Universal reference book for medicines
Product name: NACEF® (NACEF)

Active substance: cefazolin

Type: 1st generation cephalosporin

Manufacturer: АБОЛмед (Russia)
Composition, form of production and packaging
Powder for preparation of a solution for iv and in / m introduction
white or white with a yellowish shade of color.

1 f.

cefazolin (in the form of the sodium salt) 500 mg

Solvent: water d / and (5 ml).

Vials with a capacity of 10 ml (1) - packs cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Vials of glass with a capacity of 10 ml (1) complete with a solvent (1 pc.) - packings of cellular contour (1) - packs of cardboard.

Vials with a capacity of 10 ml (5) - packings, cellular, planimetric (1) - packs cardboard.

Glass bottles with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular contour (2) - packs of cardboard.

Powder for preparation of a solution for iv and in / m introduction white or white with a yellowish shade of color.

1 f.

cefazolin (in the form of the sodium salt) 1 g

Solvent: water d / and (5 ml).

Vials with a capacity of 10 ml (1) - packs cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.

Vials of glass with a capacity of 10 ml (1) complete with a solvent (1 pc.) - packings of cellular contour (1) - packs of cardboard.

Vials with a capacity of 10 ml (5) - packings, cellular, planimetric (1) - packs cardboard.

Glass bottles with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular contour (2) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

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

PHARMACHOLOGIC EFFECT

Cephalosporin antibiotic of the first generation for parenteral use.
It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Has a wide spectrum of action, is active against Gram-positive (Staphylococcus spp., Staphylococcus aureus (not producing and producing penicillinase, including Streptococcus pneumoniae), Corynebacterium diphtheriae, Bacillus anthracis) and Gram-negative (Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp. , Salmonella spp., Escherichia coli, Klebsiella spp., Treponema spp., Leptospira spp.) Of microorganisms. It is active against Haemophilus influenzae, some strains of Enterobacter and Enterococcus.
Ineffective against Pseudomonas aeruginosa, indolpositive strains of Proteus spp., Mycobacterium tuberculosis, Serratia spp., Anaerobic microorganisms, methicillin-resistant strains of Staphylococcus spp.

PHARMACOKINETICS

The time to reach C max at a / m dose of 500 and 1,000 mg, respectively, is 2 and 1 hour. C max is 38 and 64 μg / ml;
after intravenous administration, the time to reach C max is at the end of the infusion, after intravenous administration of 1000 mg C max 180 μg / ml. Penetrates into joints, tissues of the cardiovascular system, into the abdominal cavity, kidneys and urinary tracts, placenta, middle ear, respiratory tract, skin and soft tissues. In small amounts excreted in breast milk. Concentration in the tissue of the gallbladder and bile is much higher than in the serum. With obstruction of the gallbladder, the concentration in the bile is less than in the plasma. V d = 0.12 l / kg. Relationship with plasma proteins 85%. T 1/2 with a / m introduction - 1.8 h, with the / in the introduction - 2 h. If the renal function T 1/2 - 20-40 h.
It is excreted mainly by the kidneys in an unchanged form: within the first 6 hours, 60-90%, after 24 hours, 70-95%.
With max in the urine 1000 μg / ml and 4000 μg / ml after the / m administration and doses of 500 mg and 1000 mg respectively.
INDICATIONS

- bacterial infections of the upper and lower respiratory tract, urinary and biliary tract, pelvic organs, skin and soft tissues, bones and joints;

- endocarditis, sepsis, peritonitis, otitis media, osteomyelitis, mastitis;

- wound, burn and postoperative infections;

- other infectious diseases caused by microorganisms sensitive to cefazolin.

- prevention of surgical infections in the pre- and postoperative period.

DOSING MODE

In / m, in / in (struyno and drip).

The average daily intake for adults is 1 g;
multiplicity of administration - 2 times / day. The maximum daily dose is 6 g (in rare cases - 12 g); the frequency of administration can be increased up to 3-4 times / day.
The average duration of treatment is 7-10 days.

For the prevention of postoperative infection 1 g - 30 minutes before surgery, 0.5-1 g - during surgery and 0.5-1 g every 6-8 h within 24 hours after the operation.

