1 g powder for solution for infusion,
erythromycin
1. What Abboticin is and what it is used for
Abboticin interferes with the bacteria’s production of proteins and thus prevents the bacteria from multiplying.
Abboticin is mainly used in various bacterial infections of the respiratory tract such as pneumonia, pertussis, and diphtheria. Abboticin is also used in infections in the abdomen as well as in eye inflammation and pneumonia in newborns caused by a Chlamydia bacterium.
Abboticin is also used in the treatment of community-acquired pneumonia, skin, and soft tissue infections in people who do not tolerate penicillin or where penicillin is inappropriate for other reasons.
Erythromycin contained in Abboticin may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you should know before you receive Abboticin
You must not be given Abboticin
- if you are allergic to erythromycin or any of the other ingredients of this medicine (listed in section 6).
- if you have abnormally low levels of potassium or magnesium in your blood (hypomagnesemia or hypokalaemia )
- if you or someone in your family has a history of cardiac arrhythmias (ventricular arrhythmia or torsades de pointes ) or an abnormality in the electrocardiogram (electrical recording of the heart) called “long QT syndrome”.
- if you are taking any of the following medicines:
- astemizole or terfenadine (medicines for allergies )
- cisapride (medicine for gastrointestinal disorders)
- dihydroergotamine (medicine for low blood pressure )
- disopyramide (medicine for heart problems)
- ergotamine (anti-migraine medication )
- pimozide (medicine for mental illness)
- drugs called statins, e.g. simvastatin, atorvastatin, and lovastatin (medicines to treat high blood fats).
- domperidone (medicines for nausea and vomiting)
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Abboticin
- if you have impaired liver function
- if you are taking other medicines that are known to cause severe heart rhythm disorders
- if you have heart problems.
- if you suffer from Myasthenia gravis, as symptoms may worsen.
If your child gets Abboticin and starts vomiting or gets irritated during feeding, contact a doctor immediately.
Bacteria can cause diarrhea during and after treatment with Abboticin. Contact your doctor if you have prolonged or severe diarrhea.
Contact a doctor if you get a new infection while you are being treated with Abboticin. Your doctor will decide if you need to change treatment
If you notice any visual impairment after treatment with this medicine, consult a doctor.
If you are going to take a urine sample, tell your doctor that you are using erythromycin, as it may affect some tests.
Other drugs and Abboticin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to consult a doctor if you are taking any of the medicines mentioned in the section ” You must not be given Abboticin”.
Ask your doctor for advice if you are taking the following medicines:
- fluconazole, ketoconazole, and itraconazole (used to treat fungal infections)
- protease inhibitors (used in HIV – infection )
- oral contraceptives ( birth control pills )
- clarithromycin, rifampicin (for bacterial infections)
- digoxin, quinidine (used for heart problems)
- cilostazol (used for window disease )
- anticoagulants, e.g. warfarin, acenocoumarol, and rivaroxaban (used for blood thinning)
- fexofenadine (used to treat allergies )
- valproate, carbamazepine, phenobarbital, or phenytoin (for epilepsy )
- theophylline (used for asthma and other respiratory problems)
- ciclosporin, tacrolimus (used after organ transplantation)
- bromocriptine (used to treat Parkinson’s disease )
- zopiclone, triazolam, alprazolam, clozapine, midazolam, hexobarbitone (used for anxiety, worry, and sleep disorders)
- alfentanil (for pain during surgery)
- cimetidine, omeprazole (used to treat acid reflux and stomach ulcers )
- colchicine (used for joint pain)
- methylprednisolone (used to suppress the body’s immune system eg in case of allergies and inflammation )
- St. John’s wort (a natural remedy)
- verapamil (used to treat heart disease such as high blood pressure )
- vinblastine (used to treat certain types of cancer)
- sildenafil (used for erection problems)
Important! Do not change the dosage of one of these drugs on your own without first talking to your doctor.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Women who are planning to become pregnant or are pregnant should not use Abboticin. Treatment with Abboticin should be taken only if absolutely necessary and only after a doctor’s prescription.
Breast-feeding
Abboticin should be used with caution in breast-feeding mothers as erythromycin is excreted in human milk and may cause side effects in the baby.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
No effects on the ability to drive and use machines have been observed
3. How to get Abboticin
Abboticin is given to you by a doctor or nurse, as an infusion directly into the bloodstream. Dose one is determined by the doctor, who adjusts it individually for you. The size of the dose depends on the type and severity of the infection.
The recommended dose for adults is 15-20 mg / kg / day. If necessary, the dose can be increased up to 4 grams per day. Abboticin can be given in divided doses every 6 or 8 hours or as a continuous intravenous infusion.
The recommended dose for children is 15-50 mg/kg/day in divided doses every 6 or 8 hours or as a continuous intravenous infusion.
