Universal reference book for medicines
Name of the preparation: CEFTAZIDIME

Active substance: ceftazidime

Type: Third generation cephalosporin

Manufacturer: MAKIZ-PHARMA (Russia) manufactured by Shijiazhuang Pharmaceutical Group Ouyi (China)
Composition, form of production and packaging
Powder for the preparation of solution for intravenous and / or injection of
crystalline, almost white or yellowish color.

1 f.

ceftazidime (in the form of pentahydrate) 1 g

- "- 2 g

Excipients: sodium carbonate.

Glass bottles (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Ceftazidime is an antibacterial agent from the group of third generation cephalosporins.
Has a wide spectrum and acts bactericidal, disrupts the synthesis of the cell wall of microorganisms. Resistant to the action of most beta-lactamases.
The drug is active against gram-negative microorganisms: Haemophillus influenzae, Neisseriaspp.
and most representatives of the Enterobacteriaceae family (Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella pneumoniae and other Klebsiella spp., Morganella morganii and other Morganella spp., Proteusmirabilis (including indole positive), Proteus vulgaris and other Proteus spp ., Providensia rettgeri and other Providensia spp. And Serratia spp., Salmonella spp., Shigella spp., And Yersinia enterocolitica), Acinetobacter spp., Haemophillus parainfluenzae (including ampicillin resistant strains), Pasteurella multocida, Pseudomonas spp., (In including Pseudomonas aeruginosa).
The drug is active against Gram-positive bacteria: Micrococcuspp., Streptococcus pneumoniae, Streptococcus pyogenes group A, Streptococcus viridans and other Streptococcus spp.
(excluding Streptococcus faecalis); strains sensitive to methicillin: Staphylococcus aureus, Staphylococcus epidermidis.
Ceftazidime is active against anaerobic bacteria: Bacteroides spp.
(most strains of Bacterioides fragilis are resistant), Clostridiumperfingens, Peptococcus spp., Peptostreptococcus spp. and Propionobacterium spp.
The drug is not active against methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis;
Streptococcus faecalis, Campylobacter spp., Chlamydia spp., Clostridium difficile, Enterococcus spp., Listeria monocytogenes and others Listeria spp.
PHARMACOKINETICS

Suction

After intravenous administration in doses of 0.5 g and 1 g of C max in blood plasma - 17 mg / l and 39 mg / l, respectively, T max - 1 hour. C max after IV bolus in doses of 0.5, 1 and 2 g is 42 mg / l, 69 mg / l and 170 mg / l, respectively.
Therapeutic serum concentrations persist for 8-12 hours after IV and IM.
Distribution

Binding to plasma proteins is less than 15%.
Concentrations of ceftazidime that exceed the minimum inhibitory concentration for most common pathogens can be achieved in bone tissue, heart, bile, sputum, synovial, intraocular, pleural and peritoneal fluids. It easily penetrates the placental barrier and is excreted in breast milk.In the absence of an inflammatory process, it penetrates poorly through the BBB. With meningitis, the concentration in the cerebrospinal fluid reaches a therapeutic level (4-20 mg / L and higher).
Excretion

T 1/2 - 1.9 h, in newborns - 3-4 times longer;
with hemodialysis - 3-5 hours.
It is not metabolized in the liver.
It is excreted by the kidneys (80-90% unchanged by glomerular filtration), within 24 hours; with bile - less than 1%.
INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- meningitis;

- peritonitis;

- sepsis (septicemia);

- severe purulent-septic conditions;

- infections of bones and joints (septic arthritis, osteomyelitis, bacterial bursitis);

- Infections of the lower respiratory tract (acute and chronic bronchitis, infected bronchiectasias, pneumonia, lung abscess, pleural empyema);

- urinary tract infections (acute and chronic pyelonephritis, pyelitis, prostatitis, cystitis, urethritis, kidney abscess);

- skin and soft tissue infections (mastitis, wound infections, phlegmon, erysipelas, infected burns);

- infections of the gastrointestinal tract, abdominal cavity and biliary tract (enterocolitis, retroperitoneal abscesses, diverticulitis, cholecystitis, cholangitis, empyema of the gallbladder);

- infection of female genital organs (endometritis);

- infections of the ear, throat, nose (otitis media, sinusitis, mastoiditis);

- gonorrhea (especially if hypersensitivity to antibacterial drugs from the penicillin group).

