Spayzef

General characteristics. Structure:

Active ingredient: 750 mg or 1500 mg of a tsefuroksim (in the form of sodium salt).

Pharmacological properties:

Pharmacodynamics. Spayzef - a tsefalosporinovy antibiotic of Iipokoleniya for parenteral use. Spayzef acts bakteritsidno, breaking synthesis of a cell wall of bacteria. Possesses a broad spectrum of activity. Spayzef is steady against action of the majority beta лактамаз, is highly active in the relation:

- aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalacticae, Streptococcus mitis, Staphylococcus aureus, Staphylococcus epidermidis (including the strains which are producing and not producing a penicillinase), Bordetellapertusis;

- aerobic gram-negative bacteria: Haemophilus influenzae (including the strains which are producing and not producing a penicillinase), Escherichia coli, Klebsiella spp., Proteusmirabilis, Moraxella catarrhalis, Neisseria gonorrhoeae (including the strains which are producing and not producing a penicillinase), Neisseria meningitidis, Salmonella spp;

- anaerobic gram-positive bacteria: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Propionibacterium spp;

- anaerobic gram-negative bacteria: Bacteroides spp., Fusobacterium spp.; and also it is active concerning Borrelia burgdorferi.

Pharmacokinetics. At introduction in oil Cmax is reached in 30-45 min. after an injection.

The concentration of a tsefuroksim exceeding the minimum overwhelming concentration for the majority of microorganisms are reached in a bone tissue, synovial fluid and intraocular liquid. At meningitis tsefuroksy gets through a blood-brain barrier. Linkng with proteins of plasma of-50%. Therapeutic concentration remains in an organism during 5,3 – 8 h.

Tsefuroksim does not biotransformirutsya in an organism. T1/2 both at in oil, and at in introduction makes about 70 min. 89% of a tsefuroksim is removed in not changed in a view with urine due to canalicular secretion and glomerular filtering.

Indications to use:

— pneumonia, bronchitis, pharyngitis, tonsillitis, sinusitis;

— infections of urinary tract;

— infections of soft tissues and skin;

— infections of bones and joints;

— sepsis;

— meningitis;

— gonorrhea, the uncomplicated and disseminated gonococcal infections;

— Lyme's disease at an early stage and the subsequent prevention of late manifestations at adults and children is more senior than 12 years;

— prevention of infectious complications at operations on bodies of a thorax, abdominal cavity, bodies of a small pelvis, at orthopedic operations.

Route of administration and doses:

The adult in oil or in/in appoint 750 mg of 3 times/days. At heavy infections – in/in 1500 mg of 3 times/days. If necessary the interval between injections can be reduced to 6 h; maximum single dose of 1500 mg/days; the maximum daily dose of drug – 3-6 g/days.

To children (since 3 months) drug appoint in a dose 50-100 mg/kg/days in 3-4 introductions. For the majority of infections the daily dose makes 60 mg/kg.

At infections of urinary tract, soft tissues and skin, the disseminated gonococcal infections and uncomplicated pneumonia about 750 mg each 8 h are recommended. At the heavy or complicated pneumonia 1500 mg each 8 h are recommended. At infections of bones and joints 1500 mg each 8 h are recommended. At bacterial meningitis the dosage should not exceed 3 g each 8 h. At gonorrhea a dose of 1500 mg in oil it is single-step, in the form of 2 injections on 750 mg to different areas.

The average course of treatment makes 7-10 days. For prevention of infectious complications at operations, the recommended dose makes 1500 mg in 30 min. or 1 h before operation, with further introduction of 750 mg in/in or each 8 h in oil.

Recommend to patients with a renal failure at KK of 10-20 ml/min. drug on 750 mg of 2 times/days; at KK less than 10-20 ml/min. – on 750 mg of 1 times/days.

Rules of preparation of solutions for parenteral administration. For in oil or in/in injections add water for injections (according to the table), carefully stir up before formation of suspension.

For introduction in oil:

Dose	Amount of water for injections
750 mg	3 ml

 

For in/in introductions:

Dose	Amount of water for injections
750 mg	7 ml
1500 mg	14 ml

Jet in/in introduction – slowly within 3-5 min. For a continuous infuzionnogov / to introductions, solution Spayzef it is possible to add to the following infusion solutions: solution of sodium of chloride of 0,9%, solution of a dextrose of 5% and 10%.

Features of use:

Use at pregnancy and feeding by a breast. It is contraindicated at pregnancy, in the period of a lactation.

Use at renal failures. Recommend to patients with a renal failure at KK of 10-20 ml/min. drug on 750 mg of 2 times/days; at KK less than 10-20 ml/min. – on 750 mg of 1 times/days.

Use for children. To children (since 3 months) drug appoint in a dose 50-100 mg/kg/days in 3-4 introductions. For the majority of infections the daily dose makes 60 mg/kg.

It is contraindicated at children's age up to 3 months.

Special instructions. Spayzef the patients having in the anamnesis allergic reactions to antibiotics of penicillinic group and/or another beta лактамным to antibiotics should appoint with care. Carefully appoint Spayzef along with furosemide, and anticoagulants. At the patients receiving Spayzef it is recommended when determining level of glucose in blood to use a glucokinase or a hexokinase.

Influence on ability to driving of motor transport and to control of mechanisms. Considering side effects of medicine it is necessary to be careful at control of motor transport or potentially dangerous mechanisms.

Side effects:

— nausea, vomiting, diarrhea, meteorism, lock, abdominal pains, ulcerations of a mucous membrane of an oral cavity, pseudomembranous colitis;

— short-term eosinophilia and neutropenia, leukopenia, anemia, thrombocytopenia, change of a prothrombin time, pancytopenia, agranulocytosis;

— tranzitornoyepovysheniye of level of bilirubin, hepatic transaminases;

— skin rash, itch, small tortoiseshell, fever, multiformny erythema, bronchospasm, Stephens-Johnson's syndrome, acute anaphylaxis;

— headache, sleeplessness;

— thrombophlebitises;

— morbidity in an injection site;

— intersticial nephrite.

Interaction with other medicines:

Spayzef's appointment in combination with antibiotics from group of aminoglycosides, metronidazole is possible. In a combination with them works it is additive, but an action synergism can sometimes be observed.

At simultaneous use of Spayzef in high doses with strong diuretics (furosemide) and aminoglycosides canalicular secretion is slowed down, the renal clearance decreases, concentration in plasma increases and the elimination half-life of a tsefuroksim increases that increases risk of emergence of nephrotoxic effects.

Contraindications:

— hypersensitivity to cephalosporins and another beta лактамным to antibiotics;

— pseudomembranous colitis in the anamnesis;

— to children up to 3 months;

— pregnancy and period of a lactation.

Overdose:

Symptoms: neurologic disturbances, including spasms are possible.

Treatment: hemodialysis or peritoneal dialysis.

Storage conditions:

To store in dry, protected from light and the place, unavailable to children, at a temperature not over 25 ºС. A period of storage - 2 years.

Issue conditions:

According to the recipe

Packaging:

Bottles glass (1) - boxes cardboard.
Bottles glass (50) - boxes cardboard.