Description
The instruction for medical use
of ERYTHROMYCIN medicine
the Trade name
Erythromycin
the International unlicensed
name Erythromycin Dosage Form
of the Tablet, covered with a kishechnorastvorimy cover, 100 mg and 250 mg
Structure
One tablet contains
active agent:
erythromycin (in terms of active agent)-117.0 mg (100 mg) and 292.4 mg (250 mg)
excipients:
stearate calcium monohydrate, sucrose (white sugar), polysorbate-80 (twin-80), lactoses monohydrate (sugar milk), sodium carboxymethylstarch (sodium starch is glikolit), starch potato
structure of a cover:
methacrylic acid copolymer, magnesium hydrosilicate (talc), polysorbate-80 (twin-80), povidone, the titan E171 dioxide
the Description
of the Tablet of round shape, with a biconvex surface, coated color, white or white with a grayish shade,
Pharmacotherapeutic group
Antibacterial drugs for system use
of Makrolida
the ATX J01FA01 Code
the Pharmacological
Pharmacokinetics Absorption properties – high. Meal does not influence the oral forms of erythromycin in the form of the basis covered with a kishechnorastvorimy cover. The maximum concentration (Cmax) is reached after intake in 2-4 h. Communication with proteins of plasma – 80%.
Bioavailability – 30-65%. In an organism it is distributed unevenly. In large numbers collects in a liver, a spleen, kidneys. In bile and urine the concentration exceeds concentration in plasma ten times. Well gets into tissues of lungs, lymph nodes, exudate of a middle ear, a prostate secret, sperm, a pleural cavity, ascitic and synovial liquids. Milk of the feeding women contains 50% of concentration in plasma. Badly gets through a blood-brain barrier, into cerebrospinal fluid (its concentration makes 10% of drug content in plasma). At inflammatory processes in brain covers, their permeability for erythromycin increases a little. Gets through a placental barrier and comes to fruit blood where its contents reaches 5-20% of content in mother’s plasma.
It is metabolized in a liver (more than 90%), partially with formation of inactive metabolites. Elimination half-life (T1/2) – 1.4-2 h, at an anury – 4-6 h. Removal with bile – 20-30% in not changed look, kidneys (in not changed look) after intake – 2-5%.
The pharmacodynamics
the Bacteriostatic antibiotic from group of macroleads, reversibly contacts 50S a subunit of ribosomes in its donor part that breaks formation of peptide bonds between molecules of amino acids and blocks protein synthesis of microorganisms (does not influence synthesis of nucleic acids). At use in high doses can show bactericidal action. The spectrum of action includes gram-positive (Staphylococcus spp. which are producing and not producing penicillinase including Staphylococcus aureus, Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes), alpha and hemolytic streptococcus (Viridans groups), Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium minutissimum) and gram-negative microorganisms (Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis, Brucella spp., Legionella spp., including Legionella pneumophila) and other microorganisms: Mycoplasma spp. (including Mycoplasma pneumoniae), Chlamydia spp. (including Chlamydia trachomatis), Treponema spp., Rickettsia spp., Entamoeba histolytica, Listeria monocytogenes.
Gram-negative bacteria are steady: Escherichia coli, Pseudomonas aeruginosa and also Shigella spp., Salmonella spp., etc. Microorganisms which growth is delayed at concentration of an antibiotic less than 0.5 mg/l, srednechuvstvitelny – 1-6 mg/l, moderately steady and steady – 6-8 mg/l belong to group of sensitive.
Indications
– diphtheria (including a bacteriocarrier), whooping cough (including. prevention), trachoma, a brucellosis, a disease of legionaries, an erythrasma, listeriosis, scarlet fever, amoebic dysentery
– the urinogenital infections at pregnant women caused by Chlamydia trachomatis
– primary syphilis (at patients with an allergy to penicillin), uncomplicated clamidiosis at adults (with localization in lower parts of urinogenital ways and a rectum), gonorrhea
– tonsillitis, otitis, sinusitis
– cholecystitis
– tracheitis, bronchitis, pneumonia, pneumonia at children
– pustulous diseases of skin, including youthful eels, contaminated wounds, decubituses, burns of the II-III St, trophic ulcers
– infections of a mucous membrane of eyes
– prevention of exacerbations of a streptococcal infection at patients with rheumatism
– prevention of infectious complications at medical and diagnostic procedures (including preoperative preparation of intestines, dental interventions, endoscopy, at patients with heart diseases).
Route of administration and doses
Inside.
The single dose for adults and teenagers is more senior than 14 years – 0.25-0.5 g, daily – 1-2 g in 2-4 receptions, the maximum daily dose – 4 g.
Children are from 6 to 14 years old, depending on age, body weights and weights of an infection – on 30-50 mg/kg/days in 2-4 receptions. In case of heavy infections, the dose can be doubled.
For treatment of diphtheritic carriage – on 0:25 g 2 times a day. A course dose for treatment of primary syphilis – 30-40 g, treatment duration – 10-15 days.
In amoebic dysentery the adult – on 0:25 g 4 times a day, to children – on 30-50 mg/kg/days, course duration – 10-14 days.
In legionellosis – on 0.5-1 g 4 times a day within 14 days.
In gonorrhea – on 0.5 g each 6 h within 3 days, further on 0:25 g each 6 h within 7 days.
For preoperative preparation of intestines for the purpose of prevention of infectious complications – inside, on 1 g for 19 h, 18 h and 9 h prior to operation (only 3 g).
