Ecomed - instructions for use, doses, side effects, contraindications

Excipients: lactulose 300 mg (or 600 mg), calcium phosphate dihydrate 59.8 mg (or 119.6 mg), corn starch 24.0 mg (or 48.0 mg), hypromellose 5.0 mg (or 10.0 mg) , sodium lauryl sulfate 1.2 mg (or 2.4 mg), croscarmellose sodium 20.0 mg (or 40.0 mg), magnesium stearate 6.0 mg (or 12.0 mg), microcrystalline cellulose to give a tablet without a coat a mass of 700 mg (or 1400 mg);

shell auxiliary substances: hypromellose 9.49 mg (or 18.98 mg), titanium dioxide 5.2 mg (or 10.4 mg), macrogol 4000 4,16 mg (or 8.32 mg), talc 1.12 mg (or 2 , 24 mg), tropeolin dye-0.03 mg (or 0.06 mg), to obtain a tablet with a coating weight of 720 mg (or 1440 mg).

Description:

Tablets covered with a film membrane of yellow color, capsular, biconvex. Two layers are visible on the cross-section. The inner layer is white or almost white.

Pharmacotherapeutic group:Antibiotic-azalide

ATX: & nbsp

J.01.F.A.10 Azithromycin

Pharmacodynamics:

Antibacterial preparation of a wide spectrum of action from the group of macrolides-azalides, acts bacteriostatically. Communicating with 50S subunit of ribosomes, inhibits peptidranslokase at the stage of translation, suppresses protein synthesis, slows the growth and multiplication of bacteria, has a bactericidal effect at high concentrations. It acts on extracorporeal and intracellular pathogens.

Microorganisms can be initially resistant to the action of the antibiotic or can acquire resistance to it.

The sensitivity scale of microorganisms to azithromycin (Minimum inhibitory concentration (MIC), mg / l):

Microorganisms	MIC, mg / l
Microorganisms	Sensitive	Sustainable
Staphylococcus	< 1	^l>2
Streptococcus A, B, C, G	<0,25	>0,5
Streptococcus pneumoniae	<0,25	>0,5
Haemophilus influenzae	<0,12	>4
Moraxella catarrhalis	<0,5	>0,5
Neisseria gonorrhoeae	< 0,25	>0,5

Sensitive:

aerobic Gram-positive microorganisms:

Staphylococcus aureus (methicillin-sensitive),
Streptococcus pneumoniae (penicillin-sensitive),
Streptococcus pyogenes;

aerobic gram-negative microorganisms:

Haemophilus influenzae,

Haemophilus parainfluenzae,
Legionella pneumophila,
Moraxella catarrhalis,
Pasteurella multocida,
Neisseria gonorrhoeae;

anaerobic microorganisms:

Clostridium perfringens,

Fusobacterium spp.,
Prevotella spp.,
Porphyromonas spp .;

other:

Chlamydia trachomatis,

Chlamydia pneumoniae,
Chlamydia psittaci,
Mycoplasma pneumoniae,
Mycoplasma hominis,
Borrelia burgdorferi.

Moderately sensitive or insensitive:

aerobic Gram-positive microorganisms:

Streptococcus pneumoniae (moderately sensitive or resistant to penicillin).

Stable:

aerobic Gram-positive microorganisms:

Enterococcus faecalis,

Staphylococci spp. (methicillin-resistant),

Anaerobes:

Group Bacteroides fragilis.

Streptococcus pneumoniae, beta-hemolytic Streptococcus spp. groups A, Enterococcus faecalis and Staphylococcus aureus (including methicillin-sensitive strains), resistant to erythromycin and other macrolides, and lincosamides are resistant to azithromycin.

Pharmacokinetics:

After oral administration azithromycin well absorbed and quickly distributed in the body. Bioavailability after a single dose of 0.5 g - 37% (the effect of "first passage" through the liver), the maximum concentration (Cmah) after oral intake of 0.5 g - 0.4 mg / l, the time to reach the maximum concentration (TCmAh) 2-3 hours. The concentration in tissues and cells is 10-50 times higher than in serum. The volume of distribution is 31.1 l / kg, binding to plasma proteins is inversely proportional to the concentration in the blood and leaves 7-50%. Azithromycin acid-fast, lipophilic. Easily passes through gistogematicheskie barriers, well penetrates the respiratory tract, urogenital organs and tissues, incl. in the prostate gland, skin and soft tissue. To the site of infection is also transported by phagocytes, polymorphonuclear leukocytes and macrophages, where it is released in the presence of bacteria. It penetrates the cell membranes and creates high concentrations in them, which is especially important for the eradication of intracellular pathogens.

In foci of infection, the concentration is 24-34% higher than in healthy tissues and correlates with the severity of the inflammatory process. It remains in effective concentrations for 5-7 days after the last dose.

In the liver demethylated, the metabolites formed are not active. In the metabolism of the drug, isozymes participate CYP3A4, CYP3A5, CYP3A7, of which it is an inhibitor. Plasma clearance - 630 ml / min: half-life between 8 and 24 hours after admission - 14-20 hours, half-life between 24 and 72 hours - 41 hours. More than 50% of the drug is excreted unchanged, 6% - kidney .

Eating significantly changes the pharmacokinetics: Cmah increases (by 31%), the indicator area under the curve "concentration-time" (AUC) does not change.

In elderly men (65-85 years) the pharmacokinetic parameters do not change, in women C increasesmah (by 30-50%).