Even after a couple of days of treatment with Abboticin, you can feel better. However, it is very important that the entire course is completed according to the doctor’s prescription. If this does not happen, the bacteria are given the opportunity to recover and infection can flare up again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you get any of the following symptoms:
- swelling of the face, tongue, or throat, difficulty swallowing hives, and difficulty breathing.
These symptoms may be signs of angioedema or allergic reaction ( anaphylaxis ). Angioedema occurs in an unknown number of people (no known frequency) while allergic reactions can occur in up to 1 in 100 people (rare)
The following side effects have been reported in an unknown number of users. Contact a doctor immediately if you get the following symptoms:
- severe skin reaction: red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis ).
- skin and mucosal changes (sometimes severe) and severe skin damage (skin peeling).
- abnormal heart rhythm (including palpitations, rapid heartbeat, life-threatening irregular heartbeat called torsades de pointes, or abnormal ECG heart tracking) or cardiac arrest.
- inflammation of the kidneys (a condition called interstitial nephritis).
- certain forms of hepatitis (cholestatic and hepatocellular hepatitis ).
- jaundice (causes yellowing of the skin and whites of the eyes).
- hepatic impairment, liver enlargement, and liver failure.
- prolonged or severe diarrhea
Other side effects:
Common (may affect up to 1 in 10 people)
- stomach upset (in the form of nausea, stomach cramps, and diarrhea).
- rash.
- swelling and pain at the infusion site.
Uncommon (may affect up to 1 in 100 people)
- hives.
Rare (may affect up to 1 in 1000 people)
- temporary hearing loss especially in patients with high doses or who have impaired renal function)
- elevated liver values (seen with laboratory tests)
- bile stasis (a condition caused by a blockage in the liver)
- liver inflammation ( hepatitis ).
Has been reported (occurs in an unknown number of users ) :
- feeling sick
- abdominal pain
- inflamed pancreas ( pancreatitis )
- vomiting
- tinnitus ( tinnitus )
- deafness
- chest pain
- fever
- loss of appetite
- confusion
- cramps
- dizziness
- impaired vision
- hallucinations (seeing or hearing things that are not there),
- low blood pressure
- itching
- increase in the number of white blood cells in the blood ( eosinophilia )
Fungal overgrowth in the oral cavity and abdomen may occur.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Abboticin
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 label after EXP. The expiration date is the last day of the specified month.
No special storage instructions
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. Contents of the packaging and other information
Content declaration
- The active substance is erythromycin. 1 vial contains erythromycin lactobionate equivalent to 1 g of erythromycin.
- Other ingredients: none
What the medicine looks like and the contents of the pack
White or almost white powder.
Pack size: Vial, 1g.
Marketing Authorisation Holder
Amdipharm Limited
Temple Chambers
3 Burlington Road
Dublin 4
Ireland
Tel. +44 1268 82 3049
Manufacturer
Delpharm Saint Remy
Rue de l’Isle
Saint Remy Sur Avre,
28380, France
This leaflet was last modified on 7 October 2020
The following information is intended for healthcare professionals only:
USED FOR IV INFUSION ONLY.
MAY NOT BE GIVEN AS A BOLUS INJECTION.
Preparation of 1 g powder for solution for infusion
1: Preparation of stock solution:
A 5% stock solution (50 mg erythromycin/ml) is prepared by dissolving the powder in the vial (1 g erythromycin) in 20 ml water for injections. The stock solution must be further diluted before administration. The stock solution should be used immediately after reconstitution and any residue discarded. For aseptic preparation, the stock solution can be stored for up to 24 hours in a refrigerator (2 ° C – 8 ° C).
2: Dilution of stock solution
a) Infusion fluid for intermittent infusion:
Further, dilute 20 ml of the stock solution by adding 200-250 ml of suitable infusion solution (see below).
b) infusion for continuous infusion:
Further, dilute 20 ml of the stock solution by adding 500 ml or 1000 ml of suitable infusion solution (see below).
A reconstituted infusion solution should be used immediately after reconstitution.
Infusion fluids suitable for diluting the stock solution:
- Call isotonic saline solution, Sodium chloride 9 mg/ml solution for infusion.
- Glucose 50 mg / ml and 100 mg / ml and Ringer glucose with sodium bicarbonate 14 mg / ml.
Solutions containing glucose must first be added to sodium bicarbonate as a buffer to ensure neutrality.
Make sure that the finished infusion solution is free of particles before administration.
Method of administration
As rapid infusion is more commonly associated with arrhythmias or hypotension, it is recommended that Abboticin infusion fluid be given slowly. This should be especially considered for patients with risk factors or previous signs of arrhythmias.
The low infusion rate is also recommended for heart disease and premature infants.
a) Intermittent infusion:
The reconstituted infusion solution is infused slowly intravenously (max. 5 ml/min for 20-60 minutes) to avoid local irritation.
b) Continuous infusion:
The finished infusion solution is administered as a continuous infusion over up to 24 hours