Zuromin AZITHROMYCINUM tablets 500mg №3

Zuromin AZITHROMYCINUM tablets 500mg №3

Product Code: 4258
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Composition

active substance:azithromycin;

1 tablet contains azithromycin (in the form of azithromycin dihydrate) 500 mg

other ingredients:lactose, corn starch, hydroxypropyl cellulose nizkosoleva, calcium hydrogen phosphate, sodium lauryl sulfate, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate

shell:", Opadry" white (Y-1-7000): hypromellose, titanium dioxide (E 171), polyethylene glycol.

The

Dosage form

film-coated Tablets.

The

drug description

Antimicrobial agents for systemic use. Macrolides, lincosamide and streptogramin.

PBX code J01F a10.

Reading

infections caused by microorganisms susceptible to azithromycin:

The
    The
  • infections of the upper respiratory tract and LOR-organov (acute pharyngitis and tonsillitis, acute otitis media, sinusitis);
  • The
  • infections of the lower respiratory tract (acute exacerbation of chronic bronchitis, bacterial and atypical pneumonia)
  • The
  • infections of skin and soft tissues: erythema migrans (initial stage of Lyme disease), erysipelas, impetigo, secondary pyodermatosis. Treatment of non-severe forms of acne vulgaris;
  • sexually transmitted infections: uncomplicated and complicated urethritis/cervicitis caused byChlamydia trachomatis.

Contra

The
  • hypersensitivity to the active substance, to any other component of the drug or to other macrolide antibiotics;
  • The
  • severe violations of the liver and kidney;
  • The
  • via the theoretical possibility of ergotism, the drug should not be administered concurrently with ergot derivatives.

Method of application and doses

Syomin must be taken one hour before or after 2:00 after eating, as simultaneous reception gives the absorption of azithromycin. The drug is taken 1 time a day. The pills are swallowed without chewing.

dosing Regimen for adults, including elderly patients, for children weighing more than 45 kg:

The
  • ENT organs: 500mg (1 tablet) daily for 3 days;
  • respiratory infections: 500 mg (1 tablet) daily for 3 days;
  • The
  • infections of skin and soft tissue: 500 mg (1 tablet) daily for 3 days;
  • migratory erythema: adults-1 time per day for 5 days 1 day - 1 g (2 tablets of 500 mg),

from 2nd to 5th day - 500 mg (1 tablet)

The
  • when acne vulgaris course dose is 6 g. the following treatment regimen is Recommended: the first 3 days of 1 tablet of 500 mg 1 time a day, the next 9 weeks-1 tablet of 500 mg 1 time a week, and the second week the tablet is used 7 days after the previous administration;
  • uncomplicated urethritis or cervicitis caused byChlamydia trachomatis: single dose - 1000 mg of azithromycin (2 tablets) Course dose-1 g.

in elderly patients, the pharmacokinetic properties of azithromycin do not differ from those of young people. There is no need to adjust the dose.

Renal failure:patients with minor renal dysfunction (creatinine clearance>40 ml/min) do not need to change the dosage. There have been no studies in patients with a creatinine clearance of

Hepatic insufficiency:since azithromycin is metabolized in the liver and excreted in the bile, the drug should not be used in patients with severe liver disease.

Side effects

sirain well tolerated with a low incidence of side effects.

Assessment of side effects is based on a classification taking into account the frequency of reactions: very common (> 10%); often (> 1% and <10%); infrequently (>0.1% - by <1%); rare (> 0.01% to <0,1%); very rare (<0.01%) including isolated cases.

From the side of blood system:rarely - thrombocytopenia.

there were few reports on the periods of transient, mild neutropenia.

however, the causal relationship with azithromycin treatment has not been confirmed.

on the mental side:rarely - aggressiveness, hyperactivity, anxiety and nervousness.

from the nervous system:infrequently - dizziness/vertigo, drowsiness, syncope, headache, convulsions (they have also been found to be caused by other macrolide antibiotics), perversion of taste and smell; rarely - paresthesia, asthenia, insomnia.

by hearing organs:it has rarely been reported that macrolide antibiotics cause hearing damage. Some patients who took azithromycin, reported hearing loss, onset of deafness and ringing in the ears. Most of these cases are associated with experimental studies in which azithromycin has been used in high doses for a long time. According to available follow-up reports, most of these problems were reversible.

by cardiac activity:rare - palpitations, arrhythmia with associated ventricular tachycardia (they have also been found to be caused by other macrolide antibiotics) very rare - QT elongation and fluttering-ventricular flicker, arterial hypotension.

from the digestive tract:frequent nausea, vomiting, diarrhea, discomfort in the abdomen (pain/spasms); infrequently - liquid stool, flatulence, digestive disorders, anorexia; rarely - constipation, discoloration. It was reported about pseudomembranous colitis, pancreatitis, dyspepsia, ground.

From the liver and gall bladder:rare - hepatitis and cholestatic jaundice, including abnormal performance of functional tests of the liver necrotic hepatitis and liver dysfunction, and in rare cases leads to death.

the skin israrely, allergic reactions including angioedema, urticaria and photosensitivity; serious skin reactions (polymorphic erythema, Stevens-Johnson syndrome and toxic epidermal necrolysis).

infrequently allergic reactions, including itching and rashes;

From the side of musculoskeletal system:infrequently - artralgia.

from the urinary system:rare - interstitial nephritis and acute renal failure.

on the part of the reproductive system:infrequently vaginitis.

abuses:rare - anaphylaxis, including edema (in rare cases leads to death), candidiasis.

changes in laboratory parameters:it is possible to increase serum creatinine levels, increase phosphokinase, potassium with a frequency of less than 1% observed leukopenia, neutropenia, thrombocytopenia, bilirubin, glucose, increase in alkaline phosphatase.

Overdose

Typical symptoms of overdose: reversible hearing impairment, severe nausea, vomiting, diarrhea.

in case of overdose, take activated charcoal and apply General symptomatic and supportive therapy. Antidote to Thyromine does not exist.

Use in pregnancy and lactation

Azithromycin penetrates the placenta to the fetus, but no adverse effect of the drug on the fetus has been found. There are no relevant and well-controlled studies in pregnant women.

azithromycin can therefore be used during pregnancy only when the expected benefit exceeds the potential risk and in the absence of adequate alternative medicines.

if you need to use the drug during breastfeeding, you need to decide whether to stop breastfeeding.

The

Children

sirain not intended for the treatment of children weighing less than 45 kg.

application Features

Azithromycin can not be applied to patients with pneumonia of moderate and severe symptoms, which can not carry out outpatient treatment, and in the presence of the following risk factors:

The
  • infectious disease acquired by the patient during hospital stay
  • bacteremia or its symptoms;
  • hospitalization if necessary
  • elderly patients or poor patients; The

  • patients with weakened immun

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