Azithromycin Forte-OBL, 500 mg, film-coated tablets, 3 pcs.


Azithromycin Forte-OBL, 500 mg, film-coated tablets, 3 pcs.

Pharmaceutical action: Broad-spectrum antibacterial agent, azalide, 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 intracellular pathogens. Active against gram-positive microorganisms: Streptococcus spp. (groups C, F and G, except those resistant to erythromycin), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans group, Staphylococcus epidermidis, Staphylococcus aureus; gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Prevotella bivia, Clostridium perfringens, Peptostreptococcus spp; as well as Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycobacterium avium complex, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. Inactive against gram-positive bacteria resistant to erythromycin. Pharmacokinetics: Absorption - high, acid-stable, lipophilic. Bioavailability after a single dose of 0.5 g is 37% (the “first pass” effect through the liver), Cmax after oral administration of 0.5 g is 0.4 mg/l, TCmax is 2.5-2.9 hours; in tissues and cells the concentration is 10-50 times higher than in blood serum, the volume of distribution is 31.1 l/kg. Easily passes histohematic barriers. Penetrates well into the respiratory tract, genitourinary organs and tissues, into the prostate gland, into the skin and soft tissues; accumulates in an environment with low pH, in lysosomes (which is especially important for the eradication of intracellular pathogens). It is also transported by phagocytes, polymorphonuclear leukocytes and macrophages. Penetrates through cell membranes and creates high concentrations in them. The concentration in foci of infection is significantly higher (24-34%) than in healthy tissues, and correlates with the severity of inflammatory edema. At the site of inflammation, it remains in effective concentrations for 5-7 days after taking the last dose. Bonding with plasma proteins is 7-50% (inversely proportional to blood concentration). 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: T1/2 between 8 and 24 hours after administration - 14-20 hours, T1/2 in the range from 24 to 72 hours - 41 hours. 50% is excreted in bile unchanged, 6% - kidneys. Food intake significantly changes pharmacokinetics (depending on the dosage form): capsules - Cmax decreases (by 52%) and AUC (by 43%); suspension - Cmax increases (by 46%) and AUC (by 14%); tablets - Cmax increases (by 31%), AUC does not change. In elderly men (65-85 years), the pharmacokinetic parameters do not change; in women, Cmax increases (by 30-50%), in children aged 1-5 years, Cmax, T1/2, and AUC decrease.

Azithromycin Forte-OBL tablet film 500 mg x3

Azithromycin Forte tablet film 500 mg x3, ATX code: J01FA10 (Azithromycin) Active substance: azithromycin (azithromycin) Rec.INN registered by WHO

Dosage form

AZITHROMYCIN FORTE

tab., cover film coating, 500 mg: 3 or 6 pcs.reg. No.: LSR-009004/10 from 09/11/12 - Indefinitely

Release form, composition and packaging

Tablets, film-coated, white or white with a yellowish tint, oval.

1 tab.

azithromycin (dihydrate) 500 mg

Excipients: calcium stearate, starch 1500, potato starch, crospovidone (kollidon CL-M), povidone (polyvinylpyrrolidone), lactose, talc, microcrystalline cellulose.

Shell composition: hypromellose (hydroxypropyl methylcellulose), macrogol (polyethylene oxide 4000, polyethylene glycol 4000), titanium dioxide (titanium dioxide).

Clinical-pharmacological group: Antibiotic of the macrolide group - azalide Pharmaco-therapeutic group: Antibiotic, azalide The scientific information provided is general and cannot be used to make a decision on the possibility of using a specific drug.

pharmachologic effect

An antibiotic of the macrolide group, a representative of the azalides. Suppresses RNA-dependent protein synthesis of sensitive microorganisms.