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- infections of the upper respiratory tract and ENT organs: pharyngitis, tonsillitis, sinusitis, otitis media;

- infections of the lower respiratory tract: acute bronchitis, exacerbation of chronic bronchitis, pneumonia, incl. caused by atypical pathogens;

- infections of the skin and soft tissues: acne vulgaris of medium severity, erysipelas, impetigo, secondarily infected dermatoses;

- the initial stage of Lyme disease (borreliosis) - migrating erythema (erythema migrans);

- urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Contraindications:

- hypersensitivity to antibiotics of the macrolide group;

- severe hepatic and / or renal insufficiency;

- Children under 12 years of age with a body weight of less than 45 kg (for this dosage form);

- breast-feeding;

- simultaneous reception with ergotamine and dihydroergotamine.

Carefully:

- moderate violations of the liver and kidneys;

- at arrhythmias or predisposition to arrhythmias and lengthening of the interval QT;

- with the joint use of terfenadine, warfarin, digoxin.

Pregnancy and lactation:

Azithromycin in pregnancy is recommended to be prescribed only in cases when the expected benefit from taking it for the mother exceeds the potential risk to the fetus.

During treatment with azithromycin, breastfeeding is suspended.

Dosing and Administration:

Ecomed ® is taken orally, without chewing, once a day, regardless of food intake.

Adults (including the elderly) and children over 12 years of age with a body weight of over 45 kg.

In infections of the upper and lower respiratory tract. ENT-organs. skin and soft tissues: for 0.5 g per day for 3 days (exchange dose - 1.5 g).

For acne vulgaris of medium severity: 0.5 g per day for 3 days, then 0.5 g once a week for 9 weeks. The first weekly tablet should be taken 7 days after taking the first daily tablet (the 8th day from the start of treatment), the subsequent 8 weekly tablets - with an interval of 7 days. The course dose is 6.0 g.

With migratory erythema: 1 time per day for 5 days, 1st day 1.0 g then from 2nd to 5th day for 0.5 g. Course dose 3.0 g.

In cases of urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): L0 g once.

Assignment to patients with impaired renal function.

For patients with moderate impairment of kidney function (creatinine clearance> 40 ml / min) dose adjustment is not needed.

Side effects:

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, loose stools, flatulence, digestive disorders, anorexia, constipation, discoloration of the tongue, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory function indicators liver, liver failure, necrosis of the liver (possibly fatal).

Allergic reactions: itching, skin rashes, angioedema, hives, photosensitization, anaphylactic reaction (in rare cases, fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the side of the cardiovascular system: palpitation, arrhythmia, ventricular tachycardia, interval increase QT, bidirectional ventricular tachycardia.

From the central nervous system: dizziness / vertigo, headache, cramps, drowsiness, paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.

From the sense organs: noise in the ears, reversible hearing loss down to deafness (with high doses for a long time), a violation of the perception of taste and smell.

From the side of the circulatory and lymphatic systems: thrombocytopenia, neutropenia, eosinophilia.

From the side of the musculoskeletal system: arthralgia.

From the genitourinary system: interstitial nephritis, acute renal failure.

Other: vaginitis, candidiasis.

Overdose:

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

Treatment is symptomatic.

Interaction:

Antacids do not affect the bioavailability of azithromycin, but reduce the maximum concentration in the blood by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs and food.

When parenteral application azithromycin does not affect the concentration of cimetidine, efavirenz, fluconazole, indinavir, midazolam, triazolam, co-trimoxazole in plasma in a joint application, but do not exclude the possibility of such interactions in the administration of azithromycin for oral administration.

If it is necessary to share with cyclosporine, it is recommended to monitor the content of cyclosporine in the blood.

With the joint administration of digoxin and azithromycin, it is necessary to monitor the concentration of digoxin in the blood, many macrolides increase absorption of digoxin in the intestine, thereby increasing its concentration in the blood plasma. If it is necessary to share with warfarin, careful monitoring of prothrombin time is recommended.

Simultaneous reception of terfenadine and antibiotics of the macrolide class causes arrhythmia and lengthening QT interval. Proceeding from this, it is impossible, to exclude the aforementioned complications in the joint administration of terfenadine and azithromycin. Since it is possible to inhibit the isoenzyme CYP3A4 azithromycin in parenteral form when combined with cyclosporine, terfenadine, ergot alkaloids, cisapride,^; pimozide, quinidine, astemizole and other drugs whose metabolism occurs with the participation of this isoenzyme, the possibility of such interaction in the administration of azithromycin for oral administration should be considered.

With the joint administration of azithromycin and zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or on the excretion of its kidney and its glucuronated metabolite. Nevertheless, the concentration of the active metabolite - phosphorylated zidovudine - increases in mononuclear cells of peripheral vessels. The clinical significance of this fact is not clear.

With the simultaneous administration of macrolides with ergotamine and dihydroergotamine, their toxic effect is possible.

Special instructions:

In case of missing the antibiotic, the missed dose should be taken as soon as possible, subsequent doses should be taken at intervals of 24 hours.

After the withdrawal of azithromycin therapy, hypersensitivity reactions in some patients may persist for a long time and may require specific therapy under the supervision of a physician.

Effect on the ability to drive transp. cf. and fur:

Given the likelihood of side effects from the central nervous system, care should be taken when driving vehicles and working with mechanisms.

Form release / dosage:

Tablets, film-coated 250 mg, 500 mg.

Packaging:

For 6 tablets with a dosage of 250 mg, 3 tablets with a dosage of 500 mg are placed in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered.

For 6 tablets with a dosage of 250 mg, 3 tablets with a dosage of 500 mg in bottles for medicines made of plastic or in polymeric bottles.

Each vial, 1 circuit cell pack together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:PL-000268

Date of registration:17.02.2011

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp26.10.2015

Illustrated instructions

Instructions

Ecomed® (Ecomed®)