Ecohoney

General characteristics. Structure:

Active agent: azithromycin (in the form of a dihydrate) 250 mg

Excipients: lactulose - 300 mg, phosphate calcium a dihydrate - 59.8 mg, starch corn - 24 mg, a gipromelloza - 5 mg, sodium lauryl sulfate - 1.2 mg, croscarmellose sodium - 20 mg, magnesium stearate - 6 mg, cellulose microcrystallic - to 700 mg.

Structure of a cover: (a gipromelloza - 9.49 mg, titanium dioxide - 5.2 mg, a macrogoal of 4000 - 4.16 mg, talc - 1.12 mg, dye tropeolin-O - 0.03 mg) - to 720 mg.

Active agent: azithromycin (in the form of a dihydrate) 500 mg

Excipients: lactulose - 600 mg, phosphate calcium a dihydrate - 119.6 mg, starch corn - 48 mg, a gipromelloza - 10 mg, sodium lauryl sulfate - 2.4 mg, croscarmellose sodium - 40 mg, magnesium stearate - 12 mg, cellulose microcrystallic - to 1400 mg.

Structure of a cover: (a gipromelloza - 18.98 mg, titanium dioxide - 10.4 mg, a macrogoal of 4000 - 8.32 mg, talc - 2.24 mg, dye tropeolin-O - 0.06 mg) - to 1440 mg.

Pharmacological properties:

Pharmacological action. Antibacterial drug of a broad spectrum of activity of group of azaleads, works bacteriostatically. Communicating with 50S in subunit of ribosomes, oppresses to a peptidtranslokaz at a broadcasting stage, suppresses protein synthesis, slows down growth and reproduction of bacteria, in high concentration renders bactericidal effect. Works on out of - and intracellularly located activators. It is active concerning gram-positive microorganisms: Streptococcus spp. (groups C, F and G, except steady against erythromycin), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Staphylococcus epidermidis, Staphylococcus aureus; gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp; and also Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycobacterium avium complex, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. It is inactive concerning the gram-positive bacteria steady against erythromycin.
The lactulose which is Ekomed's part as a bifidogenny factor is synthetic disaccharide which molecule consists of the remains of a galactose and fructose. Lactulose in a stomach and upper parts of intestines is not soaked up and not hydrolyzed. Ekomeda who is released from tablets lactulose as substrate is fermented by normal microflora of a large intestine, stimulating growth of bifidobacteria and lactobacilli. As a result of hydrolysis of lactulose in a large intestine organic acids - milk, acetic and ant, suppressing growth of pathogenic microorganisms and reducing thereof products of nitrogen-containing toxic substances are formed.
Thus, lactulose as a part of Ekomed reduces the damaging action of an antibiotic on the normal intestinal microflora and risks of side effects connected with disbioza.

Pharmacokinetics. Absorption - high, кислотоустойчив, липофилен. Bioavailability after a single dose of 0.5 g - 37% (effect of "the first passing" through a liver), Cmax after oral administration of 0.5 g - 0.4 mg/l, TCmax - 2.5-2.9 h; in fabrics and cells concentration is 10-50 times higher, than in blood serum, distribution volume - 31.1 l/kg. Easily passes gistogematichesky barriers. Well gets into respiratory organs, urinogenital bodies and fabrics, a prostate gland, skin and soft tissues; collects in the environment with low pH, in lysosomes (that is especially important for an eradikation of intracellularly located activators). It is transported by phagocytes, polymorphonuclear leukocytes and macrophages. Gets through membranes of cells and creates high concentration intracellularly. Concentration in the centers of an infection are 24-34% higher, than in healthy fabrics and correlate with expressiveness of inflammatory process. In the center of an inflammation remains in effective concentration within 5-7 days after reception of the last dose. Communication with proteins of plasma - 7-50% (it is inversely proportional concentration in serum). In a liver it demetilirutsya, the formed metabolites are not active. Isoenzymes of CYP3A4, CYP3A5, CYP3A7 which inhibitor it is participate in metabolism of drug. Plasma clearance - 630 ml/min.: T1/2 between 8 and 24 h after reception is 14-20 h, T1/2 in the range from 24 to 72 h - 41 h. More than 50% of drug are removed with bile in not changed look, 6% - kidneys. Meal significantly changes pharmacokinetics (depending on a dosage form): suspension - Cmax increases (by 46%) and AUC (for 14%); tablets - Cmax increases (by 31%), AUC does not change. At elderly men (65-85 years) pharmacokinetic parameters do not change, at women Cmax increases (by 30-50%), at children at the age of 1-5 years Cmax, T1/2, AUC decrease.
The lactulose which is Ekomed's part does not exert impact on the key pharmacokinetic parameters characterizing bioavailability of azithromycin.

Indications to use:

— the infections of upper parts of respiratory tracts and ENT organs caused by activators, sensitive to azithromycin: pharyngitis, tonsillitis, laryngitis, sinusitis, average otitis; scarlet fever;
— infections of lower parts of respiratory tracts: pneumonia (including atypical), bronchitis;
— infections of skin and soft tissues: eels ordinary (moderately severe), the ugly face, impetigo for the second time infected a dermatosis;
— infections of urinary tract: gonorrheal and not gonorrheal urethritis, cervicitis;
— Lyme's disease (an initial stage - erythema migrans);
— the peptic ulcer of a stomach and a 12-perstny gut associated with Helicobacter pylori (as a part of a combination therapy).

