ERYTHROMYCIN 250MG TABLETS
Active substance: ERYTHROMYCIN
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
RETCIN / Erythromycin 250 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin Ph. Eur. 274.00 mg
3
PHARMACEUTICAL FORM
Enteric-coated tablet
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the prophylaxis and treatment of infections caused by Erythromycinsensitive organisms. 1. Upper and lower respiratory tract infections. 2. Soft tissue and skin infections. 3. Bone infections. 4. Oral and dental infection. 5. Gastro-intestinal infections. 6. Eye infections. 7. Sexually transmitted diseases. 8. Prophylaxis. 9. Microbiological indications. Erythromycin is active against staphylococci, streptococci, haemophilus influenzae, L-forms, mycoplasma pneumoniae, legionella pneumophila, branhamella catarrhalis, bordetella pertussis, corynebacterium diphtheriae, neisseria, treponema pallidum, chlamydia trachomatis, clostridia, ureaplasma urealytica, campylobacter. In the case of corynebacterium diphtheriae should be used as an adjunct to antitoxin.
4.2
Posology and method of administration Adults and children over 8 years: 1-2 g daily in divided doses for mild to moderate infection. This dosage may be increased to 4 g daily in divided doses. Tablets should be taken before or with meals. Elderly: No special dosage recommendations. Period of dosing with regard to indications: Upper respiratory tract infections: 5 to 10 days Lower respiratory tract infections: 7 to 14 days or until the signs and symptoms indicate that the condition is cured. Legionnaire's Disease requires prolonged treatment. It is recommended that initially Erythromycin lactobionate intravenously should be administered. Skin and soft tissue infections: 5 to 10 days. Acne may require prolonged treatment. Sexually transmitted diseases - NGU and syphilis: 10 to 21 days. Some conditions may require prolonged treatment. Oral and dental infections: at least 5 days. Eye infections - Chlamydia inclusion conjunctivitis: 3 weeks. Gastro-intestinal infections - Campylobacter: a minimum of 5 days. RETCIN is taken by mouth.
4.3
Contraindications RETCIN is contraindicated in patients sensitive to Erythromycin. Use of RETCIN in conjunction with other anti-infection agents except when especially warranted. Erythromycin is contraindicated with either Astemizole or Terfenadine and is also contra-indicated with ergotamine and di-hydroergotamine.
4.4
Special warnings and precautions for use Caution should be exercised when administering RETCIN to patients with impaired hepatic function as the drug is principally excreted by the liver. Super infection caused by non-susceptible bacteria or fungi may occur during prolonged or repeated therapy and this is more likely when other anti-bacterial agents are simultaneously employed. Hepatic dysfunction including increased liver enzymes and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin. Renal impairment. Prolongation of QT interval (ventricular tachycardia reported). Porphyria. RETCIN contains lactose and is unsuitable for people with lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome. The product also contains ponceau 4R (E124) which may cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
4.5
Interaction with other medicinal products and other forms of interaction Concomitant use of Erythromycin with terfenadine or astemizole is likely to result in an enhanced risk of cardiotoxicity with these drugs. The concomitant use of Erythromycin with either astemizole or terfenadine is therefore contraindicated. There is also an increased risk of ventricular arrhythmias when erythromycin is given with cisapride, pimozide or sertindole. Concomitant use should be avoided. Note, there is a similar risk with amiodarone, amisulpride, moxifloxacin or quinidine when given with parenteral erythromycin. Concurrent use of erythromycin with ergotamine or di-hydroergotamine has been associated in some patients with acute ergotoxicity with the rapid development of severe peripheral vasospasm and dysethesia. The anticoagulant effect of coumarins may be increased by erythromycin. With the following drugs an increase in serum concentration and/or inhibition of their metabolism may occur when they are administered concurrently with erythromycin: acenocoumarol, alfentanil, astemizole, bromocriptine, buspirone, carbamazepine, cabergoline, ciclosporin, corticosteroids, digoxin, disopyramide, eletriptan, eplerenone, galantamine, immuno-suppressants (e.g. sirolimus, tacrolimus), methylprednisolone, midazolam, phenytoin, sildenafil, terfenadine, triazolam, valproate, vardenafil, warfarin, zopiclone and possibly clozapine, felodipine, rifabutin, tadalafil and loratidine. Also avoid concomitant use of mizolastine and cilostazol. Monitoring should be undertaken and dosage adjusted accordingly.
