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ERYTHROMYCIN PANPHARMA 1G POWDER FOR SOLUTION FOR INFUSION

Active substance(s): ERYTHROMYCIN LACTOBIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

ERYTHROMYCIN 1g
powder for solution for infusion

Erythromycin (as erythromycin lactobionate)
Read all of this leaflet carefully before you start using 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.
–– This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
–– 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.
2.
3.
4.
5.
6.

What ERYTHROMYCIN is and what it is used for
What you need to know before you use ERYTHROMYCIN
How to use ERYTHROMYCIN
Possible side effects
How to store ERYTHROMYCIN
Contents of the pack and other information

The name of your medicine is ‘Erythromycin Panpharma 1g, powder for
solution for infusion’ but will be referred to as ‘Erythromycin’ in this leaflet.

1. What ERYTHROMYCIN is and what it is used for
ERYTHROMYCIN is an antibiotic that contains erythromycin (as
erythromycin lactobionate). It is a type of antibiotic called macrolide
which acts by preventing the growth and multiplication of bacteria.
ERYTHROMYCIN is used for the treatment of serious infections caused
by bacteria in patients adults and children when oral adminitration of
erythromycin is not possible or insufficient or in patients in whom the
severity of the infection requires high levels of erythromycin or when
patients are allergic or hypersensitive to beta-lactams class of antibiotics
or when these antibiotics are not appropriate for other reasons.
Once the acute phase of the infection is controlled, your doctor will
replace the intravenous erythromycin with an oral form of erythromycin.
ERYTHROMYCIN is used to treat infections such as:
–– Respiratory tract infections: pneumonia, whooping cough;
–– Ear infections;
–– Eye infections (conjunctivitis);
–– Skin and soft tissue (such as muscles, blood vessels, tendons, fat)
infections;
–– Gastrointestinal infections;
–– Urogenital infections (relative to infections of the reproductive and
urinary organs);
–– Lymphogranuloma venerum (a sexually transmitted disease);
–– Diphtheria (an upper respiratory tract illness)

2. What you need to know before you use ERYTHROMYCIN
Do not use ERYTHROMYCIN
–– if you are allergic (or hypersensible) to erythromycin;
–– if you are allergic (or hypersensible) to other macrolide antibiotics;
–– if you are taking any of the following medicines:
• Astemizole, terfenadine (used to treat allergic reactions);
• Disopyramide (antiarrhythmic medicine used in the treatment of
ventricular tachycardia);
• Cisapride (used to treat gastroesophageal reflux disease);
• Pimozide (used in the treatment of psychiatric disorders);
• Ergotamine or dihydroergotamine (for migraine);
• Lovastatin, simvastatin and atorvastatin (blood cholesterol
lowering medicines);
• Antiarrhythmic class Ia and III (used to treat ventricular
arrhythmias, to prevent paroxysmal recurrent atrial fibrillation,
to treat Wolff-Parkinson-White syndrome, to treat ventricular
tachycardias, atrial fibrillation and atrial flutter);
• Neuroleptics (used to manage psychosis (including delusions,
hallucinations, or disordered thought));
• Tri- and tretracyclic antidepressants (used in the treatment of
depression);
• Fluoroquinolones (antibiotics used to treat certain infections);
• Arsenic trioxide (used to treat cancer);
• Methadone (used to manage opioid dependence, such as heroin
addiction);
• Budipine (antiparkinson agent);
• Antifungal and anti-malarial medicines;
–– if you have problems with the way your liver works. This is because
erythromycin is mainly excreted by the liver (see section 3 – “How to
use ERYTHROMYCIN”);
–– if you have cardiac disorders
–– if you have problems with your electrolyte balance (for example:
deficiency in potassium or magnesium)

