The instruction for medical use
of Ziromin Torgovoye medicine a name
Mezhdunarodnoye the unlicensed
name Azithromycin Dosage Form
of the Tablet, coated 500 mg
1 tablet contains Structure:
active agents: azithromycin of 500.0 mg (azithromycin of a dihydrate of 525.0 mg),
excipients: calcium hydrophosphate, povidone (K30), starch corn, sodium lauryl sulfate, magnesium stearate, sodium glikolit starch.
structure of a cover: a hydroksipropilmetiltsellyuloz (E15), the titan dioxide (E171), polyethyleneglycol 6000, propylene glycol, talc purified.
of the Tablet, coated white color, a capsulovidny form with an engraving of AZN500 on one party and dividing risky on another.
Antibacterial drug of system use. Macroleads, linkozamida and streptogramina.
The ATX J01FA10 code
Pharmacokinetics Absorption properties happens quickly and completely after intake. Meal authentically reduces degree (to 50%) and absorption speed and therefore azithromycin should be accepted for an hour before meal or in 2 hours after that. Time of achievement of the maximum plasma concentration – 2-3 hours.
Distribution results from intensively high extent of penetration into fabrics that provides much higher concentration in fabrics, than in plasma (to 50 times). Azithromycin quickly gets into phagocytes and fibroblastny cells and creates high intracellular and extracellular concentrations. Its intra phagocytal concentration remains high after exhaustion of extracellular concentration. In the presence of bacteria in the inflamed fabrics, azithromycin quickly gets into extracellular space. Extent of linking with proteins of plasma about 20%. Metabolism is carried out in a liver by means of demethylation. Elimination half-life – 48 – 96 hours.
Removal. It is removed, generally with bile in not changed look.
Small amounts are removed with urine.
Ziromin’s pharmacodynamics is the representative of subgroup of makrolidny antibiotics – azaleads, possesses a wide range of antibacterial action. Contacting 5OS – a subunit of ribosomes, Ziromin suppresses synthesis of protein in a microbic cell.
Ziromin is active concerning a row:
– gram-positive microorganisms: Streptococcus pneumoniae, Str. pyrogenes, Str. agalactiae, streptococci of groups C, F and G, Staphylococcus aureus Star. epidermidis, Corynebacterium diphtheriae.
– gram-negative microorganisms: Haemophilus influenza, N. parainfluenzae and N. of ducrevi, Moraxella catarrhalis, Bordetella pertussis and V. of parapertussis, Neisseria gonorrhoeae and N.meningitidis, Brucella melitensis, Helicobacter pylori, gardnerella vaginalis.
– anaerobic microorganisms: Clostridium spp., Peptostreptococcus spp. and Peptococcus spp.
– intracellular and other microorganisms: Legionella pneumophila, Chamydia trachomatis and S. of pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma avium, Ureaplasma urealyticum, Lysteria monocytogenes, Treponema pallidum, Borrelia burgdorferi, Toxoplasma gondii.
Cross azithromycin resistance about erythromycin – resistant gram-positive strains was noted. The majority of strains of Enterococcus faecalis and Methicillinum – resistant staphylococcus are resistant to azithromycin.
Ziromin is inactive concerning the gram-positive bacteria resistant to erythromycin.
– upper respiratory tract infections: pharyngitis, tonsillitis, sinusitis, average otitis
– lower respiratory tract infections: bronchitis, exacerbation of chronic bronchitis, extra hospital or hospital pneumonia
– infections of skin and soft tissues: the chronic migrating erythema, an ugly face, impetigo, secondary pyodermatoses
– a gonorrheal and not gonorrheal urethritis and/or a cervicitis
– the diseases of a stomach and a duodenum associated with Helicobacter pylori
– an initial stage of a disease Laima (borreliosis) – the migrating erythema.
The route of administration and doses
use Drug inside in 1 hour prior to or in 2 hours after a meal.
In infections of upper and lower parts of airways, in infections of skin and soft tissues (except for the chronic migrating erythema): 500 mg/days for 1 reception within 3 days.
At the chronic migrating erythema: 1000 mg/days in the first day for 1 reception, further on 500 mg/days daily from 2 to 5 day.
In an uncomplicated urethritis / cervicitis – once 1000 mg. Complicated, it is long the proceeding urethritis/cervicitis caused by Chlamydia trachomatis – 1000 mg 3 times at an interval of 7 days (1-7-14 days). Course dose: 3000 mg.
At initial stages of a disease Laima (borreliosis): 1000 mg in the first day and 500 mg/days from 2 to 5 day.