Active against gram-positive bacteria: Staphylococcus aureus, Streptococcus spp. (including Streptococcus pneumoniae, streptococcus pyogenes /group A /), gram -negative bacteria: haemophilus influenzae, haemophilus parainfluenzae, haemophilus ducreyi, Moraxella Catarhaalhal IS, Escherichia Coli, Bordetella Pertussis, Bordetella Paratussis, Borrelia Burgdorferi, Neisseria Gonorrhoeae, Campylobacter SPP. , Legionella pneumophila, anaerobic bacteria: Bacteroides fragilis.

Azithromycin is also active against Chlamydia trachomatis, Mycoplasma pneumoniae, Mycoplasma hominis, Treponema pallidum.

Also active against Toxoplasma gondii.

Pharmacokinetics: Rapidly absorbed from the gastrointestinal tract. Eating reduces the absorption of azithromycin. Cmax in plasma is achieved after 2-3 hours. It is quickly distributed in tissues and biological fluids. 35% of azithromycin is metabolized in the liver by demethylation. More than 59% is excreted unchanged in bile, about 4.5% is excreted unchanged in urine.

Indications Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin, incl. bronchitis, pneumonia, skin and soft tissue infections, otitis media, sinusitis, pharyngitis, tonsillitis, gonorrheal and non-gonorrheal urethritis and/or cervicitis, Lyme disease (borreliosis). ICD-10 codes

Dosage regimen

They are established individually, taking into account the nosological form, the severity of the disease and the sensitivity of the pathogen.

Adults orally - 0.25-1 g 1 time / day, children - 5-10 mg/kg 1 time / day. Duration of treatment is 2-5 days.

Side effect

From the digestive system: nausea, vomiting, flatulence, diarrhea, abdominal pain, transient increase in the activity of liver enzymes, rarely - cholestatic jaundice.

Allergic reactions: rarely - skin rash, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Dermatological reactions: rarely - photosensitivity.

From the side of the central nervous system: dizziness, headache, rarely - drowsiness, weakness.

From the hematopoietic system: rarely - leukopenia, neutropenia, thrombocytopenia.

From the cardiovascular system: rarely - chest pain.

From the genitourinary system: vaginitis, rarely - candidiasis, nephritis, increased residual urea nitrogen.

Other: rarely - hyperglycemia, arthralgia.

Contraindications for use: Hypersensitivity to azithromycin and other macrolide antibiotics.

Use during pregnancy and breastfeeding

Azithromycin penetrates the placental barrier. Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use azithromycin during lactation, the issue of stopping breastfeeding should be decided.

Use for liver dysfunction It is not recommended for use in patients with liver dysfunction.

Use for impaired renal function Use with caution in impaired renal function.

Use in children

Application is possible according to the dosage regimen.

special instructions

Not recommended for use in patients with impaired liver function.

Use with caution in case of impaired renal function.

Azithromycin should be taken at least 1 hour before or 2 hours after meals or antacids.

Drug interactions

When used simultaneously with ergot alkaloids, the risk of developing ergotism cannot be excluded.

With simultaneous use of azithromycin with warfarin, cases of increased effects of the latter have been described.

With the simultaneous use of digoxin or digitoxin with azithromycin, a significant increase in the concentration of cardiac glycosides in the blood plasma and the risk of developing glycoside intoxication are possible.

When used simultaneously with disopyramide, a case of the development of ventricular fibrillation has been described.

When used simultaneously with lovastatin, cases of rhabdomyolysis have been described.

When used simultaneously with rifabutin, the risk of developing neutropenia and leukopenia increases.

With simultaneous use, the metabolism of cyclosporine is disrupted, which increases the risk of developing side and toxic reactions caused by cyclosporine.

Comparison of the safety of Azithromycin forte-obi and Azithromycin-obi

The safety of a drug includes many factors.

At the same time, for Azithromycin forte-obi it is higher than for Azithromycin-obi. It is important where the drug is metabolized: drugs are excreted from the body either unchanged or in the form of products of their biochemical transformations. Metabolism occurs spontaneously, but most often involves major organs such as the liver, kidneys, lungs, skin, brain and others. When assessing the metabolism of Azithromycin forte-obi, as well as Azithromycin-obi, we look at which organ is the metabolizing organ and how critical the effect on it is.