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ERYTHROMYCIN:
–– if you have cardiac disorders, troubles in the heartbeat such
as prolongation of the “QT interval” or “ventricular arrhythmia”
can occur, talk to your doctor, pharmacist or nurse before using
ERYTHROMYCIN.
–– Serious allergic reactions can occur, do not use ERYTRHOMYCIN if
you are allergic or hypersensible to Erythromycin or other drugs of
the macrolides class of antibiotics, talk to your doctor, pharmacist or
nurse before using ERYTHROMYCIN.
–– if you have myasthenia gravis, erythromycin may aggravate the
symptoms which can lead to serious respiratory troubles,
if you are elderly, because you have a greater risk of developing a kidney
disease. Your doctor will adjust your dose and take into account the way
your kidneys work (see section 3 – “How to use ERYTHROMYCIN”) It is
generally not recommended to combine erythromycin with:
–– Alfuzosin (used to treat benign prostatic hyperplasia);
–– Buspirone (used to treat generalized anxiety disorder);
–– Cyclosporine and Tacrolimus (used in organ transplantation to
prevent rejection);
–– Colchicine (used in treatment of gout);
–– Ebastine (antihistaminic);
–– Tolterodine (used as a treatment for urinary incontinence);
–– Triazolam (used as a sedative to treat severe insomnia).
You will receive this medicine continuously or slowly in order to avoid
pain.
Newborn infants and children
Contact your doctor immediately if your child vomits (projectile nonbilious vomiting) and/or if he/she has troubles eating during treatment
with this medicine. Your doctor will decide on your child’s dose (see
section 3 – “How to use ERYTHROMYCIN”).
Other medicines and ERYTHROMYCIN
If you are asked to provide a urine test, tell your doctor that you are
using Erythromycin, as it may interfere with some tests.
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
It is generally not recommended to combine erythromycin with:
–– Warfarin and coumarin derivatives (used to thin the blood);
–– Zopiclone (induces sleep);
–– Theophylline (helps breathing);
–– Sildenafil (used to treat erectile dysfunction and pulmonary arterial
hypertension)
–– Some cytostatic medicines and vinblastine (used to treat cancer);
–– Digoxin (used to treat heart problems);
–– Carbamazepine (used to treat epilepsy and neuropathic pain);
–– Alfentanil (anaesthesia);
–– Bromocriptine (used in Parkinson disease, hyperprolactinaemia);
–– Cilostazole (used to treat Intermittent claudication);
–– Methylprednisolone (corticosteroid drug used for its antiinflammatory effects);
–– Midazolam (used to induce anaesthesia or moderately severe
insomnia);
–– Omeprazole (used to reduce gastric acid secretion);
–– Valproate (anticonvulsant and mood-stabilizing drug);
–– Cimetidine (inhibits stomach acid production);
–– Rifampicin (antibiotic);
–– Phenytoin (used as an anticonvulsant);
–– Phenobarbital (anticonvulsive drug);
–– Benzodiazepines (anxiolytic, anticonvulsant, muscle relaxant,
sedative…);
–– Fexofenadine (used to treat allergic reactions);
–– St. John’s Wort (Hypericum perforatum) (medicinal herb used to
treat moderate depression)
Pregnancy and breast-feeding
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 using this
medicine.
Erythromycin has been reported to cross the placenta and reach the
unborn child.
Erythromycin passes into breast milk.
Your doctor will decide if you should be administered this medicine, only
after making sure that the benefits outweigh the potential risks.
Driving and using machines
The occurrence of side effects of ERYTHROMYCIN may affect the ability
to drive and use machines.
Experience to date shows that erythromycin has negligible influence on
the ability to concentrate and react.

The following information is intended for healthcare professionals only
For information on resistance data for Erythromycin, please see the technical information on Erythromycin.
Posology
Adults and children over 12 years old or weighing > 40 kg
The usual dose is 1 to 2 g per day equivalent to 25 mg/kg/day in divided doses (generally 3-4 single doses).

