Active substanceAzithromycinAzithromycin
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet contains:

    Active substance: azithromycin dihydrate 524.0 mg (equivalent of 500.0 mg azithromycin).

    Excipients: corn starch 250.0 mg, corn starch for pasta 40.0 mg, calcium phosphate 150.0 mg, talc 3.0 mg, magnesium stearate 2.0 mg, sodium carboxymethyl starch 3.0 mg, croscarmellose sodium 2.0 mg.

    Tablet casing:

    Tablet coating "Tabcoat white" 46.0 mg (hypromellose 14.4 mg, macrogol 5.4 mg, titanium dioxide E171 16.2 mg, talc 10.0 mg).

    Description:Tablets are white or almost white in the form of a capsule (caplets), with a risk on both sides, covered with a film membrane. On the cross-section - the core of the tablet is white or almost white.
    Pharmacotherapeutic group:Antibiotic - azalide
    ATX: & nbsp

    J.01.F.A.10   Azithromycin

    Pharmacodynamics:

    Azithromycin is a macrolide antibiotic of the azalide group. Reversibly communicating with 50S- subunit of ribosomes of bacterial cells, disrupts the translocation of the growing polypeptide chain from the aminoacyl region to the peptidyl, leading to suppression of protein synthesis in bacterial cells.

    Sensitive: aerobic Gram-positive microorganisms - Staphylococcus aureus (methicillin-sensitive), Streptococcus pneumoniae (penicillin-sensitive), Streptococcus pyogenes, aerobic gram-negative microorganisms - Haemophilus influenzae, Haemophilus parainjluenzae, 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).

    Stable: aerobic Gram-positive microorganisms - Enterococcus faecalis, Staphylococcus spp. (methicillin-resistant); anaerobes: group Bacteroidesfragilis, Streptococcus pneumoniae, beta-hemolytic Streptococcus spp. groups A, Enterococcus faecalis and Staphylococcus aureus (including methicillin-resistant strains), resistant to erythromycin and other macrolides, and lincosamides are resistant to azithromycin.

    Pharmacokinetics:

    After oral administration, the bioavailability is 37%, the maximum concentration in the blood plasma (Cmax) is created in 2-3 hours, the volume of distribution is 31 l / kg. Binding to plasma proteins is inversely proportional to the concentration in the blood and is 12-52%. Penetrates through, cell membranes (effective for infections caused by intracellular pathogens). It is transported by phagocytes, polymorpho- nuclear leukocytes and macrophages to the site of infection, where is released in presence of bacteria. Easily passes through the histohematological barriers and enters the tissues. The concentration in tissues and cells is 50 times higher than in plasma, and in the focus of infection - 24-34% more than in healthy tissues. Slowly removed from the tissues and has a long half-life of 2-4 days. The therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is excreted, basically, in the unchanged form -50% by the intestine, 12% by the kidneys. In the liver, demethylated, losing activity. In patients with renal insufficiency (creatinine clearance less than 10 ml / min), the half-life of azithromycin increases by 33 %.

    Indications:

    Infectious-inflammatory diseases caused by microorganisms susceptible to azithromycin:

    1) Infections of the upper respiratory tract and ENT organs (pharyngitis, tonsillitis, sinusitis, otitis media);

    2) Infections of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia, including caused by atypical pathogens);

    3) Infections of the skin and soft tissues (simple eels of medium severity, erysipelas, impetigo, secondarily infected dermatoses);

    4) The initial stage of Lyme disease (borreliosis) - migrating erythema (erythema migrans);

    5) Uncomplicated urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

    Contraindications:

    Hypersensitivity to azithromycin, other macrolides, components of the drug, simultaneous use with ergot derivatives, severe hepatic / renal failure, children under 12 years of age.

    Carefully:

    The syndrome of an elongated interval Q-T, chronic renal failure (CC more than 40 ml / min), simultaneous reception with terfenadine, warfarin, digoxin, drugs that extend the interval Q-T.

    Pregnancy and lactation:

    The use of the drug during pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during lactation, issue 6 of the termination of breastfeeding should be resolved.

    Dosing and Administration:

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

    Adults (including the elderly) and children over 12 years of age with a body weight of over 45 kg. With infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues:

    500 mg (1 tablet) 1 time per day for 3 days (course dose of 1.5 g)

    The initial stage of Lyme disease:

    1 time per day forx5 days: 1st day - 1.0 g (2 tablets), then from 2 to 5 days - 500 mg (1 tablet) (course dose 3.0 g)

    In uncomplicated infections of the genitourinary tract, the pathways caused by Chlamidia trachomatis (urethritis, cervicitis):

    1 g (2 tablets) once.

