Active ingredients: Erythromycin
ERYTHROCIN 250 MG TABLETS COATED WITH FILM
EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION
ERYTHROCIN 200 MG CHEWABLE TABLETS
ERYTHROCIN 600 MG TABLETS COATED WITH FILM
ERYTHROCIN 500 MG GRANULES FOR ORAL SUSPENSION
ERYTHROCIN 1000 MG GRANULATE FOR ORAL SUSPENSION
ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION
Indications Why is Erythrocin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY:
Macrolide antibiotic
THERAPEUTIC INDICATIONS
Streptococcus pyogenes (beta-haemolytic streptococcus group A): infections of the upper and lower respiratory tract, skin and soft tissues. In the case of oral administration, the importance of precise compliance by the patient with the prescribed dosage regimen should be emphasized. A therapeutic dose must be administered for at least 10 days.
Alpha-haemolytic streptococci (viridans group): short-term prophylaxis of bacterial endocarditis before dental or other surgical procedures in patients with a history of rheumatic fever or congenital heart disease.
Staphylococcus aureus: acute infections of the skin and soft tissues. Resistant organisms may appear in the course of treatment.
Diplococcus pneumoniae: upper respiratory tract infections (eg otitis media, pharyngitis) and lower respiratory tract infections (eg pneumonia, bronchitis).
Mycoplasma pneumoniae (Eaton's agent, pleuro-pneumonium-like organisms): in the treatment of atypical primary pneumonia when it is due to this organism.
Treponema pallidum: Erythromycin is an alternative to the treatment of primary syphilis in patients allergic to penicillins.
Corynebacterium diphteriae and C. minutissimum: as an adjuvant of the antitoxin in order to prevent the creation of carriers and for the elimination of the organism in the carriers themselves.In the treatment of erythrasma.
Listeria monocytogenes: infections caused by this organism.
Legionella pneumophila: in the prophylaxis and treatment of acute pulmonary episodes resulting from infections caused by this microorganism.
Bordetella pertussis: the efficacy of erythromycin in eliminating this organism from the nasopharyngeal area has been clinically demonstrated. Some studies suggest that erythromycin has been shown to be active in the prophylaxis of individuals exposed to infection sustained by this microorganism.
Clamydia trachomatis: in infections of the urogenital tract, sustained by this microorganism
Contraindications When Erythrocin should not be used
Erythromycin is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.
Erythromycin is contraindicated in patients treated with terfenadine, astemizole, cisapride, pimozide and ergotamine or dihydroergotamine (see Precautions for use and interactions sections).
Precautions for use What you need to know before taking Erythrocin
As erythromycin is metabolized and excreted mainly in the liver, particular caution should be exercised when administering the drug to patients with impaired hepatic function, in subjects with moderate or severe renal impairment and in the elderly (over 65 years).
Elderly patients, especially with hepatic or renal dysfunction, have an increased risk of hearing loss associated with erythromycin.
In pregnant women, and in very early childhood, the product should be administered in cases of real need, under the direct supervision of the doctor.
The administration of erythromycin, especially if in the form of estolate (lauryl sulfate propionate), at high doses for periods of time longer than two weeks, can cause disturbances in liver function which must therefore be monitored, discontinuing the treatment in case of abnormal reactions.
Undesirable effects due to the use of erythromycin, such as urticaria or other allergic-type reactions, have rarely been observed.
If signs of hypersensitivity appear, administration should be discontinued and adrenaline or steroids used.
Interactions Which drugs or foods can modify the effect of Erythrocin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
In case of administration of erythromycin associated with theophylline, serum increases of the latter may occur with a consequent increase in toxic effects. In this case it is necessary to reduce the quantity of theophylline administered.
Triazolobenzodiazepines (such as triazolam and alzoprazolam) and related benzodiazepines: Erythromycin has been reported to decrease the clearance of triazolam, midazolam and related benzodiazepines and consequently may cause an increase in the pharmacological effect of these benzodiazepines.
Erythromycin potentiates the effect of digoxin when administered concurrently, therefore plasma digoxin concentrations should be closely monitored while patients are receiving concomitant digoxin and erythromycin therapy.
Erythromycin potentiates the effect of oral anticoagulants (eg Warfarin) when administered simultaneously, with risk of bleeding and an increase in the international normalized ratio (INR). The INR and prothrombin time should be frequently monitored in those patients who are treated concurrently. with erythromycin and anticoagulant agents.
Erythromycin, like other macrolides, should be used with caution in patients taking medications known to prolong the QT interval (eg Class IA and III antiarrhythmics, tricyclic antidepressants, fluoroquinolones, antipsychotics) (see section Special warnings).
The use of erythromycin in patients concomitantly taking drugs metabolised by cytochrome P450 may be associated with increased serum levels of these drugs. Interactions of erythromycin with Carbamazepine, Cyclosporine, Esobarbital, Phenytoin, Alfentanil, Disopyramide, Bromocriptine, Valproate have been reported. , Tacrolimus, Quinidine, Methylprednisolone, Cilostazol, Vinblastine, Sildenafil, Terfenadine, Astemizole Serum concentrations of drugs metabolised by cytochrome P450 should be monitored when taken concomitantly with Erythromycin.
