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General characteristics. Structure:

One bottle contains tsefuroksy sodium - 789 mg (it is equivalent to a tsefuroksim – 750 mg).

Description: 
Powder of color, white or white with a yellowish shade.

Pharmacological properties:

Tsefuroksim - a tsefalosporinovy antibiotic of the II generation for parenteral use. Works bakteritsidno, breaks synthesis of a cell wall of microorganisms. Possesses a broad spectrum of activity. It is steady against action of the majority beta лактамаз.
It is highly active concerning Staphylococcus aureus, including the strains steady against penicillin (except for rare strains, resistant to Methicillinum), S.epidermidis, Haemophilus influenzae, Klebsiella spp., Enterobacter spp., Streptococcus pyogenes, Escherichia coli, Streptococcus mitis (viridans group), Clostridium spp., Proteus mirabilis, Proteus rettgeri, Salmonella typhi, S. typhimurium, and other types of Salmonella spp., Shigella spp., Neisseria spp. (including the strains of N. gonorrhoeae producing beta lactamazu) and Bordetella pertusis.
Drug is also moderately active concerning strains of Pr.Vulgaris, Pr.morganii. The majority of strains of Bacteroides fragilis are not sensitive to drug. Campilobacter, Acinobacter calcoaceticus, the majority of strains of Serratia, Clostridium difficile is inactive concerning Pseudomonas. After intramuscular introduction in a dose of 750 mg the maximum concentration is created in 45-60 min. and makes about 27 mkg/ml.
At intravenous administration of 750 mg and 1,5 g in 15 min. levels are equal in plasma to 50 and 100 mkg/ml respectively, therapeutic concentration remains 5 and 8 h respectively.
The elimination half-life at intravenous and intramuscular administration makes about 80 min. (at newborns can be 3-5 times higher). Contacts proteins of plasma for 50%. About 80% of a dose are removed by kidneys during 8 h in not changed look (creates high concentration in urine), in 24 h is removed completely: 50% cosecrete in renal tubules, 50% are filtered in balls.
Therapeutic concentration are registered in pleural and synovial liquids, bile, a phlegm, a bone tissue, cerebrospinal fluid (at an inflammation of a meninx), a myocardium, skin and soft tissues. Passes through a placenta and in breast milk.

Indications to use:

The infectious and inflammatory diseases caused by activators, sensitive to drug, including infections of upper and lower respiratory tracts, skin and soft tissues, urinogenital ways, joints, wounds, bodies of a small pelvis and abdominal cavity, bilious ways and the digestive tract (DT), gonorrhea, sepsis, osteomyelitis, peritonitis, meningitis. Prevention of infectious complications at operations.

Route of administration and doses:

The drug is administered intramusculary and intravenously. Intramuscular introduction. Add 3 ml of water for injections to 750 mg of drug and carefully stir up before receiving an opaque suspension.
For intravenous jet administration of 750 mg of drug dissolve in not less than 9 ml of water for injections. As solvent it is possible to use also isotonic solution of sodium of chloride or 5% glucose solution. Enter slowly within 3-5 minutes.
The adult in oil or in/in appoint 0.75-1.5 g 3 times a day. If necessary the interval between injections can be reduced till six o'clock; a daily dose of drug - 3-6 g.
To children appoint drug in a dose of 30-100 mg/kg/days in 3-4 introductions. For the majority of infections the optimum daily dose makes 60 mg/kg. The newborn appoint on 30-100 mg/kg/days in 2-3 introductions. In the first weeks of life the elimination half-life of a tsefuroksim from blood serum of newborns can be in 3-5 times more, than at adults.
At gonorrhea drug appoint in a dose 1.5 g once in the form of 1 injection or in the form of 2 injections on 750 mg entered into both buttocks.
At meningitis the adult appoint 3 g in/in each 8 h.
To children of chest and more advanced age appoint 200-400 mg/kg/days in/in in 3-4 introductions. At achievement of optimum therapeutic effect it is possible to reduce a dose of drug to 100 mg/kg/days intravenously. The newborn appoint drug in an initial dose of 100 mg/kg/days intravenously.
At achievement of optimum therapeutic effect it is possible to reduce a dose to 50 mg/kg/days intravenously.
For prevention of infections at abdominal, pelvic and orthopedic operations the drug is administered in/in in an average dose of 1.5 g along with introduction of an anesthesia.
If necessary additional administrations of drug in oil in a dose of 750 mg in 8 and 16 h are possible.
The patient with renal failures at clearance of creatinine of 10-20 ml/min. 2 times/days recommend to administer the drug on 750 mg; at clearance of creatinine less than 10 ml/min. - on 750 mg 1 times/days. The patient on dialysis at the end of each procedure enter 750 more mg.
At continuous peritoneal dialysis drug is appointed on 750 mg by 2 times/days.

