AZITHROMYCIN ECOMED por. d/prig. susp. 200 mg/5 ml vial. 16.5 g

Azithromycin Ecomed - Suspension

Home / Ecoanalogues / Azithromycin Ecomed / Suspension

A broad-spectrum antibacterial drug from the group of macrolides-azalides, it acts bacteriostatically. By binding to the 50S ribosomal subunit, it inhibits peptide translocase at the translation stage, suppresses protein synthesis, slows down the growth and reproduction of bacteria, and in high concentrations has a bactericidal effect. Acts on extra- and intracellularly located pathogens. Azithromycin Ecomed can be considered as the drug of choice for patients with an allergy to β-lactam antibiotics in respiratory pathology, especially in people with an increased risk of developing dysbiosis.

Registration number: Trade name of the drug: Azithromycin Ecomed® International non-proprietary or generic name: azithromycin Dosage form: powder for the preparation of a suspension for oral administration. Description: White or yellowish-white powder with a faint fruity odor. Ready suspension: white to light yellow, homogeneous with a faint fruity odor. Pharmacotherapeutic group: antibiotic – azalide. ATX code: J01FA10

Expand all

Composition Expand

5 ml of the finished suspension (one dosage spoon) contains: Active substance: azithromycin dihydrate (in terms of azithromycin) - 100 mg/200 mg; Excipients: lactitol – 200.0 mg/400.0 mg, xanthan gum – 15.0 mg/15.0 mg, crospovidone (Kollidon CL-M) – 65.0 mg/65.0 mg, colloidal silicon dioxide ( aerosil) – 5.5 mg/5.5 mg, anhydrous sodium carbonate – 83.0 mg/83.0 mg, sodium benzoate – 16.5 mg/16.5 mg, titanium dioxide – 10.0 mg/10, 0 mg, strawberry flavor – 55.0 mg/55.0 mg, mint 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.

Pharmacological action Expand

A broad-spectrum antibacterial drug from the group of macrolides-azalides, has a bacteriostatic effect. By binding to the 50S ribosomal subunit, it inhibits peptide translocase at the translation stage, suppresses protein synthesis, slows down the growth and reproduction of bacteria, and in high concentrations has a bactericidal effect. Acts on extra- and intracellularly located pathogens. Microorganisms may be initially resistant to the action of an antibiotic or may acquire resistance to it. Scale of sensitivity of microorganisms to azithromycin (Minimum inhibitory concentration, mg/l): Staphylococcus: sensitive ≥1 mg/l, resistant >2 mg/l; Streptococcus A, B, C, G: sensitive ≤0.25 mg/l, resistant >0.5 mg/l; Streptococcus pneumoniae: sensitive ≥0.25 mg/l, resistant >0.5 mg/l; Haemophilus influenzae: sensitive ?0.12 mg/l, resistant >4 mg/l; Moraxella catarrhalis: sensitive ≤0.5 mg/l, resistant >0.5 mg/l; Neisseria gonorrhoeae: sensitive ≤0.25 mg/l, resistant >0.5 mg/l; 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).

Resistant:

• aerobic gram-positive microorganisms: Enterococcus faecalis, Staphylococci spp. (methicillin-resistant).

• anaerobes: Bacteroides fragilis group. Streptococcus pneumoniae, beta-hemolytic Streptococcus spp. group A, Enterococcus faecalis and Staphylococcus aureus (including methicillin-sensitive strains), resistant to erythromycin and other macrolides, lincosamides, and resistant to azithromycin.

Pharmacokinetics Expand

After oral administration, azithromycin is well absorbed and quickly distributed in the body. Bioavailability after a single dose of 0.5 g is 37% (the “first pass” effect through the liver), maximum concentration (Cmax) after oral administration of 0.5 g is 0.4 mg/l, time to reach maximum concentration (TCmax) is 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 remains 7-50%. Azithromycin is acid-stable and lipophilic. Easily passes through histohematic barriers, penetrates well into the respiratory tract, internal organs and tissues, including the prostate gland, skin and soft tissues. It is also transported to the site of infection by phagocytes, polymorphonuclear leukocytes and macrophages, where it is released in the presence of bacteria. Penetrates through 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. Remains in effective concentrations for 5-7 days after taking the last dose. It is demethylated in the liver, the resulting metabolites are not active. The metabolism of the drug involves isoenzymes CYP3A4, CYP3A5, CYP3A7, of which it is an inhibitor. Plasma clearance - 630 ml/min: half-life between 8 and 24 hours after administration - 14-20 hours, half-life in the range from 24 to 72 hours - 41 hours. More than 50% of the drug is excreted through the intestines unchanged, 6% - kidneys. Food intake significantly changes pharmacokinetics: Cmax increases (by 31%), the area under the concentration-time curve (AUC) does not change. In elderly men (65-85 years old), the pharmacokinetic parameters do not change; in women, Cmax increases (by 30-50%).