For prevention of a streptococcal infection (in tonsillitis, pharyngitis) to adult – 20-50 mg/kg/days, to children – 20-30 mg/kg/days, course duration – not less than 10 days.
For prevention of a septic endocarditis at patients with heart diseases – on 1 g for adults and on 20 mg/kg – for children, for 1 h prior to a medical or diagnostic procedure, further on 0.5 g – for adults and 10 mg/kg for children, repeatedly in 6 h.
In whooping cough – 40-50 mg/kg/days within 5-14 days.
In pneumonia at children – 50 mg/kg/days in 4 receptions, during not less than 3 weeks.
In urinogenital infections during pregnancy – 0.5 g 4 times a day within not less than 7 days or (at bad shipping of such dose) – on 0:25 g 4 times a day within not less than 14 days.
At adults, in uncomplicated clamidiosis and intolerance of tetracyclines – on 0.5 g 4 times a day within not less than 7 days.
Side effects
Sometimes:
– skin allergic reactions (a small tortoiseshell, other forms of rash)
– an eosinophilia
– nausea, vomiting, a gastralgia, tenesmus, abdominal pains, diarrhea, dysbacteriosis
– an abnormal liver function, increase in activity of ‘hepatic’ transaminases, pancreatitis
– decrease in hearing and/or sonitus (at use of high doses – more than 4 g/days, decrease in hearing after drug withdrawal is usually reversible)
Seldom
– cholestatic jaundice
– tachycardia, lengthening of an interval of QT on the ECG, ventricular arrhythmias, including ventricular tachycardia (pirouette type), at patients with the extended interval are QT
– oral cavity candidiasis, a pseudomembranous coloenteritis (both during treatment, and after it)
– an acute anaphylaxis
–
Contraindication spasms
– hypersensitivity to drug
– liver diseases
– considerable decrease in hearing
– a concomitant use of a terfenadin or an astemizol
– hereditary intolerance of fructose, deficiency of Larr-lactases enzyme, glucose galactose malabsorption
– the lactation period
– children’s age up to 6 years
With care
– arrhythmias (in the anamnesis), lengthening of an interval of QT, jaundice (in the anamnesis)
– a liver and/or renal failure.
Medicinal interactions
the Drugs blocking canalicular secretion extend elimination half-life of erythromycin.
It is incompatible with lincomycin, clindamycin and chloramphenicol (antagonism).
Reduces bactericidal action beta laktamnykh antibiotics (penicillin, cephalosporins, karbopenema).
Increases theophylline content.
At a concomitant use with drugs which metabolism is carried out in a liver (theophylline, carbamazepine, valproic acid, hexobarbital, Phenytoinum, an alfentanil, Disopyramidum, a lovastatin, Bromocriptinum) the concentration of these drugs in plasma can increase (is inhibitor of microsomal enzymes of a liver).
Increases nephrotoxicity of cyclosporine (especially at patients with the accompanying renal failure). Reduces clearance of a triazolam and midazolam in this connection can enhance pharmacological effects of benzodiazepines.
At a concomitant use with terfenadiny or astemizoly – a possibility of development of arrhythmia, with dihydroergotamine or not hydrogenated ergot alkaloids – vasoconstriction to a spasm, a dizesteziya.
Slows down elimination (enhances effect) Methylprednisolonum, a felodipin and anticoagulants of a coumarinic row.
At joint appointment with lovastatiny the rhabdomyolysis amplifies.
Increases bioavailability of digoxin.
Reduces efficiency of hormonal contraception.
Special instructions
At long therapy it is necessary to exercise control of laboratory indicators of function of a liver.
Symptoms of cholestatic jaundice can develop in several days after the beginning of therapy, however risk of development increases after 7-14 days of continuous therapy.
Some resistant strains of Haemophilus influenzae are sensitive to a concomitant use of erythromycin and streptocides.
Can interfere with definition of catecholamines in urine and activity of ‘hepatic’ transaminases in blood (colorimetric definition by means of a definilgidrazin).
Pregnancy and the period of a lactation
At use of drug during pregnancy it is necessary to estimate expected advantage for mother and potential risk for a fruit.
Due to a possibility of penetration into breast milk, it is necessary to refrain from feeding by a breast when prescribing erythromycin.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Overdose
Symptoms: nausea, diarrhea, discomfort in a stomach, acute pancreatitis benign, dizziness (especially at patients with a liver and renal failure), an abnormal liver function, up to an acute liver failure, a hearing loss.
Treatment: activated carbon, careful control of a condition of a respiratory system. Gastric lavage is effective at reception of the dose fivefold exceeding average therapeutic. The hemodialysis, peritoneal dialysis, an artificial diuresis are inefficient.
The form of release and packing
of the Tablet covered with a kishechnorastvorimy cover, 100 mg and 250 mg.
On 10 tablets (for a dosage of 100 mg) in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 10 tablets (for a dosage of 250 mg) in bank of polymeric.
1 blister strip packaging (for a dosage of 100 mg) or each can (for a dosage of 250 mg) together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions in the dry place, at a temperature not above 25 °C.
To store out of children’s reach!
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
JSC Biosintez Producer,
Russian Federation. 440033, Penza, Druzhby St., 4, ph. / fax (8412) 57-72-49
e-mail: certificate@biosintez.com
Owner of the registration certificate
of JSC Biosintez, Russian Federation.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of JSC Biosintez,
Russian Federation 440033, Penza, Druzhby St., 4, ph. / fax (8412) 57-72-49
e-mail:
To develop certificate@biosintez.com
Additional information
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