Features of use:

The patients who had allergic reactions to penicillin in the anamnesis can have hypersensitivity to tsefalosporinovy antibiotics. During treatment false positive forward reaction of Koombs and false positive reaction of urine to glucose is possible. At the patients receiving tsefuroksy when determining concentration of glucose in blood it is recommended to use tests with glucose oxydas or a hexokinase. At prolonged use it is recommended to control function of kidneys (especially when using high doses) and to perform prevention of dysbacteriosis. At patients with a renal failure the dose has to be lowered taking into account expressiveness of a renal failure and sensitivity of the activator. After elimination of symptoms of a disease treatment should be continued during 48-72 h.

Side effects:

From a GIT: nausea, vomiting, diarrhea, spasms and abdominal pain; ulcerations of a mucous membrane of an oral cavity; cases of pseudomembranous colitis, oral cavity candidiasis are described.
From system of a hemopoiesis: anemia, eosinophilia, leukopenia, neutropenia.
From TsNS: spasms.
From urinogenital system: a renal failure, a dysuria, an itch in crotches, a vaginitis.
From sense bodys: decrease in hearing.
From laboratory indicators: tranzitorny increase in content of hepatic transaminases in a blood plasma, increase in level of bilirubin, an alkaline phosphatase.
Allergic reactions: skin rash, itch, small tortoiseshell, fever; extremely seldom – an acute anaphylaxis.
Local reactions: morbidity, at intravenous administration - thrombophlebitis.
Positive reaction of Koombs was found in some patients receiving Tsefuroksim.

Interaction with other medicines:

Tsefuroksim, suppressing an indestinal flora, interferes with vitamin K synthesis. Therefore at co-administration with the drugs reducing aggregation of thrombocytes (NPVP, salicylates, Sulfinpyrazonum) the risk of development of bleedings increases. For the same reason at co-administration with anticoagulants strengthening of anticoagulating action is noted. At co-administration with diuretics and potentially nefrotoksichny antibiotics the risk of development of nephrotoxic action increases. Simultaneous peroral purpose of "loopback" diuretics slows down canalicular secretion, reduces renal clearance, increases concentration in plasma and increases T ½ tsefuroksim. Probenetsid reduces canalicular secretion, reduces renal clearance.
Pharmaceutical we will combine: with the aqueous solutions containing to 1% of lidocaine of a hydrochloride, 0,9% solution of sodium of chloride, 5 and 10% solution of a dextrose, 0,18% solution of sodium of chloride and 4% solution of a dextrose, 5% solution of a dextrose and 0,9% chloride sodium solution, Ringer's solution, Hartman's solution, lactate sodium solution, heparin (10 PIECES/ml and 50 PIECES/ml) in 0,9% chloride sodium solution.
Pharmaceutical it is incompatible: with solutions of aminoglycosides (it is impossible to mix in one syringe); with solution of Natrii hydrocarbonas of 2,74%.

Contraindications:

Hypersensitivity to a tsefuroksim and another beta лактамным to antibiotics. Bleedings and gastrointestinal diseases in the anamnesis, including nonspecific ulcer colitis.

With care:
It is necessary to be careful at purpose of drug: to the newborn, premature children weakened and the exhausted patients, patients with the expressed renal failures, at colitis, at the lowered coagulability of blood, stomach ulcer and a duodenum, ulcer colitis.

Use at pregnancy and a lactation:
Use of drug at pregnancy is possible only when the potential advantage for mother exceeds possible risk for a fruit. In need of use of drug in the period of a lactation it is necessary to stop breastfeeding.

Overdose:

Symptoms: excitement, spasms.
Treatment: haemo - and peritoneal dialysis.

Storage conditions:

To store at a temperature not over 25 ºС. To store in the place, unavailable to children. Period of validity: 2 years. Not to use after the term specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Powder for preparation of solution for intramuscular and intravenous administration on 750 mg of a tsufuroksim in the bottle from transparent colourless glass like III corked by a chlorbutyl rubber bung and which is pressed out by an aluminum cap with the latched cap of red color. One bottle together with the application instruction is placed in a cardboard pack. From 50 to 100 bottles together with application instructions place in a cardboard box (for hospitals).