Erythromycin Tablets Bp 250mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Erythromycin Tablets BP 250 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin BP 250 mg.
3. PHARMACEUTICAL FORM
Reddish, orange coloured, opaque enteric coated round tablets with no markings on either side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Antibiotic, highly effective in the treatment of a great variety of clinical infections such as.
Upper respiratory tract infections: Laryngitis, pharyngitis, sinusitis, secondary infections in colds and influenza, tonsilitis, peritonsillar abcess.
Lower respiratory tract infections: Acute and chronic bronchitis, tracheitis, pneumonia, bronchiectasis, legionnaires disease.
Eye Infections: Blepharitis.
Ear Infections: Otitis media and otitis externa, mastoiditis.
Oral Infections: Gingivitis, Vincents’ angina.
Skin and soft-tissue infections: Boils and carbuncles, abcesses, pustular acne, paronychia, impetigo, cellulitis, erysipelas.
Gastro-intestinal infections: Staphylococcal enterocolitis, cholecystitis.
Other Infections: Gonorrhoea, syphilis, urethritis, osteomyelitis, lymphogranuloma venereum, diptheria, prostatitis, scarlet fever.
Prophylaxis: Pre- and post-operative burns, trauma, rheumatic fever.
4.2. Posology and method of administration
For oral administration Adults and Children over 8 years
For mild to moderate infections 250 mg - 500 mg every 6 hours. This may be increased to 4g or more per day according to the severity of the infection. Children aged 2 to 8 years
For mild to moderate infections 250 mg every 6 hours. This dose may be doubled for more severe infections.
Infants and babies up to 2 years
Erythromycin tablets are not an appropriate preparation for use in this patient group, therefore use of Erythromycin ethyl succinate granules for oral suspension is recommended.
If administration on a twice daily schedule is desirable in adults or children, one-half of the total daily dose may be given every 12 hours, one hour before meals.
Elderly
No special dosage recommendations.
4.3. Contra-Indications
Known hypersensitivity to erythromycin or to any of the excipients. Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide, mizolastine, ergotamine, dihydroergotamine, cisapride or cilostazol.
4.4 Special warnings and precautions for use
Erythromycin is excreted principally by the liver, so caution should be exercised in administering the antibiotic to patients with impaired hepatic function or concomitantly receiving potentially hepatotoxic agents.
Hepatic dysfunction including increased liver enzymes and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with erythromycin.
There have been reports suggesting erythromycin does not reach the foetus in adequate concentrations to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.
There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.
Erythromycin interferes with the fluorometric determination of urinary catecholamines.
As with other broad spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin (see section 4.8).
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin (see section 4.5).
Colchicine toxicity has been reported in patients receiving erythromycin concomitantly with colchicine.
There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious, vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or chlamydia), the benefit of erythromycin therapy needs to be carefully considered against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability occur.
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant use of erythromycin with terfenadine, astemizole, mizolastine or pimozide is likely to result in an enhanced risk of cardiotoxicity and therefore concomitant use of erythromycin with any of these drugs is contraindicated. (There is a possible risk of arrythmias if erythromycin is given with pimozide). The metabolism of terfenadine and astemizole is significantly altered when either are taken concomitantly with erythromycin. Rare cases of serious cardiovascular events have been observed, including torsades de pointes, other ventricular arrhythmias and cardiac arrest. Death has been reported with the terfenadine / erythromycin combination.
Elevated cisapride levels have been reported in patients receiving erythromycin and cisapride concomitantly. This may result in QT prolongation and cardiac arrythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes. Concomitant use is therefore contraindicated. Similar effects have been observed with the concomitant administration of pimozide and clarithromycin, another macrolide antibiotic
Concurrent use of erythromycin and ergotamine or dihydroergotamine is contraindicated, as it has been associated in some patients with acute ergot toxicity characterised by the rapid development of severe peripheral vasospasm and dysaesthesia.
When oral erythromycin is given concurrently with theophylline, there is also a significant decrease in erythromycin serum concentrations. The decrease could result in subtherapeutic concentrations of erythromycin
Erythromycin and other macrolides have the potential to interact with a large number of drugs through their action on hepatic cytochrome P450 isoenzymes, particularly CYP1A2 and CYP3A4. Macrolides inhibit drug metabolism by microsomal cytochromes by competitive inhibition and by the formation of inactive complexes. Increases in serum concentrations of the following drugs metabolised by the cytochrome P450 may therefore occur when administered concurrently with erythromycin: acenocoumarol, alfentanil, astemizole, bromocriptine, carbamazepine, cabergoline, cilostazol, clozapine (possible increased risk of convulsions), cyclosporin, digoxin, dihydroergotamine, disopyramide, eletriptan, ergotamine, felodipine, lisuride, loratidine, methylprednisolone (and possibly other corticosteroids), midazolam, phenytoin, quinidine, rifabutin (risk of uveitis - reduce rifabutin dose), sildenafil (reduce initial dose of sildenafil), tacrolimus, terfenadine, theophylline, tolterodine (avoid concomitant use), valproate, vinblastine, warfarin and zopiclone. Appropriate monitoring should be undertaken and dosage should be adjusted as necessary.
Ritonavir may increase the plasma concentration of some macrolides. Concomitant administration of amprenavir and erythromycin may increase the plasma concentration of both drugs. Cimetidine increases the plasma erythromycin concentration leading to increased risk of toxicity, including deafness.
