Azithromycin Ecomed - Instructions For Use, Suspension, Reviews, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Azithromycin Ecomed

Azithromycin Ecomed: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Azithromycin Ecomed

ATX code: J01FA10

Active ingredient: azithromycin (Azithromycin)

Manufacturer: AVVA RUS, JSC (Russia)

Description and photo update: 2019-08-07

Prices in pharmacies: from 120 rubles.

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Azithromycin Ecomed is a broad-spectrum oral antibiotic from the macrolide group.

Release form and composition

Dosage forms of Azithromycin Ecomed:

• hard gelatin capsules: white body, red cap, size No. 00; the capsules contain an almost white or white granular powder [in a cardboard box 1 can (bottle) of 6 capsules or 1 blister pack of 6 or 10 capsules];
• film-coated tablets: yellow, capsular, biconvex; the inner layer in the cross section is white or almost white (dosage 250 mg: in a cardboard box 1 blister pack of 6 tablets; dosage 500 mg: in a cardboard box 1 blister pack of 3 tablets);
• powder for preparation of suspension for oral administration: white or yellowish-white, with a slight fruity odor; suspension after preparation has the same color, smell and homogeneous consistency (in a cardboard box 1 glass bottle of 60 ml, complete with a dosing syringe and a double-sided dosing spoon of 2.5 and 5 ml).

Each pack also contains instructions for the use of Azithromycin Ecomed.

Composition of 1 capsule:

• active substance: azithromycin (in the form of a dihydrate) - 250 mg;
• auxiliary components: lactulose - 250 mg; povidone - 9.3 mg; calcium stearate - 5.6 mg; sodium lauryl sulfate - 0.95 mg; microcrystalline cellulose - until the contents of a capsule weighing 560 mg are obtained;
• capsule body: titanium dioxide - 2%; gelatin - up to 100%;
• capsule cap: titanium dioxide - 2.5%; dye iron oxide red - 0.85%; food coloring E124 (Ponso 4R / crimson) - 1.36%; gelatin - up to 100%.

Composition of 1 tablet:

• active substance: azithromycin (in the form of a dihydrate) - 250 or 500 mg;
• auxiliary components (250/500 mg): lactulose - 300/600 mg; calcium phosphate dihydrate - 59.8 / 119.6 mg; corn starch - 24/48 mg; hypromellose - 5/10 mg; sodium lauryl sulfate - 1.2 / 2.4 mg; croscarmellose sodium - 20/40 mg; magnesium stearate - 6/12 mg; microcrystalline cellulose - up to 700/1400 mg;
• shell: (hypromellose - 9.49 / 18.98 mg; titanium dioxide - 5.2 / 10.4 mg; macrogol 4000 - 4.16 / 8.32 mg; talc - 1.12 / 2.24 mg; dye Tropeolin O - 0.03 / 0.06 mg) - up to 720/1440 mg.

Composition of 5 ml suspension:

• active substance: azithromycin (in the form of a dihydrate) - 100 or 200 mg;
• auxiliary components (100/200 mg): sodium benzoate - 16.5 / 16.5 mg; titanium dioxide - 10/10 mg; crospovidone (Kollidon CL-M) - 65/65 mg; colloidal silicon dioxide (aerosil) - 5.5 / 5.5 mg; anhydrous sodium carbonate - 83/83 mg; lactulose - 200/400 mg; xanthan gum - 15/15 mg; cinnamon flavor - 13.75 / 13.75 mg; strawberry flavor - 55/55 mg; apple flavor - 13.75 / 13.75 mg; mint flavor - 0.5 / 0.5 mg; sucrose - up to a mass of 3750/3750 mg.

Pharmacological properties

Pharmacodynamics

Azithromycin - the active substance of Azithromycin Ecomed, is a broad-spectrum bacteriostatic antibiotic belonging to the group of macrolides-azalides. Has a wide spectrum of antimicrobial action, the mechanism of which is based on the suppression of the protein biosynthesis of the microbial cell. When binding to the 50S-subunit of the ribosome, the peptide translocase is inhibited by azithromycin at the translation stage and protein synthesis is suppressed, which slows down the growth and reproduction of bacteria. When used in high concentrations, the substance has a bactericidal effect.

Azithromycin is active against a number of gram-positive and gram-negative anaerobes, intracellular and other microorganisms. They can initially show resistance to antibiotic effects or acquire it.

