The instruction for medical use
of ЗИТМАК® 100 medicine
the Trade name
name Azithromycin Dosage Form Powder for preparation of suspension for intake of 100 mg / 5 ml complete with the water purified
active agent – azithromycin a dihydrate of 419.24 mg (400 mg of azithromycin are equivalent).
excipients: sugar (icing sugar), sodium phosphate anhydrous, hydroxypropyl cellulose (Klutsel EXF), xanthane gum, banana fragrance, cherry fragrance.
Powder of white color with a smell of banana and cherry.
After cultivation the water purified forms uniform suspension of yellow-white color with a smell of banana and cherry.
Antibacterial drugs for system use. Macroleads, linkozamida and streptogramina. Macroleads. Azithromycin.
The ATX J01FA10 code
Pharmacokinetics Azithromycin properties is quickly soaked up at oral administration that is caused by its stability in acidic environment and lipophilicity. After single dose 37% of azithromycin are inside soaked up, and the peak of concentration in plasma (0.41µg/мл) is registered in 2-3 hours. The volume of distribution of Vd is about 31 l/kg. Azithromycin well gets into airways, bodies and fabrics of an urogenital path, a prostate, into skin and soft tissues, reaching from 1 to 9 µg/мл depending on a type of fabric. High concentration in fabrics (is 50 times higher, than concentration in plasma) and the long half-life period is caused by low linking of azithromycin with proteins of blood plasma and also its ability to get into eukaryotic cells and to concentrate in the environment with a low rn, a surrounding lysosome. The ability of azithromycin to collect in lysosomes is especially important for elimination of intracellular activators. Phagocytes deliver azithromycin to places of localization of an infection where it is released in the course of phagocytosis. But, despite high concentration in phagocytes, azithromycin does not affect their function. Therapeutic concentration remains 5-7 days after intake of the last dose. At intake of azithromycin perhaps tranzitorny increase in activity of liver enzymes. Removal of a half of a dose from blood plasma is reflected on reduction of a half of a dose in fabrics within 2-4 days. After administration of drug in the range from 8 till 24 o’clock elimination half-life makes 14-20 hours, and after administration of drug in the range from 24 till 72 o’clock – 41 hour that ZITMAK of 1 times a day allows to accept. The main way of removal – with bile. About 50% are removed in not changed look, other 50% – in the form of 10 inactive metabolites. About 6% of the accepted dose are removed by kidneys.
Active agent of the drug ZITMAK® – azithromycin is an antibiotic of a broad spectrum of activity, the first representative of new subgroup of makrolidny antibiotics – azaleads. Possesses bacteriostatic action, but during creation in the center of inflammation of high concentrations renders bactericidal effect. Azithromycin suppresses synthesis of protein in sensitive microorganisms, showing activity concerning the majority of strains of gram-positive, gram-negative, anaerobic, intracellular and other microorganisms: Mycoplasma pneumoniae, Haemophilus ducreyi, Moraxella catarrhalis, Propionibacterium acnes, Gardnerella vaginalis, Actinomyces species, Bordetella pertussis, Borrelia burgdorferi, Mobiluncus species, Haemophilus influenzae, Streptococcus pyogenes, Haemophilus parainfluenzae, Streptococcus pneumoniae, Legionella pneumophila, Streptococcus agalactiae, Neisseria meningitides, Streptococcus viridans, Neisseria gonorrhoeae, Streptococcus group C, F, G, Helicobacter pylori, Peptococcus species, Campylobacter jejuni, Peptostreptococcus, Pasteurella multocida, Fusobacterium necrophorum, Pasteurella haemolytica, Clostridium perfringens, Brucella melitensis, Bacteroides bivius, Bordetella parapertussis, Chlamydia trachomatis, Vibrio cholerae, Chlamydia pneumoniae, Vibrio parahaemolyticus, Ureaplasma urealyticum, Plesiomonas shigelloides, Listeria monocytogenes, Staphylococcus epidermidis, Staphylococcus aureus * (*эритромицин – a sensitive strain), Escherichia coli, Bacteroides fragilis, Salmonella enteritidis, Bacteroides oralis, Salmonella typhi, Clostridium difficile, Shigella sonnei, Eubacterium lentum, Yersinia enterocolitica, Fusobacterium nucleatum, Acinetobacter calcoaceticus, Aeromonas hydrophilia.
– upper respiratory tract infections (bacterial pharyngitis / tonsillitis, sinusitis, average otitis)
– lower respiratory tract infections (bacterial bronchitis, interstitial and alveolar pneumonia, exacerbation of chronic bronchitis)
– infections of skin and soft tissues (the chronic migrating erythema – an initial stage of a disease of Lyme, an ugly face, impetigo, secondary pyodermatoses)
– the diseases of a stomach and a duodenum associated with Helicobacter pylori
the Route of administration and doses
ЗИТМАК® in the form of oral suspension accept 1 time a day in 1 hour prior to or in 2 hours after a meal by means of a measured spoon.
Infections of upper and lower airways, skin and soft tissues (except for the chronic migrating erythema)
the Course dose makes 30 mg/kg.
