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ERYTHROMYCIN 1G POWDER FOR SOLUTION FOR INFUSION

Active substance(s): ERYTHROMYCIN LACTOBIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Erythromycin 1 g powder for solution for infusion
erythromycin lactobionate
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or nurse.
• If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Erythromycin is and what it is used for
2. What you need to know before you use
Erythromycin
3. How you will be given Erythromycin
4. Possible side effects
5. How to store Erythromycin
6. Contents of the pack and other information
1. What Erythromycin is and what it is
used for
The name of your treatment is Erythromycin 1 g
powder for solution for infusion.
Erythromycin contains the active substance
erythromycin lactobionate which belongs to a group
of antibacterial substances for systemic use (suitable
for intravenous infusion). Erythromycin is used in
adults and children (including newborn babies).
Erythromycin is used when an intravenous antibiotic
is required to treat severe infections, if you cannot
swallow erythomycin tablets or if you are at particular
risk of developing an infection.
Erythromycin 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
• Endocarditis
Erythromycin can also be used to treat patients for
which bacteria spread into the blood.
2. What you need to know before you use
Erythromycin
Do not use Erythromycin:
• if you are allergic to erythromycin or any of
antibiotics from the same group such as
clarithromycin or azithromycin
• if you are taking ergotamine or dihydroergotamine
(used to treat migraines) while taking erythromycin
as this may cause serious side effects
• if you 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.
Warnings and precautions
Talk to your doctor or nurse before taking
Erythromycin 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
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
• 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.
Other medicines and Erythromycin
Tell your doctor or nurse if you are taking, have
recently taken or might take any other medicines.
The section "Do not use Erythromycin" above lists
medicines that may not be taken together with
Erythromycin.
Erythromycin can affect or can be affected by certain
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 relive
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)
• 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 supress 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 your are receiving erythromycin as
this may interfere with some test results.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before you will be given this
.../...
medicine.

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY:
The full information can be found in the Summary of Product Characteristics for Erythromycin.
RECOMMENDED ADMINISTRATION
Bolus injection (IV) push is contraindicated.
Continuous infusion of Erythromycin 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 to the 1 g
vial.
Step 2 - add 20 ml of Step 1 solution to 200-250 ml of
0.9% (9 mg/ml) sodium chloride solution for injection.
The resulting diluted solution contains 5 mg/ml –
4 mg/ml (0.5 – 0.4%) of erythromycin.
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.
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.
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.
05635_A00

For Continuous Infusion of 1 gram dose:
Step 1 - add 20 ml of Water for Injections to the 1 g
vial.
Step 2 - add 20 ml of Step 1 solution to 5001000 ml of 0.9% (9 mg/ml) sodium chloride solution
for injection. The resulting diluted solution contains
2 mg/ml – 1 mg/ml (0.2 – 0.1%) of erythromycin.
Alternative Step 2 diluents:
Compound Sodium Lactate Injection (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: Glucose Injection (5%), or
Sodium Chloride and Glucose Injection (usually 0.18%
sodium chloride and 4.0% glucose).
The stability of solutions of Erythromycin is adversely
affected below pH 5.5.
Special precautions for disposal and other
handling
Continuous intravenous infusion with an erythromycin
concentration of 1 mg/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 5 mg/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.

Erythromycin should be used by woman during
pregnancy only if clearly needed and only if
prescribed by a doctor.
Driving and using machines
No side effect that can affect your ability to drive and
use machines has been reported with Erythromycin.
3. How you will be given Erythromycin
For patients with severe infections or those who are
at particular risk of developing infections, the
recommended dose of Erythromycin is:
For adults:
50 mg per kg body weight per day.
For patients with mild to moderate infections who
cannot swallow tablets, the usual dose is
25 mg per kg of body weight per day.
For children:
12.5 mg per body weight four times daily.
For newborn infants (birth to 1 month):
10-15 mg per kg of body weight three times daily.

• Being sick
• Anorexia
• Various liver or gall-bladder problems, which can
cause yellowing of the skin and/or eyes (jaundice)
or pale stools with dark urine
• 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)
• Inflammation of the kidneys (a condition known as
interstitial nephritis)
• Chest pains
• Fever
• Feeling generally unwell (malaise)
Other side effects that may show up in blood tests:
• Increase in a particular type of white blood cells
(eosinophilia)
Reporting of side effects
If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in
this leaflet. You can also report side effects directly
via Yellow Card Scheme. Website: www.mhra.gov.uk/
yellowcard

Doses can be doubled in severe infections.
Your doctor will calculate the correct dose for you.
Erythromycin will be given either in divided doses
throughout the day or as a continuous slow infusion.

