Cefazolin sodium salt 1000mg bottle №1

Farmgroup

Antibacterial agents

Composition

Active ingredient: cefazolin sodium in terms of the active substance - 1.0 g.

Mechanism of action

I generation cephalosporin antibiotic for parenteral use. Effective bactericidal, disrupting the synthesis of the cell wall of microorganisms. It has a wide spectrum of action, it is active against gram-positive (Staphylococcus spp., Staphylococcus aureus (non-sociable, non-sociable, non-sociable, non-sociable, bourne, Bacillus anthracis) and Gram-negative (Neissero-chennephterriae, Bacillus anthracis) and Gram-negative (Neisserynthropheniae, Bacillus anthracis) and Gram-negative (Neisserynthropheniae)., Escherichia coli, Klebsiella spp., Treponema spp., Leptospira spp.) Microorganisms.

It is active against Haemophilus influenzae, some Enterobacter and Enterococcus strains.

It is ineffective against Pseudomonas aeruginosa, indole-positive strains of Proteus spp., Mycobacterium tuberculosis, Serratia spp., Anaerobic microorganisms, methicillin-resistant strains of Staphylococcus spp.

Pharmacokinetics

The period of maximum concentration with intramuscular injection in a dose of 0.5 and 1 g, respectively - 2 and 1 hour; maximum concentration - 38 and 64 mcg / ml; After intravenous administration, the period of maximum concentration is at the end of the infusion, after intravenous administration, 1 g maximum concentration is 180 μg / ml. It penetrates the joints, the tissues of the heart and blood vessels, the abdominal cavity, the kidneys and the urinary tract, the placenta, the middle ear, the respiratory tract, the skin and soft tissues. In small quantities excreted in breast milk. The concentration in the tissue of the gallbladder and bile is significantly higher than in the serum. During obstruction of the gallbladder, the concentration in bile is lower than in plasma.Distribution volume - 0.12 l / kg. Communication with plasma proteins - 85%. The half-life for intramuscular injection is 1.8 hours, for intravenous administration it is 2 hours. In case of impaired renal function, the half-life is 20 to 40 hours.

Excreted mainly by the kidneys in unchanged form: during the first 6 hours - 60 - 90%, after 24 hours - 70 - 95%. After intramuscular administration in doses of 0.5 and 1 g, the maximum concentration in the urine is 1 mg / ml and 4 mg / ml, respectively.

Indications for use

Bacterial infections of the upper and lower respiratory tract, ENT organs (including otitis media), urinary and biliary ducts, pelvic organs (including gonorrhea), skin and soft tissues, bones and joints (including osteomyelitis), endocarditis, sepsis, peritonitis, mastitis, wound, burn and postoperative infections, syphilis.

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

Contraindications

Hypersensitivity, neonatal period (up to 1 month).

With caution:

Renal failure, intestinal diseases (including history of colitis), children under 1 year of age.

Use during pregnancy and lactation:

When pregnancy is prescribed only for health reasons (strictly controlled studies have not been conducted).

Category of action on the fetus by the FDA - B.

If necessary, the appointment of the drug during lactation should stop breastfeeding (cefazolin penetrates into breast milk).

Special notes

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

During treatment with cefazolin, it is possible to obtain positive direct and indirect Coombs samples, as well as a false positive reaction of urine to sugar.

In the appointment of the drug may aggravate diseases of the gastrointestinal tract, especially colitis.

During the period of treatment, care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.

Dosage and administration

Intramuscularly, intravenously (struino and drip). The average daily intake for adults is 1 to 4 g; the frequency of administration is 3-4 times a day. Maximum Daily Dose - 6 g. The average duration of treatment is 7 - 10 days.

For the prevention of postoperative infection - intravenously, 1 g for 0.5 - 1 hour before surgery, 0.5 - 1 g - during surgery and 0.5 - 1 g - every 8 hours during the first days after surgery.

Patients with impaired renal function a change in the dosage regimen is required in accordance with the values ​​of creatinine clearance (CC): with a CC of 55 ml / min or more or with a plasma creatinine concentration of 1.5 mg% or less, the full dose can be administered; with QC 54 - 35 ml / min or plasma creatinine concentration of 3 - 1.6 mg%, the full dose can be administered, but the intervals between injections should be increased to 8 hours; at CC 34 - 11 ml / min or creatinine concentration inplasma 4.5 to 3.1 mg% - 1/2 dose at 12-hour intervals; if QC is 10 ml / min or less, or when plasma creatinine concentration is 4.6 mg% or more, 1/2 of the usual dose every 18 - 24 hours. All recommended doses are administered after the initial dose of 0.5 g.

Children 1 month and older - 25 - 50 mg / kg / day; in case of severe infection, the dose may be increased to 100 mg / kg / day. The frequency of administration - 3 - 4 times a day. In children with impaired renal function, dosing regimen adjustment is carried out depending on the values ​​of creatinine clearance (CK): with CK 70 - 40 ml / min - 60% of the average daily dose and administered every 12 hours; with CC 40 - 20 ml / min - 25% of the average daily dose with an interval of 12 hours; with CC 5 - 20 ml / min - 10% of the average daily dose every 24 hours. All recommended doses are administered after the initial “loading” dose.

In case of moderate infectionscaused by sensitive gram-positive microorganisms, a single dose for adults - 0.25 - 0.5 g every 8 hours. With pneumococcal pneumonia - 0.5 g every 12 hours, with acute uncomplicated diseases of the urinary tract - 1 g every 12 hours.

Preparation of solutions for injection and infusion: 0.5 g of the drug is dissolved in 2 ml of water for injection, 1 g in 4 ml of water for injection. For intravenous bolus administration, the resulting solution is diluted with 5 ml of water for injection, then injected slowly over 3 to 5 minutes. For intravenous drip, the drug is diluted with 50-100 ml of 5-10% dextrose solution, 0.9% sodium chloride solution, Ringer's solution, 5% sodium bicarbonate solution.

During breeding, the vials should be shaken vigorously until complete dissolution.

Side effect

Allergic reactions: Pyrexia, rash, hives, itchy skin, toxic epidermal necrosis, bronchospasm, eosinophilia, fever, angioneurotic edema, angioedema, arthralgia, anaphylactic shock, erythema multiforme (including Stevens-Johnson syndrome).

The nervous system: cramps.

On the part of the urinary system: in patients with kidney disease in the treatment with large doses (6 g) - impaired renal function (in these cases, reduce the dose and treatment is carried out under the control of the dynamics of the concentration of urea nitrogen and creatinine in the blood).

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, pseudomembranous colitis, cholestatic jaundice, hepatitis.

From the side of blood formation organs: leukopenia, neutropenia, agranulocytosis, thrombocytopenia, thrombocytosis, lymphocytosis, hemolytic anemia.

Local reactions: formation of infiltrates and abscesses, phlebitis, thrombophlebitis.

Other: dysbacteriosis, superinfection caused by antibiotic-resistant strains, candidiasis (including candidal stomatitis).

Laboratory values: positive Coombs reaction, increased activity of liver transaminases, hypercreatininemia, increased prothrombin time.

Interaction with other drugs

Concurrent use with anticoagulants and diuretics is not recommended. With the simultaneous use of cefazolin and "loop diuretics" there is a blockade of its tubular secretion.

Aminoglycosides increase the risk of kidney damage. Pharmaceutically incompatible with aminoglycosides (mutual inactivation).

Drugs that block tubular secretion, increase the concentration in the blood, slow down the excretion and increase the risk of toxic reactions.

Release form

Injection Powders

Storage conditions

List B. In a dry dark place at a temperature of no higher than 5 ⁰WITH