Tsefdim

General characteristics. Structure:

Active ingredient: 250 mg or 500 mg of a ceftazidime.

Pharmacological properties:

Pharmacodynamics. Generation cephalosporin III. The ceftazidime works bakteritsidno, inhibiting synthesis of mukopeptid of a cell wall of bacteria in a mitosis phase.

Possesses a broad spectrum of activity. It is steady against action of the majority β-лактамаз.

The ceftazidime is active concerning gram-positive bacteria: streptococci of groups A, B, C and G, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Staphylococcus aureus, Staphylococcus epidermidis; gram-negative bacteria: Aeromonas hydrophila, Bacillus subtilis, Borrelia burgdorferi, Morganella morganii, Citrobacter diversus, Clostridium perfringens, Corynebacterium diphtheriae, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Enterobacter spp., Haemophilus spp., Moraxella catarrhalis, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Eubacterium spp., Shigella spp., Salmonella spp., Yersinia spp.

Pharmacokinetics. Absorption. In 5 min. later in/in introductions of a ceftazidime in a dose of 500 mg, 1 g or 2 g its concentration in serum makes respectively 45 mkg/ml, 90 mkg/ml or 170 mkg/ml. Therapeutic concentration in a blood plasma remains during 8-12 h.

Distribution. Linkng with proteins of plasma makes 10-17%. The ceftazidime well gets into all bodies and fabrics. At an inflammation of a meninx it is found in cerebrospinal fluid in therapeutic concentration.

Metabolism. In an organism drug is not metabolized.

Removal. T1/2 makes 1,9 h. About 80-90% of a dose are removed by kidneys during 24 h.

Pharmacokinetics in special clinical situations. T1/2 at patients with renal failures makes 2,2 h. Abnormal liver functions do not influence drug pharmacokinetics.

Indications to use:

— infections of a heavy current (a septicaemia, bacteremia, peritonitis, meningitis, infections at patients with reduced immunity, infections at the patients who are in intensive care units including with the infected burns);

— pneumonia;

— abscess of lungs;

— pleura empyema;

— infections of urinary tract (including pyelonephritis);

— infections of ENT organs;

— infections of skin and soft tissues;

— infections of a GIT, biliary tract and abdominal organs;

— infections of bones and joints;

— infections of bodies of a small pelvis;

— the infections connected with a hemodialysis and peritoneal dialysis;

— prevention of infectious complications at operative measures.

Route of administration and doses:

The adult drug appoint 1-6 g/days in a dose. The daily dose is entered into 2-3 receptions in 8-12 h in/in or in oil.

At infectious diseases of urinary tract drug each 12 h appoint in a dose 0.5-1 g.

At a severe disease, especially at patients with reduced immunity, at heavy gynecologic infections and infections of abdominal organs, at meningitis appoint in a dose 2 g in each 8 h.

To newborns and children up to 2 months drug appoint in a dose 30 mg/kg of mass of bodies/days in 2 introductions.

To children 2 months drug are more senior appoint in a dose 30-50 mg/kg/days, the maximum daily dose - 6 g.

To patients 80 years are more senior the recommended daily dose makes no more than 3 g.

The dosing mode for patients with renal failures is set depending on KK values. The initial dose makes 1 g. The recommended maintenance doses are presented in the table:

KK (ml/min.)	Dosing mode
31-50	1 g each 12 h.
16-30	1 g each 24 h.
6-15	500 mg each 24 h.
<5	500 mg each 48 h.

Krom in/in introductions, Tsefdim at peritoneal dialysis it is possible to add to dialysis solution in a dose 125-250 mg on 2 l.

Rules of preparation and administration of solutions. For preparation of solution for in/in jet introductions as solvent use water for injections or any other solvent.

For preparation of solution for in/in drop introductions as solvent use 0,9% solution of sodium of chloride or 5% dextrose solution.

For preparation of solution for introduction in oil as solvent use water for injections or 1% lidocaine solution.

Amount of drug		Amount of solvent (ml)	Concentration (mg/ml)
500 mg	in oil in/in	1.5 5	280 100
1 g	in oil in/in struyno	3 10	280 100

 

After dissolution drug is stable at a temperature not above 25 °C during 24 h, at a temperature not above 5 °C - 7 days (when using sterile water for injections as solvent).

Features of use:

Use at pregnancy and feeding by a breast. Use of drug at pregnancy is possible only in that case when the estimated advantage for mother surpasses potential risk for a fruit.

In need of use of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.

Use at abnormal liver functions. Use at abnormal liver functions is possible.

Use at renal failures. Patients should appoint drug with care with disturbances of functions of kidneys of heavy degree. At a renal failure correction of the mode of dosing is required.

Special instructions. Patients should appoint drug with care with renal failures of heavy degree and the newborn.

Side effects:

From TsNS and peripheral nervous system: headaches, dizziness, encephalopathy, paresthesias, disturbance of flavoring feelings, tremor, spasms.

From the alimentary system: nausea, vomiting, abdominal pains, diarrhea, dysbacteriosis, tranzitorny increase in activity of hepatic transaminases, pseudomembranous colitis.

From system of a hemopoiesis: reversible leukopenia, neutropenia, eosinophilia, thrombocytopenia, agranulocytosis, lymphocytosis.

From an urinary system: intersticial nephrite, tranzitorny increase in level of creatinine of blood serum.

Allergic reactions: rash, urticaria, skin itch, bronchospasm, Quincke's edema, acute anaphylaxis, mnogoformny erythema, Stephens-Johnson's syndrome.

Local reactions: phlebitis and thrombophlebitis at in introduction, morbidity in the place in oil of an injection.

Others: fever, candidiasis.

Interaction with other medicines:

At simultaneous use of Tsefdim and chloramphenicol it is necessary to take possible antagonistic action into account.

At simultaneous use of Tsefdim with "loopback" diuretics, aminoglycosides the risk of development of nephrotoxic action (at purpose of this combination of medicines it is necessary to be careful) increases.

Contraindications:

— hypersensitivity to cephalosporins and another beta лактамным to antibiotics;

— hypersensitivity to lidocaine.

Overdose:

Symptoms: tremor, encephalopathy, spasms, headaches, paresthesias.

Treatment: symptomatic therapy. There is no specific antidote. Tsefdim's concentration in blood serum can be reduced by means of a hemodialysis or peritoneal dialysis.

Storage conditions:

Drug should be stored in dry, protected from light, the place, unavailable to children, at a temperature not above 25 °C. A period of validity - 2 years. Drug cannot be used after expiry date.

Issue conditions:

According to the recipe

Packaging:

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