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

Excipients: lactulose - 200.0 mg / 400.0 mg, xanthan gum - 15.0 mg / 15.0 mg, crospovidone (Kollidone CL-M) - 65.0 mg / 65.0 mg, silicon dioxide colloid (aerosil) - 5.5 mg / 5.5 mg, sodium carbonate anhydrous - 83.0 mg / 83.0 mg, sodium benzoate - 16.5 mg / 16 , 5 mg, titanium dioxide 10.0 mg / 10.0 mg, strawberry flavoring 55.0 mg / 55.0 mg, peppermint flavor 0.5 mg / 0.5 mg, apple-cinnamon flavor 27, 5 mg / 27.5 mg, sucrose - up to 3.75 g / 3.75 g.

Description:

The powder is white or yellowish white with a faint fruity odor. Cellular suspension: from white to light yellow, homogeneous with a faint fruity smell.

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, has a bacteriostatic effect. 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 (Minimal inhibitory concentration, mg / l):

Microorganisms	MIC, mg / l
Microorganisms	Sensitive	Sustainable
Staphylococcus	< 1	>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, lincosamides, are resistant to azithromycin.

Pharmacokinetics:

After oral administration azithromycin well absorbed and quickly distributed in the body. Bioavailability after a single dose 0.5 g - 37% (the effect of "first pass" 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 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 the histohematetic barriers, well penetrates the respiratory tract, internal organs and tissues, including the prostate gland, skin and soft tissues. 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 in the interval from 24 to 72 hours - 41 hours. More than 50% of the drug is excreted through the intestine in unchanged form, 6% kidneys.

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 susceptible to azithromycin:

- 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: erysipelas, impetigo, secondarily infected dermatoses;

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

Contraindications:

- increased sensitivity to azithromycin (including other macrolides) or other components of the drug;

- severe renal failure (creatinine clearance (CK) less than 40 ml / min);

- severe hepatic insufficiency (class C on the Child-Pugh scale);

- breast-feeding;

- simultaneous administration with ergotamine and dihydroergotamine;

- children up to 6 months;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

Carefully:

- renal failure (creatinine clearance (CC) more than 40 ml / min);

- hepatic insufficiency (class A and B on the Child-Pugh scale);

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

- when combined with terfenadine, warfarin, digoxin;

- myasthenia gravis.

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® in the form of a suspension for oral administration is prescribed to children from 6 months of age. 3-day course: at the rate of 10 mg / kg once a day (course dose of 30 mg / kg). 5-day course: with Lyme disease (borreliosis) for treatment of stage I (erythema migrans) in children, the dose is 20 mg / kg on the first day and 10 mg / kg from 2 to 5 days of the disease; the course dose of 60 mg / kg.

Method of preparing the suspension

The suspension is prepared immediately before use.

The powder in the vial is pre-shaken, 12 ml of boiled and cooled to room temperature water are added using a syringe for dosing, mixed to obtain a uniform suspension. For an accurate dosage of the suspension, a dosage two-pronged spoon or syringe should be used, which must be rinsed well with water after each use.

After reconstitution, the finished suspension should be stored for no more than 5 days in the refrigerator, but do not freeze.

Side effects:

From the digestive systemNausea, vomiting, diarrhea, abdominal pain, diarrhea, flatulence, indigestion, anorexia, constipation, change the language of color, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory parameters of liver function, liver failure, liver necrosis (possibly

with fatal outcome), hyperbilirubinemia, pancreatitis, fulminant hepatitis.

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, increased interval QT, bidirectional ventricular tachycardia, lowering blood pressure.

From the nervous systemDizziness / vertigo, headache, seizures, drowsiness, paresthesia, fatigue, insomnia, hyperactivity, aggressiveness, anxiety, nervousness, fear, male.

From the sense organs: tinnitus, reversible hearing loss down to deafness (when taking high doses for a long time), a violation of the perception of taste and smell, a violation of the clarity of visual perception.

On the part of the organs of hematopoiesis: thrombocytopenia, neutropenia, eosinophilia, lymphopenia, hemolytic anemia.

From the side of the musculoskeletal system: arthralgia.

From the genitourinary system: interstitial nephritis, acute renal failure, increased urea and creatinine concentrations in the blood plasma.

Other: vaginitis, candidiasis, weakness, peripheral edema, malaise.

