Azitrox - Instruction, Use For Children, Price, Suspension, Capsules

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

Azitrox

Azitrox: 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. Special instructions
8. 8. Application during pregnancy and lactation
9. 9. Use in childhood
10. 10. In case of impaired renal function
11. 11. For violations of liver function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Azitrox

ATX code: J01FA10

Active ingredient: azithromycin (Azithromycin)

Manufacturer: Pharmstandard-Leksredstva (Russia)

Description and photo update: 2019-20-08

Prices in pharmacies: from 49 rubles.

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Azitrox is a broad spectrum antibiotic.

Release form and composition

Dosage forms of Azitrox:

• capsules 250 mg - white, size No. 0; the contents of the capsules are white or white with a yellowish tinge powder (in a cardboard box 1, 2, 6 or 12 blisters of 6 or 10 capsules);
• capsules 500 mg - hard gelatinous, size No. 00, white body and yellow lid (in a cardboard box 1, 2, 6 or 12 blisters of 2, 3, 6 or 10 capsules);
• powder for preparation of suspension for oral administration 100 mg / 5 ml or 200 mg / 5 ml: white or white with a yellowish or creamy tinge, or light yellow, granular / crystalline powder with a slight fruity odor; the prepared suspension has a characteristic fruity odor and a uniform consistency from white or light gray with a yellowish or creamy shade to light yellow (in a cardboard box 1 bottle of 15.9 g, complete with a pipette and a measuring spoon for dosing).

Composition of 1 capsule:

• active substance: azithromycin - 250 or 500 mg (in the form of azithromycin dihydrate);
• auxiliary components: mannitol (mannitol), corn starch, magnesium stearate, sodium lauryl sulfate;
• capsule body and cap: titanium dioxide (E171), medical gelatin; additionally for capsules of 500 mg - sunset yellow dye (E110), quinoline yellow dye (E104).

Powder composition for suspension preparation for 1 bottle:

• active substance: azithromycin - 400 or 800 mg (in the form of azithromycin dihydrate - 419.3 or 838.6 mg);
• auxiliary components: sucrose, sodium carbonate, xanthan gum, hyprolose, Banana, Vanilla and Cherry flavoring.

Pharmacological properties

Pharmacodynamics

Azithromycin is a broad-spectrum antibiotic, a representative of the macrolide antibiotic subgroup - azalides. Due to the binding with the 50S ribosome subunit, it inhibits peptide translocase at the translation stage, inhibits protein synthesis, and slows down the growth and reproduction of bacteria. Azitrox acts bacteriostatically on intra- and extracellular pathogens, and has bactericidal properties in high concentrations.

Microflora, in relation to which azithromycin is active:

• gram-positive aerobic microorganisms: Streptococcus pyogenes, Streptococcus spp. (groups A, B, C, G), Streptococcus pneumoniae (penicillin-sensitive), Staphylococcus aureus (methicillin-sensitive);
• gram-negative aerobic microorganisms: Haemophilus parainfluenzae, Haemophilus influenzae, Pasteurella multocida, Moraxella catarrhalis, Neisseria gonorrhoeae, Legionella pneumophila;
• some anaerobic microorganisms: Fusobacterium spp., Clostridium perfringens, Prevotella spp., Porphyromonas spp.;
• other microorganisms: Borrelia burgdorferi, Chlamydia trachomatis, Chlamydia psittaci, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumonia.

Microorganisms that can develop resistance to azithromycin: gram-positive aerobes (Streptococcus pneumoniae penicillin-resistant).

Microorganisms initially resistant to Azitrox: aerobic gram-positive microorganisms, including Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus aureus (methicillin-resistant strains), Enterococcus faecalis; anaerobic microorganisms, including Bacteroides fragilis.

Pharmacokinetics

Azithromycin is rapidly absorbed from the gastrointestinal tract (GIT). This is due to its lipophilicity and stability in an acidic environment. After oral administration of 500 mg, the maximum plasma concentration of azithromycin in the blood is reached in 2.5–3 hours, its value is 0.4 mg / l. Bioavailability - 37%.

Azithromycin is able to penetrate well into the respiratory tract, tissues and organs of the urogenital tract (including the prostate gland), soft tissues and skin. The high concentration of the substance in the tissues (10-50 times higher than the plasma level) and the long half-life are a consequence of the low binding of the substance to blood plasma proteins. They are also due to the ability of azithromycin to penetrate into eukaryotic cells and concentrate in the low pH environment surrounding the lysosome. In turn, this determines a high plasma clearance and a large apparent volume of distribution (31.1 l / kg). The ability of a substance to accumulate, mainly in lysosomes, with the aim of eliminating intracellular pathogens is considered especially important. It has been established that azithromycin is delivered to the sites of infection localization by phagocytes,where the substance is released during phagocytosis. In the foci of infection, the concentration of azithromycin significantly exceeds that in healthy tissues (on average, by 24–34%). It correlates with the degree of inflammatory edema.