Two schemes of treatment are applied:
1) 10 mg/kg of body weight once a day within 3 days
2) 10 mg/kg of body weight in the first day and on 5 mg/kg of body weight from the 2nd to the 5th day
to Children with body weight less than 14 kg appoint mg ЗИТМАК® 100 suspension / 5 ml proceeding from weight:
ЗИТМАК® powder for preparation of oral suspension of 100 mg / 5 ml
kg 2.5 ml (50 mg)
kg 3 ml (60 mg)
kg 3.5 ml (70 mg)
kg 4 ml (80 mg)
kg 4.5 ml (90 mg)
kg 5 ml (100 mg)
the Chronic migrating erythema
the Course dose of drug makes 60 mg/kg: once on 20 mg/kg –
in the 1st day and on 10 mg/kg – in the subsequent, from 2 to 5 days.
Diseases of a stomach and a 12-perstny gut, associated with Helicobacter pylori:
The dosage of azithromycin makes 20 mg/kg of body weight in combination with anti-secretory means and other medicines once a day (in complex therapy).
In case the dose of drug was passed, it needs to be accepted at once, and then to accept the subsequent doses at an interval of the 24th hour.
For a dosage Зитмак® 200:
Infections of an urogenital path:
Not gonococcal urethritis / cervicitis – 1 g once.
Gonococcal and also complicated, it is long the proceeding urethritis/cervicitis – on 1 g three times at an interval of 7 days (1-7-14). Course dose of 3 g.
The way of preparation of suspension
For contents of one bottle is added by 10 ml of the water purified and mix before receiving uniform suspension of 20 ml.
Before reception the bottle contents are carefully shaken up before receiving uniform suspension. Directly after intake of suspension to the child allow to drink several drinks of liquid to wash away and swallow the remained amount of suspension in an oral cavity.
Often (& gt, 1/100, & lt, 1/10)
– nausea, vomiting, diarrhea, an abdominal pain
not often (& gt, 1/1000, & lt, 1/100)
– a liquid chair, a meteorism, a digestive disturbance, loss of appetite
Seldom (& gt, 1/1000, & lt, 1/100)
– a headache, dizziness, drowsiness, spasms
– aggression, excitement, concern, nervousness, insomnia
– paresthesias and an asthenia
– a hearing disorder, deafness and sonitus
– heartbeat, arrhythmia with ventricular tachycardia, lengthening
of an interval of QT
– discoloration of language, a constipation, pseudomembranous colitis
– tranzitorny rise in level of aminotransferases of a liver, bilirubin,
cholestatic jaundice, hepatitis
– reactions of hypersensitivity (reddening, skin rash, an itching,
a small tortoiseshell, a Quincke’s disease, photosensitivity),
a multiformny erythema, Stephens-Johnson’s syndrome and a toxic
– an arthralgia
Very seldom (& gt, 1/10000, & lt, 1/1000)
– interstitial nephrite, an acute renal failure
– fatigue, convulsions
– change of taste and sense of smell
– an arthralgia
– vaginita, candidiasis, superinfections
– an acute anaphylaxis including hypostasis (in rare instances leading to
– hypersensitivity to makrolidny antibiotics
– heavy abnormal liver functions and kidneys
– pregnancy and the period of a lactation
Antacids substantially reduce absorption ЗИТМАКА® of suspension therefore the drug should be taken in one hour prior to or in two hours after intake of these drugs. Makrolidny antibiotics interact with digoxin, cyclosporine, astemizoly, triazolamy, midazolam or alfentanily. It is recommended to make careful observation at a concomitant use of these drugs.
Azithromycin does not connect R-450 cytochrome and therefore does not interact with theophylline, terfenadiny, warfarin, carbamazepine, Methylprednisolonum and Cimetidinum.
At simultaneous use of azithromycin and anticoagulants of indirect action perhaps bleedings. Therefore at the same time it is necessary to carry out control of a prothrombin time.
Rifabutin: joint use of azithromycin and a rifabutin did not change their plasma concentration. However at the same time the neutropenia was observed.
indications ЗИТМАК® 100 of mg / 5 the ml is intended for use for children.
Duration of use of drug should not exceed the terms specified in the instruction.
It is necessary to take with care the drug in abnormal liver functions and kidneys, to the patient having disturbances or predisposed to arrhythmias and lengthening of an interval of QT.
Pregnancy and the period of a lactation
Safety of use ЗИТМАК® for pregnant women is not established therefore it is not recommended to appoint it during pregnancy.
Azithromycin gets into breast milk therefore the women nursing should not appoint ЗИТМАК®.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of medicine it is necessary to be careful at control of motor transport and potentially dangerous mechanisms.
of Data concerning overdose are insufficient.
Symptoms: nausea, vomiting, diarrhea, temporary hearing loss
Treatment: to wash out a stomach and to appoint symptomatic treatment
the Form of release and packing
On 19.0 g of powder place in the plastic bottles of white color corked by the screwing-up polyethylene cover with control of the first opening.
On a bottle paste the label.
1 bottle complete with a measured spoon plastic and a plastic bottle with the water purified 10 ml (for preparation of 20 ml of suspension of 100 mg / 5 ml) together with the instruction for medical use in the state and Russian languages is placed in a cardboard pack.
To Store storage conditions at a temperature not over 25 ºС, in the dry, protected from light place.
To store out of children’s reach!
A period of storage
not to apply after the storage expiration
the Period of storage of the prepared suspension
of 14 days
According to the prescription
the Producer / Packer
of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
Republic of Kazakhstan, Almaty, Shevchenko St. 162 E.
The owner of the registration certificate
of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Phone number: (+7 727) 399-50-50Номер fax: (+7 727) 399-60-60
To Develop the e-mail address of firstname.lastname@example.org