Erythropac

Erythropac

erythromycin

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Full Prescribing Info
Contents
Erythromycin.
Description
Each film-coated tablet contains: Erythromycin BP equivalent to erythromycin 250 mg and 500 mg.
Action
Pharmacology: Pharmacodynamics: Erythromycin exerts antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms suppresses protein synthesis. Erythromycin is usually active against most strains of the following organisms both in vitro and in clinical infections: Gram positive bacteria - Listeria monocytogenes. Corynebacterium diphtheriae (as an adjunct to antitoxin), Staphylococci spp, Streptococci spp (including Enterococci).
Gram negative bacteria - Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Campylobacter spp.
Mycoplasma - Mycoplasma pneumoniae, Ureaplasma urealyticum.
Other organisms - Treponema pallidum, Chlamydia spp, Clostridia spp, L-forms the agents using trachoma and lymphogranuloma venereum.
Note: The majority of strains of Haemophilus influenza are susceptible to the concentrations reached after ordinary doses.
Pharmacokinetics: Absorption: Erythromycin is adversely affected by gastric acid. For this reason, erythromycin tablets are enteric coated.
It is absorbed from the small intestine. It is widely distributed throughout body tissues.
Little metabolism occurs and only about 5% is eliminated in the urine. It is excreted principally by the liver.
Indications/Uses
For the prophylaxis and treatment of infection caused by erythromycin organisms.
Erythromycin is highly effective in the treatment of a great variety of clinical infections such as: Upper Respiratory Tract infections: tonsillitis, peritonsillar abscess, pharyngitis, laryngitis. Sinusitis, secondary infections in influenza and common colds.
Lower Respiratory Tract infection: tonsillitis, acute and chronic bronchitis, pneumonia (lobar pneumonia, bronchopneumonia, primary atypical pneumonia), bronchiectasis, Legionnaire's disease.
Ear infection: otitis media and otitis externa mastoiditis.
Oral infections: gingivitis, Vincent's angina.
Eye infection: blepharitis.
Skin & soft tissue infection: boils and carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas.
Gastrointestinal infections: cholecystitis, staphylococcal enterocolitis.
Prophylaxis: pre- and post. Operative trauma, burns, rheumatic fever.
Other infections: osteomyelitis, urethritis, gonorrhea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever.
Dosage/Direction for Use
Adults and older children: Usual oral dosage 1 tablet every four to six hours, increased to 4 g per day in unusually severe infections.
Overdosage
Symptoms: hearing loss, severe nausea, vomiting and diarrhoea.
Treatment: gastric lavage, general supportive measures.
Contraindications
Known hypersensitivity to erythromycin. Erythromycin is contraindicated in patients taking astemizole, terfenadine, cisapride or pimozide.
Erythromycin is contraindicated with ergotamine and dihydroergotamine.
Warnings
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 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 with 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.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin.
Special Precautions
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.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin.
Side Effects
Occasional side effects such as nausea, abdominal discomfort, vomiting and diarrhea may be experienced. Reversible hearing loss associated with doses of erythromycin usually greater than 4g 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. There are no reports implicating erythromycin products with abnormal tooth development, and only rare reports of damage to the blood, kidneys or central nervous system.
Cardiac arrhythmias have been very rarely reported in patients receiving erythromycin therapy. There have been isolated reports of chest pain, dizziness and palpitations, however, a cause and effect relationship has not been established.
Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test result may occur.
Drug Interactions
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.
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 arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de pointes.
Similar effects have been observed with concomitant administration of pimozide and clarithromycin, another macrolide antibiotic.
Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by the rapid development of severe peripheral vasospasm and dysaesthesia.
Storage
Store in a cool & dry place. Protect from light.
Store below 30°C.
MIMS Class
ATC Classification
J01FA01 - erythromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 250 mg x 10 x 10's. 500 mg x 10 x 10's.
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