Patient leaflet - Erythromycin 1 g powder for concentrate for solution for infusion
1. What Erythromycin is and what is it used for
Erythromycin contains the active ingredient erythromycin (as erythromycin lactobionate) which belongs to a group of medicines called macrolide antibiotics. Erythromycin 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. 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;
- Septicaemia (blood poisoning);
- Endocarditis (infection of the heart).
2. What you need to know before you are given Erythromycin
You should not receive Erythromycin:
if you are allergic to erythromycin or any other ingredients of this medicine
(listed in section 6);
- if you are allergic to other macrolide antibiotics 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 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;
- if you are using simvastatin (used to lower cholesterol and triglycerides (types of fat) in the blood);
- if you are using tolterodine (used for treating overactive bladder with symptoms of urinary frequency, urgency, and leakage);
if you have abnormally low levels of potassium or magnesium in your blood
(hypokalaemia and hypomagnesaemia);
if you or someone in your family has a history of heart rhythm disorders
(ventricular cardiac arrhythmia or Torsades de Pointes) or an abnormality of the electrocardiogram (electrical recording of the heart) called “long QT syndrome”;
Package leaflet: Information for the user
Erythromycin 1g powder for concentrate for solution for infusion
erythromycin lactobionate
- if you are taking lomitapide (used to lower increased blood fats such as cholesterol and triglycerides). Taking this medicine at the same time as erythromycin may lead to a rise in enzymes produced by liver cells (transaminases), which indicates that the liver is under stress and may lead to liver problems.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Erythromycin:
- if you are taking colchicine (used for treatment of gout and arthritis) whilst taking erythromycin as this may cause serious side effects;
- if you have any liver problems or have been told that any drugs you are taking can cause liver problems;
- if you are taking other medicines which are known to cause serious disturbances in heart rhythm;
- if you have heart problems;
- if you have previously experienced diarrhoea following the use of antibiotics;
if you 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 pregnancy, and your child is under 1 year and is prescribed erythromycin, consult your doctor before giving erythromycin to your child;
- if you suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your doctor before receiving erythromycin;
if you are taking erythromycin with ‘statins’ such as simvastatin or lovastatin
(used to lower cholesterol) as serious side effects can occur. Children
If you are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately.
Other medicines and Erythromycin
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 or amisulpride (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);
- hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as erythromycin may increase the chance of you getting side effects that affect your heart;
- 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);
- Anticoagulants e.g. warfarin, acenocoumarol and rivaroxaban (used to 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);
- corticosteroids, given by mouth, by injection or inhaled (used to help suppress the body’s immune system – this is useful in treating a wide range of conditions).
If you or your child goes for any medical tests, tell your doctor that you are receiving Erythromycin, 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 breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine. The active ingredient of Erythromycin may cross the placenta in pregnant women and is excreted in breast milk. Information from studies regarding the risk of birth defects is inconsistent, but some studies have reported heart defects following erythromycin use in early pregnancy.
3. How you will be given Erythromycin
For patients with severe infections or those who are at particular risk of developing infections, the usual dose of Erythromycin 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. Erythromycin will be given either in divided doses throughout the day or as a continuous slow infusion. You should not receive Erythromycin 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, Erythromycin 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;
a life-threatening irregular heart beat called Torsades de Pointes or abnormal
ECG (heart tracing) or heart stopping (cardiac arrest);
- 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);
- diarrhoea which may be severe or prolonged and may contain blood or mucus. Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this side effect is not known (cannot be estimated from the available data).
Other side effects of Erythromycin include:
Not known: frequency cannot be estimated from the available data
- 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);
- chest pains;
- abnormal heart rhythms (including palpitations, a faster heartbeat);
- 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;
- vomiting and irritability in young children between the age of 1 month and 12 months;
- visual impairment/blurred vision (mitochondrial optic neuropathy). Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Erythromycin
Your medicine will be stored by the hospital or clinic. Once the vial of Erythromycin has been mixed ready for use it should be used immediately. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
6. Contents of the pack and other information
What Erythromycin contains:
Each vial of Erythromycin contains 1 g of the active ingredient erythromycin as erythromycin lactobionate, as a white to slightly yellow powder. When made up with 20 ml of Water for Injections, each ml of solution contains 50 mg of erythromycin. This solution must be further diluted prior to use. There are no other ingredients in the product.
Erythromycin is available as single 1 g vials.
Marketing Authorisation Holder:
Flynn Pharma Ltd
5th Floor, 40 Mespil Road, Dublin 4, IRELAND, D04 C2N4
Manufacturer:
Inresa Arzneimittel GmbH
Obere Hardtstr. 18, 79114 Freiburg
Germany
This leaflet was last revised in September 2025.
The following information is intended for healthcare professionals only:
Erythromycin 1g powder for concentrate for solution for infusion
Intravenous therapy 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.
Presentation
Erythromycin 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 as erythromycin lactobionate. 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.
FOR I.V. INFUSION USE ONLY.
Microbiological Indications
Erythromycin is usually active in vitro and in clinical infections against most strains of the following organisms:
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.
Posology
Adults: Severe and immunocompromised infections, 50 mg/kg/day, preferably by continuous infusion (equivalent to 4 g per day for adults). Mild to moderate infections (oral route compromised) 25 mg/kg/day.
Neonates (birth to 1 month): 10-15 mg/kg three times daily.
Children: 12.5 mg/kg four times daily (daily doses can be doubled in severe infections).
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
Add 20 ml Water for Injections to the 1 g vial. No other solvent apart from Water for Injections should be used to prepare this initial solution.
Step 2
Add 20 ml of Step 1 solution to 200-250 ml Sodium Chloride 0.9% (9 mg/ml) solution for injection. 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.
When administering the product by intermittent infusion do not use solution strengths greater than 5 mg/ml and the time of each infusion should be between 20 and 60 minutes.
Preparation of 1 g dose for continuous infusion
Step 1
Add 20 ml Water for Injections to the 1 g vial. No other solvent apart from Water for Injections should be used to prepare this initial solution.
Step 2
Add 20 ml of Step 1 solution to 500 ml - 1,000 ml Sodium Chloride 0.9% (9 mg/ml) solution for injection. The resulting diluted solution contains 2 mg/ml - 1 mg/ml (0.2 - 0.1%) of erythromycin.
8021713 Alternative Step 2 diluents:
Compound Sodium Lactate Intravenous infusion (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, or 0.18% Sodium Chloride and 4% Glucose intravenous infusion. The stability of solutions of Erythromycin Lactobionate is adversely affected below pH 5.5.
The infusion should be completed within 8 hours of preparation to ensure potency.
Storage information for reconstituted and diluted solution
Once reconstituted (Step 1), this product should be used immediately but can be stored for up to 8 hours in a refrigerator between 2 °C and 8 °C. Once diluted (Step 2), use immediately and discard any remainder of the contents.
PRODUCT: Amends: Approval:
Indesign CC
FF37
Erythromycin 1g powder for solution for infusion Leaflet UK
1.2.22
150x310 mm x 3 glued
6
22.9.25
Leaflet (PIL)
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N
DIN font family min 10 pts
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