MIC (minimum inhibitory concentration) of the sensitivity / resistance of microorganisms:

• Neisseria gonorrhoeae: 0.5 mg / L;
• Staphylococcus: 2 mg / l;
• Streptococcus pneumonia: 0.5 mg / L;
• Streptococcus A, B, C, G: 0.5 mg / l;
• Moraxella catarrhalis: 0.5 mg / l;
• Haemophilus influenza: 4 mg / l.

Microorganisms that are in most cases sensitive to the effects of azithromycin:

• anaerobes: Fusobacterium spp., Porphyromonas spp., Prevotella spp., Clostridium perfringens;
• gram-negative aerobes: Legionella pneumophila, Neisseria gonorrhoeae, Pasteurella multocida, Haemophilus influenzae, Moraxella catarrhalis, Haemophilus parainfluenzae;
• gram-positive aerobes: Streptococcus pneumoniae penicillin-sensitive, Staphylococcus aureus methicillin-sensitive, Streptococcus pyogenes;
• other microorganisms: Mycoplasma pneumoniae, Borrelia burgdorferi, Mycoplasma hominis, Chlamydia trachomatis, Chlamydia psittaci, Chlamydia pneumoniae.

Microorganisms with an initial resistance to the drug:

• gram-positive aerobes: Staphylococcus (methicillin-resistant staphylococci have a very high degree of resistance to the action of macrolides), Enterococcus faecalis;
• gram-positive bacteria that are resistant to erythromycin;
• anaerobes: Bacteroides fragilis.

Streptococcus pneumoniae penicillin-resistant can develop resistance to the action of azithromycin.

The capsule contains lactulose (as a bifidogenic factor). It is a synthetic disaccharide, its molecule consists of fructose and galactose residues. In the stomach and upper intestines, lactulose is not absorbed and does not undergo hydrolysis. After release from the capsule, it is fermented by the normal microflora of the large intestine (as a substrate), while the growth of lactobacilli and bifidobacteria is stimulated.

Due to the hydrolysis of lactulose in the large intestine, organic acids are formed - lactic, acetic and formic. They inhibit the growth of pathogenic microorganisms, which helps to reduce the production of nitrogen-containing toxic substances.

Lactulose, thus, reduces the damaging effect of the antibiotic on the normal intestinal microflora and the likelihood of developing adverse reactions associated with dysbiosis.

Pharmacokinetics

Azithromycin after oral administration is well absorbed and rapidly distributed in the body. Bioavailability after a single dose of 500 mg of the substance is 37% (due to the effect of the first passage through the liver). After taking the specified dose, C _max (maximum concentration) is 0.4 mg / l, the time to reach it is from 2 to 3 hours. The concentration of azithromycin in cells and tissues is 10-50 times higher than serum. V _d (volume of distribution) is 31.1 l / kg. The indicator of binding to plasma proteins is inversely proportional to the concentration of the substance in the blood and ranges from 7 to 50%.

Azithromycin is an acid-fast lipophilic substance. Easily penetrates histohematogenous barriers. It penetrates well into the respiratory tract, urogenital tissues and organs (including the prostate gland, soft tissues and skin). Also, azithromycin is transported to the site of infection by phagocytes (macrophages and polymorphonuclear leukocytes), where it is released in the presence of bacteria. After penetration of the substance through the cell membranes, high concentrations are created in them, which is especially important for the eradication of pathogens located intracellularly.

The concentration of azithromycin in the foci of infection is higher than in healthy tissues by 24–34%. It correlates with the severity of the inflammatory process. After taking the last dose, it remains in effective concentration for 5-7 days.

In the liver, the substance is demethylated. The metabolites that are formed in this case have no activity. In the metabolism of azithromycin, isoenzymes are involved, the inhibitor of which it is - CYP3A4, CYP3A5, CYP3A7.

Plasma clearance of azithromycin is 630 ml / min. Removal of a substance from blood plasma takes place in two stages:

• the first stage: T _1/2 (half-life) in the interval from 8 to 24 hours after administration is 14–20 hours;
• second stage: T _1/2 in the range from 24 to 72 hours after administration is 41 hours.

This allows you to use the drug once a day. More than 50% of the substance is excreted unchanged by the intestines, 6% - by the kidneys.

Food intake has a significant effect on pharmacokinetic parameters. The C _max value increases by 31%, while the AUC value (area under the concentration-time curve) remains unchanged.

In elderly men (from 65 to 85 years), pharmacokinetic parameters do not change, in women of this age group, an increase in C _max is observed by 30-50%.

