Tsepir

General characteristics. Structure:

Active ingredient: 1 g of a tsefpirom (in the form of sulfate).

Pharmacological properties:

Pharmacodynamics. Tsepir is a tsefalosporinovy antibiotic of the IV generation. Works with Tsepir bakteritsidno by inhibition of synthesis of mukopeptid of a cell wall of bacteria in a mitosis phase. Possesses a broad spectrum of activity concerning gram-positive and gram-negative bacteria, strains, resistant to aminoglycosides or tsefalosporinovy antibiotics of the III generation.

Tsepir it is active concerning gram-positive bacteria: Staphylococcus aureus, Staphylococcus spp. (it is steady against action of a coagualase of gram-negative strains), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae Streptococcus viridans, Corynebacterium spp., Peptostreptococcus spp.; gram-negative bacteria: Pseudomonas aeruginosa, Escherichia coli, Enterobacter, Klebsiella spp., Proteus spp., Morganella morganii, Providencia spp., Citrobacter spp., Serratia spp., Haemophilus influenzae, Moraxella catarrhalis, Acinetobacter spp., Bacteroides spp.

Pharmacokinetics. By Tsefpir it is not soaked up from digestive tract owing to what it is applied in the form of intravenous injections or infusions. Within 5 min. after intravenous administration of 1 g of drug average concentration in a blood plasma makes 81 mg/l. About 10% of drug contact proteins of a blood plasma. Tsefpirom's T1/2 at patients with normal function of kidneys makes about 1,8 - 2,2 h. Cumulation of drug at repeated introduction is not observed. Tsefpir it is allocated mainly with kidneys by glomerular filtering; usually 80 – 90% of the administered drug are removed with urine in the first 24 h.

At patients 65 years within 5 min. after intravenous administration of 1 g of drug average concentration in a blood plasma are more senior makes 127,1 mg/l, and the elimination half-life after intravenous administration of the same dose increases to 4,5 h. Cumulation of drug at elderly patients at repeated introduction is not observed.

Indications to use:

— respiratory infections (pneumonia, lung abscess, pleura empyema);

— the complicated infections of upper and lower urinary tract;

— gynecologic infections (adnexitis, endometritis, parametritis, pelviperitonitis, abscess of a duglasov of space, abscess of bartolinovy gland);

— infections of skin and soft tissues;

— bacteremia, septicaemia;

— infections at patients with a neutropenia and the weakened immunity.

Route of administration and doses:

Tsepirom's dosage, way of introduction and duration of treatment depend on weight of an infection, sensitivity of microorganisms, renal function and are established by the attending physician.

The recommended doses for patients with normal function of kidneys (clearance of creatinine> of 50 ml/min. are given in the following table):

Severity of a disease	Single dose	Interval between introductions	Daily dose
Heavy infections	1 g	12 h	2 g
The complicated, life-threatening infections	2 g	12 h	4 g

The dosage of drug is adjusted, in view of clearance of creatinine.

Rules of preparation of solutions for parenteral administration. Tsepir enter only in / century. For in/in administrations of drug contents of a bottle are dissolved in 10 ml of water for injections and entered slowly in/in within from 3 to 5 min.

For in/in Tsepirom's infusions contents of a bottle are dissolved in 100 ml of water for injections and entered in/in within from 20 to 30 min. As solvent the following infusion solutions can be used: 0,9% chloride sodium solution, Ringer's solution, standard solution of electrolytes, 5% and 10% solution of glucose, 5% fructose solution. For in/in injections it is not necessary to dissolve drug in carbonate sodium solution.

Solution of drug is stored at the room ^{temperature (25 0C)} during 6 h or at ^{a temperature from +2 of 0C} to + ^{8 0C} (in the place protected from light) during 24 h.

Features of use:

Use at pregnancy and feeding by a breast. Use of drug during pregnancy is possible only under observation of the doctor and is justified only when the estimated advantage for mother exceeds potential risk for a fruit. For treatment feeding by a breast is recommended to be stopped.

Use at renal failures. At a renal failure the dosage of drug is adjusted, in view of clearance of creatinine.

Special instructions. Tsepir with care appoint to patients with any forms of an allergy, especially at allergic reactions to medicines in the anamnesis. Emergence of allergic reactions against the background of therapy by Tsepirom demands the treatment termination.

At prolonged use it is necessary to take measures for the prevention of development of dysbacteriosis and to watch a picture of blood and function of kidneys. In the first weeks of treatment development of pseudomembranous colitis is possible.

Influence on ability to driving of motor transport and to control of mechanisms. Does not influence.

Side effects:

— diarrhea, nausea, vomiting, pseudomembranous colitis, abdominal pains, lock, taste change;

— rash, itch, urticaria, anaphylactic reactions;

— increase in ALT, nuclear heating plant, alkaline phosphatase, general bilirubin, eosinophilia, increase in a prothrombin time or partial tromboplastinovy time, temporary increase in an urea nitrogen of blood and/or creatinine of serum, tranzitorny thrombocytopenia, tranzitorny leukopenia and neutropenia, anemia;

— intersticial nephrite, renal failure;

— dizziness, headache, confusion of consciousness, sleeplessness, reversible encephalopathy;

— disturbance of a rhythm, hemorrhage;

— phlebitis, an inflammation or pain in the place of an injection.

Interaction with other medicines:

With extra care it is necessary to apply Tsepir with aminoglycosides, furosemide and other loopback diuretics as increase nefro-and ototoxicity is possible at their combined use.

Probenetsid slows down Tsepirom's excretion from an organism and, thereby, increases its concentration in a blood plasma.

At simultaneous administration of solution of Tsepirom with solutions of metronidazole, Vancomycinum, gentamycin perhaps pharmaceutical interaction. At Tsepirom's appointment with the listed drugs it is necessary to enter each antibiotic separately.

Contraindications:

Hypersensitivity to tsefalosporinovy antibiotics, penicillin or another beta лактамным to antibiotics.

Overdose:

Symptoms: encephalopathy symptoms are possible.

Treatment: symptomatic. Level of a serumal tsefpirom is reduced by peritoneal dialysis and a hemodialysis. About 50% of the drug which is in an organism are removed from an organism at a 4-hour hemodialysis.

Storage conditions:

To store in dry, protected from light and the place, unavailable to children, at a temperature below +25 °C. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

Bottles glass (1) - packagings cardboard.