Composition, form of production and packaging
Hard gelatin capsules, size в„–00, with a white casing and a red lid; the contents of the capsules are a granular powder of white or almost white color.
1 caps.
azithromycin (in the form of dihydrate) 250 mg
Excipients: lactulose (300 mg), povidone, calcium stearate, microcrystalline cellulose.
Structure of the capsule: gelatin, dye crimson (Ponso 4R), iron oxide red, titanium dioxide.
6 pcs. - polymer cans (1) - packs of cardboard.
6 pcs. - bottles (1) - packs of cardboard.
6 pcs. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Antibiotic of a wide spectrum of action. Is a representative of a subgroup of macrolide antibiotics - azalides. When creating a high inflammation in the focus of inflammation has a bactericidal effect.
Ecomedes are sensitive Gram-positive cocci: Streptococcus pneumoniae, St. pyogenes, St.agalactiae, streptococci of groups CF and G, Staphylococcus aureus, St.viridans; Gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, B. parapertussis, Legionella pneumophila, H.ducrei, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp; as well as Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdoferi. Ecomedes is inactive against gram-positive bacteria resistant to erythromycin.
Lactulose, which is part of Ecomed as a bifidogenic factor, is a synthetic disaccharide, the molecule of which consists of the remains of galactose and fructose.Lactulose in the stomach and upper intestine is not absorbed and not hydrolyzed. Released from Ecomed tablets Lactulose as a substrate is fermented by normal microflora of the large intestine, stimulating the growth of bifidobacteria and lactobacilli. As a result of hydrolysis of lactulose in the large intestine, organic acids are formed - lactic, acetic and formic, suppressing the growth of pathogenic microorganisms and thereby reducing the production of nitrogen-containing toxic substances.
Thus, lactulose in Ecomed reduces the damaging effect of the antibiotic on the normal intestinal microflora and the risks of side effects associated with dysbiosis.
PHARMACOKINETICS
Ecomed is rapidly absorbed from the digestive tract, which is due to its resistance in acidic environment and lipophilicity. After oral administration of 500 mg, the maximum concentration of Ecomed in the blood plasma is achieved through 2.5 - 2.96 hours and is 0.4 mg / l. Bioavailability is 37%.
Ecomed penetrates well into the respiratory tract, organs and tissues of the urogenital tract (particularly the prostate gland), the skin and soft tissues. High concentration in tissues (10-50 times higher than in plasma) and a long half-life are due to low binding of Ecomed to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in a medium with a low pH surrounding the lysosome. This, in turn, determines the large apparent volume of distribution (31.1 l / kg) and high plasma clearance. The ability of Ecomed to accumulate mainly in lysosomes is especially important for the elimination of intracellular pathogens. It is proved that phagocytes deliver Ecomedes to places of infection localization, where it is released during phagocytosis. The concentration of Ecomed in the foci of infection is significantly higher than in healthy tissues (an average of 24-34%) and correlates with the degree of inflammatory edema. Despite the high concentration in phagocytes, Ecomed does not have a significant effect on their function. Ecomedes persists in bactericidal concentrations in the inflammatory focus within 5-7 days after the last dose, which allowed the development of short (3-day and 5-day) treatment courses.
In the liver demethylated, the metabolites formed are not active.
Excretion of Ecomed from the blood plasma takes place in 2 stages: the half-life is 14-20 hours in the interval from 8 to 24 hours after taking the drug and 41 hours in the interval from 24 to 72 hours, which allows using the drug once a day.
Lactulose, which is part of Ecomed, does not affect the main pharmacokinetic parameters characterizing the bioavailability of azithromycin.
INDICATIONS
- Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:
- infections of the upper respiratory tract and ENT organs (sore throat, sinusitis, tonsillitis, pharyngitis, otitis media);
scarlet fever;
- infections of the lower respiratory tract (bacterial and atypical pneumonia, bronchitis);
- infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);
- infection of the urogenital tract (uncomplicated urethritis and / or cervicitis);
- Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans);
- Disease of the stomach and duodenum, associated with Helicobacter pylori (as part of combination therapy).