Since macrolides significantly alter the metabolism of Terfenadine, the concomitant administration of Erythromycin and Terfenadine is not recommended as well as the concomitance of Erythromycin and Lovastatin.
HMG-CoA reductase inhibitors: Erythromycin has been reported to increase the concentrations of HMG-CoA reductase inhibitors (eg lovastatin and simvastatin). Rhabdomyolysis has rarely occurred in patients taking concomitant medications.
Concomitant use of erythromycin and colchicine has reported post-marketing cases of colchicine toxicity.
Erythromycin significantly alters the metabolism of terfenadine and astemizole when administered concomitantly. Cases of severe cardiovascular episodes including death, cardiac arrest, torsades de pointes and other ventricular arrhythmias have been observed rarely (see Contraindications and Side Effects sections).
Elevated cisapride levels have been reported in patients treated with erythromycin and cisapride concomitantly. This can lead to QT interval prolongation and cardiac arrhythmias such as ventricular tachycardia, ventricular fibrillation and torsades de pointes. Similar effects have been seen in patients taking pimozide and clarithromycin, another macrolide antibiotic.
Post-marketing cases indicate that concomitant administration of erythromycin with ergotamine or dihydroergotamine has been associated with acute ergotamine toxicity characterized by vasospasm and ischaemia of the extremities and other tissues including the central nervous system (see Contraindications section).
Erythromycin has been observed to decrease the clearance of zopiclone and consequently may cause an increase in the pharmacodynamic effect of this drug.
Warnings It is important to know that:
Cases of infantile hypertrophic pyloric stenosis have been reported in children receiving erythromycin therapy. In particular, non-biliary vomiting was found in infants who had taken erythromycin for pertussis prophylaxis; they were subsequently diagnosed with pyloric stenosis which necessitated surgical pyloromyotomy. Considering that erythromycin is used in children for the treatment of conditions associated with significant mortality or morbidity such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of erythromycin therapy must be carefully weighed against the potential risk of stenosis. hypertrophic pylorus.
Parents should be informed so that they report to the doctor any episodes of vomiting or difficulties in breastfeeding the infant.
Following the administration of Erythromycin, the onset of hepatic dysfunction, elevated liver enzymes and hepatocellular and / or colostatic hepatitis, with or without jaundice, has been reported in rare cases. The patient should be advised to discontinue treatment and contact your doctor if you have signs and symptoms of liver disease, such as anorexia, jaundice, dark urine, itching or abdominal pain.
Pseudomembranous colitis ranging in severity from mild to life-threatening has been reported with nearly all antibacterials, including macrolides.
Some reports suggest that Erythromycin is unable to reach the fetus at adequate concentrations to prevent congenital syphilis. Infants of mothers treated during pregnancy with erythromycin administered orally for the purpose of treating early syphilis should be treated with recurrent to an adequate penicillin-based therapeutic regimen.
There have been reports of QT interval prolongation, including rare cases of arrhythmia and torsade de pointes, including fatal ones, in patients receiving erythromycin. Due to the risk of QT interval prolongation, erythromycin should be used with caution. in patients with coronary artery disease, severe heart failure, hypomagnesaemia, bradycardia (
Elderly patients have an increased risk of QT interval prolongation and torsades de pointes.
There have been reports of rhabdomyolysis with or without renal impairment in severely ill patients receiving erythromycin therapy administered concomitantly with HMG-CoA reductase inhibitors (statins).
Prolonged or repeated use of erythromycin may lead to an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, administration of erythromycin should be stopped immediately and appropriate therapy instituted.
If necessary, incisions and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.
Cases have been reported in which the intake of Erythromycin could aggravate the weakened state of patients presenting with myasthenia gravis.
Erythromycin interferes with the fluorometric determinations of urinary catecholamines.
The medicine is not contraindicated in people with celiac disease. Important information about some excipients:
- EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION and 10% GRANULATE FOR ORAL SUSPENSION contain sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate which can cause allergic reactions and sorbitol, if your doctor has diagnosed an intolerance to some sugars contact him before taking this medicine ..
- 500 MG GRANULATE FOR ORAL SUSPENSION - 1000 MG GRANULATE FOR ORAL SUSPENSION contains Sucrose: if your doctor has diagnosed you have an intolerance to some sugars contact your doctor before taking this medicine
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine
There are no adequate and well controlled studies conducted in pregnant women. However, observational studies in humans have reported the occurrence of cardiovascular malformations after exposure to erythromycin-containing medicinal products during the early months of pregnancy. The safety of erythromycin during pregnancy or breastfeeding has not been established. Erythromycin should only be taken by pregnant women if it has been established that it is necessary. Erythromycin crosses the placental barrier but plasma levels of erythromycin in the fetus were generally low and its presence in breast milk is also known.
Effects on ability to drive and use machines
No effects of drowsiness or reduced ability to use machines have been reported.