Plasma concentration of erythromycin may be increased by ritonavir and amprenavir. Cimetidine increases plasma-erythromycin concentration and increases risk of toxicity including deafness. Erythromycin increases the toxicity of vinblastine therefore avoid concomitant use. Concurrent administration of Theophylline with oral erythromycin produces a significant decrease in erythromycin serum concentration, which could result in sub-therapeutic concentrations of erythromycin. Plasma concentration of rosuvastatin and zafirlukast is reduced by erythromycin. Increased risk of myopathy with simvastatin and possibly atorvastatin, therefore avoid concomitant use. Avoid concomitant use with lercanidipine, reboxitine and tolterodine.
4.6
Pregnancy and lactation There is no evidence of risk from erythromycin in human pregnancy. It has been in wide use for many years without apparent ill consequence. Animal studies have reported no risk. Erythromycin is excreted in breast milk, therefore caution should be exercised when erythromycin is administered to a breast-feeding patient.
4.7
Effects on ability to drive and use machines Not applicable
4.8
Undesirable effects Allergic reactions are rare and mild but anaphylaxis has occurred. Skin reactions ranging from mild eruptions to erythema multiforme, StevensJohnson Syndrome and toxic epidermal necrolysis have rarely been reported. Occasionally nausea, abdominal discomfort and vomiting which subside after a few days without having to discontinue treatment. As with other broad spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin. Reversible hearing loss associated with doses of erythromycin usually greater then 4 g per day has been reported.
Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. Cardiac effects including chest pain and arrhythmias) and myasthenia-like synndrome have also been reported.
4.9
Overdose Gastric lavage and supportive measures.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties The action of Erythromycin is bacteriostatic or bactericidal, depending on the organism and the concentration achieved. The effects of Erythromycin in combination with other antibiotics are unpredictable. The synthesis of penicillinase is variably affected, resulting in synergy where antagonism with susceptible beta-lactams. The listericidal effects of penicillins, rifampicin and gentamycin are antagonised. Erythromycin is synergistic with sulphonamides against H.influenzae.
5.2
Pharmacokinetic properties Erythromycin binding to plasma is 73% for the base. The drug is distributed within an apparent volume of 0.75 l./kg. and eliminated with a half-time of 1 to 1.5 hours. Erythromycin is inactivated by N-demethylation in the liver, but the concentration of active drug in the bile is high and there is evidence of entero-hepatic circulation. The drug passes the placental barrier to reach concentrations in foetal plasma of 5-20% of those in the maternal circulation. Erythromycin is distributed to most sites, except brain and CSF. Erythromycin base is concentrated within alvolar macrophages by active transport to a concentration of 20-30 times that in the plasma. The drug is also concentrated in polymorphonuclear leucocytes. Erythromycin is inactivated by N-demethylation in the liver. From 5 to 10% of the dose is excreted unchanged in the urine.
5.3
Preclinical safety data Not applicable
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Lactose Maize starch Potato starch Sodium starch glycollate Magnesium stearate Cellacephate Diethylphthalate Aluminium lake E124, approx. 20% dye content Carnauba wax Beeswax
6.2
Incompatibilities None known
6.3
Shelf life 36 months
6.4
Special precautions for storage Keep container tightly closed. Protect from light. Store below 25C in a dry place.
6.5
Nature and contents of container High density polystyrene or polypropylene containers with polythene or polypropylene lids and polyurethane/polythene inserts Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000.
6.6
Special precautions for disposal Not applicable.
