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Zinnat 10s 125 mg coated tablets

$17.60

f5c3a947e84b

Description

The instruction for medical use

of Zinnat Torgovoye medicine a name

Zinnat

Mezhdunarodnoye the unlicensed

name Tsefuroksim Lekarstvennaya

the Tablet form, coated, 125 mg and 250 mg

Structure

One tablet contains

active agent – a tsefuroksima aksetit 150.36 mg and 300.72 mg

(corresponds to a tsefuroksim) (125.00) (250.00),

excipients: microcrystalline cellulose, sodium of a kroskarmelloz, type A, sodium lauryl sulfate, the vegetable oil hydrogenated silicon dioxide colloidal anhydrous,

structure of a cover: gipromelloza, propylene glycol, methylparahydroxybenzoate (E218), propilparagidroksibenzoat (E216), Opaspry white M-1-7120J,

Opasprey’s list white: a gipromelloza 5sr or 6sr, the titan dioxide (E171),

Natrium benzoicum, alcohol denatured (74 SHOUTING), the water purified.

The description

of the Tablet of a capsulovidny form, coated, white or whitish color, with a biconvex surface, with marking of GX ES5 (for a dosage of 125 mg) and GX ES7 (for a dosage of 250 mg) on the one hand and smooth with another.

Pharmacotherapeutic group

Antibacterial drugs for system use. Beta laktamnye antibacterial drugs other. Cephalosporins of the second generation. Tsefuroksim.

The ATX J01DC02 code

tsefuroksy aksetit the Pharmacological Pharmacokinetics Absorption Later properties of intake is soaked up from digestive tract and quickly hydrolyzed in a mucous membrane of intestines and blood with release of a tsefuroksim in a system blood stream. Optimum absorption is reached at reception of tablets after a meal.

After reception of a tsefuroksim together with food its maximum concentration (2.9 mg/l for 125 mg, 4.4 mg/l for 250 mg, 7.7 mg/l for 500 mg and 13.6 mg/l for 1 g) in blood plasma is defined in 2.4 hours.

Distribution

makes Extent of linking of a tsefuroksim with proteins of blood plasma from 33% to 50%, depending on a route of administration.

Metabolism

Tsefuroksim is not metabolized in an organism.

Removal

Elimination half-life of a tsefuroksim makes 1-1.5 hours.

Tsefuroksim is allocated with kidneys in an invariable look by glomerular filtration and canalicular secretion. Competitive purpose of a probenitsid increases AUC indicator by 50%.

A renal failure

the Pharmacokinetics of a tsefuroksim was not investigated at patients with various degree of renal dysfunction. Elimination half-life of a tsefuroksim increases with depression of function of kidneys that is the main management for selection of a dose at such patients. At the patients who are on a hemodialysis, at least 60% of the general dose of a tsefuroksim are present at an organism at the time of the beginning of dialysis which is removed within 4 hours of the procedure of dialysis. Thus, such patients need purpose of an additional dose of a tsefuroksim on completion of the procedure of a hemodialysis.

A pharmacodynamics

Zinnat – a tsefalosporinovy antibiotic of the II generation. Possesses a broad spectrum of activity. It is resistant to action of the majority – laktamaz therefore ampicillin – resistant or amoxicillin – resistant strains is active in the relation. Works bakteritsidno, breaks synthesis of a cell wall of bacteria as a result of linking with the main proteins targets.

The resistance of strains depends on a geographical location and time. Use local data on resistance for treatment of heavy infections.

Tsefuroksim is effective concerning the following microorganisms

Aerobic gram-positive bacteria:

Streptococcus pyogenes *

Beta-hemolytic streptococci

Aerobic gram-negative bacteria:

Haemophilus influenzae * (including ampicillin – resistant strains)

Haemophilus parainfluenzae *

Moraxella catarrhalis *

Neisseria gonorrhea * (including the strains which are producing and not producing penicillinase)

Anaerobic gram-positive bacteria:

Peptostreptococcus spp.

Propionibacterium spp.