Severe infections
Dosage can be increased up to 4 g per day equivalent to 50 mg/kg/day in severe infections.
The maximum daily dose is 4 g.
Children up to 12 years old or weighing ≤ 40 kg
1 months to up to 12 years old: The daily dose for infants and children up to 12 years old for most infections is 15-20 mg of erythromycin/kg of body
weight divided over 3-4 single doses. This dose may be doubled depending on the indication.
Term newborn infants (birth to 1 month):
10-15mg/kg/day divided over 3 singles doses
Renal/hepatic impairment
Patients with impaired hepatic function:
In the presence of normal hepatic function, erythromycin is concentrated in the liver and excreted in the bile. Although the effect of hepatic dysfunction
on the excretion of erythromycin and its half-life in such patients is not known, caution should be exercised in administering the antibiotic in such
cases particularly if patients with acute hepatic insufficiency receive high doses of erythromycin. In that case, monitoring of serum levels and dosage
reduction will be required.
Patients with impaired renal function:
The low proportion of renal excretion would suggest that dosage modification in patients with impaired renal function (slight or moderate impaired
renal function with a creatinine clearance levels higher than 10ml/min) may not be necessary.
In moderate to severely impaired patients however, toxicity has been reported and dosage adjustment in these cases may be warranted:
–– Administration of doses of ≥ 4 g/day may increase the risk for the development of erythromycin-induced hearing loss in elderly patients, particularly
those with reduced renal or hepatic function.
–– In moderate to severely impaired renal function (with a level of serum creatinine of 2.0 mg/dl, kidney failure with anuria), the maximum daily dose for
adolescents over 14 years old and adults (with a body weight over 50 kg) is 2 g Erythromycin per day.
–– In patients with acute renal insufficiency (creatinine clearance levels lower than 10ml/min), the erythromycin dose must be reduced to 50% to 75%
of the normal dose, to be administered in accordance with the habitual treatment regimen. The maximum daily dose must not exceed 2g.
Erythromycin is not removed by haemodialysis or peritoneal dialysis. For patients who have regular dialysis, an additional dose is therefore not
recommended.
Elderly
Use adult dosage with care. Elderly patients, particularly those with reduced renal or hepatic function may be at increased risk for developing
erythromycin-induced hearing loss, when erythromycin doses of 4 g/day or higher are given.
Method of administration

Precautions to be taken before handling or administering the medicinal product
For instructions on reconstitution of the medicinal product before administration, see section 6.6.

