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Zitmak 6’s 125 mg film-coated tablets

$19.00

a8749eef9d1b

Description

The instruction for medical use

of Zitmak medicine 500
Zitmak 250
Zitmak 125

Trade name
Zitmak 500
Zitmak 250
Zitmak 125

International unlicensed

names Azithromycin Dosage Form
of the Tablet, film coated, 500 mg, 250 mg and 125 mg

Structure
One tablet contains
active agent – azithromycin a dihydrate of 524.0 mg or 262.0 mg or 131.0 mg 500 mg, 250 mg and 125 mg of azithromycin respectively,
excipients are equivalent: starch prezhelatinizirovanny, LHPC 21, sodium lauryl sulfate, sodium of a kroskarmelloz, calcium hydrophosphate dihydrate, aerosil 200, lactose anhydrous, magnesium stearate,
structure of a cover: a hydroksipropilmetiltsellyuloza, cellulose microcrystalline, the titan dioxide, a macrogoal – 40 OE stearate.

The description
of the Tablet, film coated white color, oblong shape, with risky on one party.

Pharmacotherapeutic group
Antimicrobial drugs for system use. Macroleads
the Code of automatic telephone exchange J01FA10

the Pharmacological

Pharmacokinetics Azithromycin properties is quickly soaked up from digestive tract and widely distributed on all organism. Higher concentration of azithromycin in fabrics, than in plasma or serum is caused by its property of fast distribution. At reception of a single dose of 500 mg inside the maximum concentration makes 0.5 mkg/ml and is reached within 2.5 – 3 hours (= Tmax). The seeming constant volume of distribution (Vd) is about 31.1 l/kg. Elimination half-life makes 14-72 hours. The prolonged final elimination half-life is caused by big accumulation and the subsequent removal of drug from fabrics. Removal of azithromycin with bile, mainly in not changed look, is the main way of elimination. At use of a course over a week, about 6% of the accepted dose are removed by urine in not changed look. At use of the mode of treatment of 500 mg in the first day and 250 mg daily within 4 days in cerebrospinal fluid only very low concentration (less than 0.01 mkg/ml) were found.
The pharmacodynamics
Azithromycin is derivative erythromycin and belongs to ozalid group, a subclass of makrolidny antibiotics. Azithromycin works by means of linking with a ribosomalny subunit 50S at sensitive microorganisms and, thereby, interferes with protein synthesis of microorganisms. Does not influence synthesis of nucleic acids.
In comparison with ZITMAK erythromycin is more active concerning gram-negative microorganisms, is steadier in acidic environment of a stomach, it is more slowly allocated from an organism and works more for a long time, it is better to be transferred, to a lesser extent inhibits liver R-450 cytochrome.
Zitmak possesses a wide range of antimicrobic action. It is highly effective concerning many strains below the listed microorganisms as in vitro, and in clinically apparent infections:
Chlamydia pneumonia, Chlamydia trachomatis, Mycoplasma pneumonia, Borrelia burgdorferi, Mycoplasma pneumonia, Treponema pallidum, Ureaplasma urealyticum.
Aerobic gram-positive microorganisms
of Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes, streptococci (C, F groups, G), Viridans group streptococci.
Aerobic gram-negative microorganisms
of Haemophilus influenzae, Moraxella catarrhalis, Bordatella pertussis, Campylobacter jejuni, Legionella pneumophila.
Anaerobic microorganisms
of Bacteroides bivius, Clostridium perfringes, types of Peptostreptococcus.
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.

Indications
– exacerbation of the chronic obstructive pulmonary disease caused
by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumonia
– the acute bacterial sinusitis caused by Haemophilus influenzae,
Moraxella catarrhalis or Streptococcus pneumonia
– the community-acquired pneumonia caused by Chlamydia pneumonia,
Haemophilus influenzae, Mycoplasma pneumonia or Streptococcus pneumonia at patsiyen-
t suitable for oral therapy
– pharyngitis/tonsillitis, the caused Streptococcus pyogenes
– the uncomplicated infections of skin and soft tissues caused
by Staphylococ-cus aureus, Streptococcus pyogenes or Streptococcus agalactiae
– the urethritis and a cervicitis caused by Chlamydia trachomatis,
Neisseria gonorrhoeae
– ulcers of external genitals, the caused Haemophilus ducreyi
(venereal ulcer)
– Lyme’s disease
– the diseases of a stomach and a duodenum associated
with Helicobacter pylori (as a part of complex therapy)

the Route of administration and doses
the Drug is taken for 1 h to or in 2 h after a meal.
Adults and teenagers are more senior than 16 years:

An infection

the Recommended
therapy dose/Duration

Community-acquired pneumonia
(easy degree)

Skin / soft tissues uncomplicated)

the Single dose of 500 mg (1 tablet Zitmak 500) in the first day, then from the second to the fifth day of 250 mg
(1 tablet ZITMAK 250)
once a day

Exacerbations of chronic obstructive pulmonary diseases
(from easy to moderate degree)

500 mg (1 tablet Zitmak 500) once a day within 3 days
OR
the Single dose of 500 mg (1 tablet Zitmak 500) in the first day, then from the second to the fifth day
of 250 mg (1 tablet ZITMAK 250)
once a day

Acute bacterial sinusitis

of 500 mg (1 tablet Zitmak 500)
once a day within 3 days

of the Ulcer of genitals
(venereal ulcer)

the Single dose of 1 grams
(2 tablets Zitmak 500)

Not gonococcal urethritis and a cervicitis

the Single dose of 1 grams
(2 tablets Zitmak 500)

the Gonococcal urethritis and a cervicitis

the Single dose 2 grams
(4 tablets Zitmak 500)

Lyme the First Disease put Pharyngitis/tonsillitis – 1 g (2 tablets Zitmak 500) once, from the second to the fifth day on 500 mg (1 tablet Zitmak 500) (a course of treatment – 5 days, a course dose – 3 g or 6 tablets ZITMAK 500)

In the diseases of a stomach and duodenum associated with Helicobacter pylori appoint 1 g (on 2 tablets Zitmak 500) in day within 3 days as a part of combination therapy.
To children 6 years are more senior it is recommended to apply tablets ZITMAK 125 according to the following scheme: in the first day – 10mg/kg, then 4 days – on 5 mg/kg a day or on 10 mg/kg a day within 3 days (a course dose – 30 mg/kg), in Lyme’s disease in the first day – 20 mg/kg, from the 2nd to the 5th day – 10мг/кг/сутки.

Side effects
– nausea, vomiting, diarrhea, a constipation, a meteorism, an abdominal pain
– cholestatic jaundice
– a stethalgia, heartbeat
– weakness, a headache, dizziness, drowsiness
– nephrite
– pseudomembranous colitis
– a vaginitis
– a neutropenia or a neutrophilia, an eosinophilia
– candidiasis
– a photosensitization
– rash, a Quincke’s disease
at children
– a hyperkinesia, excitement, nervousness, insomnia,

Contraindication conjunctivitis
– hypersensitivity to azithromycin, erythromycin or any
antibiotic from group of macroleads
– heavy abnormal liver functions and kidneys
– children’s age up to 6 years

Medicinal interactions
At simultaneous use Zitmak with:
– the antacids containing hydroxide of aluminum and magnesium concentration of drug
– Cimetidinum decreases, Cimetidinum use (800 mg) in two hours prior to intake of azithromycin does not influence absorption of the last
– theophylline, in therapeutic doses azithromycin moderately affects theophylline pharmacokinetics (intravenous and peroral)
– warfarin, azithromycin does not influence a prothrombin time at use of a single dose of warfarin. However, the care of use in medical practice provides attentive observation of a prothrombin time at all patients receiving simultaneous treatment by azithromycin and warfarin
– digoxin, azithromycin leads to increase in concentration of digoxin
– ergotamine or dihydroergotamine, there can be acute intoxication ergotaminovy drugs which is characterized by a peripheral vasospasm and a dizesteziya (disturbance of sensitivity)
– ergot alkaloids, the effect of alkaloids of an ergot
– tetracyclines and chloramphenicol amplifies, strengthen action (synergism)
– linkozamidam, lower effect of drug
– antacids, ethanol, food slow down and lower absorption
– Cycloserinum, indirect anticoagulants, Methylprednisolonum and felodipiny, azithromycin slows down excretion, increases concentration in blood serum and enhances toxicity
– carbamazepine, ergot alkaloids, valproyevy acid, hexobarbital, Phenytoinum, Disopyramidum, Bromocriptinum, theophylline and other ksantinovy derivatives, oral hypoglycemic means, azithromycin inhibiting microsomal oxidation in hepatocytes, extends elimination half-life, slows down excretion, increases concentration and toxicity
– heparin, pharmaceutical is incompatible.