Dosage and method of use How to use Erythrocin: Dosage
The recommended dosage is as follows:
a) INFANTS (2-6 kg): Erythrocin EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION (erythromycin ethylsuccinate): The average recommended dose is 50 mg for each kg of body weight per day in three administrations, or according to the judgment doctor's (5 ml = 200 mg).
The dropper is set at 50 mg (1/2 dose) and 100 mg (1 dose). (Example: 3 kg = 1/2 dose, 3 times a day).
b) CHILDREN (6-30 kg): ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION: 50 mg / kg / day in three doses; up to 7.5 kg: 1 small scoop (125 mg) 3 times a day; up to 15 kg: 1/2 large scoop (250 mg) 3 times a day; up to 30 kg: 1 large scoop (500 mg) 3 times a day.
c) SCHOOL age (3-12 YEARS): Erythrocin 200 mg CHEWABLE TABLETS (erythromycin ethylsuccinate): 1 chewable tablet every 12 kg of weight 3 times a day (1 tablet = 200 mg); Erythrocin 500 mg granules for oral suspension (erythromycin ethylsuccinate): 1 sachet 3 times a day.
d) ADULTS: Erythrocin 600 mg film coated tablets (erythromycin ethylsuccinate) 1 tablet 3 times a day (1 tablet = 600 mg); Erythrocin 1000 mg granules for oral suspension (erythromycin ethylsuccinate) 1 sachet 2 times a day. The recommended dosage can be elevated up to 4 g daily or more depending on the judgment of the doctor. It is advisable to avoid the administration of the product during meals or immediately after. Treatment should be continued for more than 48 hours after symptoms disappear and after the temperature has returned to normal. For the treatment of Legionnaires' disease the recommended dose in adults is 1.6 / 4 g per day in divided doses.
In more severe infections the same dose can be given every four hours. The dose for children is in proportion to age and weight.
In the treatment of streptococcal infections, a therapeutic dose of erythromycin should be administered for at least 10 days. In continuous prophylaxis of streptococcal infections in subjects with a history of rheumatic heart disease, the dose is 250 mg twice daily.
Preparation of the suspension in bottle and sachets:
To prepare the Erythrocin suspension, add water to the granules contained in the bottle up to the imprinted mark. Shake well and leave to rest for a few minutes. Since the preparation of the suspension takes place with a reduction in volume, it is necessary to add more water until the level of the suspension is brought back to the mark. The suspension thus prepared must be kept in the fridge and used within 10 days.
To prepare the suspension in sachets at the time of administration pour the contents into a glass of water. Shake until a homogeneous suspension is obtained
Overdose What to do if you have taken too much Erythrocin
Undesirable effects involving the gastrointestinal tract have occurred. They are characterized by epigastric pain, nausea and mild diarrhea. These disturbances become frequent when doses of 8 to 12 grams are used for several days. These pains disappear with the cessation of administration of the antibiotic.
The appearance of colostatic jaundice is known in the literature, which occurs only in subjects treated with erythromycin estolate.
In the event of an overdose, erythromycin administration should be discontinued. Overdose should be managed through prompt elimination of unabsorbed drug and other appropriate measures.
ECG monitoring should be performed because of the possibility of QT interval prolongation.
Erythromycin is not eliminated by peritoneal dialysis or hemodialysis.
In case of accidental ingestion / intake of an excessive dose of Erythrocin, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Erythrocin
Like all medicines, Erythrocin can cause side effects, although not everybody gets them.
The most frequent side effects of oral erythromycin are gastrointestinal and dose related. These effects include nausea, vomiting, abdominal pain, diarrhea and anorexia.
Symptoms of hepatitis, liver dysfunction and / or liver function test results may show abnormal values (see Special Warnings section).
Cases of pseudomembranous colitis have rarely been reported in association with erythromycin therapy.
There have been isolated reports of transient central nervous system side effects such as confusion, hallucinations, seizures, dizziness and tinnitus; however, a causal relationship with the intake of this drug has not yet been established.
As with other macrolides, cases of QT interval prolongation, ventricular tachycardia and torsades de pointes have rarely been reported.
Allergic reactions of varying degrees have occurred characterized by the onset of urticaria, mild skin rashes, anaphylaxis. toxic epidermal necrolysis.
Rarely, cases of pancreatitis and convulsions have occurred.
In the course of prolonged or repeated therapies, there is the rare possibility of an overgrowth of non-sensitive bacteria or fungi, if such infections occur, the administration of the drug must be suspended and appropriate therapy must be resorted to.
Cases of reversible deafness have also been reported in patients with reduced renal function and in patients who have received high doses of erythromycin.
There have been cases of interstitial nephritis coinciding with the use of erythromycin.
Finally, the following have occasionally been reported: cardiac arrhythmias, including ventricular tachycardia; effects on the central nervous system (convulsions, hallucinations, dizziness, confusional states).
However, a causal relationship between these events and drug intake has not been demonstrated.
There have been reports of hypertrophic pyloric stenosis in infants who received erythromycin (see Precautions for use section).
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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. Undesirable effects can also be reported directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package. The expiry date indicated refers to the product in intact packaging, correctly stored.
CAUTION: DO NOT USE THE MEDICINAL PRODUCT AFTER THE EXPIRY DATE STATED ON THE PACKAGE. .