Patients with impaired renal function require a change in the dosing regimen in accordance with the values ​​of creatinine clearance (CK).
With SC 55 ml / min or more, or with a plasma creatinine content of 1.5 mg% or less, a full dose can be administered. With SC 54-35 ml / min, or with a creatinine content of 3-1.6 mg% in the plasma, a full dose can be given, but the intervals between injections can be increased to 8 hours. In the case of SC, 34-11 ml / min or creatinine in the plasma 4.5-3.1 mg % - 1/2 doses at intervals of 12 hours. Patients with CC 10 ml / min or less, or with a plasma creatinine content of 4.6 mg% or more - 1/2 of the average dose every 18-24 hours. All recommended doses are administered after the initial shock dose.
The average daily dose for children is 20-50 mg / kg;
In severe infection, the dose can be increased to 100 mg / kg / day. Multiplicity of administration -3-4 times / day. In children with impaired renal function, the dosage regimen is adjusted depending on the values ​​of the CC. With CC 70-40 ml / min - 60% of the average daily dose and injected after 12 hours. At KK 40-20 ml / min - 25% of the average daily dose with an interval of 12 hours. Children with KK 5-20 ml / min - 10% of the average daily dose every 24 hours. All recommended doses are given after the initial shock dose.
Preparation of solutions

For the / m introduction, the drug is dissolved in 4-5 ml of water for injection, isotonic sodium chloride solution or 0.25-0.5% solution of novocaine.

For intravenous drip, the drug is dissolved in 100-250 ml of isotonic sodium chloride solution or 5% glucose solution;
the injection is carried out for 20-30 minutes (rate of administration of 60-80 drops per minute).
For IV injection, a single dose of the drug is diluted in 10 ml of isotonic sodium chloride solution and injected slowly for 3-5 minutes.

During the dilution, the vials are vigorously shaken until completely dissolved.

SIDE EFFECT

Allergic reactions: hyperthermia, skin rash, urticaria, skin itching, bronchospasm, eosinophilia, Quincke's edema, arthralgia, anaphylactic shock, erythema multiforme, malignant exudative erythema (Stevens-Johnson syndrome).

From the side of the central nervous system: convulsions.

From the side of the urinary system: in patients with kidney disease in the treatment of large doses (6 g) - renal dysfunction (in these cases, the dose is reduced and the treatment is controlled by the dynamics of urea nitrogen and creatinine in the blood).

On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain, pseudomembranous enterocolitis, rarely - cholestatic jaundice, hepatitis.

From the hematopoiesis: leukopenia, neutropenia, thrombocytopenia, thrombocytosis, hemolytic anemia.

With long-term treatment - dysbacteriosis, superinfection caused by antibiotic-resistant strains, candidiasis (including candidiasis stomatitis).

Laboratory indicators: positive Coombs reaction, increased activity of "liver" transaminases, hypercreatininaemia, increase in prothrombin time.

Local reactions: with the / m introduction - soreness (at the injection site), with / in the introduction - phlebitis.

CONTRAINDICATIONS

- hypersensitivity to cephalosporins and other beta-lactam antibiotics.

- Pregnancy and lactation.
If necessary, breast-feeding is stopped.
- Do not appoint a newborn (up to 1 month).

With caution: renal / hepatic insufficiency, pseudomembranous enterocolitis.

PREGNANCY AND LACTATION

The drug is contraindicated during pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Use with caution in renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Use with caution in liver failure.

APPLICATION FOR CHILDREN

Safety of use in preterm infants and children of the first year of life is not established.

SPECIAL INSTRUCTIONS

Patients who had a history of allergic reactions to penicillins, carbapenems may have increased sensitivity to cephalosporin antibiotics.

During treatment with cefazolin, positive direct and indirect Coombs probes can be obtained, as well as a false positive urine reaction to sugar.

When prescribing the drug, the exacerbation of GIT diseases, especially colitis, is possible.

Use in Pediatrics

Safety of use in preterm infants and children of the first year of life is not established.

DRUG INTERACTION

It is not recommended simultaneous reception with anticoagulants and diuretics.
With the simultaneous use of cefazolin and "loop diuretics", a blockade of its tubular secretion occurs.
Aminoglycosides increase the risk of kidney damage.
Pharmaceutically incompatible with aminoglycosides (mutual inactivation).
Drugs that block tubular secretion, increase concentration in the blood, slow down excretion and increase the risk of developing toxic reactions.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. In a dry, the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life 3 years.
Do not use after the expiration date.
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