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ERYTHROMYCIN 1G POWDER FOR SOLUTION FOR INFUSION

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

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PATIENT INFORMATION LEAFLET

2900
08.03.17[4]

Erythrocin® IV 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.
The name of your treatment is Erythrocin IV 1g powder for solution for
infusion.
This medicine is available using the above name but will be referred to as
Erythrocin lV throughout this leaflet.
In this leaflet:
1. What Erythrocin lV is and what is it used for
2. Before you are given Erythrocin lV
3. How you will be given Erythrocin lV
4. Possible side effects
5. How to store Erythrocin lV
6. Further information
1. What Erythrocin lV is and what is it used for
Erythrocin lV contains the active ingredient erythromycin which belongs to
a group of medicines called macrolide antibiotics.
Erythrocin lV 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 lV 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 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 lV
You should not receive Erythrocin lV if you:
 have been told 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 or mizolastine (widely taken for
hayfever and allergies), domperidone (for nausea (feeling sick) and
vomiting (being sick)), cisapride (for stomach disorders) or pimozide or
amisulpride (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.
 simvastatin (used to lower cholesterol and triglycerides (types of fat) in
the blood).
 tolterodine (used for treating overactive bladder with symptoms of
urinary frequency, urgency, and leakage).
Take special care with Erythrocin lV 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;

TECHNICAL LEAFLET

Erythrocin® I.V. Lactobionate 1g
Powder for Solution for Infusion

 are pregnant and have been told that you have a sexual 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 erythromycin, 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);
 domperidone (used to treat nausea (feeling sick) and vomiting (being
sick))
 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);
 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 lV, 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.

4. Possible side effects
Like all medicines, Erythrocin lV 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 lV 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

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.

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

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 1gm 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 2mg/ml – 1mg/ml (0.2 –
0.1%) of erythromycin.

Intravenous therapy effective in serious bacterial infections
Presentation
Erythrocin l.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.

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.

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 lV will be given either in divided doses throughout the day or
as a continuous slow infusion. You should not receive Erythrocin lV 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.

3. How you will be given Erythrocin lV
For patients with severe infections or those who are at particular risk of
developing infections, the usual dose of Erythrocin lV is:

(erythromycin lactobionate)

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 l.M. OR l.V. BOLUS USE. FOR l.V. INFUSION USE
ONLY.

For Children:
12.5 mg per kg of body weight four times daily

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 200250 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 2060 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
hypertension.

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).

5. How to store Erythrocin lV
Keep out of the sight and reach of children.
Once reconstituted use immediately.
Any remaining contents should be discarded.
Powder is stable at room temperature.
Do not use after the expiry date. This date is printed on your pack.
The Expiry date refers to last day of that month.
If the powder becomes discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. Further information
What Erythrocin lV contains
 The active substance is erythromycin lactobionate.
 Each vial contains 1 g erythromycin as 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.
What Erythrocin lV looks like and contents of the pack
Erythrocin lV is a white powder packed in a transparent glass vial with
rubber stopper with red flip topped aluminium seal.
Each pack contains a 1g vial.
Manufacturer and Product Licence holder
Manufactured by
Famar L’Aigle, Usine de St Remy, Rue de l’sle, BP 103
28380 SAINT REMY SUR AVRE, France.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.

POM

PL 20636/2900

Leaflet revision and issue date (Ref) 08.03.17[4]
Erythrocin is a trademark of Amdipharm Mercury International Limited.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

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.

Prescribing Information
Erythrocin l.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 l.M. or l.V. bolus

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.
Further Information: Contains no sodium.
Product licence holder
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.

POM
PL 20636/2900
Leaflet revision and issue date (Ref.) 08.03.17[4]

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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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