    With acne:

    the course dose is 6 g: 500 mg (1 tablet) 1 time per day for 3 days, then 500 mg once a week for 9 weeks.

    The appointment of patients with impaired renal function:

    For patients with moderate impairment of kidney function (CK> 40 ml / min) dose adjustment is not needed.

    Side effects:

    Co sides of hemopoiesis: lymphocytopenia, eosinophilia, leukopenia, thrombocytopenia, transient neutropenia, hemolytic anemia.

    From the nervous system: dizziness, vertigo, drowsiness, headache, convulsions, paresthesia, hyposthenia, asthenia, insomnia, hyperactivity, aggressiveness, anxiety, anxiety, nervousness.

    From the sense organs: hearing impairment; deafness, ringing in the ears, distortion of taste or smell, reduced visual acuity.

    From the side of the cardiovascular system: palpitation, arrhythmia (including ventricular tachycardia, pirouette tachycardia), lengthening of the interval Q-T.

    From the digestive system: nausea, vomiting, diarrhea, abdominal pain, or cramps in the abdomen, unformed stool - flatulence, digestive disorders, gastritis, anorexia, constipation, change; color of the tongue, pseudomembranous colitis, hepatitis, cholestatic jaundice, impaired functional liver tests, liver necrosis and hepatic insufficiency (up to a lethal outcome).

    From the musculoskeletal system: arthralgia.

    From the genitourinary system: vaginitis, interstitial nephritis, acute renal failure.

    Allergic reactions: itching and rash, angioedema, hives, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic reactions.

    Laboratory indicators: increased serum concentrations of bilirubin, urea, creatinine, potassium ions; decrease in serum bicarbonate concentration.

    Other: Candidiasis, chest pain, swelling, fainting, myasthenia exacerbation gravis.

    Overdose:

    Symptoms: temporary loss of hearing, nausea and vomiting, diarrhea.

    Treatment: reception of activated carbon, maintenance of vital functions organism.

    Interaction:

    Antacids reduce the maximum concentration, azithromycin for 30%, therefore azithromycin should be taken 1 hour before or 2 hours after taking antacids.

    When used simultaneously with cyclosporine, the concentration of cyclosporin in the blood should be monitored.

    When used simultaneously with indirect anticoagulants, the frequency of bleeding may increase, prothrombin time and the international normalized ratio (MNO) should be monitored.

    With simultaneous use with digoxin, an increase in the concentration in the blood of the latter is possible, therefore, the concentration of digoxin in the blood should be monitored.

    With simultaneous use with ergotamine, ergotism can develop; simultaneous use is not recommended.

    The simultaneous use of macrolides and theophylline in some cases led to an increase in the concentration of the latter.

    Azithromycin increases the content of zidovudine triphosphate (an active metabolite of zidovudine) in mononuclear cells, the clinical significance of this phenomenon is unknown.

    Simultaneous use with rifabutin can lead to neutropenia.

    At simultaneous reception fluconazole reduces the maximum concentration of azithromycin by 18%.

    Special instructions:

    In case of missed intake of one dose of the drug, the missed dose should be taken as soon as possible, and subsequent with interruptions of 24 hours.

    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.

    With the use of azithromycin, as well as with the use of other antibiotics, there is a risk of developing superinfection (including fungal).

    With prolonged use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile. With the development of diarrhea against the background of taking azithromycin, and also 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded.

    Effect on the ability to drive transp. cf. and fur:In case of adverse reactions from the nervous system, patients are advised to refrain from driving and other mechanisms, and take care when engaging in activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:

    Tablets, film-coated, 500 mg.

    Packaging:

    For 3 tablets in a blister of aluminum and polyvinyl chloride (A1 / PVC). 1 blister with instructions for use in a cardboard box.

    Storage conditions:

    In dry, the dark place at a temperature of no higher than 25C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not take it after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014489 / 02-2002
    Date of registration:11.11.2008
    The owner of the registration certificate:Oxford Laboratories Pvt. Ltd.Oxford Laboratories Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspOXFORD LABORATORY Pvt. Ltd. OXFORD LABORATORY Pvt. Ltd. India
    Information update date: & nbsp30.08.2015
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