In a peptic ulcer of a stomach and the duodenum associated with Helicobacter pylori: 1000 mg/days within 3 days in combination with anti-secretory means and other medicines.
Appoint tablets of 500 mg to children with body weight more than 45 kg 1 times/day within 3 days or in the first day on 10 mg/kg of body weight, then on 5 – 10 mg/kg of body weight a day within 3 days. At body weight less than 45 kg it is necessary to take other dosage form.
At the chronic migrating erythema: the dose makes 20 mg/kg of body weight in the first day and on 10 mg/kg of body weight from 2 to 5 day.
At treatment of the first stage of a disease of Lyme: the dose makes 20 mg/kg of body weight in the first day and on 10 mg/kg of body weight from 2 to 5 day.
– nausea, vomiting, abdominal discomfort (pain/spasm), diarrhea
– reversible increase in level of liver enzymes (alaninaminotranspherases, aspartate aminotransferases, lactate dehydrogenases), creatinine, bilirubin, the changed indicators return to limits of norm in 2-3 weeks after the therapy termination
– morbidity and inflammation in the place of an injection
– a meteorism, digestion disturbances, a liquid chair
– cholestatic jaundice, hepatitis, including increase in functional hepatic trials, in rare instances liver necrosis, a liver failure
– an arthralgia
– a headache, dizziness, drowsiness, spasms, fatigue, an indisposition, a faddism of food and sense of smell
– a vaginitis
– allergic reactions, including skin rash,
– thrombocytopenia, a neutropenia
– hypotension, heart consciousness, arrhythmias, including ventricular tachycardia, lengthening of an interval of QT, arrhythmia like torsades de pointes
– a ring in ears, decrease in hearing, deafness, vertigo, disorders of vision
– anorexia, discoloration of language, pancreatitis, pseudomembranous colitis, a constipation
– an anaphylaxis, including a Quincke’s disease, an acute anaphylaxis
– a fungal infection of a mucous membrane of an oral cavity and genitals
– paresthesias, an asthenia, insomnia, hyperexcitability, a faint
– aggression, concern, alarm, nervousness
– interstitial nephrite, an acute renal failure
– urticaria, a multiformny erythema, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis,
the Contraindication photosensitization
– hypersensitivity to antibiotics of group of macroleads
– children up to 12 years
– heavy abnormal liver functions and kidneys
Antacids (aluminum and magnesium containing), ethanol and food slow down and reduce absorption.
At joint prescribing of Warfarin and Ziromin (in usual doses) changes of a prothrombin time it is not revealed, however, considering that in interaction of macroleads and warfarin strengthening of anti-coagulative effect is possible, careful control of a prothrombin time is necessary for patients.
Digoxin: increase in concentration of digoxin.
Ergotamine and dihydroergotamine: strengthening of toxic action (vasospasm, dizesteziya).
To triazoles: decrease in clearance and increase in pharmacological action of a triazolan.
Slows down removal and increases concentration in blood plasma and toxicity of Cycloserinum, indirect anticoagulants, Methylprednisolonum, a felodipin and also the medicines which are exposed to microsomal oxidation (carbamazepine, terfenadin, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, Disopyramidum, Bromocriptinum, Phenytoinum, oral hypoglycemic means, theophylline, etc. ksantinovy derivatives) – at the expense of inhibition of microsomal oxidation in hepatocytes by Ziromin. Linkozamina weaken efficiency, tetracycline and chloramphenicol – strengthen.
instructions Be careful when prescribing drug the patient with insufficiency of function of a liver and kidneys. Pregnancy and a lactation
At pregnancy drug should be used only when the expected advantage exceeds potential risk. At use of drug in the period of a lactation it is necessary to stop breastfeeding.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous Ziromin mechanisms does not affect ability to driving of motor transport and control of dangerous mechanisms.
Symptoms: temporary hearing loss, nausea, vomiting and diarrhea. Treatment: symptomatic.
A form of release and packing
On 3 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a cardboard box.
To Store storage conditions in the dry place at a temperature not above 25 °C.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
According to the prescription
it Is made ‘BAILEY LABORATORY – KPEAT’, France (Shmen de Nouizmen of Z | I. 150 Arpen, 28500 Vernuye – Frans) according to the license ‘MEDRAYK’, Great Britain.
The owner of a trademark and the certificate of registration is
the UORLD MEDITSIN LIMITED company, London/Great Britain
(WORLD MEDICINE LIMITED, London/Great Britain)
Ph. / fax: 8 (7272) 529090
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of RK Almaty, Suyunbaya 222 Ave. of B