Active substanceAzithromycinAzithromycin
Similar drugsTo uncover
  • Azibiot®
    pills inwards 
  • Azivok
    capsules inwards 
    Vokhard Ltd     India
  • Azidrope
    drops d / eye 
    LABORATOUR TEA     France
  • Azithral
    capsules inwards 
  • Azitrox®
    capsules inwards 
  • Azitrox®
    capsules inwards 
  • Azitrox®
    powder inwards 
  • Azithromycin
    pills inwards 
  • Azithromycin
    capsules inwards 
  • Azithromycin
    pills inwards 
    ATOLL, LLC     Russia
  • Azithromycin
    capsules inwards 
  • Azithromycin
    pills inwards 
    Kern Pharma S.L.     Spain
  • Azithromycin
    capsules inwards 
    OZONE, LLC     Russia
  • Azithromycin
    capsules inwards 
    VERTEKS, AO     Russia
  • Azithromycin
    pills inwards 
    REPLEK FARM Skopje, OOO     Macedonia
  • Azithromycin
    capsules inwards 
    DALHIMFARM, OJSC     Russia
  • Azithromycin
    pills inwards 
    VERTEKS, AO     Russia
  • Azithromycin Zentiva
    pills inwards 
    Zentiva c.s.     Czech Republic
  • Azithromycin Sandoz
    powder inwards 
    Sandoz d.     Slovenia
  • Azithromycin Forte-OBL
    pills inwards 
  • Azithromycin-Abrichin
    pills inwards 
    AKRIKHIN HFK, JSC     Russia
  • Azithromycin-LEXMM®
    pills inwards 
    PROTEK-SVM, LLC     Russia
  • Azithromycin-Macleodz
    pills inwards 
  • AzitrRus®
    capsules inwards 
    SYNTHESIS, OJSC     Russia
  • AzitrRus®
    powder inwards 
    SYNTHESIS, OJSC     Russia
  • AzitRus® forte
    pills inwards 
  • Zetamax retard
    powder inwards 
  • ZI-Factor®
    capsules inwards 
    VEROPHARM SA     Russia
  • ZI-Factor®
    pills inwards 
    VEROPHARM SA     Russia
  • Zyromin
    pills inwards 
  • Zitnob®
    pills inwards 
  • Zitrolide®
    capsules inwards 
    VALENTA PHARM, PAO     Russia
  • Sietrolide® forte
    capsules inwards 
    VALENTA PHARM, PAO     Russia
  • Zitrocin
    pills inwards 
  • Sumaclide
    capsules inwards 
    BIOSINTEZ, PAO     Russia
  • Sumaclide
    pills inwards 
    BIOSINTEZ, PAO     Russia
  • Sumamed®
    lyophilizate d / infusion 
  • Sumamed®
    pills inwards 
  • Sumamed®
    powder inwards 
  • Sumamed®
    capsules inwards 
  • Sumamed®
    pills inwards 
  • Sumamed® forte
    powder inwards 
  • Sumamecin
    capsules inwards 
  • Sumamox
    capsules inwards 
  • Sumamox
    pills inwards 
  • OZONE, LLC     Russia
  • OZONE, LLC     Russia
  • Tremac-Sanovel
    pills inwards 
  • Tremac-Sanovel
    powder inwards d / children 
  • Hemomycin
    powder inwards 
    Hemofarm AD     Serbia
  • Hemomycin
    lyophilizate d / infusion 
    Hemofarm AD     Serbia
  • Hemomycin
    pills inwards 
    Hemofarm AD     Serbia
  • Hemomycin
    capsules inwards 
    Hemofarm AD     Serbia
  • Hemomycin
    powder inwards 
    Hemofarm AD     Serbia
  • Ecomed®
    capsules inwards 
    AVVA RUS, OJSC     Russia
  • Ecomed®
    powder inwards 
    AVVA RUS, OJSC     Russia
  • Ecomed®
    pills inwards 
    AVVA RUS, OJSC     Russia
  • Dosage form: & nbspcapsules
    Composition:

    Name of components

    amount

    Active substance:


    Azithromycin

    500 mg

    in the form of azithromycin dihydrate

    525 mg

    Excipients:


    Sodium lauryl sulfate

    3.0 mg

    Magnesium stearate

    2.0 mg

    Shell composition:


    Titanium dioxide

    1,1999%

    Water

    14,5 + 1,5%

    Sodium lauryl sulfate

    0,08 %

    Methylparahydroxybenzoate

    from 0.64 to 0.8%

    Propyl parahydroxybenzoate

    from 0.16 to 0.2%

    Gelatin

    up to 100%

    Description:Hard gelatin capsules, size "O", body and cap white. The contents of the capsules are white powder.
    Pharmacotherapeutic group:Antibiotic - azalide
    ATX: & nbsp

