diluted (step 2) prior to administration.
Preparation of 1 g dose for intermittent infusion

STEP 1

STEP 2

102503/LF/156/02

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ERYTHROCIN IV. 1g
1 Vial
Leaflet
102503
UK
Famar
1
18/02/2015
PAT

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REGULATORY AUTHORITY
APPROVAL CONFIRMATION

Add 20 ml Water for Injections Ph.Eur to the 1 g
vial. No other solvent apart from Water for
Injections Ph.Eur should be used to prepare this
initial solution.

Add 20 ml of Step 1 solution to 200-250 ml Sodium
Chloride Intravenous Infusion B.P. (0.9% saline).
The resulting diluted solution contains
5 mg/ml - 4 mg/ml (0.5% - 0.4%) of erythromycin.
The recommended infusion time is 20-60 minutes.
Therefore a longer period of infusion should be used
in patients with risk factors or previous evidence of
arrhythmias.
Rapid infusion is more likely to be associated with
arrhythmias or hypotension.

Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc.) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

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When administering the product by intermittent infusion do not use solution strengths greater than
5 mg/ml and do not use rapid infusion rates - failure to observe these precautions may result in pain
along the vein. For detailed instructions on administration, see section 4.2.
For continuous infusion of 1 gram dose: Add 20 ml of Step 1 solution to 500 ml - 1,000 ml Sodium Chloride
Intravenous Infusion B.P. (0.9% saline).
The resulting diluted solution contains 2 mg/ml - 1 mg/ml (0.2 - 0.1%) of erythromycin.

Date ...........................................................................

PAGE 1 OF 2

Alternative Step 2 diluents:
Compound Sodium Lactate Intravenous infusion B.P. (Hartmann’s Solution).
Solutions containing glucose may also be used but sodium bicarbonate must first be added as a buffer
to ensure neutrality.
5 ml of sterile 8.4% w/v sodium bicarbonate solution will neutralise one litre of:
5% Glucose intravenous infusion B.P. , or 0.18% Sodium Chloride and 4% Glucose intravenous infusion B.P.
The stability of solutions of Erythromycin Lactobionate is adversely affected below pH 5.5.
Once reconstituted, use immediately and discard any remainder of the contents.
Dosage
Adults : 2-4 g daily in divided doses.
Neonates (birth to 1 month) : 10-15 mg/kg three times daily.
Children : 12.5 mg/kg four times daily (doses can be doubled in severe infections).

Prescribing Information
Erythrocin I.V. Lactobionate: 1.0 g erythromycin per vial.
Dose: Adults: mild to moderate infections 25 mg/kg/day; in divided doses. In cases of severe infections the dose
may be increased up to 50 mg/kg/day. Neonates (birth to 1 month):
10-15 mg/kg three times daily. Children: 12.5 mg/kg four times daily (doses can be doubled in severe infections).
Contraindications: Sensitivity to erythromycin. Concurrent astemizole, terfenadine, cisapride or pimozide use.
Administration via I.M. or I.V. bolus
Side Effects: The following have been reported: diarrhoea, nausea, vomiting, abdominal pain, reversible hearing
loss associated with doses usually greater than 4 g per day, mild allergic reactions, rarely anaphylaxis, symptoms
of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur.
Precautions: Impaired liver function. Infrequently, hepatic dysfunction including increased liver enzymes and/or
cholestatic hepatitis, with or without jaundice. May aggravate the weakness of patients with myasthenia gravis.
Rarely pseudomembranous colitis has been reported.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving
erythromycin concomitantly with drugs known as 'statins'. If the patient has ever experienced diarrhoea
following the use of antibiotics. Prolonged QTc interval and ventricular arrhythmias have rarely been reported in
patients receiving erythromycin IV. Potentiation of drugs metabolised by the cytochrome P450 system.
Product Licence Number: 20072/0038
Further Information: Contains no sodium.
Legal Category POM
Marketed by
Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Erythrocin is a registered trademark of Amdipharm Mercury International Limited