Azithromycin has no significant effect on the function of phagocytes. The substance remains in bactericidal concentrations in the inflammation focus after taking the last dose for 5–7 days, which allows it to be used in short courses (3 and 5 days each).

Demethylated in the liver, the resulting metabolites are inactive.

Removal from blood plasma takes place in 2 stages:

• interval 8-24 hours after administration: half-life - 14-20 hours;
• interval 24–72 hours after administration: half-life - 41 hours.

This allows Azitrox to be used once a day.

Azithromycin is excreted mainly unchanged by the kidneys and intestines (12 and 50%, respectively).

Indications for use

According to the instructions, Azitrox is used for the following diseases:

• Inflammation of the respiratory tract (tonsillitis, pharyngitis, otitis media, sinusitis);
• ENT infections (bronchitis and exacerbation of chronic bronchitis, hospital or community-based pneumonia);
• Sexually transmitted diseases;
• Lesions of the skin and soft tissues (impetigo, erysipelas, chronic erythema migrans, secondary pyodermal dermatoses);
• Duodenal and gastric infections caused by Helicobacter pylori.

Contraindications

Absolute:

• combination therapy with ergotamine and dihydroergotamine;
• severe renal failure (with creatinine clearance less than 40 ml / min);
• severe hepatic impairment (more than 9 points on the Child-Pugh scale);
• fructose intolerance, sucrase / isomaltase deficiency, glucose-galactose malabsorption (powder for suspension);
• age up to 6 months (powder for suspension preparation);
• age up to 12 years and / or body weight less than 45 kg (capsules);
• individual intolerance to the components of the drug, including other macrolides.

Relative (Azitrox is prescribed under medical supervision):

• moderate impairment of hepatic function (7-9 points on the Child-Pugh scale);
• chronic renal failure (with creatinine clearance more than 40 ml / min);
• arrhythmias or predisposition to arrhythmias and prolongation of the QT interval;
• prolongation of the QT interval, as well as the presence of risk factors for prolongation of the QT interval, including hypokalemia / hypomagnesemia, clinically significant bradycardia or severe heart failure, combined therapy with cisapride, class IA, III antiarrhythmics (500 mg capsules, powder for suspension preparation);
• combined use with terfenadine, warfarin, digoxin;
• myasthenia gravis;
• diabetes mellitus (powder for suspension preparation);
• pregnancy.

Instructions for the use of Azitrox: method and dosage

Children and adults should take Azitrox one hour before meals or two hours after meals no more than once a day. This is due to the long period of elimination of the drug from the body.

The capsules should be swallowed whole. A suspension is prepared from the powder: water (distilled or boiled and cooled) in a volume of 9.5 ml is added to the bottle, then thoroughly shaken until a homogeneous suspension is obtained. The volume of the finished product will be 20 ml. Shake the bottle well before each dose of the Azitrox suspension. For ease of dosing, use a measuring spoon or pipette. Immediately after taking the drug, you need to drink a few sips of water in order to wash off its remnants in the mouth and swallow.

The average therapeutic dose is 250-500 mg, depending on the indications, is selected by the doctor on an individual basis.

The daily dose of Azitrox depends on the indications and ranges from 500 mg to 1000 mg.

Side effects

During the use of Azitrox, side reactions may occur, most of which are not grounds for stopping treatment, but only require a reduction in dosage. Among them:

• Vomiting, nausea, diarrhea, bloating, and abdominal pain;
• Headache, neutropenia, dizziness, eosinophilia, arthralgia;
• Vaginitis, agitation, angioedema, nervousness, insomnia, paresthesia, hypotension, chest pain, palpitations, erythema, lesions of the skin and mucous membranes.

Typical symptoms of an azithromycin overdose are partial hearing loss, vomiting, nausea, diarrhea. In this case, the appointment of activated carbon, gastric lavage and symptomatic therapy are indicated.

special instructions

Since the simultaneous intake of Azitrox with food reduces and slows down the absorption of azithromycin in the gastrointestinal tract, it should not be taken with food.

If you skip the next dose of the drug, the missed dose must be taken as early as possible, and the subsequent ones should be taken at an interval of 24 hours.

During the use of Azitrox, both against the background of its intake and 2–3 weeks after the completion of the course, pseudomembranous colitis (diarrhea caused by Clostridium difficile) may develop. With a mild course of the disease, it is enough to cancel Azitrox and prescribe ion exchange resins (colestyramine, colestipol). In the case of severe diarrhea, it is recommended to replace the loss of fluid, electrolytes and protein; requires vancomycin, bacitracin, or metronidazole. Medicines that suppress intestinal motility are categorically unacceptable.