Indications for use Expand

Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:

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

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

• infections of the skin and soft tissues: erysipelas, impetigo, secondary infected dermatoses;

• the initial stage of Lyme disease (borreliosis) – erythema migrans;

Contraindications Expand

Contraindications:

• hypersensitivity to azithromycin (including other macrolides) or other components of the drug;

• severe renal failure (creatinine clearance (CC) less than 40 ml/min);

• severe liver failure (class C on the Child-Pugh scale);

• breast-feeding;

• simultaneous use with ergotamine and dihydroergotamine;

• children up to 6 months;

• sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully:

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

• liver failure (class A and B on the Child-Pugh scale);

• with arrhythmias or predisposition to arrhythmias and prolongation of the QT interval;

• with the combined use of terfenadine, warfarin, digoxin;

• myasthenia gravis.

Use during pregnancy and lactation Expand

Azithromycin is recommended to be prescribed during pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. During treatment with azithromycin, breastfeeding is suspended.

Dosing regimen Expand

Azithromycin Ecomed® in the form of an oral suspension is prescribed to children from 6 months. 3-day course: at the rate of 10 mg/kg 1 time per day (course dose 30 mg/kg). 5-day course: for Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) in children, the dose is 20 mg/kg on the first day and 10 mg/kg from days 2 to 5 of the disease; course dose 60 mg/kg. Method of preparing the suspension The suspension is prepared immediately before use. The powder in the bottle is first shaken, 12 ml of boiled and cooled to room temperature water is added using a dosing syringe, mixed to obtain a homogeneous suspension. To accurately dose the suspension, use a double-sided dosing spoon or syringe, which should be rinsed well with water after each use. After dilution, the prepared suspension should be stored for no more than 5 days in the refrigerator, but not frozen.

Side effect Expand

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, loose stools, flatulence, indigestion, anorexia, constipation, discoloration of the tongue, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory parameters of liver function, liver failure, liver necrosis (possibly fatal), hyperbilirubinemia, pancreatitis, fulminant hepatitis. Allergic reactions: itching, skin rashes, angioedema, urticaria, photosensitivity, anaphylactic reaction (in rare cases fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. From the cardiovascular system: palpitations, arrhythmia, ventricular tachycardia, increased QT interval, bidirectional ventricular tachycardia, decreased blood pressure. From the nervous system: dizziness/vertigo, headache, convulsions, drowsiness, paresthesia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness, fainting, myasthenia. From the senses: tinnitus, reversible hearing loss up to deafness (when taking high doses for a long time), impaired perception of taste and smell, impaired clarity of visual perception. From the hematopoietic organs: thrombocytopenia, neutropenia. Eosinophilia, lymphopenia, hemolytic anemia. From the musculoskeletal system: arthralgia. From the genitourinary system: interstitial nephritis, acute renal failure, increased concentrations of urea and creatinine in the blood plasma. Other: vaginitis, candidiasis, weakness, peripheral edema, malaise.

Overdose Expand

Symptoms: temporary hearing loss, nausea, vomiting, diarrhea. Treatment is symptomatic.