ERYTHROCIN 1000 MG GRANULATE FOR ORAL SUSPENSION: store at a temperature not exceeding 25 ° C.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
COMPOSITION
ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION
100 ml of reconstituted suspension contains:
Active principle:
Erythromycin base 10 g (contained as Erythromycin Ethylsuccinate)
Excipients:
Isomalt, sorbitol, carmellose sodium, aluminum and magnesium silicate, sodium citrate, sodium cyclamate, citric acid, polyoxyethylene-polyoxypropylene copolymer, color E-124, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, cream flavor, strawberry flavor.
EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION
100 g of granules contain:
Active principle:
Erythromycin base 10.524 g (contained as Erythromycin Ethylsuccinate)
Excipients:
Isomalt, sorbitol, carmellose sodium, aluminum and magnesium silicate, sodium citrate, sodium cyclamate, citric acid, polyoxyethylene-polyoxypropylene copolymer, color E-124, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, cream flavor, strawberry flavor.
ERYTHROCIN 200 MG CHEWABLE TABLETS
Each tablet contains:
Active principle:
Erythromycin Ethylsuccinate equal to Erythromycin base 200 mg
Excipients:
Mannitol, Anhydrous Sodium Citrate, Sodium Saccharin, Magnesium Stearate, Cherry Essence, Amberlite XE 88
ERYTHROCIN 500 MG GRANULES FOR ORAL SUSPENSION
Each 4.75 g sachet contains:
Active principle:
Erythromycin Ethylsuccinate equal to Erythromycin base 0.5 g
Excipients:
Sucrose, sodium citrate, aluminum and magnesium silicate, sodium saccharin, orange flavor, colloidal silicon dioxide, sodium carboxymethylcellulose, poloxamer 188.
ERYTHROCIN 1000 MG GRANULATE FOR ORAL SUSPENSION
Each 9.5 g sachet contains:
Active principle:
Erythromycin Ethylsuccinate equal to Erythromycin base g 1
Excipients:
Sucrose, sodium citrate, aluminum and magnesium silicate, sodium saccharin, orange flavor, carmellose sodium, colloidal silicon dioxide, polyoxyethylene-polyoxypropylene copolymer.
ERYTHROCIN 600 MG TABLETS COATED WITH FILM
Each coated tablet contains:
Active principle:
Erythromycin Ethylsuccinate equal to Erythromycin base 600 mg
Excipients:
Dibasic calcium phosphate, sodium starch glycolate, corn starch, povidone, magnesium stearate, hypromellose, macrogol 400, macrogol 8000, titanium dioxide, sorbic acid.
ERYTHROCIN 250 MG TABLETS COATED WITH FILM
Each coated tablet contains:
Active principle:
Erythromycin stearate equal to base 0.250 g
Excipients:
Sodium citrate, povidone, corn starch, carmellose sodium, Amberlite IRP-88 resin, cellulose acetophthalate, propylene glycol, polysorbate 80, castor oil, macrogol 6000
PHARMACEUTICAL FORM AND CONTENT:
Granules for oral suspension - 100 ml bottle
Granules for oral suspension - Bottle of 50 g
12 chewable tablets of 200 mg
12 sachets of granules for oral suspension of 500 mg
6 sachets of granules for oral suspension of 1000 mg
12 film-coated tablets of 600 mg
12 film-coated tablets of 250 mg
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
Erythrocin
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
ERYTHROCIN 250 mg FILM COATED TABLETS
Each coated tablet contains:
Active principle:
Erythromycin stearate equal to Erythromycin base 0.250 g.
EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION
100 g of granules contain:
Active principle:
Erythromycin base (as erythromycin ethylsuccinate) 10.524 g.
ERYTHROCIN 200 mg CHEWABLE TABLETS
Each tablet contains:
Active principle:
Erythromycin ethylsuccinate equal to erythromycin base 200 mg.
ERYTHROCIN 600 mg FILM COATED TABLETS
Each coated tablet contains:
Active principle:
Erythromycin ethylsuccinate equal to erythromycin base 600 mg.
ERYTHROCIN 500 MG GRANULES FOR ORAL SUSPENSION
Each 4.75g sachet contains:
Active principle:
Erythromycin ethylsuccinate equal to erythromycin base 0.5 g.
ERYTHROCIN 1000 MG GRANULATE FOR ORAL SUSPENSION
Each 9.5 g sachet contains:
Active principle:
Erythromycin ethylsuccinate equal to erythromycin base 1 g.
ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION
100 ml of reconstituted suspension contains:
Active principle:
Erythromycin ethylsuccinate equal to erythromycin base 10 g.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Granules for oral suspension.
Chewable tablets.
Film-coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Streptococcus pyogenes (beta-haemolytic streptococcus group A): infections of the upper and lower respiratory tract, skin and soft tissues. In the case of oral administration, the importance of precise compliance by the patient with the prescribed dosage regimen should be emphasized. A therapeutic dose must be administered for at least 10 days.