    J.01.F.A.10   Azithromycin

    Pharmacodynamics:

    Antibiotic of a wide spectrum of action. Is a representative of a subgroup of macrolide antibiotics - azalides. It has a wide spectrum of antimicrobial action. Communicating with 5 OSthe subunit of the ribosome, suppresses the biosynthesis of the proteins of the microorganism.When creating a high inflammation in the focus of inflammation has a bactericidal effect. It is active against Gram-positive aerobic microorganisms: Streptococcus spp. (groups a, b, c, g), Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes, Staphylococcus aureus (methicillin-sensitive); Gram-negative aerobic microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Legionella pneumophila, Neisseria gonorrhoeae, Pasteurella multocida; some anaerobic microorganisms: Prevotella spp., Clostridium perfringens, Fusobacterium spp,, Porphyriomonas spp.; and Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

    Microorganisms that can develop resistance to azithromycin: gram-positive aerobes (streptococcus pneumoniae (penicillin-resistant)). Initially, stable microorganisms: gram-positive aerobes (enterococcus faecalis, staphylococcus spp. (methicillin-resistant staphylococci exhibit a very high degree of resistance to macrolides), Gram-positive bacteria resistant to erythromycin); anaerobes (bacteroides fragilis).

    Pharmacokinetics:

    Azithromycin is rapidly absorbed from the gastrointestinal tract, which is due to its stability in an acidic environment and lipophilicity. After oral administration of 500 mg, the maximum concentration of azithromycin in the blood plasma is achieved after 2.5 - 2.96 hours and is 0.4 mg / l. Bioavailability is 37%.

    Azithromycin well penetrates the respiratory tract, organs and tissues of the urogenital tract (particularly the prostate gland), the skin and soft tissues. High concentrations in tissues (10-50 times higher than in plasma) and a long half-life are due to low binding of azithromycin to blood plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in a medium with a low pH surrounding the lysosome. This, in turn, determines the large apparent volume of distribution (31.1 l / kg) and high plasma clearance. The ability of azithromycin to accumulate mainly in lysosomes, is especially important for the elimination of intracellular pathogens. It is proved that phagocytes deliver azithromycin in places of infection localization, where it is released during phagocytosis. The concentration of azithromycin in the foci of infection is significantly higher than in healthy tissues (an average of 24-34%) and correlates with the degree of inflammatory edema. Despite the high concentration in phagocytes, azithromycin does not have a significant effect on their function. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which allowed the development of short (3-day and 5-day) treatment courses. 50% is excreted with bile in unchanged form, 6% - kidneys, in the liver it is demethylated, the formed metabolites are not active. Excretion of azithromycin from the blood plasma takes place in 2 stages: the period half-life is 14-20 hours in the interval from 8 to 24 hours after taking the drug and 41 hours in the range of 24 to 72 hours, which allows the drug to be used once a day.

    Eating significantly changes the pharmacokinetics (depending on the dosage form): capsules - the maximum plasma concentration (Cmah) is reduced (by 52%) and the area under the curve "concentration-time" (AUC) (by 43%). 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 (sore throat, sinusitis, tonsillitis, pharyngitis, otitis media);

    Infections of the lower respiratory tract (bacterial pneumonia, including caused by atypical pathogens, bronchitis);

    Infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);

    Infections of the urogenital tract (uncomplicated urethritis and / or cervicitis) caused by Chlamydia trachomatis;

    Lyme disease (borreliosis), for treatment of the initial stage (erythema migrans).

    Contraindications:

    Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug; severe hepatic insufficiency (Child-Pugh class C); severe renal dysfunction (creatinine clearance (CK) less than 40 ml / min); deficiency of lactase, lactose intolerance, glucose-galactose malabsorption; lactation period (for the duration of treatment they are suspended); children under 12 years of age with a body weight of less than 45 kg; simultaneous reception with ergotamine and dihydroergotamine.

    Carefully:

    Myasthenia gravis; mild to moderate liver dysfunction; mild and moderate renal dysfunction (CC more than 40 ml / min); in patients with proarrhythmogenic factors (especially in elderly patients); with congenital or acquired lengthening of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride. terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disturbances of water electrolyte balance, especially in case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia, or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporine; pregnancy.

    Pregnancy and lactation:Can be used when the potential benefit to the mother significantly exceeds the potential risk to the fetus. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
    Dosing and Administration:

    Inside, 1 hour before or 2 hours after meals 1 time per day.

    Adults (including the elderly) and children over 12 years of age with a body weight of over 45 kg

    When infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues - 500 mg / day for 1 reception for 3 days (exchange dose 1.5 g).

    In infections of the urogenital tract (uncomplicated urethritis or cervicitis) caused by Chlamydia trachomatis - once 1 g.