HMG-CoA Reductase Inhibitors: Erythromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g. lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly (see section 4.4). Concomitant use of simvastatin and erythromycin has been reported to be associated with an increased risk of cataract development.
Triazolobenzodiazepines (such as alprazolam) and related benzodiazepines: Erythromycin has been reported to decrease the clearance of midazolam, and zopiclone and thus may increase the pharmacologic effect of these benzodiazepines.
Concomitant use of reboxetine and artemether with lumefrantine is not recommended.
In vitro studies suggest there is a possible interaction between erythromycin and docetaxel. The plasma concentration of zafirlukast is reduced by erythromycin.
4.6. Pregnancy and lactation
Like all drugs erythromycin should be used in pregnancy only when clearly indicated as erythromycin crosses the placental barrier
Erythromycin is readily excreted in breast milk; therefore caution should be exercised when erythromycin is administered to a nursing mother
4.7. Effects on ability to drive and use machines
No effect.
4.8 Undesirable effects
The most frequent side-effects of erythromycin are gastro-intestinal and are dose-related. Nausea, vomiting and diarrhoea often occur infrequently with usual doses. The rare possibility of superi nfection caused by overgrowth of non-susceptible bacteria or fungi should be considered during prolonged or repeated therapy, especially when other antibacterial agents are simultaneously employed.
As with other broad spectrum antibiotics, pseudomembranous colitis has been reported rarely with erythromycin which may range in severity from mild to life threatening (see section 4.4).
Reversible hearing loss associated with doses of erythromycin usually greater than 4 g per day has been reported.
Allergic reactions are rare and mild, although anaphylaxis has occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson Syndrome and toxic epidermal necrolysis have rarely been reported.
Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur.
There are rare reports of rare reports of damage to the blood, kidneys and central nervous system. There have been isolated reports of chest pain, dizziness and palpitations, however a cause and effect relationship has not been established.
As with other macrolides, QT prolongation, ventricular tachycardia, and Torsades de Pointes have rarely been reported with erythromycin.
There have been very rare reports of pancreatitis.
4.9. Overdose
Symptoms are nausea, vomiting, hearing loss and diarrhoea. Treatment is gastric lavage, general supportive measures.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Erythromycin is a macrolide antibiotic, which acts by interfering with bacterial protein synthesis by binding to the 50S ribosomal subunit of the microorganism and is bacteriostatic or bactericidal depending on its concentration and the type of organism. Sensitive organisms include:
Gram-positive bacteria such as Staphlococcus aureus, Staphlococcus epidermis, Streptococcus pyogenes, Streptococcus pneumoniae , Streptococcus.viridans, corynebacterium diptheriae and listeria monocytogenes.
Gram-negative bacteria such as Haemophilus influenzae, Neisseria meningitides, Neisseria.gonorrhoeae, Bordetella.pertussis, campylobacter strains and legionella pneumophila.
Mycoplasma pneumoniae, Ureaplasma urealyticum
Other organisms such as Treponema pallidum, Clostridia spp, Chlamydia spp, L-forms, the agents causing trachoma and Lymphogranuloma venereum
The majority of the strains of Haemophilus influenza are susceptible to the concentrations reached after ordinary dose.
5.2. Pharmacokinetic properties
Peak blood levels normally occur within 4 hours of dosing of erythromycin ethyl succinate tablets. The elimination half-life is approximately 2 hours. Doses may be administered 2, 3 or 4 times a day.
Erythromycin is adversely affected by gastric acid. For this reason erythromycin tablets are enteric coated. It is absorbed from the small intestine and absorption may be slightly delayed by food. It is widely distributed
throughout the body tissues. Little metabolism occurs and only about 5% is eliminated in the urine. It is excreted principally in the liver.
5.3. Pre-clinical safety data
Animal studies carried out, show no evidence of embryo toxicity and no further hazards, which are not already described under the section “Precautions, Warnings and Interactions”.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch EP
Croscarmellose Sodium Type A HSE
Povidone (Kollidon K90) BP
Talc EP
Magnesium Stearate EP
Sub Coat
Hydroxypropyl methylcellulose USP
Polyethylene Glycol 6000 USP
Dispersed Red 18152 (E110 and E124)
Enteric Coat
Methacrylic acid copolymer HSE
Polyethylene Glycol 6000 USP
Talc EP
Polysorbate 80 EP
Dispersed Red 18152 (E110 and E124)
6.2. Incompatibilities
None known
6.3. Shelf life
24 months
6.4. Special precautions for storage
Securitainers and polybags: Prot 20°C).
Keep containers tightly closed.
Securitainers and polybags: Protect from light, store in a dry place (below 20°C).
Keep containers tightly closed.
Blister Packs: Protect from light, store in a dry place (below 20°C).
6.5. Nature and contents of container
Polypropylene pots with polyethylene caps and polyethylene tamper evident seals containing 21, 100, 250, 500 and 1000 tablets.
250pm PVC/20pm aluminium blister packs containing 28, 56, 84 and 100 tablets.
Polybags, free from additives inside a cardboard outer container of 5,000 and 10,000 tablets for bulk supply.
6.6. Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Generics [UK] Ltd t/a Mylan
Station Close
Potters Bar
Herts
EN6 1TL
8. MARKETING AUTHORISATION NUMBER
PL 4569/0319
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/06/2007
10 DATE OF REVISION OF THE TEXT
05/03/2010