The risk-benefit ratio is when the prescription of a drug is undesirable, but justified under certain conditions and circumstances, with the obligatory observance of caution in use. At the same time, Azithromycin forte-obi has fewer risks when used than Azithromycin-obi.

Also, when calculating safety, it is taken into account whether only allergic reactions occur or possible dysfunction of the main organs. In other matters, as well as the reversibility of the consequences of using Azithromycin forte-obi and Azithromycin-obi.

Azithromycin Forte-OBL

Azithromycin Forte tablet film 500 mg x3, ATX code: J01FA10 (Azithromycin) Active substance: azithromycin (azithromycin) Rec.INN registered by WHO

Dosage form

AZITHROMYCIN FORTE

tab., cover film coating, 500 mg: 3 or 6 pcs.reg. No.: LSR-009004/10 from 09/11/12 - Indefinitely

Release form, composition and packaging

Tablets, film-coated, white or white with a yellowish tint, oval.

1 tab.

azithromycin (dihydrate) 500 mg

Excipients: calcium stearate, starch 1500, potato starch, crospovidone (kollidon CL-M), povidone (polyvinylpyrrolidone), lactose, talc, microcrystalline cellulose.

Shell composition: hypromellose (hydroxypropyl methylcellulose), macrogol (polyethylene oxide 4000, polyethylene glycol 4000), titanium dioxide (titanium dioxide).

Clinical-pharmacological group: Antibiotic of the macrolide group - azalide Pharmaco-therapeutic group: Antibiotic, azalide The scientific information provided is general and cannot be used to make a decision on the possibility of using a specific drug.

pharmachologic effect

An antibiotic of the macrolide group, a representative of the azalides. Suppresses RNA-dependent protein synthesis of sensitive microorganisms.

Active against gram-positive bacteria: Staphylococcus aureus, Streptococcus spp. (including Streptococcus pneumoniae, streptococcus pyogenes /group A /), gram -negative bacteria: haemophilus influenzae, haemophilus parainfluenzae, haemophilus ducreyi, Moraxella Catarhaalhal IS, Escherichia Coli, Bordetella Pertussis, Bordetella Paratussis, Borrelia Burgdorferi, Neisseria Gonorrhoeae, Campylobacter SPP. , Legionella pneumophila, anaerobic bacteria: Bacteroides fragilis.

Azithromycin is also active against Chlamydia trachomatis, Mycoplasma pneumoniae, Mycoplasma hominis, Treponema pallidum.

Also active against Toxoplasma gondii.

Pharmacokinetics: Rapidly absorbed from the gastrointestinal tract. Eating reduces the absorption of azithromycin. Cmax in plasma is achieved after 2-3 hours. It is quickly distributed in tissues and biological fluids. 35% of azithromycin is metabolized in the liver by demethylation. More than 59% is excreted unchanged in bile, about 4.5% is excreted unchanged in urine.

Indications Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin, incl. bronchitis, pneumonia, skin and soft tissue infections, otitis media, sinusitis, pharyngitis, tonsillitis, gonorrheal and non-gonorrheal urethritis and/or cervicitis, Lyme disease (borreliosis). ICD-10 codes

Dosage regimen

They are established individually, taking into account the nosological form, the severity of the disease and the sensitivity of the pathogen.

Adults orally - 0.25-1 g 1 time / day, children - 5-10 mg/kg 1 time / day. Duration of treatment is 2-5 days.

Side effect

From the digestive system: nausea, vomiting, flatulence, diarrhea, abdominal pain, transient increase in the activity of liver enzymes, rarely - cholestatic jaundice.

Allergic reactions: rarely - skin rash, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Dermatological reactions: rarely - photosensitivity.

From the side of the central nervous system: dizziness, headache, rarely - drowsiness, weakness.

From the hematopoietic system: rarely - leukopenia, neutropenia, thrombocytopenia.