Borrelia burgdorferi spirochetes *

Organisms with a possible rezistentost to a tsefuroksim

Aerobic gram-positive bacteria:

Staphylococcus spp., including S. aureus (only Methicillinum – sensitive isolates) *

Streptococcus pneumoniae *

Aerobic gram-negative bacteria:

Citrobacter spp., not including

C. freundii Enterobacter spp., not including E. aerogenes and

E. cloacae Escherichia coli *

Klebsiella spp., including Klebsiella pneumoniae *

Proteus mirabilis Proteus spp., not including P. penneri and

P. vulgaris Providencia spp.

Anaerobic gram-positive bacteria:

Clostridium spp., not including C. Difficile

Anaerobic gram-negative bacteria:

Bacteroides spp., not including

B. fragilis Fusobacterium spp.

Enterococcus spp., including E. faecalis and

E. faecium Listeria monocytogenes Acinetobacter spp. Burkholderia cepacia Campylobacter spp. Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Morganella morganii Proteus penneri Proteus vulgaris Pseudomonas spp., including

Pseudomonas aeruginosa Serratia spp are resistant to a tsefuroksim.

Stenotrophomonas maltophilia Clostridium difficile Chlamydia species Mycoplasma species Legionella species Bacteroides fragilis

* Clinical performance was not confirmed in clinical trials

Indications

Treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to drug:

– an upper respiratory tract infection, ENT organs (including acute

average otitis, sinusitis, tonsillitis and pharyngitis)

– lower respiratory tract infections, for example, pneumonia, an acute bronchitis, exacerbation of chronic bronchitis

– an infection of an urinogenital system (including pyelonephritis, cystitis,

an urethritis)

– gonorrhea, an acute uncomplicated gonococcal urethritis, a cervicitis

– infections of skin and soft tissues, for example, a furunculosis, a pyoderma,

impetigo

– Lyme’s disease at an early stage and the subsequent prevention of late

stages of this disease at adults and children is more senior than 12 years

the Sensitivity of strains can vary depending on a geographical location and time. Use whenever possible local data on sensitivity of microorganisms.

The route of administration and doses

averages Duration of use of drug 7 days (from 5 to 10 days). For optimum absorption the drug should be taken after a meal.

Adults

The majority of infections

on 250 mg twice a day

An infection of an urinogenital path

on 125 mg 2 times a day

Pyelonephritis

on 250 mg 2 times a day

A lower respiratory tract infection easy and moderate severity, for example, bronchitis

on 250 mg 2 times a day

Heavy lower respiratory tract infections or suspicion of pneumonia

on 500 mg 2 times a day

Uncomplicated gonorrhea

a single dose of 1 g

Lyme’s disease at adults and children are more senior than 12 years

on 500 mg 2 times a day within 20 days

Step therapy

Duration of therapy depends on disease severity and a clinical condition of the patient.

Pneumonia

Zinatsef in a dose of 1.5 g 2-3 times a day (in/in or in oil) within 48-72 hours, and then – Zinnat in a dose of 500 mg 2 times a day within 7-10 days.

Exacerbation of chronic bronchitis

Zinatsef in a dose of 750 mg 2-3 times a day (in/in or in oil) within 48-72 hours, and then – Zinnat in a dose of 500 mg 2 times a day within 5-10 days.

Children

The majority of infections

of 125 mg (1 tablet on 125 mg) 2 times a day. The maximum daily dose – 250 mg.

Average otitis or more serious infections at children at the age of 2 years are also more senior

than 250 mg (1 tablet on 250 mg or 2 tablets on 125 mg) 2 times a day. The maximum daily dose – 500 mg.

The tablets Zinnat cannot be broken therefore small detyamrekomendutsya to appoint drug in the form of suspension. There is no experience of use of a tsefuroksim of an aksetil for children 3 months are younger.

The renal failure

Tsefuroksim is removed mainly by kidneys. At patients with a renal failure the dose decline for correction of the slowed-down excretion is recommended.

The clearance

of T1/2 creatinine

(hours)

the Recommended dose

& ge, 30 ml/min.

1.4 – 2.4

Correctings of a dose is not required (a standard dose of 125 – 500 mg twice a day)

10-29 ml/min.

4.6

Standard individual dose each 24 hours

& lt, 10 ml/min.

16.8

Standard individual dose

During the procedure of a hemodialysis

2 4

Additional single individual at the end of the procedure of dialysis

Side effects

Side reactions on tsefuroksy is usually passing each 48 hours and have an easy course.

Frequency of occurrence is defined as follows: very often (& ge, 1/10), it is frequent (& ge, 1/100 – & lt, 1/10), infrequently (& ge, 1/1,000 – & lt, 1/100), is rare (& ge, 1/10,000 – & lt, 1/1,000), is very rare (& lt, 1/10,000, including separate cases), it is unknown (frequency cannot be estimated).