    In Lyme disease (borreliosis) for treatment / stage (erythema migrans) -1 g on the first day and 500 mg daily from 2 to 5 days (course dose - 3 g).

    When used in patients with impaired renal function of mild and moderate severity (CC greater than 40 ml / min),in patients with impaired liver function of mild and moderate severity, as well as in elderly patients, dose adjustment is not required.

    Side effects:

    The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely, not less than 0.01%. but less than 0.1%; very rarely - less than 0.01%: unknown frequency - can not be estimated from the available data.

    Infectious diseases: infrequently - candidiasis. including mucous membranes of the oral cavity and genitals, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis: an unknown frequency is pseudomembranous colitis.

    On the part of the blood and lymphatic system: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.

    From the side of metabolism and nutrition: infrequently - anorexia.

    Allergic reactions: infrequently - angioedema, hypersensitivity reaction; an unknown frequency is an anaphylactic reaction.

    From the nervous system: often - headache; infrequently - dizziness,a violation of taste sensations, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation: unknown frequency - hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of smell, loss of taste sensations, myasthenia gravis, delirium, hallucinations.

    From the side of the organs of sight: infrequently - impaired vision.

    On the part of the hearing organs and labyrinthine disorders: infrequently, hearing disorder, vertigo; unknown frequency - hearing impairment, including deafness and / or tinnitus.

    From the side of the cardiovascular system: infrequently - a feeling of palpitations, "tides" of blood to the face; unknown frequency - lowering of arterial pressure, increase in QT interval on electrocardiogram, arrhythmia of "pirouette" type, ventricular tachycardia.

    From the respiratory system: infrequently - shortness of breath, nosebleed.

    From the gastrointestinal tract: very often - diarrhea: often - nausea, vomiting, abdominal pain; infrequent - meteorism, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - a discoloration of the tongue, pancreatitis.

    From the liver and biliary tract: infrequently - hepatitis; rarely - a violation of the liver, cholestatic jaundice; unknown frequency - hepatic insufficiency (in rare cases with a fatal outcome mainly on the background of severe violations of the liver function); liver necrosis, fulminant hepatitis.

    From the skin and subcutaneous tissues: infrequently - skin rash, itching, hives, dermatitis, dry skin, sweating; rarely - the reaction of photosensitization; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

    From the side of the musculoskeletal system: osteoarthritis, myalgia. pain in the back, pain in the neck; unknown frequency - arthralgia.

    From the side of the kidneys and urinary tract: infrequently - dysuria, pain in the kidney; unknown frequency - interstitial nephritis, acute renal failure.

    From the genitals and breast: infrequently - metrorrhagia. dysfunction of testicles.

    Other: infrequently - asthenia, malaise, fatigue, face swelling, chest pain, fever, peripheral edema.

    Laboratory data: often - a decrease in the number of lymphocytes, an increase in the number of eosinophils.increasing the number of basophils, increased the number of monocytes, increased neutrophil count, decreased bicarbonate concentration in the blood plasma, rarely - increase of aspartate aminotransferase activity, alanine aminotransferase, increased bilirubin concentration in blood plasma, increasing concentrations of urea in blood plasma, increasing the concentration of creatinine in the blood plasma, change the content potassium in the blood plasma, increased alkaline phosphatase activity in plasma, increasing chlorine content in the blood plasma, increased concen tration of blood glucose, increase the number of platelets, increasing hematocrit, increasing bicarbonate concentration in the blood plasma, a change in the sodium content in the blood plasma.

    Overdose:

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

    Treatment should be focused on the symptoms. Specific safener (counter material) does not exist.
    Interaction:

    Antacids (Aluminum and magnesium-containing) foods and reduce the absorption of azithromycin, so the interval between their intake should be 1 hour before or 2 hours after ingestion, and these drugs.

    Cetirizine

    Simultaneous use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to pharmacokinetic interaction and a significant change in the QT interval.

    Didanosine (dideoxyinosine)

    Simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected patients showed no change in the pharmacokinetic indications of didanosine compared with the placebo group.

    If you need a joint admission with warfarin it is recommended that careful monitoring of prothrombin time be performed.

    Cimetidine

    In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin have been observed, provided cimetidine is administered 2 hours before azithromycin.

    When used simultaneously with zidovudine azithromycin has little effect on the pharmacokinetics, including the excretion of zidovudine or its glucuronide metabolite by the kidneys. However, the use of azithromycin caused an increase in the concentration of phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells.The clinical significance of this fact is unclear.

    Azithromycin weakly interacts with isoenzymes of the cytochrome P450 system. It was not revealed that azithromycin participates in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin It is not an inhibitor and inducer of cytochrome P450 isoenzymes.