From the cardiovascular system: rarely - chest pain.

From the genitourinary system: vaginitis, rarely - candidiasis, nephritis, increased residual urea nitrogen.

Other: rarely - hyperglycemia, arthralgia.

Contraindications for use: Hypersensitivity to azithromycin and other macrolide antibiotics.

Use during pregnancy and breastfeeding

Azithromycin penetrates the placental barrier. Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use azithromycin during lactation, the issue of stopping breastfeeding should be decided.

Use for liver dysfunction It is not recommended for use in patients with liver dysfunction.

Use for impaired renal function Use with caution in impaired renal function.

Use in children

Application is possible according to the dosage regimen.

special instructions

Not recommended for use in patients with impaired liver function.

Use with caution in case of impaired renal function.

Azithromycin should be taken at least 1 hour before or 2 hours after meals or antacids.

Drug interactions

When used simultaneously with ergot alkaloids, the risk of developing ergotism cannot be excluded.

With simultaneous use of azithromycin with warfarin, cases of increased effects of the latter have been described.

With the simultaneous use of digoxin or digitoxin with azithromycin, a significant increase in the concentration of cardiac glycosides in the blood plasma and the risk of developing glycoside intoxication are possible.

When used simultaneously with disopyramide, a case of the development of ventricular fibrillation has been described.

When used simultaneously with lovastatin, cases of rhabdomyolysis have been described.

When used simultaneously with rifabutin, the risk of developing neutropenia and leukopenia increases.

With simultaneous use, the metabolism of cyclosporine is disrupted, which increases the risk of developing side and toxic reactions caused by cyclosporine.

Comparison of side effects of Azithromycin forte-obi and Azithromycin-obi

Side effects or adverse events are any adverse medical event that occurs in a subject after administration of a drug.

Azithromycin forte-obi has almost the same side effects as Azithromycin-obi. They both have few side effects. This implies that the frequency of their occurrence is low, that is, the indicator of how many cases of an undesirable effect of treatment are possible and registered is low. The undesirable effect on the body, the strength of influence and the toxic effect of Azithromycin forte-obi are similar to Azithromycin-ob: how quickly the body recovers after taking it and whether it recovers at all.

Comparison of the effectiveness of Azithromycin forte-obi and Azithromycin-obi

The effectiveness of Azithromycin forte-obi is quite similar to Azithromycin-ob - this means that the ability of the drug substance to provide the maximum possible effect is similar.
For example, if the therapeutic effect of Azithromycin forte-obi is more pronounced, then using Azithromycin-obi even in large doses will not achieve this effect.

Also, the speed of therapy is an indicator of the speed of therapeutic action; Azithromycin forte-obi and Azithromycin-obi are approximately the same. And bioavailability, that is, the amount of a drug reaching its site of action in the body, is similar. The higher the bioavailability, the less it will be lost during absorption and use by the body.

Comparison of addiction between Azithromycin forte-obi and Azithromycin-obi

Like safety, addiction also involves many factors that must be considered when evaluating a drug.

Thus, the totality of the values ​​of such parameters as “syndrome o” in Azithromycin-obi is less than the similar values ​​in Azithromycin forte-obi. Withdrawal syndrome is a pathological condition that occurs after the cessation of intake of addictive or dependent substances into the body. And resistance is understood as initial immunity to a drug; in this it differs from addiction, when immunity to a drug develops over a certain period of time. The presence of resistance can only be stated if an attempt has been made to increase the dose of the drug to the maximum possible.

Comparison of ease of use of Azithromycin forte-obi and Azithromycin-obi

This includes dose selection taking into account various conditions and frequency of doses. At the same time, it is important not to forget about the release form of the drug; it is also important to take it into account when making an assessment.

The ease of use of Azithromycin forte-obi is approximately the same as Azithromycin-obi. However, they are not convenient enough to use.

The drug ratings were compiled by experienced pharmacists who studied international research. The report is generated automatically.

Last update date: 2020-12-04 13:48:21

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