PATIENT INFORMATION LEAFLET
102503/LF/156/02

ERYTHROCIN® I.V. LACTOBIONATE 1G POWDER
FOR SOLUTION FOR INFUSION
(Erythromycin Lactobionate)
Read all of this leaflet carefully before you start
taking this medicine.
- Please keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are
the same as yours.
- If any of the side effects becomes severe, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Erythrocin I.V. Lactobionate is and what is it
used for
2. Before you are given Erythrocin I.V. Lactobionate
3. How you will be given Erythrocin I.V. Lactobionate
4. Possible side effects
5. How to store Erythrocin I.V. Lactobionate
6. Further information
1. WHAT ERYTHROCIN I.V. LACTOBIONATE IS AND
WHAT IS IT USED FOR
The name of your treatment is Erythrocin I.V.
Lactobionate 1g Powder for Solution for infusion.
Erythrocin I.V. Lactobionate contains the active ingredient
erythromycin which belongs to a group of medicines called
macrolide antibiotics.
Erythrocin I.V. Lactobionate is used when an intravenous
antibiotic is required to treat severe infections, if you cannot
swallow erythromycin tablets or if you are at particular risk of
developing an infection.
Erythrocin I.V. Lactobionate is used to prevent and treat
infections such as:
• Throat and sinus infections.
• Chest infections, such as bronchitis and pneumonia.
• Ear infections.
• Mouth and dental infections.
• Eye infections.
• Skin and tissue infections, such as acne.
• Stomach and intestinal infections.
• Prevention of infection following burns, operations or
dental procedures.
• Other infections, such as sexually transmitted diseases,
bone infection or scarlet fever.
• Septicaemia.
• Endocarditis.
2. BEFORE YOU ARE GIVEN ERYTHROCIN I.V.
LACTOBIONATE
You should not receive Erythrocin I.V. Lactobionate if you:
• have been told you that you are allergic to erythromycin
or other macrolide antibiotics such as clarithromycin or
azithromycin.
• are taking ergotamine or dihydroergotamine (used to
treat migraines) while taking erythromycin as this may
cause serious side effects.
• are taking terfenadine or astemizole (widely taken for
hayfever and allergies), cisapride (for stomach disorders)

or pimozide (for psychiatric conditions) while receiving
erythromycin, as combining these drugs can sometimes
cause serious disturbances in heart rhythm. Consult your
doctor for advice on alternative medicines you can take
instead.
Take special care with Erythrocin I.V. Lactobionate if
you:
• are taking colchicine (used for treatment of gout and
arthritis) whilst taking erythromycin as this may cause
serious side effects;
• have any liver problems or have been told that
any drugs you are taking can cause liver problems;
• have previously experienced diarrhoea following
the use of antibiotics;
• are pregnant and have been told that you have a sexually
transmitted disease called syphilis. In this case
erythromycin may not be effective for preventing the
transfer of this infection to your baby. Consult your doctor
before receiving erythromycin. Alternatively if you were
treated for early stages of syphilis during your pregnancy,
and your child is under 1 year and is prescribed
erthyromycin, consult your doctor before giving
erythromycin to your child;
• are treating a young child with antibiotics and they are
irritable or vomit when fed, you should contact your
doctor immediately;
• suffer from a condition called myasthenia gravis, which
causes muscle weakness, consult your doctor before
receiving erythromycin;
• are taking erythromycin with ‘statins’ such as simvastatin
or lovastatin (used to lower cholesterol) as serious side
effects can occur.
If any of these apply to you, or if you are not sure, tell your
doctor.
Please tell your doctor if you are taking, or have recently
taken any other medicines, including any medicines obtained
without a prescription.
This is especially important if you are taking medicines from
the following families:
• astemizole, terfenadine or mizolastine (used to treat
allergies such as hayfever);
• pimozide (used to treat mental problems);
• ergotamine or dihydroergotamine (used to relieve
migraine);
• cisapride (used to treat stomach disorders);
• statins (used to help lower cholesterol levels
e.g. lovastatin and simvastatin);
• protease inhibitors (used to treat viral infections
e.g. saquinavir);
• oral contraceptives.
This is also important if you are taking medicines called:
• colchicine (used to treat gout and arthritis);
• cimetidine and omeprazole (used to treat acid reflux and
other related conditions);
• clarithromycin, rifabutin, or rifampicin (medicines used to
treat different types of bacterial infection);

102503/LF/156/02

Version No.:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:

ERYTHROCIN IV. 1g
1 Vial
Leaflet
102503
UK
Famar L’Aigle
1
18/02/2015
PAT

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

250 x 210 mm
31 01160 00
428
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

No
8 pt

CRF:
DOA:
DOI:

AMCo.CRF.010.2014
N/A
N/A

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc.) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature ...................................................................
Name .........................................................................
Date ...........................................................................

PAGE 2 OF 2

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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