Special instructions
It is necessary to observe a break of 2 h at simultaneous use of antacids and the drug Zitmak.
At the patients receiving treatment by azithromycin serious allergic reactions, including a Quincke’s disease, an anaphylaxis and dermatological reactions, such as Stephens’s syndrome of Johnson and toxic epidermal necrolysis were in rare instances observed. These patients need more long period of observation and symptomatic therapy.
At treatment of pneumonia it was noted that only azithromycin is safe and effective at treatment of the community-acquired pneumonia caused by Chlamydia pneumonia, Haemophilus influenzae, Mycoplasma pneumonia or Streptococcus pneumonia in patients suitable for oral therapy. In the pneumonia which is not subject to oral therapy inefficient will appoint azithromycin for intake. Azithromycin should not be applied at patients with pneumonia at whom this disease was estimated improper for oral therapy as the disease is characterized by moderate or heavy severity or is available some of the listed risk factors:
– patients with cystous fibrosis
– patients with intrahospital infections
– patients with suspicion or the revealed bacteremia
– patients, needing hospitalization
– the elderly or weakened patients, in a condition of the expressed immunodeficiency and a functional aspleniya.
A case of pseudomembranous colitis are reported at use of almost all antibacterial agents, and on weight can be from easy to life-threatening degree. Therefore, it is important to take into account this diagnosis at patients who have a diarrhea which followed after intake of antibacterial agent.
Because azithromycin is mainly removed through a liver, it is necessary to be careful at use of azithromycin for patients with insufficiency of functions of a liver. Owing to insufficient data at persons at whom glomerular filtration rate
Use in pediatrics
to Children up to 6 years is not recommended to apply a dosage form in the form of tablets and it is recommended to apply ZITMAK suspension 100mg/5ml or ZITMAK 200mg/5 ml according to the instruction.
Use for elderly patients
patients of advanced age have no need for correction of a dose with normal renal and hepatic functions, receiving treatment.
Pregnancy and the period of a lactation
Use of medicine is possible if the expected advantage for mother exceeds potential risk for a fruit.
It is unknown whether azithromycin with breast milk is emitted therefore at use of the drug Zitmak for nursing mothers it is necessary to be careful.
Features of influence of medicine on ability to run motor transport or moving mechanisms
Considering side effects of drug it is necessary to be careful at control of motor transport or moving mechanisms.

Overdose
of Data concerning overdose are insufficient.
Symptoms: nausea, vomiting, diarrhea
Treatment: to wash out a stomach and to appoint symptomatic treatment

the Form of release and packing
of the Tablet, film coated, 500 mg, 250 mg, 125 mg
On 3 tablets (for a dosage of 500 mg), or on 6 tablets (for a dosage 250 mg and 125 mg) in blister strip packaging from a film of polyvinylchloride and printing aluminum foil.
1 packing together with the instruction for medical use in the state and Russian languages is placed in a pack cardboard with the hologram of firm – producer.

To Store storage conditions at a temperature not above 25 °C in the dry, protected from light place.
To store out of children’s reach!

2 years
not to apply a period of storage after a period of storage.

Prescription status
According to the prescription

Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer,
Almaty, Shevchenko St. 162 E.

The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
Republic of Kazakhstan
Almaty, Shevchenko St. 162 E.
Phone number: (+7 727) 275-03-05
Fax number: (+7 727) 277-64 – 34

To Develop the e-mail address of nobel@nobel-aff.kz

Additional information

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