7
MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street, 3rd floor, 1060 Nicosia Cyprus
8
MARKETING AUTHORISATION NUMBER(S)
PL 33414/0045
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/03/2006
10
DATE OF REVISION OF THE TEXT
18/02/2009
1
NAME OF THE MEDICINAL PRODUCT
RETCIN / Erythromycin 250 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin Ph. Eur. 274.00 mg
3
PHARMACEUTICAL FORM
Enteric-coated tablet
4
4.1
CLINICAL PARTICULARS
Therapeutic indications For the prophylaxis and treatment of infections caused by Erythromycinsensitive organisms. 1. Upper and lower respiratory tract infections. 2. Soft tissue and skin infections. 3. Bone infections. 4. Oral and dental infection. 5. Gastro-intestinal infections. 6. Eye infections. 7. Sexually transmitted diseases. 8. Prophylaxis. 9. Microbiological indications. Erythromycin is active against staphylococci, streptococci, haemophilus influenzae, L-forms, mycoplasma pneumoniae, legionella pneumophila, branhamella catarrhalis, bordetella pertussis, corynebacterium diphtheriae, neisseria, treponema pallidum, chlamydia trachomatis, clostridia, ureaplasma urealytica, campylobacter. In the case of corynebacterium diphtheriae should be used as an adjunct to antitoxin.
4.2
Posology and method of administration Adults and children over 8 years: 1-2 g daily in divided doses for mild to moderate infection. This dosage may be increased to 4 g daily in divided doses. Tablets should be taken before or with meals. Elderly: No special dosage recommendations. Period of dosing with regard to indications: Upper respiratory tract infections: 5 to 10 days Lower respiratory tract infections: 7 to 14 days or until the signs and symptoms indicate that the condition is cured. Legionnaire's Disease requires prolonged treatment. It is recommended that initially Erythromycin lactobionate intravenously should be administered. Skin and soft tissue infections: 5 to 10 days. Acne may require prolonged treatment. Sexually transmitted diseases - NGU and syphilis: 10 to 21 days. Some conditions may require prolonged treatment. Oral and dental infections: at least 5 days. Eye infections - Chlamydia inclusion conjunctivitis: 3 weeks. Gastro-intestinal infections - Campylobacter: a minimum of 5 days. RETCIN is taken by mouth.
4.3
Contraindications RETCIN is contraindicated in patients sensitive to Erythromycin. Use of RETCIN in conjunction with other anti-infection agents except when especially warranted. Erythromycin is contraindicated with either Astemizole or Terfenadine and is also contra-indicated with ergotamine and di-hydroergotamine.
4.4
Special warnings and precautions for use Caution should be exercised when administering RETCIN to patients with impaired hepatic function as the drug is principally excreted by the liver. Super infection caused by non-susceptible bacteria or fungi may occur during prolonged or repeated therapy and this is more likely when other anti-bacterial agents are simultaneously employed. Hepatic dysfunction including increased liver enzymes and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin. Renal impairment. Prolongation of QT interval (ventricular tachycardia reported). Porphyria. RETCIN contains lactose and is unsuitable for people with lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome. The product also contains ponceau 4R (E124) which may cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
4.5
Interaction with other medicinal products and other forms of interaction Concomitant use of Erythromycin with terfenadine or astemizole is likely to result in an enhanced risk of cardiotoxicity with these drugs. The concomitant use of Erythromycin with either astemizole or terfenadine is therefore contraindicated. There is also an increased risk of ventricular arrhythmias when erythromycin is given with cisapride, pimozide or sertindole. Concomitant use should be avoided. Note, there is a similar risk with amiodarone, amisulpride, moxifloxacin or quinidine when given with parenteral erythromycin. Concurrent use of erythromycin with ergotamine or di-hydroergotamine has been associated in some patients with acute ergotoxicity with the rapid development of severe peripheral vasospasm and dysethesia. The anticoagulant effect of coumarins may be increased by erythromycin. With the following drugs an increase in serum concentration and/or inhibition of their metabolism may occur when they are administered concurrently with erythromycin: acenocoumarol, alfentanil, astemizole, bromocriptine, buspirone, carbamazepine, cabergoline, ciclosporin, corticosteroids, digoxin, disopyramide, eletriptan, eplerenone, galantamine, immuno-suppressants (e.g. sirolimus, tacrolimus), methylprednisolone, midazolam, phenytoin, sildenafil, terfenadine, triazolam, valproate, vardenafil, warfarin, zopiclone and possibly clozapine, felodipine, rifabutin, tadalafil and loratidine. Also avoid concomitant use of mizolastine and cilostazol. Monitoring should be undertaken and dosage adjusted accordingly.