Indications for use

Azithromycin Ecomed is prescribed for the treatment of infectious and inflammatory diseases caused by microorganisms that are sensitive to its action:

• pharyngitis, sinusitis, tonsillitis, otitis media, acute bronchitis, pneumonia (including caused by atypical pathogens), exacerbation of chronic bronchitis (infections of the upper and lower respiratory tract and ENT organs);
• impetigo, erysipelas, common acne of moderate severity, secondarily infected dermatoses (infections of the skin and soft tissues);
• cervicitis, urethritis (urinary tract infections caused by Chlamydia trachomatis);
• erythema migrans (erythema migrans) - the initial stage of Lyme disease (borreliosis).

Contraindications

Absolute:

• severe hepatic dysfunction;
• renal dysfunction in severe course (in patients with creatinine clearance less than 40 ml / min);
• combination therapy with dihydroergotamine and ergotamine;
• deficiency of sucrase / isomaltase, glucose-galactose malabsorption, fructose intolerance (powder for suspension);
• age up to 6 months (powder for suspension preparation) or up to 12 years with a weight of up to 45 kg (tablets and capsules);
• lactation period;
• individual intolerance to azithromycin, erythromycin, other macrolides / ketolides, as well as auxiliary components of the drug.

Relative (Azithromycin Ecomed is prescribed under medical supervision):

• impaired liver function of mild and moderate course;
• impaired renal function of mild and moderate course (in patients with creatinine clearance of 40 ml / min and above);
• the presence of proarrhythmogenic factors (especially in elderly patients): congenital / acquired lengthening of the QT interval; combined therapy with class IA and III antiarrhythmics, terfenadine, cisapride, antipsychotics, fluoroquinolones, antidepressants; violations of the water and electrolyte balance, especially against the background of hypomagnesemia or hypokalemia; clinically significant bradycardia, severe heart failure, or arrhythmia;
• combined use with digoxin, warfarin, cyclosporin;
• pregnancy.

Azithromycin Ecomed, instructions for use: method and dosage

Azithromycin Ecomed is intended for oral administration.

The drug should be taken once a day one hour before or two hours after a meal.

Recommended dosing regimen for adults and children over 12 years old, weighing more than 45 kg (all dosage forms):

• infections of ENT organs, upper and lower respiratory tract, skin and soft tissues (except for chronic erythema migrans): 3 days in a daily dose of 500 mg;
• acne vulgaris of moderate severity: 3 days at a daily dose of 500 mg, then Azithromycin Ecomed should be used for 9 weeks at 500 mg once every 7 days; the first weekly dose is taken on the eighth day of treatment; course dose - 6000 mg;
• acute infections of the genitourinary organs: once in a dose of 1000 mg;
• Lyme disease (borreliosis) in the treatment of stage I (erythema migrans): 1000 mg on the first day, then 500 mg daily for 4 days; course dose - 3000 mg.

Recommended dosing regimen for children from 6 months (Azithromycin Ekome suspension prepared from powder):

• a course lasting 3 days: daily at 10 mg / kg; course dose 30 mg / kg;
• a course of 5 days (for Lyme disease for the treatment of stage I): on the first day 20 mg / kg, then for four days at 10 mg / kg; course dose 60 mg / kg.

The suspension is prepared as follows, immediately before taking:

1. The powder in the bottle must be shaken vigorously.
2. It is necessary to add 12 ml of boiled water cooled to room temperature to the bottle using a syringe for dosing.
3. The resulting mixture must be mixed until a suspension of uniform consistency is formed.

The finished suspension can be stored for no longer than 5 days in the refrigerator.

Side effects

Possible side reactions of Azithromycin Ecomed (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):