Interaction with other drugs Expand

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 administration should be 1 hour before or 2 hours after taking these drugs. When used simultaneously with ergotamine and dihydroergotamine derivatives, the toxic effect of the latter may be enhanced (vasospasm, dysesthesia). When used together with indirect coumarin anticoagulants (warfarin), patients need careful monitoring of prothrombin time. Caution must be exercised when co-administering terfenadine and azithromycin, since concomitant use of terfenadine and macrolides has been found to cause arrhythmia and prolongation of the QT interval. Based on this, the above complications cannot be excluded when taking terfenadine and azithromycin together. When used simultaneously with cyclosporine, it is necessary to monitor the concentration of cyclosporine in the blood. When used simultaneously with digoxin, it is necessary to control the concentration of digoxin in the blood (it is possible to increase the absorption of digoxin in the intestine). When used simultaneously with nelfinavir, it is possible to increase the frequency of adverse reactions of azithromycin (decreased hearing, increased activity of liver transaminases). When used simultaneously with zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or the renal excretion of it 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 has not been determined. The possibility of inhibition of the CYP3A4 isoenzyme by azithromycin should be taken into account when used simultaneously with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs whose metabolism occurs with the participation of this enzyme. Azithromycin does not affect the blood concentrations of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim/sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin and methylprednisolone when used simultaneously.

Special instructions Expand

If a dose is missed, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart. Azithromycin should be taken 1 hour before or 2 hours after taking antacid medications. Use with caution in patients with moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe liver failure. If there are symptoms of liver dysfunction (rapidly increasing asthenia, jaundice, darkening of urine, tendency to bleeding, hepatic encephalopathy), azithromycin therapy should be discontinued and a study of the functional state of the liver should be performed. In case of moderate renal failure (creatinine clearance more than 40 ml/min), the use of azithromycin should be carried out under the control of renal function. Concomitant use of azithromycin with ergotamine and dihydroergotamine derivatives is contraindicated due to the possible development of ergotism. When using the drug, both while taking it and 2-3 weeks after stopping treatment, diarrhea caused by Clostridium difficile (pseudomembranous colitis) may develop. In mild cases, it is sufficient to discontinue treatment and use ion-exchange resins (colestyramine, colestipol); in severe cases, replacement of loss of fluid, electrolytes and protein, and the appointment of vancomycin, bacitracin or metronidazole are indicated. Do not use medications that inhibit intestinal motility. Since QT interval prolongation is possible in patients receiving macrolides, caution should be exercised when using azithromycin in patients with known risk factors for QT interval prolongation: advanced age; electrolyte imbalance (hypokalemia, hypomagnesemia); congenital long QT syndrome; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous use of drugs that can prolong the QT interval (including antiarrhythmic drugs of classes IA and III, tricyclic and tetracyclic antidepressants, antipsychotics, fluoroquinolones). When using azithromycin, myasthenic syndrome or exacerbation of myasthenia may develop. Effect on the ability to drive vehicles and machinery During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form Expand

Powder for the preparation of suspension for oral administration 100 mg/5 ml, 200 mg/5 ml. 16.5 g in 60 ml dark glass bottles with a screw-on plastic cap. One bottle along with a double-sided dosing spoon (small with a capacity of 2.5 ml, large - 5 ml), a syringe for dosing and instructions for use are placed in a cardboard pack.

Expiration date Expand

2 years. Ready suspension – 5 days. Do not use after expiration date.

Storage conditions Expand

In a place protected from moisture and light at a temperature not exceeding 25 ° C. The finished suspension is stored at a temperature from 2? C to 8? C in a tightly closed bottle. Keep out of the reach of children.

Vacation conditions Expand

On prescription.

Owner of the registration certificate Expand

JSC "AVVA RUS", Russia, 121614 Moscow, st. Krylatsky Hills. 30, bldg. 9. Tel. www.avva-rus.ru

Manufacturer/organization receiving claims Expand

JSC "AVVA RUS", Russia, 610044 Kirov, st. Luganskaya, 53A. Tel., www.avva-rus.ru, www.ecoantibiotic.ru Send consumer complaints to the manufacturer.

Share information:

Azithromycin: indications for use and contraindications

The manufacturer's instructions for the drug indicate the following pathologies for which the drug is sufficiently effective:

• inflammatory processes in the respiratory tract, with the formation of sinusitis, tonsillitis, pharyngitis, laryngitis, otitis media, pneumonia or exacerbation of chronic bronchitis;
• damage to the genitourinary tract without secondary complications - urethritis, cervicitis;
• infection of the dermis and soft tissues - infectious superficial pyoderma, erysipelas, dermatitis;
• initial borreliosis, scarlet fever, gastrointestinal pathologies associated with Helicobacter pylori.

The medication is not prescribed for complex diseases of the kidneys, liver, or allergic reactions to macrolides. The suspension is not used for babies weighing no more than 5 kg, and tablets and capsules - less than 45 kg.