The instruction for medical use
The Trade name
Mezhdunarodnoye the unlicensed
name Tsefuroksim Lekarstvennaya a form
Powder for preparation of solution for injections of 0.75 g or 1.5 g
active agent – tsefuroksy (in the form of sodium salt) 0.75 g or 1.5 g
Powder of white color
Tsefuroksim in a combination with other antimicrobial
drugs Code of Automatic Telephone Exchange J01RA03 Pharmacological Pharmacokinetics Later Properties of intramuscular administration of drug in a dose of 750 mg the maximum concentration of a tsefuroksim in blood plasma is reached by ZOTsEF in 15-60 min. and makes 27 mkg/ml. After intravenous administration in doses of 750 mg and 1.5 g the maximum concentration is reached in 15 min. and makes respectively 50 and 100 mkg/ml. Therapeutic concentration remains during 5.3 and 8 h respectively. Linking with proteins of blood 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.
Tsefuroksim does not biotransformirutsya in an organism. Elimination half-life both at intramuscular, and at intravenous administration makes about 70 minutes, at newborns increases by 3-5 times. It is removed with urine in not changed look due to canalicular secretion and glomerular filtration.
Zotsef – a 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.
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)
– an endocarditis
– prevention of infectious complications at abdominal organs surgeries, a small pelvis, at orthopedic operations, heart surgeries, lungs, a gullet, and vessels.
The route of administration and doses
Establish individually, taking into account weight of a course and localization of an infection, sensitivity of the activator. Apply intramusculary or intravenously. At parenteral administration the single dose for adults makes 0.75-1.5 g 3 times a day. Depending on an etiology of a disease apply 1.5 g once or on 750 mg 2 times with an interval of 8 h.
To newborns and children up to 3 months – 10-50 mg/kg/days, introduction frequency – 2-3 times, are more senior than 3 months – 15-80 mg/kg/days, maintaining frequency – 2-3 times.
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 makes, as a rule – 5-10 days
of the Rule of preparation and administration of drug
For an intramuscular injection of 750 mg of powder dissolve in 3 ml of water for injections. Carefully stir up before formation of opaque suspension. As solvent at intramuscular introduction it is possible to use 1% lidocaine solution in the same proportions.
For intravenous injection of 750 mg of powder dissolve in not less than 6 ml (according to 1.5 g – in 15 ml) waters for injections. For short-term intravenous injections (up to 30 min.) 1.5 g of drug dissolve in 50 ml of water for injections. These solutions can be entered directly into a vein or into a dropper tube if the patient receives liquids parenterally.
Zotsef it is not necessary to mix in one syringe with antibiotics of group of aminoglycosides and Euphyllinum.
– nausea, vomiting, diarrhea, tranzitorny increase in activity of hepatic transaminases, cholestatic jaundice, hepatitis, pseudomembranous colitis
– skin rash, an itching, an eosinophilia, a small tortoiseshell, fever, a mnogoformny erythema or Stephens’s syndrome – Johnson, an acute anaphylaxis (collapse, a bronchospasm, a laryngeal edema)
– it is rare – a Quincke’s edema
– are possible: a leukopenia, a neutropenia, thrombocytopenia, hemolytic anemia (at prolonged use in high doses)
– a prothrombinopenia
– interstitial nephrite
– oral cavity candidiasis, vagina candidiasis
– phlebitis (at intravenous administration), morbidity in the place of an injection (at intramuscular introduction).
– hypersensitivity to a tsefuroksim and other cephalosporins.
Tsefuroksim, 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.
With care apply in the profound renal failures. 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.
At use of the drug Zotsef with piperidic acid there is a danger of development of neurotoxicity.
Pregnancy and the period of a lactation
Zotsef is allocated with breast milk in insignificant concentration concentration. Use of a tsefuroksim at pregnancy (especially in 1 trimester) and in the period of a lactation perhaps in cases when the expected advantage of therapy for mother exceeds potential risk for a fruit.
The feature of influence on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Symptoms: neurotoxic syndrome (nystagmus, behavior disorders, hallucinations, spasms).
Treatment: symptomatic, hemodialysis or peritoneal dialysis.
A form of release and packing
On 815 mg (for a dosage of 750 mg) or on 1630 mg (for a dosage of 1.5 g) drug in colourless glass bottles with a capacity of 10 ml (for a dosage of 750 mg) or 20 ml (for a dosage of 1.5 g) corked by rubber bungs and which are pressed out by aluminum caps with covers of violet color with the relief inscription FLIP OFF or with covers of red color with the relief inscription FLIP OFF (for a dosage of 1.5 g).
On 1 bottle together with the instruction for use in the state and Russian languages place in a cardboard box.
To Store storage conditions in the place protected from light at a temperature not above +25 °C
to Store out of children’s reach!
not to use a period of storage after an expiration date.
According to the prescription
the Name and the address
of producer Alkem Laboratories Ltd Alkem House Devashish, Senapati Bapat Marg, Lower Parel, Mumbai – 400,013
Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Alkem Laboratories Ltd in RK
acting through the authorized representative Sandip Kumar Dubey
Ph./fax: 266-3990, 275-69-65
To develop email@example.com