• blood and lymphatic system: infrequently - neutropenia, leukopenia, eosinophilia; very rarely - hemolytic anemia, thrombocytopenia;
• respiratory system: infrequently - nosebleeds, shortness of breath;
• central and peripheral nervous system: often - headache; infrequently - paresthesias, nervousness, dizziness, impaired taste, insomnia, drowsiness; rarely - agitation; with an unknown frequency - fainting, hypesthesia, psychomotor hyperactivity, aggression, anxiety, convulsions, perversion of the sense of smell, loss of smell, myasthenia gravis, loss of taste, hallucinations, delirium;
• cardiovascular system: infrequently - flushing of the face, palpitations; with an unspecified frequency - a decrease in blood pressure, ventricular tachycardia, pirouette-type arrhythmia, an increase in the QT interval on the ECG;
• hepatobiliary system: infrequently - hepatitis; rarely - cholestatic jaundice, liver dysfunction; with an unknown frequency - liver failure (rarely fatal, which usually occurs against the background of severe hepatic dysfunction), fulminant hepatitis, liver necrosis;
• gastrointestinal tract: very often - diarrhea; often - vomiting, nausea, abdominal pain; infrequently - dyspepsia, flatulence, constipation, gastritis, bloating, dysphagia, belching, xerostomia, increased secretion of the salivary glands, ulcers of the oral mucosa; very rarely - pancreatitis, discoloration of the tongue;
• musculoskeletal system: infrequently - myalgia, osteoarthritis, neck and back pain; with an unknown frequency - arthralgia;
• skin and subcutaneous tissues: infrequently - itching, skin rash, dermatitis, urticaria, sweating, dry skin; rarely - photosensitivity reaction; with an unknown frequency - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme;
• genitals and mammary gland: infrequently - dysfunction of the testicles, metrorrhagia;
• kidneys and urinary tract: infrequently - pain in the kidney area, dysuria; with an unknown frequency - acute renal failure, interstitial nephritis;
• immune system: infrequently - hypersensitivity reaction, angioedema; with an unknown frequency - anaphylactic reactions;
• infectious diseases: infrequently - gastroenteritis, candidiasis (including candidiasis of the oral mucosa and genitals), pharyngitis, pneumonia, rhinitis, respiratory diseases; with an unknown frequency - pseudomembranous colitis;
• metabolism and nutrition: infrequently - anorexia;
• organ of sight and hearing: infrequently - visual impairment, hearing impairment, vertigo; with an unspecified frequency - hearing impairment (including tinnitus and / or deafness);
• laboratory data: often - a decrease in the number of lymphocytes, an increase in the number of eosinophils, basophils, neutrophils, monocytes, a decrease in the plasma concentration of bicarbonates in the blood; infrequently - an increase in the activity of aspartate aminotransferase, alanine aminotransferase, an increase in the plasma concentration of bilirubin, urea, creatinine in the blood, a change in the content of potassium and sodium in the blood plasma, an increase in the content of chlorine in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in hematocrit, an increase in the concentration of glucose and bicarbonate in the blood, increased platelet count;
• others: infrequently - malaise, asthenia, fatigue, chest pain, facial edema, peripheral edema, fever.

The frequency and severity of adverse reactions may vary depending on the dosage form of Azithromycin Ecomed.

Overdose

• main symptoms: vomiting, nausea, diarrhea, temporary hearing loss;
• therapy: symptomatic.

special instructions

If a single dose has been missed, it must be taken as early as possible, subsequent doses are taken at intervals of 24 hours.

With the use of antacids, the interval should be observed: Azithromycin Ecomed is taken at least 1 hour before or 2 hours after taking them.

Patients with mild to moderate impairment of hepatic function during the period of therapy should be careful, since taking Azithromycin Ecomed can lead to the development of severe hepatic failure and fulminant hepatitis.

If symptoms of liver dysfunction are present, including rapidly increasing asthenia, jaundice, a tendency to bleeding, dark urine, hepatic encephalopathy, Azithromycin Ecomed is discontinued. In this case, a study of the functional state of the liver is required.

For mild and moderate renal impairment (in patients with creatinine clearance more than 40 ml / min), therapy is carried out under the control of the renal function.

During therapy with Azithromycin Ecomed, it is necessary to regularly examine patients for signs of the development of superinfections (including fungal infections) and the presence of microorganisms resistant to the drug.

The drug should not be taken longer than the recommended period.

During long-term treatment, pseudomembranous colitis caused by Clostridium difficile can develop. Its severity can range from mild diarrhea to severe colitis.

On the background of the use of macrolides, including azithromycin, an increase in the QT interval and cardiac repolarization was observed, while the risk of developing cardiac arrhythmias, including pirouette-type arrhythmias, increased.

Taking Azithromycin Ecomed can cause myasthenic syndrome or exacerbate myasthenia gravis.

5 ml of a suspension containing 100 or 200 mg of azithromycin contains 0.32 and 0.29 XE (bread units), respectively.

Influence on the ability to drive vehicles and complex mechanisms

When driving motor vehicles, you need to take into account the likelihood of disturbances from the organ of vision and the nervous system, which requires caution.

Application during pregnancy and lactation

• pregnancy: the use of Azithromycin Ecomed is possible only if the expected benefit is higher than the possible risk;
• lactation period: breastfeeding should be interrupted during therapy.

Pediatric use

Contraindications to the use of the drug in pediatrics, depending on the dosage form:

• powder for suspension preparation Azithromycin Ecomed: infant age up to 6 months;
• tablets and capsules Azithromycin Ecomed: children up to 12 years old with a child weighing up to 45 kg.