3. How to use ERYTHROMYCIN
Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
This medicine will always be administered to you by your doctor or a
healthcare professional. It will be given intravenously (into a vein) over 60
minutes.
Adults and children over 12 years old or weighing > 40 kg
The usual dose is 1 to 2 g per day equivalent to 25 mg/kg/day in divided
doses (generally 3-4 single doses).
This may be increased to 4 g per day if your infection is very severe.
It is important that you complete your full course of antibiotics; do not
stop receiving your infusion treatment early, even if you feel better.
Children over 1 month to 12 years old or weighing ≤ 40 kg
The usual dose is 15-20 mg/kg of body weight divided over 3-4 single
doses.
Your doctor will calculate the exact dose your child will receive taking into
account his/her body weight.
Term newborn infants (birth to 1 month)
The usual dose is 10-15 mg/kg divided over 3 single doses.
Your doctor will calculate the exact dose your child will receive taking into
account his/her body weight.
Use in patients with severe kidney problems
Your doctor will calculate your exact dose according to the way your
kidney work.
Use in elderly patients
Your doctor will carefully decide your dose and take into account the
way your kidneys and liver work because you have a greater risk of
developing kidney disease.
If you use more ERYTHROMYCIN than you should
If you believe that you or your child has been given too much medicine,
contact your doctor. Symptoms of overdose include ototoxicity (damage
to the ear), hearing loss, severe nausea, vomiting and diarrhoea.
If you forget to use ERYTHROMYCIN
If you think you may have missed a dose of this medicine, contact your
doctor or other healthcare professionals immediately.
If you stop using ERYTHROMYCIN
Do not stop using this medicine until your doctor tells you to.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you develop an allergic reaction, this may result in a rash and swelling
of certain parts of your body, including the face and neck, accompanied
by difficulty in breathing. If this happens to you, stop using this
medicine and seek urgent medical help immediately.
The most frequently side effects are anorexia (lack of appetite), retching,
vomiting, abdominal pains, nausea, flatulence, discomfort, cramps, soft
stools or diarrhoea.
The following side effects have been reported:
Uncommon (may affect up to 1 in 100 people):
–– Fungal infections (candidiasis) of the mouth with white coating
–– Vaginal inflammation
–– Itching of the vulva in women
–– Allergic reactions
–– Widespread skin rash (urticarial exanthema)
–– Skin itchiness
–– Redness of the skin with increase of blood flow (hyperaemia)
–– Abnormal liver and gallbladder function detected by blood tests
–– Pain or irritation at the site of injection
–– Swelling and redness along a vein which is extremely tender when
touched
Rare (may affect up to 1 in 1,000 people):
–– Swelling of certain part of your body including face and neck (allergic
oedema/angioedema, anaphylaxis)
–– Symptom of poor appetite (anorexia)
–– Epigastric pain radiating to the back with nausea, vomiting, diarrhoea
and loss of appetite (pancreatitis)
–– Itchiness with jaundice, pale stool and dark urine (cholestasis and
cholestatic jaundice)
–– Swollen joints
–– Fever
–– Hives
–– Skin eruptions
–– Inflammation of the colon with severe diarrhoea

Unknown (frequency cannot be estimated from the available data):
–– Chest pain, feeling unwell
–– Irregular heartbeat, the heart beating forcefully or rapidly
–– Chest discomfort, difficulty breathing, abnormally fast and superficial
breathing, pain in the upper spine
–– Dyspnoea (including asthmatic circumstances)
–– Visual disturbances, including diplopia and blurred vision
–– Psychic disturbances (such as mood swings and impaired judgment)
–– Confusion, hallucinations
–– Dizziness, sleepiness, vertigo
–– Epileptic seizures, convulsions
–– Low blood pressure (hypotension)
–– Blood disorders affecting the cell components of the blood and
usually detected by blood tests
–– Headaches
Additional side effects in newborn infants and children
Vomiting (projectile non-bilious vomiting) or having troubles eating and
weight loss (infantile hypertrophic pyloric stenosis).
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.

5. How to store ERYTHROMYCIN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
vial and carton after {EXP}. The expiry date refers to the last day of that
month.
After reconstitution:
Diluted solutions should be used immediately.
Do not freeze the reconstituted solution.
For the reconstituted solution: Chemical and physical in-use stability has
been demonstrated for 24 h in the refrigerator (2 to 8°C).
For the diluted solution: Chemical and physical in-use stability has been
demonstrated for 24 h in the refrigerator (2 to 8°C).
From a microbiological point of view, 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 in the refrigerator, unless reconstitution/dilution has taken place
in controlled and validated aseptic 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 lactobionate.
Each vial contains 1 gram of erythromycin.
There are no other ingredients in this medicine.
What ERYTHROMYCIN looks like and contents of the pack
Before reconstitution, ERYTHROMYCIN is a white to slightly yellow
hygroscopic powder for solution for infusion in a glass vial. After
reconstitution, the solution is clear and colourless.
ERYTHROMYCIN is available in packs containing 1, 10 or 20 glass vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
PANPHARMA
Z.I. DU CLAIRAY
35133 LUITRE
FRANCE
{tel}+33 2 99 97 92 12
{fax}+33 2 99 97 91 27
{e-mail} panpharma@panpharma.fr
Authorized Manufacturer responsible for batch release:
PANPHARMA
10 rue du Chênot
Parc d’Activité du Chênot
56380 BEIGNON
FRANCE
{tel}+33 2 97 75 84 00
{fax}+33 2 97 75 84 84
{e-mail} panpharma@panpharma.fr
This leaflet was last revised in May 2016