Overdose:

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

Treatment is symptomatic.

Interaction:

Antacids (aluminum and magnesium-containing) do not affect bioavailability, but reduce the concentration of azithromycin in the blood by 30%, so the interval between their intake should be 1 hour before or 2 hours after taking these drugs.

With simultaneous use with derivatives of ergotamine and dihydroergotamine, the toxic effect of the latter (vasospasm, dysesthesia) is possible.

When combined with anticoagulants indirect effect of the coumarin series (warfarin) patients need careful monitoring of prothrombin time.

Caution should be exercised in the joint appointment of terfenadine and azithromycin, since it was found that the simultaneous administration of terfenadine and macrolides causes arrhythmia and lengthening Q-T interval. Proceeding from this, it is impossible to exclude the aforementioned complications in the joint administration of terfenadine and azithromycin.

When used simultaneously with cyclosporine, the concentration of cyclosporin in the blood should be monitored.

With simultaneous use with digoxin, it is necessary to control the concentration of digoxin in the blood (there may be an increase in absorption of digoxin in the intestine).

At simultaneous application with nelfinavir it is possible to increase the incidence of adverse reactions of azithromycin (decrease in hearing, increase of activity of "liver" transaminases). When combined with zidovudine azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or on excretion by the kidneys of its and its metabolite - glucuronide, but the concentration of the active metabolite of phosphorylated zidovudine in mononuclear cells of peripheral vessels increases. The clinical significance of this fact is not determined.

The possibility of inhibiting the isoenzyme should be considered CYP3A4 azithromycin with simultaneous application with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs, the metabolism of which occurs with the participation of this enzyme.

Azithromycin does not affect the concentration of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin and methylprednisolone in the blood together.

Special instructions:

In case of missed dose, the missed dose should be taken as soon as possible, and the subsequent dose should be taken at intervals of 24 hours. Azithromycin should be taken 1 hour before or 2 hours after taking antacid medicines.

Take with caution patients with moderate hepatic impairment because of the possibility of developing fulminant hepatitis and severe hepatic insufficiency. In the presence of symptoms of impaired liver function (rapidly increasing asthenia, jaundice, darkening of the urine, a tendency to bleeding, hepatic encephalopathy) therapy with azithromycin should be discontinued and a study functional state of the liver.

With moderate renal failure (CC greater than 40 ml / min), azithromycin should be administered under the control of kidney function.

Contraindicated simultaneous administration of azithromycin with derivatives of ergotamine and dihydroergotamine because of the possible development of ergotism. When using the drug, both on the background of taking and 2-3 weeks after discontinuation of treatment, it is possible to develop diarrhea caused by Clostridium difficile (pseudomembranous colitis). In mild cases, it is sufficient to discontinue treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole. Do not use drugs that inhibit the intestinal motility.

Since it is possible to extend the interval Q-T in patients receiving macrolides, when using azithromycin, caution should be used in patients with known risk factors for lengthening the interval Q-T: elderly age; violation of electrolyte balance (hypokalemia, hypomagnesemia); congenital lengthening syndrome Q-T; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous reception of drugs that can lengthen the interval Q-T (including antiarrhythmic drugs IA and III classes, tricyclic and tetracyclic antidepressants, neuroleptics, fluoroquinolones).

With the use of azithromycin, the development of myasthenic syndrome or myasthenia exacerbation is possible.

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

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Powder for the preparation of a suspension for oral administration 100 mg / 5 ml, 200 mg / 5 ml.

Packaging:

Powder for the preparation of a suspension for oral administration 100 mg / 5 ml, 200 mg / 5 ml.

By 16.5 g in bottles of dark glass of 60 ml with a screwed plastic lid.

For 1 bottle together with a dispensing double-spoon (small capacity 2.5 ml, large - 5 ml), a syringe for dosing and instructions for use are placed in a pack of cardboard.

Storage conditions:

In a place protected from moisture and light at a temperature of no higher than 25 ° C. The finished suspension is stored at a temperature of 2 ° C to 8 ° C in a tightly closed vial.

Keep out of the reach of children.

Shelf life:

2 years.

The finished suspension is 5 days.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002025

Date of registration:13.03.2013

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

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp31.08.2015

Illustrated instructions

Instructions

Ecomed® (Ecomed®)