DOSING MODE

Enter in / m (should be injected into large muscles) or iv in (jet or drip).
The dose of the drug is set individually, taking into account the severity of the disease, localization of infection and sensitivity of the pathogen, age and body weight, kidney function.
Adults and children over 12 years of age

Complicated urinary tract infections - 500 mg - 1 g every 8-12 hours.

Uncomplicated pneumonia and skin infections - 500 mg - 1 g every 8 hours.

Cystic fibrosis, lung infections caused by Pseudomonas spp .
- from 100 to 150 mg / kg / day, the frequency of administration - 3 times / day (dose up to 9 g / day in such patients did not cause complications).
Infections of bones and joints - in / in 2 g every 12 h.

Neutropenia and severe course of the disease - 2 g every 8 or 12 hours.

In extremely severe or life-threatening infections - in / in 2 g every 8 h.

After an initial dose of 1 g for adults with impaired renal function (including patients undergoing dialysis) , a dose reduction may be required as follows:

Creatinine clearance

> 50 ml / min (0.83 ml / s) Usual doses for adults and children over 12 years of age

31-50 ml / min (0.52-0.83 ml / s) 1 g every 12 hours

16 - 30 ml / min (0.27-0.50 ml / sec) 1 g every 24 hours

6-15 ml / min (0.10-0.25 ml / s) For 500 mg every 24 hours

<5 ml / min (0.08 ml / sec) For 500 mg every 48 hours

Patients undergoing hemodialysis 1 g after each hemodialysis session

Patients undergoing peritoneal dialysis By 500 mg every 24 hours

These indicators are indicative.
In such patients it is recommended to monitor the serum level of the drug, which should not exceed 40 mg / l.
T 1/2 of the drug during hemodialysis is 3-5 hours. The appropriate dose of the drug should be repeated after each period of dialysis.

With peritoneal dialysis, ceftazidime can be included in dialysis fluid at a dose of 125 mg to 250 mg per 2 liters of dialysis fluid.
Elderly patients with a maximum daily dose of 3 g.
Children under the age of 12 years

Children under 2 months of age - IV infusion of 30 mg / kg / day (multiplicity of administration 2 times / day).

Children aged 2 months to 12 years - IV infusion 30-50 mg / kg / day (the frequency of administration 3 times / day).

For children with reduced immunity, cystic fibrosis, meningitis, the drug is prescribed in a dose of up to 150 mg / kg / day every 12 hours.

The maximum daily dose for children should not exceed 6 g.

Rules for the preparation of solutions for parenteral administration

1. Primary dilution

Dose Volume of solvent with / m introduction Volume of solvent with / in the introduction

1 g 3 ml water for injection 10 ml water for injection

2 g 3 ml water for injection 10 ml water for injection

2. Secondary breeding

For intravenous administration, the solution of the preparation prepared in the manner described above is diluted in 50-100 ml of one of the following solvents for intravenous administration: sodium chloride solution 0.9%, Ringer's solution, lactated Ringer's solution, 5% glucose (dextrose) solution, glucose solution (dextrose) 5% with sodium chloride solution 0.9%, glucose solution (dextrose) 10%.

During the dilution the vials with the preparation should be vigorously shaken until the contents are completely dissolved.

Before introducing the solution, you should visually check that there are no foreign particles or sediment and that the color of the drug for parenteral administration is unchanged.
The color of the solutions can vary from light yellow to amber, depending on the solvent and volume, which does not affect the efficiency. In the prepared solution, small bubbles of carbon dioxide may be present, which does not affect the effectiveness of the preparation.
Only freshly prepared mortar can be used.

SIDE EFFECT

Allergic reactions: urticaria, chills or fever, rash, itching;
rarely - bronchospasm, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, anaphylactic shock.
On the part of the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbiosis, impaired liver function (transient increase in hepatic transaminase activity, APF, hyperbilirubinemia), rarely - stomatitis, glossitis, pseudomembranous enterocolitis, cholestasis.

On the part of the hematopoiesis: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation, an increase in prothrombin time.

On the part of the urinary system: renal dysfunction (azotemia, hypercreatininaemia, increased urea in the blood), oliguria, anuria, toxic nephropathy.

From the side of the central nervous system and peripheral nervous system: headache, dizziness, paresthesia, convulsive attacks, encephalopathy, "fluttering" tremor.

Local reactions: phlebitis, pain along the vein, soreness and infiltration at the site of the / m introduction.