With impaired renal function

• severe renal failure (in patients with creatinine clearance less than 40 ml / min): therapy is contraindicated;
• impaired renal function of mild and moderate course (in patients with creatinine clearance of 40 ml / min and above): Azithromycin Ecomed should be used under medical supervision.

For violations of liver function

• severe hepatic impairment: therapy is contraindicated;
• impaired liver function of mild and moderate course: Azithromycin Ecomed should be used under medical supervision.

Use in the elderly

In elderly patients with persistent proarrhythmogenic factors, caution should be exercised during therapy with Azithromycin Ecomed, which is associated with a high probability of developing arrhythmias, including arrhythmias of the pirouette type.

Drug interactions

• antacid drugs: they have no effect on the bioavailability of azithromycin, however, with combined use, the C _max value in the blood decreases by 30%, therefore, Azithromycin Ecomed is taken at least 60 minutes before or 2 hours after eating and taking these drugs;
• P-glycoprotein substrates (digoxin): there is an increase in their concentration in blood serum;
• zidovudine (from 1000 mg of azithromycin once or repeatedly at a dose of 600 or 1200 mg): azithromycin slightly affects the pharmacokinetic parameters of zidovudine, including the excretion of the substance or its glucuronide metabolite by the kidneys; at the same time, the concentration of phosphorylated zidovudine and its clinically active metabolite increases in peripheral blood mononuclear cells. The clinical significance of this interaction has not been clarified;
• ergot alkaloids: combined use is not recommended, since there is a theoretical possibility of the development of ergotism;
• atorvastatin: during the post-registration observation, some information was obtained about cases of rhabdomyolysis in patients who received azithromycin with statins at the same time;
• cimetidine: if it is used 2 hours before taking Azithromycin Ekomed, the pharmacokinetic parameters of these drugs do not change;
• cyclosporine: in combination therapy with azithromycin, care must be taken, the joint appointment of these drugs requires monitoring the plasma concentration of cyclosporine in the blood and, if necessary, adjusting the dose (associated with a significant increase in C _max in blood plasma and AUC _0-5 cyclosporine);
• terfenadine: no evidence of the development of the interaction was obtained; it was found that with the combined therapy of terfenadine with macrolides, the development of arrhythmias and prolongation of the QT interval is possible.

Analogs

Azithromycin Ecomed analogs are Azibiot, AzitRus Zetamax retard, Suitrox, Hemomycin, Sumamed, Azitral, Sumaclid, Zitnob, Azitrox, Zitrocin, Azithromycin, Sumamox, Zitrolide, Ziromin, Azivok.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

The finished suspension should be stored in a tightly closed bottle for no longer than 5 days at a temperature of 2-8 ° C.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Azithromycin Ecomed

Patients leave mostly positive reviews about Azithromycin Ecomed. The drug is characterized as inexpensive and effective. Suspension responses are the most common. The convenience of the release form, pleasant taste, and good solubility are noted.

In rare cases, insufficient therapeutic effect or its absence is indicated. The main disadvantage is most often referred to as adverse reactions from the digestive system.

Price for Azithromycin Ecomed in pharmacies

The approximate price for Azithromycin Ecomed powder for suspension preparation for 1 bottle is: 100 mg / 5 ml - 151 rubles, 200 mg / 5 ml - 227 rubles; tablets of 500 mg, 3 pcs. in the package - 161 rubles; capsules of 250 mg, 6 pcs. in the package - 132 rubles.

Azithromycin Ecomed: prices in online pharmacies

Drug name Price Pharmacy

Azithromycin Ecomed 250 mg capsules 6 pcs. 120 RUB Buy

Azithromycin Ecomed 100 mg / 5 ml powder for suspension for oral administration 16.5 g 1 pc. 131 r Buy

Azithromycin ecomed since. d / inv. suspension for oral administration 100mg / 5ml fl. 16.5g No. 1 (with dosing syringe) 147 RUB Buy

Azithromycin ecomed tab. p / o captivity. 250mg No. 6 151 RUB Buy

Azithromycin Ecomed 250 mg film-coated tablets 6 pcs. 166 r Buy

Azithromycin Ecomed 200 mg / 5 ml powder for suspension for oral administration 16.5 g 1 pc. 196 r Buy

Azithromycin Ecomed 500 mg film-coated tablets 3 pcs. 201 RUB Buy

Azithromycin ecomed since. d / inv. suspension d / oral administration 200mg / 5ml fl. 16.5g No. 1 (with dosing syringe) 259 r Buy

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!