DOSING MODE
Inside, 1 hour before or 2 hours after eating 1 time / day.
Adults with infections of the upper and lower respiratory tract -
500 mg / day for 1 reception for 3 days (exchange dose - 1.5 g).
For infections of the skin and soft tissues - 1000 mg / day on the first day for 1 reception, then 500 mg / day daily from 2 to 5 days (course dose - 3 g).
In acute infections of the urogenital organs (uncomplicated urethritis or cervicitis) - once 1 g.
In Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) - 1 g on the first day and 500 mg daily from 2 to 5 days (course dose - 3 g).
With peptic ulcer of stomach and duodenum associated with Helicobacter pylori - 1 g / day for 3 days as a combination of anti-Helicobacter therapy.
Children are prescribed at the rate of 10 mg / kg 1 time / day for 3 days or on the first day - 10 mg / kg, then 4 days - 5-10 mg / kg / day for 3 days (exchange dose - 30 mg / kg).
In the treatment of erythema migrans in children, the dose is 20 mg / kg on the first day and 10 mg / kg from 2 to 5 days.
SIDE EFFECT
From the nervous system: dizziness, headache, drowsiness; children - headache (with medication otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less).
From the cardiovascular system : palpitation, chest pain (1% or less).
On the part of the digestive system : diarrhea (5%), nausea (3%), abdominal pain (3%); 1% or less - dyspepsia, flatulence, vomiting, melena, cholestatic jaundice, increased activity of "liver" transaminases; in children - constipation, anorexia, gastritis.
From the genitourinary system : vaginal candidiasis, nephritis (1% or less).
Allergic reactions : rash, photosensitivity, Quincke's edema.
Other : increased fatigue; children - conjunctivitis, itching, hives.
CONTRAINDICATIONS
- hypersensitivity (including to other macrolides);
- Hepatic and / or renal insufficiency;
- Lactation period (for the duration of treatment, they are suspended);
- Children's age up to 12 months.
- with caution - pregnancy (can be used when the intended use of its use significantly exceeds the potential risk to the fetus), arrhythmia (ventricular arrhythmias and QT interval prolongation are possible), children with severe impaired liver or kidney function.
PREGNANCY AND LACTATION
It is used with caution in pregnancy (can be used when the intended use of its use significantly exceeds the potential risk to the fetus).
It is forbidden to use during lactation (at the time of treatment, it is suspended).
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in liver failure.
APPLICATION FOR CHILDREN
Contraindicated in children younger than 12 months. It is used in children with marked impairment of liver or kidney function.
SPECIAL INSTRUCTIONS
It is necessary to observe a break of 2 hours with the simultaneous use of antacids.
After the withdrawal of the treatment, hypersensitivity reactions in some patients may persist, which requires specific therapy under the supervision of a physician.
OVERDOSE
Symptoms: severe nausea, temporary loss of hearing, vomiting, diarrhea.
DRUG INTERACTION
Antacids (aluminum and magnesium-containing), ethanol and food slow down and reduce absorption.
With the co-administration of warfarin and Ecomed (in usual doses), no changes in prothrombin time have been detected, however, given the interaction between macrolides and warfarin, an anticoagulant effect may be enhanced, patients need careful monitoring of prothrombin time.
Digoxin: increased digoxin concentration.
Ergotamine and dihydroergotamine: increased toxic effect (vasospasm, dysesthesia).
Triazolam: reduced clearance and increased pharmacological action of triazolane.
Slows down the excretion and increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, and drugs that undergo microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine derivatives) due to the inhibition of microsomal oxidation in hepatocytes by Ecomed.
Lincosamines weaken the effectiveness, tetracycline and chloramphenicol - strengthen.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Storage conditions
List B. In a dry, the dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children.
Shelf life
2 years. Do not use after the expiration date.