Plasma concentration of erythromycin may be increased by ritonavir and amprenavir. Cimetidine increases plasma-erythromycin concentration and increases risk of toxicity including deafness. Erythromycin increases the toxicity of vinblastine therefore avoid concomitant use. Concurrent administration of Theophylline with oral erythromycin produces a significant decrease in erythromycin serum concentration, which could result in sub-therapeutic concentrations of erythromycin. Plasma concentration of rosuvastatin and zafirlukast is reduced by erythromycin. Increased risk of myopathy with simvastatin and possibly atorvastatin, therefore avoid concomitant use. Avoid concomitant use with lercanidipine, reboxitine and tolterodine.
4.6
Pregnancy and lactation There is no evidence of risk from erythromycin in human pregnancy. It has been in wide use for many years without apparent ill consequence. Animal studies have reported no risk. Erythromycin is excreted in breast milk, therefore caution should be exercised when erythromycin is administered to a breast-feeding patient.
4.7
Effects on ability to drive and use machines Not applicable
4.8
Undesirable effects Allergic reactions are rare and mild but anaphylaxis has occurred. Skin reactions ranging from mild eruptions to erythema multiforme, StevensJohnson Syndrome and toxic epidermal necrolysis have rarely been reported. Occasionally nausea, abdominal discomfort and vomiting which subside after a few days without having to discontinue treatment. As with other broad spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin. Reversible hearing loss associated with doses of erythromycin usually greater then 4 g per day has been reported.
Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. Cardiac effects including chest pain and arrhythmias) and myasthenia-like synndrome have also been reported.
4.9
Overdose Gastric lavage and supportive measures.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties The action of Erythromycin is bacteriostatic or bactericidal, depending on the organism and the concentration achieved. The effects of Erythromycin in combination with other antibiotics are unpredictable. The synthesis of penicillinase is variably affected, resulting in synergy where antagonism with susceptible beta-lactams. The listericidal effects of penicillins, rifampicin and gentamycin are antagonised. Erythromycin is synergistic with sulphonamides against H.influenzae.
5.2
Pharmacokinetic properties Erythromycin binding to plasma is 73% for the base. The drug is distributed within an apparent volume of 0.75 l./kg. and eliminated with a half-time of 1 to 1.5 hours. Erythromycin is inactivated by N-demethylation in the liver, but the concentration of active drug in the bile is high and there is evidence of entero-hepatic circulation. The drug passes the placental barrier to reach concentrations in foetal plasma of 5-20% of those in the maternal circulation. Erythromycin is distributed to most sites, except brain and CSF. Erythromycin base is concentrated within alvolar macrophages by active transport to a concentration of 20-30 times that in the plasma. The drug is also concentrated in polymorphonuclear leucocytes. Erythromycin is inactivated by N-demethylation in the liver. From 5 to 10% of the dose is excreted unchanged in the urine.
5.3
Preclinical safety data Not applicable
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Lactose Maize starch Potato starch Sodium starch glycollate Magnesium stearate Cellacephate Diethylphthalate Aluminium lake E124, approx. 20% dye content Carnauba wax Beeswax
6.2
Incompatibilities None known
6.3
Shelf life 36 months
6.4
Special precautions for storage Keep container tightly closed. Protect from light. Store below 25C in a dry place.
6.5
Nature and contents of container High density polystyrene or polypropylene containers with polythene or polypropylene lids and polyurethane/polythene inserts Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000.
6.6
Special precautions for disposal Not applicable.
7
MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street, 3rd floor, 1060 Nicosia Cyprus
8
MARKETING AUTHORISATION NUMBER(S)
PL 33414/0045
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/03/2006
10
DATE OF REVISION OF THE TEXT
18/02/2009
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