Alpha haemolytic streptococci (viridans group): short-term prophylaxis of bacterial endocarditis before dental or other surgical procedures in patients with a history of rheumatic fever or congenital heart disease.
Staphilococcus aureus: acute infections of the skin and soft tissues. Resistant organisms may appear in the course of treatment.
Diplococcus pneumoniae: Upper respiratory tract infections (eg, otitis media, pharyngitis) and lower respiratory tract infections (eg, pneumonia).
Mycoplasma pneumoniae (Eaton's agent, pleuro-pneumonium-like organisms): in the treatment of atypical primary pneumonia when it is due to this organism.
Treponema pallidum: Erythromycin is an alternative treatment of primary syphilis in patients allergic to penicillins.
Corynebacterium diphteriae and C. minutissimum: as an adjuvant of the antitoxin in order to prevent the creation of carriers and for the elimination of the organism in the carriers themselves. In the treatment of erythrasma.
Listeria monocytogenes: infections caused by this organism.
Bordetella pertussis: erythromycin is effective in eliminating the infecting organism from the nasopharyngeal area. Some studies suggest that the drug may be useful in the prophylaxis of whooping cough in people exposed to this organism.
Legionnaires' disease: several studies have demonstrated the clinical and therapeutic validity of the treatment of this disease with erythromycin.
Chlamydia Trachomatis: erythromycin is indicated in the treatment of infections sustained by this microorganism such as: conjunctivitis in newborns, pneumonia in infancy, uro-genital and endocervical infections in adults.
04.2 Posology and method of administration
The recommended dosage is as follows:
a) INFANTS (2-6 kg): Erythrocin EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION (erythromycin ethylsuccinate): The average recommended dose is 50 mg for each kg of body weight per day in three administrations, or according to the judgment doctor's (5 ml = 200 mg).
The dropper is set at 50 mg (½ dose) and 100 mg (1 dose). (Example: 3 kg = ½ dose, 3 times a day).
b) CHILDREN (6-30 kg): ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION: 50 mg / kg / day in three doses; up to 7.5 kg: 1 small scoop (125 mg) 3 times a day; up to 15 kg: ½ large scoop (250 mg) 3 times a day; up to 30 kg: 1 large scoop (500 mg) 3 times a day.
c) SCHOOL AGE (3-12 YEARS): Erythrocin 200 mg Chewable Tablets (erythromycin ethylsuccinate): 1 chewable tablet every 12 kg of weight 3 times a day (1 tablet = 200 mg); Erythrocin 500 mg Granules for oral suspension ( erythromycin ethylsuccinate): 1 sachet 3 times a day.
d) ADULTS: Erythrocin 600 mg Film-coated tablets (erythromycin ethylsuccinate) 1 tablet 3 times a day (1 tablet = 600 mg); Erythrocin 1000 mg
Granules for oral suspension (erythromycin ethylsuccinate) 1 sachet 2 times a day.
The recommended dosage can be elevated up to 4 g daily or more depending on the judgment of the doctor. It is advisable to avoid the administration of the product during meals or immediately after. Treatment should be continued for more than 48 hours after symptoms disappear and after the temperature has returned to normal. For the treatment of Legionnaires' disease the recommended dose in adults is 1.6 / 4 g per day in divided doses.
Erythrocin 250 mg Film-coated tablets: 1 to 2 tablets every 4-6 hours. Administration should be continued for 48 hours after the patient's temperature has returned to normal.
In the treatment of streptococcal infections, a therapeutic dose of erythromycin should be administered for at least 10 days. In continuous prophylaxis of streptococcal infections in subjects with a history of rheumatic heart disease, the dose is 250 mg twice daily.
Preparation of the suspension in bottle and sachets:
To prepare the Erythrocin suspension, add water to the granules contained in the bottle up to the imprinted mark. Shake well and leave to rest for a few minutes.
Since the preparation of the suspension takes place with a reduction in volume, it is necessary to add more water until the level of the suspension is brought back to the mark. The suspension thus prepared must be kept in the fridge and used within 10 days.
To prepare the suspension in sachets at the time of administration pour the contents into a glass of water. Shake until a homogeneous suspension is obtained.
04.3 Contraindications
Erythromycin is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Erythromycin is contraindicated in patients treated with terfenadine, astemizole, cisapride, pimozide and ergotamine or dihydroergotamine (see sections 4.4 and 4.5).
04.4 Special warnings and appropriate precautions for use
As erythromycin is metabolized and excreted mainly in the liver, particular caution should be exercised when administering the drug to patients with impaired hepatic function, in subjects with moderate or severe renal impairment and in the elderly (over 65 years).
Elderly patients, especially with hepatic or renal dysfunction, have an increased risk of hearing loss associated with erythromycin.
In pregnant women, and in very early childhood, the product should be administered in cases of real need, under the direct supervision of the doctor.
The administration of erythromycin, especially if in the form of estolate (lauryl sulfate propionate), at high doses for periods of time longer than two weeks, can cause disturbances in liver function which must therefore be monitored, discontinuing the treatment in case of abnormal reactions.
Undesirable effects due to the use of erythromycin, such as urticaria or other allergic-type reactions, have rarely been observed.