Very rare (may affect up to 1 in 10,000 people):
–– Unmasking or worsening of a rare disease associated with muscle
weakness (myasthenia gravis)
–– Ringing in the ears (tinnitus) and mainly transient loss of hearing
–– Inability of the liver to perform normal function
–– Inability of the kidney to perform normal function
–– Severe skin reactions (Stevens-Johnson syndrome and erythema
multiform)
–– Skin peeling (toxic epidermal necrolysis)

Erythromycin can be administered in continuous or intermittent perfusion.
The infusion should be administered over 60 minutes as a rapid infusion is more likely to be associated with local irritative effects as well as QT interval
prolongation, arrhythmias or hypotension. A longer period of infusion should be used in patients with risk factors or previous evidence of arrhythmias.
Not less than 100 ml of diluent should be used for preparing intermittent I.V. solutions so as to minimise venous irritation. For 100 ml of infused
solution, this corresponds to about 35 drops/minute, for 250 ml of infused solution 85-90 drops/minute and for 500 ml of infused solution 170-180
drops/minute.
The erythromycin concentration should not exceed 5mg per ml and an erythromycin concentration of 1mg/ml (0.1% solution) is recommended.
Erythromycin should only be administered intravenously. Intra-arterial injection is strictly contraindicated. It can lead to angiospasm with ischaemia.
Intramuscular administration and IV bolus injection are also contraindicated.
Intravenous therapy should be replaced by oral administration after 2-7 days. In the interest of lasting successful treatment, erythromycin should be
continued for a further 2-3 days after symptoms have disappeared.
Warnings and precautions
Newborn infants and Children
Contact immediately your doctor if your child vomits and/or if irritability in connection with meals occurs because of the risk of Infantile Hypertrophic
Pyloric Stenosis (IHPS) that causes severe projectile non-bilious vomiting. Do not give this medicine to children if the potential benefits are not greater
than the risks.
Reconstitution
Each vial is for single use only.
A double dilution is required. An initial solution corresponding to 1g of erythromycin base is prepared by adding 20 ml of water for injections to the
content of the vial of Erythromycin 1g (shake abundantly until complete dissolution). For this step, a 0.9% sodium chloride solution should not be used.
For the reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 h in the refrigerator (2 to 8°C).
For the diluted solution: Chemical and physical in-use stability has been demonstrated for 24 h in the refrigerator (2 to 8°C).
From a microbiological point of view, the product should be used immediately.
This reconstituted solution can be kept in the refrigerator for 24 hours.
The diluted solution for administration: only a 0.9% sodium chloride solution or water for injection or a 5% glucose solution are to be used. It is
prepared under the same conditions by mixing the content of the vial of Erythromycin 1g (20 ml) to 500 ml of 0.9% sodium chloride solution or water
for injection or 5% glucose solution.
The diluted solution is administered without addition any other substance whatsoever.
In children, adjust the quantity of initial solution for dilution and the volume of perfusion to the dosage chosen according to the child’s weight.
After reconstitution
Diluted solutions should be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those used for reconstitution.
Erythromycin lactobionate in solution does not blend, mainly because of the pH shifts, with ß-lactam antibiotics, aminoglycosides, tetracyclines,
Chloramphenicol, Colistin, Aminophylline, barbiturates, Diphenylhydantoin, Heparin, Phenothiazine, riboflavin (vitamin B2), vitamin B6 and vitamin C.
Therefore, Erythrocin-i.v. should not be mixed with the named drugs in an infusion solution.
The addition of other solutions, which alter the range from pH 6-8, reduces the stability of erythromycin latctobionate.
Attention: Sodium chloride solutions or other solutions which contain inorganic salts should not be used to prepare the stock solution (see section 6.6
“Instructions for Use”), as it may cause precipitation.

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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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