The consequence of taking Azitrox may be the development of myasthenic syndrome or exacerbation of the existing myasthenia gravis.

If hypersensitivity reactions persist in some patients after discontinuation of treatment, appropriate therapy is required under medical supervision.

Influence on the ability to drive vehicles and complex mechanisms

If during the period of use of Azitrox there are side reactions from the central nervous system, patients are advised to refrain from driving vehicles.

Application during pregnancy and lactation

During pregnancy, Azitrox can be prescribed after evaluating the ratio of the expected benefit to the possible risk. There is no information confirming an increase in the frequency of adverse pregnancy outcomes and the occurrence of any specific malformations in a child while using the drug.

The World Health Organization (WHO) European Office for the treatment of chlamydial infection in pregnant women recommends azithromycin as the drug of choice.

Azithromycin therapy is contraindicated during lactation.

Pediatric use

In pediatric practice, it is contraindicated to use powder for the preparation of Azitrox suspension for children under 6 months.

The appointment of Azitrox capsules for children under 12 years of age with a body weight of less than 45 kg is prohibited.

With impaired renal function

• severe renal failure (with creatinine clearance less than 40 ml / min): drug therapy is contraindicated;
• chronic renal failure (with creatinine clearance more than 40 ml / min): Azitrox should be used under medical supervision.

For violations of liver function

• severe hepatic failure (more than 9 points on the Child-Pugh scale): drug therapy is contraindicated;
• moderate impairment of hepatic function (7-9 points on the Child-Pugh scale): Azitrox should be used under medical supervision.

Use in the elderly

Elderly age is a risk factor for QT interval prolongation, which must be taken into account when using Azitrox.

Drug interactions

• antacids containing aluminum and magnesium: the maximum concentration of azithromycin is significantly reduced, and therefore Azitrox should be taken 60 minutes or 2 hours after using these drugs;
• cyclosporine: it is recommended to monitor its concentration in the blood;
• indirect anticoagulants (warfarin and other coumarin-type antithrombotic substances): prothrombin time control is recommended;
• derivatives of ergotamine and dihydroergotamine: their toxic effect may increase;
• digoxin: it is necessary to monitor its concentration in the blood;
• terfenadine, cisapride: the likelihood of developing arrhythmias and prolongation of the QT interval increases;
• nelfinavir: an increase in the frequency of side effects of azithromycin is possible (manifested in the form of hearing loss, increased activity of hepatic transaminases);
• zidovudine: in monocytes, the concentration of its active metabolite, phosphorylated zidovudine, increases;
• cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs, the metabolism of which occurs with the participation of the enzyme of the isoenzyme CYP3A4: with combined use, the possibility of inhibition of this isoenzyme by azithromycin should be taken into account.

Analogs

Azitrox analogs are Zetamax retard, Tremak-Sanovel, Sumametsin, AzitRus, ZI-Factor, Azithromycin, Hemomycin, Zitrolide, Sumamox, Azitral, Sumaklid, Zitrocin, Sumamed, Zitnob, Azivok, Azidrop, Ecomed, etc., Azibiot.

Terms and conditions of storage

Store in a dry, dark place at an air temperature of 15-25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

The suspension prepared from the powder should be stored for no more than 5 days in its original packaging at temperatures up to 25 ° C. Do not freeze.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Azitrox

According to reviews, Azitrox is an effective fast-acting antibiotic. Of the advantages indicate a convenient dosing regimen and a short course of therapy. Among the disadvantages, patients include the high cost of the drug, the short shelf life of the suspension after preparation, and the development of side effects.

Price for Azitrox in pharmacies

The approximate price for Azitrox is:

• powder for preparation of suspension for oral administration: 1 bottle 100 mg / 5 ml - 162-186 rubles; 1 bottle 200 mg / 5 ml - 256–304 rubles;
• capsules 250 mg: 6 pcs. - 259-344 rubles;
• capsules 500 mg: 2 pcs. - 183-215 3 pcs. 282-318 rubles.

Azitrox: prices in online pharmacies

Drug name Price Pharmacy

Azitrox 100 mg / 5 ml powder for suspension for oral administration 15.9 g 1 pc. RUB 49 Buy

Azitrox 200 mg / 5 ml powder for suspension for oral administration 15.9 g 1 pc. RUB 99 Buy

Azitrox 500 mg capsules 2 pcs. RUB 185 Buy

Azitrox 250 mg capsules 6 pcs. RUB 200 Buy

Azitrox powder for suspension for internal approx. 100mg / 5ml 15.9g 204 RUB Buy

Azitrox capsules 500mg 2 pcs. 213 r Buy

Azitrox 500 mg capsules 3 pcs. RUB 298 Buy

Azitrox powder for suspension for internal approx. 200mg / 5ml 15.9g with measuring spoon and pipette for dosing 327 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!