Route of administration and doses:

The drug Ecohoney is accepted inside, for an hour to or in two hours after food, by 1 times/days.
The adult at infections of upper and lower parts of respiratory tracts – 0,5 g / once within 3 days (a course dose – 1.5 g).
At infections of skin and soft tissues - 1 g/days in the first day, further on 0.5 g/days daily from 2 to 5 day (a course dose - 3 g); eels ordinary - 0.5 g/days once within 3 days, then on 0.5 g/days once a week within 9 weeks. The first weekly pill should be taken in 7 days after reception of the first daily tablet (8 day for an initiation of treatment), the subsequent 8 weekly tablets - at an interval of 7 days.
At acute infections of urinogenital bodies (an uncomplicated urethritis or a cervicitis) - once 1 g.
At a disease Laima (borreliosis) for treatment of the I stage (erythema migrans) - 1 g in the first day and 0.5 g daily from 2 to 5 day (a course dose - 3 g).
At the peptic ulcer of a stomach and a 12-perstny gut associated with Helicobacter pylori - 1 g/days within 3 days as a part of the combined antikhelikobakterny therapy.
To children from 6 months, in the form of suspension for intake, Ecohoney is appointed at the rate of 10 mg/kg of 1 time/days within 3 days or the 5th dnevny course: in the first day - 10 mg/kg, then 4 days - on 5-10 mg/kg/days (a course dose - 30 mg/kg).
At treatment of erythema migrans at children a dose - 20 mg/kg in the first day and 10 mg/kg from 2 to 5 day of a disease.
Way of preparation of suspension:
Suspension prepares just before use.
Powder in a bottle is previously stirred up, add 11 ml of the boiled and cooled to room temperature water, using the syringe for dosing, mix, receiving homogeneous suspension. For an exact dosage of suspension it is necessary to use a dosing bilateral spoon which needs to be rinsed well water after each use. After cultivation it is necessary to store suspension no more than 7 days in the refrigerator, but not to freeze.

Features of use:

In case of the admission of reception of an antibiotic, the passed dose should be accepted as soon as possible, to accept the subsequent doses at an interval of 24 h.

At simultaneous use of antacids it is necessary to observe a 2-hour interval between administrations of drugs.

After therapy cancellation by azithromycin of reaction of hypersensitivity at some patients can remain for an appreciable length of time and can demand specific therapy under observation of the doctor.

Side effects:

From cardiovascular system: heartbeat, thorax pain (less than 1%). From the central nervous system: dizziness, headache, вертиго, drowsiness; children have a headache (at therapy of average otitis), hyperkinesias, uneasiness, neurosises, sleep disorders (less than 1%).
From the alimentary system: at intake - diarrhea (5%), nausea (3%), abdominal pains (3%); 1% and less - a meteorism, vomiting, a melena, cholestatic jaundice, increase in activity of "hepatic" transaminases; besides, children have locks, a loss of appetite, gastritis; candidiasis of a mucous membrane of an oral cavity.
From an urinary system: vaginal candidiasis, nephrite (less than 1%).
Allergic reactions: rash, urticaria, skin itch, Quincke's disease; seldom bronchospasm.
Others: adynamy, photosensitization; children have a conjunctivitis; taste change.

Interaction with other medicines:

The antacids including Al3 + and Mg2+, ethanol and food slow down and reduce azithromycin absorption.

At joint purpose of warfarin and azithromycin (in usual doses) changes of a prothrombin time it is not registered, however, considering that at interaction of macroleads and warfarin strengthening of anti-coagulative effect is possible, careful control of a prothrombin time is necessary for patients.

Increases concentration of digoxin due to weakening of its inactivation an indestinal flora.

Ergotamine and dihydroergotamine: strengthening of toxic action (vasospasm, dizesteziya).

To triazoles: decrease in clearance and increase in pharmacological action of a triazolam.

Slows down removal and increases concentration in plasma and toxicity of Cycloserinum, indirect anticoagulants, Methylprednisolonum, felodipin, and also the HP which are exposed to a microsomal oxidation (carbamazepine, терфенадин, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, Disopyramidum, Bromocriptinum, Phenytoinum, peroral hypoglycemic HP, theophylline, etc. ksantinovy derivatives), at the expense of inhibition an antibiotic of a microsomal oxidation in hepatocytes.

Reduces activity of linkozamid, exponentiates effect of tetracyclines and chloramphenicol.

Contraindications:

— hypersensitivity to antibiotics of group of macroleads,
— heavy liver and/or renal failure.
— with care: pregnancy, period of a lactation, arrhythmia, lengthening of an interval of Q-T (risk of development of ventricular arrhythmias).

Use of the drug EKOMED® at pregnancy and feeding by a breast
With care it is applied at pregnancy and during breastfeeding.

Use at abnormal liver functions
It is contraindicated at a heavy liver failure.

Use at renal failures
It is contraindicated at a heavy renal failure

Use for children
Use for children is possible from 6 months according to the dosing mode.

Overdose:

Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea.

Storage conditions:

Tablets, film coated 250 mg and 500 mg:
List B. In the dry, protected from light place, at a temperature not above 25 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, покр. film cover, 250 mg: 6 pieces.

Tablets, покр. film cover, 500 mg: 3 pieces.