Erythromycin intravenosum tzf

Package leaflet: Information for the patient

Erythromycinum Intravenosum TZF, 300 mg, powder for solution for infusion
Erythromycinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Erythromycinum Intravenosum TZF is and what it is used for
2. Important information before using Erythromycinum Intravenosum TZF
3. How to use Erythromycinum Intravenosum TZF
4. Possible side effects
5. How to store Erythromycinum Intravenosum TZF
6. Contents of the pack and other information

1. What Erythromycinum Intravenosum TZF is and what it is used for

Erythromycin belongs to the group of macrolide antibiotics. It exerts a bacteriostatic effect against many Gram-negative and Gram-positive bacteria.
Indications
Erythromycin administered by intravenous infusion is used in severe infections caused by susceptible microorganisms, when rapid achievement of high drug concentration in the blood is required or when oral administration is not possible.

• Upper respiratory tract infections – e.g. tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary bacterial infections during influenza or common cold.
• Lower respiratory tract infections – e.g. tracheitis, acute bronchitis or exacerbation of chronic bronchitis, pneumonia (lobar, bronchopneumonia, primary atypical pneumonia), bronchiectasis, Legionnaires' disease.
• Middle and external ear infections.
• Gingivitis, Vincent's angina.
• Blepharitis.
• Skin and soft tissue infections: furuncles, furunculosis, cellulitis, erysipelas.
• Gastrointestinal tract infections – cholecystitis, staphylococcal enteritis and colitis.
• Prevention of perioperative infections, secondary infections in burns, endocarditis in patients undergoing dental procedures.
• Endocarditis (infection of the inner lining of the heart chambers).
• Sepsis (systemic infection, septicemia).
• Other infections: osteomyelitis, urethritis, gonorrhea, primary syphilis, granuloma inguinale.

2. Important information before using Erythromycinum Intravenosum TZF

When not to use Erythromycinum Intravenosum TZF

• If the patient is allergic (hypersensitive) to erythromycin or other macrolide antibiotics.
• If the patient is concurrently using any of the following medicines:
• lovastatin, simvastatin (medicines used to lower blood cholesterol levels),
• astemizole or terfenadine (medicines commonly used in the treatment of hay fever and allergies),
• cisapride (a medicine used to treat gastrointestinal disorders),
• pimozide (a medicine used to treat psychiatric disorders),
• ergotamine or dihydroergotamine (medicines used, among others, in the treatment of migraine), during erythromycin therapy, because concomitant use of these medicines may sometimes cause serious heart rhythm disturbances. Please consult your doctor about alternative medicines that the patient may take instead of those listed above (see section 2 "Erythromycinum TZF and other medicines"),
• lomitapide (used to reduce elevated blood levels of lipids such as cholesterol and triglycerides). Taking this medicine together with erythromycin may lead to increased activity of liver enzymes (aminotransferases), indicating liver stress and possible liver dysfunction.
• If the patient has abnormally low levels of potassium or magnesium in the blood (hypomagnesemia or hypokalemia).
• If the patient or a family member has a history of heart rhythm disorders (ventricular tachycardia or torsades de pointes arrhythmia) or an abnormality in the electrocardiogram (ECG) called "long QT syndrome".
• Erythromycin solutions must not be administered by rapid intravenous injection.

Warnings and precautions
Please inform your doctor if:

• the patient has previously experienced an allergic reaction to erythromycin or other macrolide antibiotics;
• the patient has liver disease and/or is taking medicines that may be toxic to the liver;
• the patient suffers from myasthenia gravis (a disease causing muscle weakness and excessive fatigue);
• the patient is taking other medicines known to cause serious heart rhythm disturbances;
• the patient has heart problems;
• the patient develops severe and persistent diarrhea during or after treatment;
• vomiting or signs of irritability occur in infants during or after feeding while being treated.