Other: nosebleeds, candidiasis, superinfection.

CONTRAINDICATIONS

- Hypersensitivity to other cephalosporins and penicillins.

It should be used with caution in cases of severe renal dysfunction, during neonatal period, history of bleeding, NJC in history, malabsorption syndrome (increased risk of prothrombin activity, especially in those with severe renal and / or hepatic insufficiency).

PREGNANCY AND LACTATION

Given that ceftazidime, like most other cephalosporins, penetrates the placenta, ceftazidime should be given to pregnant women only in cases of vital need, with careful evaluation of the consequences of treatment in terms of possible risk to the fetus and benefit to the mother.

If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should be used in marked violations of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

It is not metabolized in the liver.

SPECIAL INSTRUCTIONS

Patients with a history of allergic reactions to penicillins are noted to have cross-sensitivity to cephalosporins.

Ceftazidime may interfere with the synthesis of vitamin K due to suppression of intestinal flora, which can cause a decrease in the level of vitamin K-dependent clotting factors, and in rare cases lead to hypothrombinemia and bleeding.
The appointment of vitamin K quickly eliminates hypothrombinemia.
In elderly and weakened patients, in patients with impaired liver function and in people with malnutrition, the risk of bleeding is highest.

Some patients may develop pseudomembranous colitis during or after the administration of ceftazidime.
In mild cases, it is sufficient to cancel the drug, and in more severe cases it is recommended to restore the water-salt and protein balance, prescribe metronidazole, bacitracin or vancomycin.
A positive Coombs reaction and a false positive urine reaction to glucose are possible.

During treatment, you can not use ethanol - there may be effects similar to the action of disulfiram (facial hyperemia, stomach and stomach spasms, nausea, vomiting, headache, lowering blood pressure, tachycardia, dyspnea).

Pharmaceutically compatible with the following solutions: at a concentration of 1 to 40 mg / ml - a solution of sodium chloride 0.9%;
sodium lactate solution;Hartman's solution; dextrose solution 5%; solution of sodium chloride 0.225% and dextrose 5%; solution of sodium chloride 0.45% and dextrose 5%; solution of sodium chloride 0.9% and dextrose 5%; solution of sodium chloride 0.18% and dextrose 4%; dextrose solution 10%; dextran with a molecular weight of 40 thousand Da 10% in a solution of sodium chloride 0.9% or in a solution of dextrose 5%; dextran with a molecular weight of about 70 thousand Da 6% in a solution of sodium chloride of 0.9 % or in a solution of 5% dextrose.
At a concentration of 0.05 to 0.25 mg / ml, ceftazidime is compatible with the solution for intraperitoneal dialysis (lactate).

For the / m administration ceftazidime can be diluted with a solution of lidocaine hydrochloride 0.5% or 1%.
Both components remain active if ceftazidime is added to the following solutions (concentration of ceftazidime 4 mg / ml): hydrocortisone (hydrocortisone sodium phosphate) 1 mg / ml in 0.9% sodium chloride solution or in 5% dextrose solution; cefuroxime (cefuroxime sodium) 3 mg / ml in a solution of sodium chloride 0.9%; cloxacillin (cloxacillin sodium) 4 mg / ml in a solution of sodium chloride 0.9%; heparin 10 IU / ml or 50 IU / ml in a solution of sodium chloride 0.9%; Potassium chloride 10 meq.k / l or 40 meq per liter in 0.9% sodium chloride solution.
When mixing a solution of ceftazidime (500 mg in 1.5 ml of water for injection) and metronidazole (500 mg / 100 ml), both components remain active.

OVERDOSE

Symptoms: dizziness, paresthesia, headache, convulsive seizures, deviations in the results of laboratory tests.

Treatment: symptomatic and maintenance therapy.
There is no specific antidote. In case of severe overdose, when conservative therapy is unsuccessful, the concentration of the drug in the blood can be reduced by hemodialysis.
DRUG INTERACTION

"Loopback" diuretics, aminoglycosides, vancomycin, clindamycin reduce the clearance of ceftazidime, as a result of which the risk of nephrotoxic action increases.

Bacteriostatic antibiotics (including chloramphenicol) reduce the effect of the drug.

Pharmaceutical interaction

Pharmaceutically incompatible with aminoglycosides, heparin, vancomycin.

Do not use sodium bicarbonate solution as a solvent.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C. Shelf life - 2 years.

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