Zotsef 10s 500 mg coated tablets

The instruction for use
medicine for experts

ZOTSEF
ZOCEF

Torgovoye a name
Zotsef

Mezhdunarodnoye the unlicensed


name Tsefuroksim Lekarstvennaya
the Tablet form, coated 250 mg, 500 mg

Structure
One tablet contains
active agent –
tsefuroksy (in the form of a tsefuroksim of an aksetil) 250 mg, 500 mg,
excipients: microcrystalline cellulose, sodium of a kroskarmeloz, sodium a lauryl sulfate, silicon colloidal anhydrous, calcium stearate, calcium a carbonate, krospovidon, a hydroksipropilmetiltsellyuloza, propylene glycol, the titan dioxide – enough.

The description
of the Tablet of 250 mg – biconvex capsulovidny tablets, coated white color or almost white color, with dividing risky on the one hand and the inscription CX 250 on the other side of
the Tablet of 500 mg – biconvex capsulovidny tablets, coated white or almost white color, with dividing risky on the one hand

Pharmacotherapeutic group
Others beta laktamnye antibiotics. Cephalosporins.
Code of automatic telephone exchange J01DA06

Pharmacological

Pharmacokinetics Absorption properties and distribution: at oral reception of a tsefuroksim the maximum concentration is reached in 2-3 h after reception. Linking with proteins of plasma makes 33-50%. The concentration of a tsefuroksim exceeding the minimum concentration for the majority of microorganisms are reached in a bone tissue, synovial fluid and intraocular liquid. In meningitis tsefuroksy gets through a blood-brain barrier. Gets through a placenta, it is allocated with breast milk.
Removal: by tsefuroksy it does not biotransformirutsya in an organism. Elimination half-life makes about 1.2 h. It is removed with urine in not changed look due to canalicular secretion and glomerular filtration.
The pharmacodynamics
the Tsefalosporinovy antibiotic of the II generation of a broad spectrum of activity, has bactericidal effect at the expense of inhibition of synthesis of a cell wall of bacteria. Zotsef acetylates membrane-bound transpeptidases, breaking, thus, the cross stitching of peptidoglikan necessary for ensuring durability and rigidity of a cell wall.
It is highly active concerning gram-negative bacteria: Escherichia coli, Haemophilus influenzae, Salmonella spp., Shigella spp., Proteus mirabilis, Neisseria gonorrhoeae, Enterobacter spp. It is active also concerning gram-positive bacteria: Staphylococcus spp., Streptococcus spp.
Methicillinum - resistant strains of Staphylococcus spp is inactive concerning Pseudomonas spp., the majority of strains of Enterococcus spp., many strains of Enterobacter cloacae. and Listeria monocytogenes.
It is resistant to action beta laktamaz.

Indications
the Infectious and inflammatory diseases caused by microorganisms, sensitive to a tsefuroksim:
- respiratory infection (including acute and chronic bronchitis, the infected bronchiectasias, bacterial pneumonia, abscess of lungs)
- abdominal and gynecologic infections
- LOR-infections (including sinusitis, tonsillitis, pharyngitis, average otitis)
- infections of urinary tract (including acute and chronic pyelonephritis, cystitis, a symptomless bacteriuria)
- infections of skin and soft tissues (including cellulitis, erysipelatous inflammation, wound fevers)
- infections of bones and joints (including osteomyelitis, septic arthritis)
- gonorrhea

the Route of administration and doses
Establish individually, taking into account weight of a course and localization of an infection, sensitivity of the activator. The single dose for adults makes 250-500 mg 3 times a day.
To children 5 years - 15-80 mg/kg/days, maintaining frequency - 2-3 times are more senior.
To patients with a renal failure the mode of dosing is set taking into account values of the clearance of creatinine (CC): at KK of 10-20 ml/min. recommend to administer the drug on 750 mg of 2 times/days, at KK less than 10 ml/min. – on 750 mg of 1 times/days.
Maximum doses: a daily dose for adults - 6 g.
The course of treatment is defined with weight of a course and localization
of an infection, sensitivity of the activator according to appointment of the attending physician.

Side effects
- nausea, vomiting, diarrhea, tranzitorny increase in activity of hepatic transaminases, cholestatic jaundice, hepatitis, pseudomembranous colitis
- skin rash, an itching, an eosinophilia, it is rare – a Quincke's edema
- at prolonged use in high doses changes of a picture of peripheral blood (leukopenia, a neutropenia, thrombocytopenia, hemolytic anemia)
- a prothrombinopenia
- interstitial nephrite
- candidiasis, spasms, a hearing disorder, drowsiness

of the Contraindication
- hypersensitivity to a tsefuroksim and other cephalosporins - diseases and bleedings of digestive tract in the anamnesis
- pregnancy and feeding by a breast
- children's age up to 5 years are possible.

Medicinal interactions
Zotsef, suppressing indestinal flora, interferes with vitamin K synthesis. Therefore at simultaneous use with the drugs reducing aggregation of thrombocytes (non-steroidal anti-inflammatory drugs, salicylates, Sulfinpyrazonum) the risk of developing bleedings increases. For the same reason at simultaneous use with anticoagulants strengthening of anticoagulating action is noted.
At simultaneous use with loopback diuretics the risk of development of nephrotoxic action increases.

Special instructions
With care apply in the profound renal failures, at instructions on colitis in the anamnesis. At patients with hypersensitivity to penicillin allergic reactions to tsefalosporinovy antibiotics are possible. During treatment the positive forward reaction of Koombs and false positive reaction of urine to glucose is possible.
Use in pediatric practice
of Data on use of drug for children up to 5 years is not available.
Influence on ability to driving of motor transport and to control of mechanisms
it is necessary to resolve the Issue of a possibility of occupations by potentially dangerous types of activity only after assessment of individual reaction of the patient to drug.

Overdose
Symptoms: spasms, nausea, vomiting.
Treatment: by means of a hemodialysis or peritoneal dialysis.

A form of release and packing
of the Tablet, coated, for intake, 250 mg or 500 mg, on 10 tablets in the aluminum blister. On 1 blister together with the instruction for use in a cardboard box.


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

An expiration date
3 years
not to use after an expiration date

Prescription status
According to the prescription

the Name and the address

of Alkem Laboratories Ltd producer Alkem House Devashish, Senapati Bapat Marg, Lower Parel, Mumbai – 400,013


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