If signs of hypersensitivity appear, administration should be discontinued and adrenaline or steroids used.
Cases of infantile hypertrophic pyloric stenosis have been reported in children receiving erythromycin therapy. In particular, non-biliary vomiting was found in infants who had taken erythromycin for pertussis prophylaxis; they were subsequently diagnosed with pyloric stenosis which necessitated surgical pyloromyotomy. Given that erythromycin is used in children for the treatment of conditions associated with significant mortality or morbidity such as pertussis or neonatal Chlamydia trachomatis infections, the benefit of erythromycin therapy must be carefully weighed against the potential risk of developing hypertrophic stenosis. of the pylorus.
Parents should be informed so that they report to the doctor any episodes of vomiting or difficulties in breastfeeding the infant.
Following the administration of Erythromycin, the onset of hepatic dysfunction, elevated liver enzymes and hepatocellular and / or colostatic hepatitis, with or without jaundice, has been reported in rare cases. The patient should be advised to discontinue treatment and contact your doctor if you have signs and symptoms of liver disease, such as anorexia, jaundice, dark urine, itching or abdominal pain.
Pseudomembranous colitis ranging in severity from mild to life-threatening has been reported with nearly all antibacterials, including macrolides.
Some reports suggest that Erythromycin is unable to reach the fetus at adequate concentrations to prevent congenital syphilis. Infants of mothers treated during pregnancy with erythromycin administered orally for the purpose of treating early syphilis should be treated with recurrent to an adequate penicillin-based therapeutic regimen.
There have been reports of QT interval prolongation, including rare cases of arrhythmia and torsade de pointes, including fatal ones, in patients receiving erythromycin. Due to the risk of QT interval prolongation, erythromycin should be used with caution. in patients with coronary artery disease, severe heart failure, hypomagnesaemia, bradycardia (
Erythromycin should not be used in patients with congenital or acquired QT interval prolongation documented and with regressed ventricular arrhythmia.
Elderly patients have an increased risk of QT interval prolongation and torsades de pointes.
There have been reports of rhabdomyolysis with or without renal impairment in severely ill patients receiving Erythromycin therapy administered concomitantly with HMGCoA reductase inhibitors (statins).
Prolonged or repeated use of erythromycin may lead to an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, administration of erythromycin should be stopped immediately and appropriate therapy instituted.
If necessary, incisions and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.
Cases have been reported in which the intake of Erythromycin could aggravate the weakened state of patients presenting with myasthenia gravis.
Erythromycin interferes with the fluorometric determinations of urinary catecholamines.
Excipients warnings:
• EARLY CHILDHOOD 0.1% ORAL SUSPENSION GRANULES and 10% ORAL SUSPENSION GRANULES contain monomethyl parahydroxybenzoate sodium and sodium propyl parahydroxybenzoate which can cause allergic reactions and sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine .
• 500 MG GRANULATE FOR ORAL SUSPENSION - 1000 MG GRANULATE FOR ORAL SUSPENSION contains Sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase insufficiency should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
In case of administration of erythromycin associated with theophylline, serum increases of the latter may occur with a consequent increase in toxic effects. In this case it is necessary to reduce the quantity of theophylline administered.
Triazolobenzodiazepines (such as triazolam and "alzoprazolam) and related benzodiazepines: Erythromycin has been reported to decrease the clearance of triazolam, midazolam and related benzodiazepines and consequently may cause the increased pharmacological effect of these benzodiazepines.
Erythromycin potentiates the effect of digoxin when administered concurrently, therefore plasma digoxin concentrations should be closely monitored while patients are receiving concomitant digoxin and erythromycin therapy.
Erythromycin potentiates the effect of oral anticoagulants (eg Warfarin) when administered simultaneously, with risk of bleeding and an increase in the international normalized ratio (INR). The INR and prothrombin time should be frequently monitored in those patients who are treated concurrently. with erythromycin and anticoagulant agents.
Erythromycin, like other macrolides, should be used with caution in patients taking medications known to prolong the QT interval (eg Class IA and III antiarrhythmics, tricyclic antidepressants, fluoroquinolones, antipsychotics) (see section 4.4).
The use of erythromycin in patients concomitantly taking drugs metabolised by cytochrome P450 may be associated with increased serum levels of these drugs.
Interactions of erythromycin with Carbamazepine, Ciclosporin, Esobarbital, Phenytoin, Alfentanil, Disopyramide, Bromocriptine, Valproate, Tacrolimus, Quinidine, Methylprednisolone, Cilostazol, Vinblastine, Sildenafil, Terfenadine, Astemizol have been reported. Serum concentrations of drugs metabolised by cytochrome P450 should be monitored when taken concomitantly with Erythromycin.
Since macrolides significantly alter the metabolism of Terfenadine, the concomitant administration of Erythromycin and Terfenadine is not recommended as well as the concomitance of Erythromycin and Lovastatin.
HMG-CoA reductase inhibitors: Erythromycin has been reported to increase the concentrations of HMG-CoA reductase inhibitors (eg lovastatin and simvastatin).
Cases of rhabdomyolysis have rarely occurred in patients taking these drugs simultaneously.