By reporting side effects you can help provide more
information on the safety of this medicine.

4. Possible side effects

Keep this medicine out of the sight and reach of
children.

Like all medicines, Erythromycin can cause side effects,
although not everybody gets them.
Conditions you need to look out for
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.
Common side effects
These may affect up to 1 in 10 people:
• Diarrhoea
• Feeling sick
• Skin eruptions
Uncommon side effects
These may affect up to 1 in 100 people:
• Urticaria
Rare side effects
These may affect up to 1 in 1000 people:
• Severe allergic reaction
• Reversible loss of hearing (usually associated with
high doses or in patients with kidney problems)
Rare side effects that may show up in blood
tests:
• Increase in liver enzymes
Other side effects
Other side effects have occurred in a small number of
people but their exact frequency is unknown:
• Allergic reaction
• Hallucinations (seeing or hearing things that aren’t
there)
• Fits (seizures)
• Confusion
• Vertigo (problems with balance that can result in
feelings of dizziness or sickness – particular on
standing)
• Ringing in the ears (tinnitus)
• Loss of hearing
• Abnormal heart rhythms (including palpitations)
• Low blood pressure
• Diarrhoea which may be severe or prolonged and
may contain blood or mucus
• Stomach pains; these may be a symptom of an
inflamed pancreas (pancreatitis)

Special precautions for storage:
After reconstitution:
After reconstitution, chemical and physical in-use
stability in water for injection has been demonstrated
for 24 hours when stored at room temperature and for
14 days when stored in a refrigerator at 2-8° C.
After reconstitution and dilution:
After reconstitution and dilution, chemical and
physical in-use stability has been demonstrated for
24 hours at room temperature when the solution is
diluted in 0.9% (9 mg/ml) sodium chloride solution for
injection or Glucose 5% and for 12 hours at room
temperature when the solution is diluted in Hartman’s
solution.
From a microbiological point of view, once opened,
the product should be used immediately.
If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the
user and would normally not be longer than 24 hours
at 2-8°C, unless reconstitution has taken place in
controlled and validated aseptic conditions.
Prescribing Information
Erythromycin: 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
05635_A00

5. How to store Erythromycin

Do not use Erythromycin after the expiry date which is
stated on the carton after ”Do not use after:” or
“EXP:” The expiry date refers to the last day of that
month.
Unopened: This product does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Erythromycin contains
The active substance is erythromycin. Each vial of
Erythromycin contains erythromycin lactobionate
equivalent to erythromycin 1 g.
There are no other ingredients in the product.
What Erythromycin looks like and contents of
the pack
Erythromycin is available as a powder for solution for
infusion. The powder is white to yellowish.
The powder is supplied as a single dose vial packed in
a carton box. Each carton box contains 1 vial or 10
vials.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
STRAGEN UK Ltd.
Castle Court
41 London Road
Reigate
Surrey RH2 9RJ
Manufacturer
FISIOPHARMA S.r.l.
Nucleo Industriale
84020 - Palomonte (SA)
ITALY
This leaflet was last revised in
May 2016

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: Erythromycin should be used with
caution in patients with impaired liver function.
Infrequently, hepatic dysfunction including increased
liver enzymes and/or cholestatic hepatitis, with or
without jaundice has been reported during
erythromycin administration.
Myasthenia gravis can exacerbate during erythromycin
treatment.
Rarely pseudomembranous colitis has been reported
in patients receiving erythromycin. If the patient has
ever experienced diarrhoea following antibiotics
course, erythromycin should be used with caution.
Rhabdomyolysis with or without renal impairment has
been reported in seriously ill patients receiving
erythromycin concomitantly with drugs known as
“statins”.
Prolonged QTc interval and ventricular arrhythmias
have rarely been reported in patients receiving
erythromycin.
Erythromycin can potentiate drugs metabolised by the
cytochrome P450 system.
Product License Number: PL21844/0034
Further information: Contains no sodium.
Legal category: POM
Marketed by: STRAGEN UK Ltd.

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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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