Tsefazim
Producer: Orchid Healthcare (Orkhid Helskea) India
Code of automatic telephone exchange: J01DA10
Release form: Liquid dosage forms. Powder for preparation of solution for injections.
General characteristics. Structure:
Active ingredient: 250 mg, 500 mg or 1000 mg of a tsefotaksim (in the form of sodium salt).
Pharmacological properties:
Pharmacokinetics. Later in/in introductions in a dose of 1 g the maximum level in serum makes 100 mkg/ml and is reached in 5 minutes after introduction. At introduction in oil of 1 g the maximum level in plasma makes 30 mg/ml in 30 minutes.
Linkng with proteins of plasma makes 30-51%. Tsefotaksim gets both through placental, and through hematoencephalic barriers.
Tsefotaksim biotransformirutsya in an organism, the period of its semi-removal makes 1 - 1,5 hour at in/in and introduction in oil. Tsefotaksim is brought to 90% with urine. Time of preservation of therapeutic concentration of Tsefotaksim makes more than 12 hours.
Pharmacodynamics. Tsefazim is an antibiotic of group of cephalosporins of the third generation for parenteral use.
Tsefazim acts bakteritsidno by inhibition of sintezamukopeptid of a cell wall of bacteria in a mitosis phase.
Possesses a broad spectrum of activity. It is steady against action of the majority a beta – лактамаз. Tsefazim is active in the relation as gram-positive flora, and especially concerning gram-negative strains of microorganisms. The following microorganisms of gram-positive flora enter a range of its activity: streptococci And, In, With and G group, Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Staphylococcus aureus, Staphylococcus epidermidis.
From gram-negative flora: Aeromonas hydrophilia, Bacillus subtilis, Borrelia burgdorferi, Morganella morganii, Citrobacter diversus, Clostridium perfringens, Corinebacterium difteriae, Neisseria gonorrhoeae, Neisseria Meningitidis, Escherichia coli, strains of Enterobacter, Haemophilus, Moraxella catarrhalis, Klebsiella pneumonia, Proteus mirabilis, Proteus vulgaris, Eubacterium, Shigella, Salmonella, Yersinia, etc.
Indications to use:
- infectious diseases of respiratory tracts
- infections of urinary tract
- infections of abdominal organs (in t.ch.peritonit)
- meningitis and other infections of TsNS
- infections of bone and joint systems (including osteomyelitis, septic arthritis)
- infections of skin and soft tissues
- prevention of complications at surgical interventions.
Route of administration and doses:
At infectious – moderately severe inflammatory diseases the daily dose of 2-6 g is entered in oil or in/in in a single dose of 1-2 g with an interval of 12 hours. At a serious illness (for example, meningitis) enter from 2 to 4 g in each 8 hours, i.e. to 12 g a day. With the preventive purpose before operation during an introduction anesthesia enter 1 g, if necessary repeat introduction in 12 hours. When performing Cesarean section at the time of imposing of clips on an umbilical vein enter 1 g in/in, then repeat a dose in 12 hours. To children with body weight to 50 kg Tsefazim appoint 50-100 mg/kg in a daily dose. Duration of treatment is established individually. At decrease in clearance of creatinine menee10 ml/min. reduce a daily dose of drug twice.
Rules of preparation and administration of solutions. For preparation of solution for in/in jet introductions as solvent apply water to injections. 500 mg of drug dissolve in 5 ml of solvent, 1 g - in 10 ml of water for injections. The drug is administered in/in slowly within 2-4 min.
For preparation of solution for in/in drop introductions as solvent apply water to injections, 5% glucose solution. For a dose of drug of 1-2 g and more use 50-100 ml of solvent. Enter slowly, not less than 30 min.
For preparation of solution for introduction in oil as solvent apply water to injections or 1% lidocaine solution. For a dose of drug of 500 mg use 2 ml of solvent, for a dose of 1 g – 4 ml.
Features of use:
With care apply Tsefazim at renal failures, and also at instructions on existence of colitis in the anamnesis.
During use of drug positive forward reaction of Koombs and in a false manner positive reaction of urine to glucose is possible.
Pregnancy and lactation. Use in the period of a lactation is justified only when the estimated advantage for mother exceeds potential risk for the child. In need of appointment in the period of a lactation it is necessary to stop breastfeeding.
Influence on ability to management transport sredstvamiya to service of moving mechanisms. It is necessary to be careful.
Side effects:
- nausea, vomiting, abdominal pains, diarrhea, dysbacteriosis, tranzitorny increase in activity of hepatic transaminases, pseudomembranous colitis, cholestatic jaundice;
- urticaria, skin itch, bronchospasm, fever, Quincke's edema, arthralgias, acute anaphylaxis, multiformny erythema, Stephens-Jones's syndrome;
- reversible leukopenia, neutropenia, eosinophilia, thrombocytopenia, agranulocytosis, hemolitic anemia;
- prothrombinopenia;
- intersticial nephrite, increase in concentration of urea of an ikreatinin in plasma;
- encephalopathy, headaches;
- arrhythmias;
- candidiasis;
- morbidity in the place in oil of an injection.
Interaction with other medicines:
At simultaneous use of Tsefazim with aminoglikozidny antibiotics, diuretics because of danger of nephrotoxic action it is necessary to control function of kidneys.
Tsefazim's solutions are incompatible with solutions of other antibiotics in one syringe or a dropper as potentiation of toxic effect of drugs is possible.
Contraindications:
- hypersensitivity to cephalosporins and another beta лактамным to antibiotics;
- hypersensitivity to lidocaine;
- pregnancy;
- children's age up to 2,5 years.
Overdose:
Symptoms: development of reversible encephalopathy is probable.
Symptomatic treatment. There is no specific antidote.
Storage conditions:
To store in the dry place protected from light, at a temperature below +25 ºС. To store in the place, unavailable to children! A period of validity - 3 years. Not to apply after the period of validity specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Powder for preparation of injection solution in glass bottles on 250 mg, 500 mg and 1000 mg enclosed together with the application instruction in cardboard packaging.