Concomitant use of erythromycin and colchicine has reported post-marketing cases of colchicine toxicity.
Erythromycin significantly alters the metabolism of terfenadine and astemizole when administered concomitantly. Cases of severe cardiovascular episodes including death, cardiac arrest, torsades de pointes and other ventricular arrhythmias have rarely been observed (see sections 4.3 and 4.8).
Elevated cisapride levels have been reported in patients treated with erythromycin and cisapride concomitantly. This can lead to QT interval prolongation and cardiac arrhythmias such as ventricular tachycardia, ventricular fibrillation and torsades de pointes. Similar effects have been seen in patients taking pimozide and clarithromycin, another macrolide antibiotic.
Post-marketing cases indicate that co-administration of erythromycin with ergotamine or dihydroergotamine has been associated with acute ergotamine toxicity characterized by vasospasm and ischaemia of the extremities (see section 4.3).
Erythromycin has been reported to decrease the clearance of zopiclone and consequently may cause an increase in the pharmacodynamic effect of this drug.
04.6 Pregnancy and lactation
There are no adequate and well controlled studies conducted in pregnant women.
However, observational studies in humans have reported the occurrence of cardiovascular malformations after exposure to erythromycin-containing medicinal products during the early months of pregnancy (see section 5.3). The safety of erythromycin during pregnancy or breastfeeding has not been established.
Erythromycin should only be taken by pregnant women if it has been established that it is necessary. Erythromycin crosses the placental barrier but plasma levels of erythromycin in the fetus were generally low and its presence in breast milk is also known.
04.7 Effects on ability to drive and use machines
No effects of drowsiness or reduced ability to use machines have been reported.
04.8 Undesirable effects
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose
Undesirable effects involving the gastrointestinal tract have occurred. They are characterized by epigastric pain, nausea and mild diarrhea. These disturbances become frequent when doses of 8 to 12 grams are used for several days. These pains disappear with the cessation of administration of the antibiotic.
The appearance of colostatic jaundice is known in the literature, which occurs only in subjects treated with erythromycin estolate.
In the event of an overdose, erythromycin administration should be discontinued.
Overdose should be managed through prompt elimination of unabsorbed drug and other appropriate measures.
Erythromycin is not eliminated by peritoneal dialysis or hemodialysis.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: macrolide antibiotic.
ATC code: J01FA01.
Erythromycin is produced from a strain of Streptomyces erythreus and belongs to the macrolide group of antibiotics.
Erythromycin acts by inhibiting protein synthesis by binding to the 50S ribosomal subunit without affecting nucleic acid synthesis.
05.2 Pharmacokinetic properties
Orally administered erythromycin is rapidly absorbed by the majority of patients, especially on an empty stomach, but variations are observed between patient and patient.
After absorption, erythromycin rapidly diffuses into most body fluids. In the absence of meningeal inflammation, low concentrations are usually reached in the spinal fluid, but passage through the blood-brain barrier increases in meningitis.
In the presence of normal hepatic function, erythromycin concentrates in the liver and is excreted in the bile. After oral administration, less than 5% of the activity of the administered dose can be found in the urine.
Erythromycin crosses the placental barrier, but fetal plasma rates are generally low.
The drug easily spreads to the liver, spleen, lung and muscles where it is found in amounts greater than blood.
Urinary elimination is poor.
Erythromycin is found in the faeces where it can be present in the quantity of 0.5 mg / g.
The oral dose of 2000 mg / kg does not cause mortality.
The tolerability found in man is very high.
Serum erythromycin levels are not related to meals. Erythromycin is distributed in most organic fluids.
05.3 Preclinical safety data
The LD50 of subcutaneous erythromycin is about 1800 mg / kg in mice.
The administration for 3-6 months of doses between 40 mg / kg and 220 mg / kg in dogs does not alter weight gain, nor does it cause haematological alterations or abnormalities of liver or kidney function.
Carcinogenesis, Mutagenesis, Impaired Fertility:
Long-term (two-year duration) studies conducted with oral erythromycin stearate in rats up to doses of approximately 400 mg / kg / day and in mice up to doses of approximately 500 mg / kg / day provided no evidence. of carcinogenesis. The mutagenicity studies conducted did not reveal the presence of any genotoxic potential and no manifest effects on male or female fertility were observed in rats treated with erythromycin base administered by force feeding at a dose of 700 mg / kg / day.
Pregnancy:
No teratogenic effects were observed or other adverse reproductive effects were reported in female rats who received force-fed erythromycin base dose of 350 mg / kg / day (7 times the human dose) over the period prior to mating, during mating, during gestation and during weaning.