Often

– the strengthened growth of steady microorganisms of the sort Candida

– an eosinophilia

– a headache, dizziness

– gastrointestinal disorders, including diarrhea, nausea, pain

in a stomach

– temporary increase in activity of enzymes of a liver (ALT, nuclear heating plant, LDG),

Infrequently

– positive reaction of Koombs, thrombocytopenia, a leukopenia (sometimes pronounced)

– skin rash

– vomiting

Seldom

– urticaria, an itching

– pseudomembranous colitis

Very seldom

– hemolytic anemia

– fever of a medicinal etiology, a serum disease, an anaphylaxis

– jaundice (mainly cholestatic), hepatitis

– a polymorphic erythema, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis (exanthematous necrolysis)

Contraindications

– hypersensitivity to antibiotics of group of cephalosporins,

penicillin and Carbapenums or to any component of drug

– children’s age up to 6 years (the tableted form of drugs is not recommended)

With care:

– the first trimester of pregnancy

Medicinal interactions

Drugs which reduce acidity of gastric juice can reduce bioavailability of the drug Zinnat and minimize effect of acceleration of absorption after meal.

As well as other antibiotics, the drug Zinnat can influence indestinal flora, thereby leading to decrease in a reabsorption of estrogen and decrease in efficiency of the combined oral contraceptives.

As when carrying out the ferrotsianidny test the false positive result can be noted, for determination of level of glucose in blood of the patients receiving therapy tsefuroksimy sodium it is recommended to use a glyukozooksidazny or hexokinase technique.

Zinnat does not affect results alkaline pikratnogo a method of determination of level of creatinine.

Simultaneous introduction with probenitsidy leads to increase AUC drug Zinnat for 50%.

The special

instructions Drug Zinnat are appointed with extra care to patients in whose anamnesis there are data on allergic reactions to penicillin or others beta laktamnye antibiotics.

As well as in a case with other antibiotics, at long-term treatment prerparaty the strengthened growth of insensitive microorganisms (Candida, Enterococci, Clostridium difficile) is possible that it can demand the treatment termination.

At appearance of diarrhea against the background of use of antibiotics, including the drug Zinnat, it must be kept in mind a possibility of development of pseudomembranous colitis which weight can vary from insignificant to zhizneugrozhayushchy. Thus, it is important to consider the possibility of presence of this pathology at patients with the diarrhea which arose against the background of treatment or after the therapy termination. In the presence at the patient of the long or profound diarrhea or in the presence of abdominal spasms, treatment has to be stopped immediately and the patient has to be directed to a further research.

At the Zinnat drug treatment of a disease of Lyme Yarisha-Gersgeymer’s reaction is sometimes noted. This reaction is a direct consequence of bactericidal action of Zinnat on an infestant Borrelia burgdorferi spirochete – and is the frequent and usually spontaneously passing treatment consequence. It is necessary to explain to patients that this usual consequence of antibiotic treatment in Lyme’s disease which is not demanding special therapy.

At step therapy time of switching to oral therapy is defined by weight of an infection, a clinical condition of patients and sensitivity of the activator. In the absence of clinical improvement for 72 h the parenteral therapy should be continued.

Study the instruction for use of the drug Zinatsef in case of its appointment.

Pregnancy and the period of a lactation

Use in II and III trimesters of pregnancy, and also in the period of a lactation perhaps in cases when the expected advantage of therapy for mother exceeds potential risk for a fruit.

The lactation

Tsefuroksim gets into breast milk in this connection use of drug when feeding has to be considered with care.

Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms

As at administration of drug Zinnat can arise dizziness cases, it is necessary to be careful at control of vehicles and other mechanisms

Overdose

Symptoms: disturbance from central nervous system which are shown by excitement, spasms.

Treatment: carry out symptomatic therapy. Zinnat is brought at a hemodialysis or peritoneal dialysis.

A form of release and packing

On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.

On 1 blister strip packaging together with the instruction for use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions at

a temperature not higher than 30 S. Hranit out of children’s reach!

3 years

not to apply a period of storage after an expiration date.

Prescription status

According to the prescription

the Producer/packer Glakso Opereyshens Great Britain Limited, Great Britain

(Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom)

the Name and the country of the owner of the registration certificate

Glakso Opereyshens Great Britain Limited, Great Britain

(Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom)

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)

of Predstavitelstvo GlaksoSmitKlyayn Export Ltd in

Kazakhstan 050059, Almaty, Furmanov St., 273

Phone number: +7 701 9908566, +7 727 258 28 92, +7 727 259 09 96

Fax number: + 7 727 258 28 90

E-mail address:

To develop kaz.med@gsk.com

Additional information

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