    Efavirenz

    Simultaneous use of azithromycin (600 mg / day once) and efavirenz (400 mg / day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.

    Fluconazole

    Simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life of azithromycin did not change with the simultaneous use of fluconazole. However, there was a decrease in Cmah azithromycin (by 18%), which had no clinical significance.

    Indinavir

    Simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg three times daily for 5 days).

    Methylprednisolone

    Azithromycin does not significantly affect the pharmacokinetics of methylprednisolone.

    Digoxin

    Simultaneous use of macrolide antibiotics, including azithromycin.with P-glycoprotein substrates, such as digoxin, leads to an increase in the concentration of the P-glycoprotein substrate in the blood serum.

    Ergotamine and dihydroergotamine: increased toxic effect (vasospasm, dysesthesia).

    Triazolam: a decrease in clearance and an increase in the pharmacological action of triazolam.

    Simultaneous application atorvastatin and azithromycin did not cause a change in the concentrations of atorvastatin in the blood plasma (based on the inhibition of GMK-CoA reductase). However, in the post-marketing period, separate reports were received on cases of rhabdomyolysis in patients receiving concomitantly azithromycin and statins.

    In a pharmacokinetic study involving healthy volunteers who within 3 days were ingested azithromycin (500 mg / day once), and then ciclosporin (10 mg / kg / day once), there was a significant increase in the maximum concentration in the blood plasma (CMax) and the area under the concentration-time curve (AUC∞) of cyclosporine. Care should be taken when using these drugs at the same time. In case of simultaneous use of these drugs, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose accordingly.

    Simultaneous use of azithromycin and nelfinavir causes an increase in the equilibrium concentrations of azithromycin in the blood serum. Clinically significant side effects were not observed and correction of the dose of azithromycin with its simultaneous application with nelfinavir is not required.

    Simultaneous use of azithromycin and rifabutin does not affect the concentration of each of the drugs in the blood serum. With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Despite the fact that neutropenia was associated with the use of rifabutin. The cause-and-effect relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established.

    Sildenafil

    When used in healthy volunteers, no evidence of the effect of azithromycin (500 mg / day daily for 3 days) on AUC and Cmah sildenafil or its main circulating metabolite.

    Care must be taken when co-designating terfenadine and azithromycin, because it was found that the simultaneous use of terfenadine and various types of antibiotics causes arrhythmia and lengthening of the QT interval.Proceeding from this, it is impossible to exclude the aforementioned complications in the joint administration of terfenadine and azithromycin.

    Theophylline

    There was no interaction between azithromycin and theophylline.

    Triazolam / midazolam

    Significant changes in pharmacokinetic parameters with the simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses are not revealed.

    Trimethoprim / sulfamethoxazole

    Simultaneous use of trimethoprim / sulfamethoxazole with azithromycin did not reveal a significant effect on Cmah, total exposure or kidney excretion of trimethoprim or sulfamethoxazole. The concentrations of azithromycin in the serum corresponded to those detected in other studies.

    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.

    The drug Azitral should be taken at least one hour before or two hours after taking antacids and food.

    The drug Azitral should be used with caution in patients with mild and moderate impairment of liver function due to the possibility of developing fulminant hepatitis and severe hepatic insufficiency.In the presence of symptoms of liver dysfunction, such as rapidly growing asthenia, jaundice, darkening of the urine, a tendency to bleeding, hepatic encephalopathy therapy with the drug Azitral should be discontinued and a study of the functional state of the liver. In patients with impaired renal function (KC more than 40 ml / min) of mild to moderate severity, Azithril should be administered with caution under the control of the state of kidney function. When using Azitral, both on the background of taking and after 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 cancel the 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.

    As with any antibiotic. in the treatment of azithromycin, it is possible to attach superinfection (including fungal). With pharyngitis and tonsillitis caused by Streptococcus pyogenes,antibiotics of choice are penicillins. The effectiveness of azithromycin for the prevention of rheumatic fever is unknown.

    The use of the drug Azitral may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.

    After the withdrawal of the treatment, hypersensitivity reactions in some patients may persist, which requires specific therapy under the supervision of a physician.

    The drug Azitral should not be used for longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosing regimen.

    SPECIAL PRECAUTIONS WHEN ANY NON-USED PREPARATION IS DESTROYED

    There is no need for special precautions when destroying an unused preparation.

    Effect on the ability to drive transp. cf. and fur:Azithromycin in dosages exceeding the recommended dosage may affect the ability to drive a vehicle or equipment.
    Form release / dosage:Capsules of 500 mg.
    Packaging:

    3 capsules per blister.

    1 blister in a cardboard box, along with instructions for use.

    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C.Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001242
    Date of registration:26.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India
    Information update date: & nbsp21.06.2017
    Illustrated instructions
      Instructions
      Up