Erythromycinum Intravenosum TZF and other medicines
Please tell your doctor about all medicines currently taken or recently used by the patient,
as well as any medicines the patient plans to take, including over-the-counter medicines.
If the patient is taking any of the following medicines, concomitant use of erythromycin is
contraindicated:

• lovastatin, simvastatin, lomitapide, astemizole, terfenadine, cisapride, pimozide, ergotamine or dihydroergotamine

It is also important whether the patient is taking medicines with the following names:

• mizolastine (used in allergic reactions)
• theophylline (used in the treatment of asthma)
• digoxin, quinidine, disopyramide, verapamil (used in the treatment of heart disorders)
• cyclosporine, tacrolimus (immunosuppressive medicines used after organ transplantation)
• cisapride, cimetidine (used in the treatment of gastrointestinal disorders)
• rifampicin, rifapentine, rifabutin (antibiotics used in the treatment of tuberculosis)
• fluconazole, ketoconazole, itraconazole (antifungal medicines)
• alfentanil, alprazolam, triazolam, midazolam (medicines used in anxiety or insomnia, often administered before surgery)
• methylprednisolone (an anti-inflammatory medicine)
• omeprazole (a medicine reducing gastric acid secretion)
• cilostazol (a medicine used in circulatory disorders)
• sildenafil (a medicine used in male erectile dysfunction)
• vinblastine (a medicine used in cancer chemotherapy)
• colchicine (a medicine used in the treatment of gout)
• bromocriptine (a medicine used in Parkinson's disease)
• zolpidem (a medicine used in insomnia)
• antiepileptic medicines (e.g. carbamazepine, phenytoin, valproic acid)
• anticoagulants, e.g. warfarin, acenocoumarol and rivaroxaban (used to thin the blood)
• antibacterial medicines (antibiotics such as penicillins, cyclosporins, clindamycin, lincomycin, chloramphenicol, streptomycin, tetracycline, colistin)
• corticosteroids, administered orally, by injection or by inhalation (used to suppress the immune system – useful in treating many conditions)
• hydroxychloroquine or chloroquine (used in the treatment of diseases such as rheumatoid arthritis or in the treatment or prevention of malaria). Taking these medicines together with erythromycin may increase the risk of abnormal heart rhythms and other serious cardiac adverse effects.
• St. John's wort (used, among others, for gastrointestinal and liver disorders, depression and insomnia).

Oral contraceptives
Erythromycin reduces their effectiveness and increases the risk of liver damage. If the patient is using
oral contraceptives, she should inform her doctor before starting erythromycin treatment. The doctor will
pay particular attention to any liver-related symptoms that may occur during treatment and may recommend
using additional, non-hormonal contraceptive methods.

Diagnostic tests
If the patient is due to have a urine test, please inform the doctor or nurse that the patient is taking
Erythromycinum Intravenosum TZF. Erythromycin may affect the results of urine tests.

Children and adolescents
In infants, cases of hypertrophic pyloric stenosis have been reported after erythromycin treatment. If vomiting or signs of feeding intolerance occur in a child treated with erythromycin, inform the doctor immediately.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The active substance of Erythromycinum Intravenosum TZF may cross the placenta in pregnant women and is excreted in breast milk. Data from studies regarding the risk of congenital malformations are inconsistent; however, some studies have reported heart defects following use of Erythromycinum Intravenosum TZF in early pregnancy.
Erythromycin may be administered to pregnant or breastfeeding women only if, in the opinion of the doctor, it is clearly necessary.

Driving and operating machinery
The medicine may cause dizziness, confusion and disorientation, which may affect the ability to drive vehicles and operate machinery.