No teratogenic or embryotoxic effects were observed when erythromycin base was force-fed to pregnant rats and female mice at a dose of 700 mg / kg / day (14 times the human dose) and female rabbits. in gestation at a dose equal to 125 mg / kg / day (2.5 times higher than the dose administered to man). A slight weight loss of pups was noted at birth when female rats were treated in the pre-mating period, during mating, during gestation and during lactation with a high oral dose of erythromycin base equal. to 700 mg / kg / day; the weight of each pup was comparable to that of the control group for weaning. With this dosage, no teratogenic effects or reproductive effects were observed. When administered during the last months of gestation and during the lactation phase, this dosage of 700 mg / kg / day (14 times higher than the dose administered to humans) had no negative effect on the weight of the young at birth. , on their growth and survival.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
ERYTHROCIN 250 mg FILM COATED TABLETS
Sodium citrate, povidone, corn starch, carmellose sodium, Amberlite IRP-88 resin, cellulose acetophthalate, propylene glycol, polysorbate 80, castor oil, macrogol 6000
EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION
Isomalt, sorbitol, carmellose sodium, aluminum and magnesium silicate, sodium citrate, sodium cyclamate, citric acid, polyoxyethylene-polyoxypropylene copolymer, color E-124, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, cream flavor, strawberry flavor.
ERYTHROCIN 200 mg CHEWABLE TABLETS
Mannitol, anhydrous sodium citrate, sodium saccharin, magnesium stearate, cherry essence, amberlite XE 88
ERYTHROCIN 600 mg FILM COATED TABLETS
Dibasic calcium phosphate, sodium starch glycolate, corn starch, povidone, magnesium stearate, hypromellose, macrogol 400, macrogol 8000, titanium dioxide, sorbic acid.
ERYTHROCIN 500 MG GRANULES FOR ORAL SUSPENSION
Sucrose, sodium citrate, aluminum magnesium silicate, sodium saccharin, artificial cherry flavor, sodium lauryl sulfate, colloidal silicon dioxide.
ERYTHROCIN 1000 MG GRANULATE FOR ORAL SUSPENSION
Sucrose, sodium citrate, aluminum and magnesium silicate, sodium saccharin, orange flavor, carmellose sodium, colloidal silicon dioxide, polyoxyethylene polyoxypropylene copolymer
ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION
Isomalt, sorbitol, carmellose sodium, aluminum and magnesium silicate, sodium citrate, sodium cyclamate, citric acid, polyoxyethylene-polyoxypropylene copolymer, color E-124, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, cream flavor, strawberry flavor.
06.2 Incompatibility
No incompatibility effects of erythromycin with other drugs have been reported.
06.3 Period of validity
When the packaging is intact, the stability is as follows:
- EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION,
- ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION: 3 years.
- ERITROCIN 200 mg CHEWABLE TABLETS, ERITROCIN 600 mg.
- ERYTHROCIN 250 mg FILM-COATED TABLETS: 3 years.
- ERYTHROCIN 500 MG GRANULATE FOR ORAL SUSPENSION, ERYTHROCIN 1000 MG GRANULATE FOR ORAL SUSPENSION: 2 years.
Once the solution has been reconstituted, the oral granulated Erythrocin should be kept in the refrigerator and used within 10 days.
06.4 Special precautions for storage
All Erythrocin are stable, unopened and at room temperature.
ERYTHROCIN 1000 MG GRANULATE FOR ORAL SUSPENSION: Do not store above 25 ° C
06.5 Nature of the immediate packaging and contents of the package
EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION, 50 g bottle
ERYTHROCIN 500 MG GRANULES FOR ORAL SUSPENSION, 12 sachets 0.5 g
ERYTHROCIN 1000 MG GRANULES FOR ORAL SUSPENSION, 6 sachets 1 g
ERYTHROCIN 600 mg FILM-COATED TABLETS, blister of 12 tablets
ERYTHROCIN 200 mg CHEWABLE TABLETS blister of 12 tablets
ERITROCIN 10% GRANULATE FOR ORAL SUSPENSION, 100 ml bottle
Erythrocin 250 mg film-coated tablets blister of 12 tablets
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Amdipharm Limited 3 Burlington Road - Dublin 4 Temple Chambers - Ireland
08.0 MARKETING AUTHORIZATION NUMBER
ERYTHROCIN 250 MG TABLETS COATED WITH FILM 007893047
EARLY CHILDHOOD EYTHROCIN 0.1% GRANULATE FOR ORAL SUSPENSION 007893124
ERYTHROCIN 200 mg CHEWABLE TABLETS 007893151
ERYTHROCIN 600 mg TABLETS COATED WITH FILM 007893199
ERYTHROCIN 500 MG GRANULES FOR ORAL SUSPENSION 007893163
ERYTHROCIN 1000 MG GRANULES FOR ORAL SUSPENSION 007893175
ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION 007893187
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
ERYTHROCIN 250 MG TABLETS COATED WITH FILM 07/11/1956
EARLY CHILDHOOD 0.1% GRANULATE FOR ORAL SUSPENSION 17/02/1969
ERYTHROCIN 200 mg CHEWABLE TABLETS 04/19/1972
ERYTHROCIN 600 mg FILM COATED TABLETS 07/22/1989
ERYTHROCIN 500 MG GRANULES FOR ORAL SUSPENSION 04/30/1982
ERYTHROCIN 1000 MG GRANULES FOR ORAL SUSPENSION 04/30/1982
ERYTHROCIN 10% GRANULATE FOR ORAL SUSPENSION 17/12/1987
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