3. How to use Erythromycinum Intravenosum TZF

This medicine should always be used as directed by the physician. In case of doubt, please
contact your doctor.
Adults
Mild to moderately severe infections (when oral administration is not possible) – 25 mg/kg body weight per day.
Severe infections – 50 mg/kg body weight per day (up to 4 g per day).
Children
Usually 12.5 mg/kg body weight given 4 times daily. In severe infections, the doctor may double the dose.
Newborns up to 1 month of age
10 to 15 mg/kg body weight 3 times daily.
Duration of treatment
The duration of treatment is determined by the physician depending on the severity and type of infection.
After clinical improvement, the physician may recommend continuing treatment with oral erythromycin.
Method of administration
This medicine is intended for intravenous infusion.
Use of a higher than recommended dose of Erythromycinum Intravenosum TZF
This medicine is administered by trained medical personnel, so administration of a higher than recommended dose is unlikely. However, if the patient believes they have received a higher than recommended dose, they should contact their physician or nurse as quickly as possible. Symptoms may include gastrointestinal disturbances (nausea, vomiting, diarrhea) and hearing disturbances.
In case of any doubts regarding the method of administration, consult the physician or nurse.
Missed dose of Erythromycinum Intravenosum TZF
Since this medicine is administered by trained medical personnel, missing a dose at the scheduled time is unlikely. However, if the patient believes they did not receive the medicine at the correct time, they should inform the physician or nurse.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Diagnostic investigations
Increased liver enzyme activity.
Blood and lymphatic system disorders
Eosinophilia, agranulocytosis.
Vascular disorders
Hypotension.
Renal and urinary disorders
Interstitial nephritis, renal function disorders.
General disorders and administration site conditions
Chest pain, fever, malaise, redness at the injection site, skin irritation.
Slow administration of adequately diluted intravenous infusion solution minimizes pain and venous irritation.
Psychiatric disorders
Hallucinations.
Cardiac disorders
Irregular heart action (including palpitations, rapid heartbeat, life-threatening arrhythmias
known as torsades de pointes, or abnormal heart function on ECG) or cardiac arrest.
The frequency of these adverse reactions is unknown (cannot be estimated from available data).
Skin and subcutaneous tissue disorders
Skin rashes, angioedema, exanthema, pruritus, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
If a patient develops a severe skin reaction: red, peeling rash with subcutaneous nodules and blisters (erythema multiforme), contact a physician immediately. The frequency of these adverse effects is unknown (cannot be estimated from available data).
Ear and labyrinth disorders
Deafness, tinnitus, especially after administration of high doses exceeding 4 g per day.
Isolated cases of transient hearing loss have been reported, particularly in patients with renal impairment or after administration of high doses.
Immune system disorders
Hypersensitivity reactions ranging from urticaria and mild skin rashes to anaphylactic reactions.
Nervous system disorders
Isolated cases of transient central nervous system disorders have been reported, including confusion, convulsions, dizziness; however, a causal relationship with erythromycin use has not been established.
Hepatobiliary disorders
Cholestatic or hepatocellular hepatitis, liver failure, liver function abnormalities, hepatomegaly, jaundice.
Gastrointestinal disorders
The most commonly occurring adverse reactions after oral administration of erythromycin are gastrointestinal disorders, which are dose-dependent:
hypertrophic pyloric stenosis in infants, anorexia, pancreatitis, abdominal pain, nausea, vomiting, diarrhea (especially after high doses), pseudomembranous colitis (may occur during or after completion of therapy).
Infections and infestations
Overgrowth of drug-resistant bacteria or fungi during prolonged or repeated erythromycin treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Erythromycinum Intravenosum TZF

Keep the medicine out of sight and reach of children.
Store below 25 °C. Protect from light.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Erythromycinum Intravenosum TZF contains
The active substance is erythromycin.
One vial contains 300 mg of erythromycin in the form of lactobionate.

What Erythromycinum Intravenosum TZF looks like and contents of the pack
White or slightly yellow powder.
Pack: one vial in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: 22 811-18-14

Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: 22 811-18-14

Manufacturer
FISIOPHARMA S.R.L
Nucleo Industriale, Palomonte (SA)
84020 Italy

For further information about this medicinal product, please contact the Marketing Authorisation Holder.

Information intended exclusively for healthcare professionals

Administration method
Erythromycinum Intravenosum TZF should be administered by continuous or intermittent infusion lasting 20 to 60 minutes, every 6 or 8 hours.
The optimal concentration of erythromycin solutions for infusion is 1 mg/ml (0.1%). If necessary, the concentration of erythromycin solutions may be increased to 5 mg/ml (0.5%). Erythromycin solutions at a concentration of 5 mg/ml should be infused over at least 60 minutes. Rapid administration increases the risk of arrhythmias or a drop in arterial blood pressure.
To minimize venous irritation, it is recommended to use at least 100 ml of diluent when preparing erythromycin solutions for intermittent infusions.
Erythromycin solutions with a concentration above 5 mg/ml should not be administered, as they may cause pain radiating along the vein.
Erythromycin solutions must not be administered as a rapid intravenous injection (bolus).

Preparation of solutions
Stock solution
The content of the vial should be dissolved in 6 ml of water for injections.

Infusion solution
The resulting stock solution should be further diluted with 0.9% sodium chloride solution or 5% glucose solution to achieve the desired concentration, and then administered intravenously by continuous or intermittent infusion.
Infusion solutions should be prepared using at least 100 ml of diluent.
According to good practice, infusion solutions should be administered immediately after preparation.
Prepared infusion solutions in 0.9% sodium chloride solution or 5% glucose solution remain stable for 24 hours at a temperature of 2°C to 8°C (refrigerated).

Pharmaceutical incompatibilities
Erythromycin lactobionate solution must not be mixed with other antibiotics, aminophylline, or barbiturates.
Erythromycin lactobionate solutions with pH below 5.5 rapidly lose activity.