Universal reference book for medicines
Product name: CEFAZOLIN SANDOZ (CEFAZOLIN SANDOZ)

Active substance: cefazolin

Type: 1st generation cephalosporin

Manufacturer: SANDOZ (Austria)
Composition, form of production and packaging
Powder for the preparation of solution for iv and in / m introduction
from white to slightly yellowish color.

1 f.

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

Vials (1) - packs of cardboard.

Bottles (50) - packs of cardboard.

Vials (50) - cardboard boxes.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Semisynthetic cephalosporin antibiotic of the first generation for parenteral administration.
Like all other beta-lactam antibiotics, it has a bactericidal effect, affecting the synthesis of the cell wall of microorganisms.
Has a wide range of activities,

It is active against Gram-positive aerobic microorganisms: Staphylococcus spp.
(sensitive to methicillin), Streptococcus spp., Streptococcus pneumoniae; Gram-negative aerobic microorganisms: Branhamella catarrhalis, Citrobacter koseri, Escherichia coli, Haemophilus influenzae, Klebsiella spp., Neisseria gonorrhoeae, Proteus mirabilis; anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Prevotella spp., Propionibacterium acnes, Veilonella spp.
Microorganisms with intermediate sensitivity: anaerobes, Eubacterum spp.

Not active against Gram-positive aerobic microorganisms : Enterococcus spp., Staphylococcus spp.
(resistant to methicillin), Listeria monocytogenes; Gram-negative aerobic microorganisms: Acinetobacter baumanii, Aeromonas spp., Alcaligenes denitrificans, Bordetella spp., Campylobacter spp., Citrobacter freundii, Enterobacter spp., Legionella spp., Morganella morganii, Proteus vulgaris, Providencia spp., Pseudomonas spp., Serratia spp. , Vibrio spp., Yersinia enterocolitica; anaerobicmicroorganisms: Bacteroides spp., Clostridium difficile; other microorganisms: Chlamydia spp., Mycobacterium spp., Mycoplasma spp., Rickettsia spp.
Penicillin-resistant Streptococcus pneumoniae has cross-resistance to cephalosporins, such as cefazolin.

PHARMACOKINETICS

Suction

After the / m administration of C max in the plasma is achieved after 30-75 minutes.

Concentrations (μg / ml) in serum after IM:

Dose 30 min 1 h 2 h 4 h 6 h 8 h

500 mg 1 g 36.2 60.1 36.8 63.8 37.9 54.3 15.5 29.3 6.3 13.2 3 7.1

Concentrations (μg / ml) in serum after iv injection at a dose of 1 g:

5 min 15 min 30 min 1 h 2 h 4 h

188.4 135.8 106.8 73.7 45.6 16.5

Distribution

The binding of cefazolin to plasma proteins is about 65-92%.
Cefazolin penetrates very well into tissues, including skeletal muscles, myocardium, bone tissue, bile and gall bladder tissue, endometrium and vagina.
Cefazolin penetrates the placental barrier, excreted in breast milk.
In small amounts, it penetrates into the cerebrospinal fluid and the intraocular fluid.
Metabolism and excretion

Cefazolin is not metabolized.
Most of the administered dose is subjected to glomerular filtration and is excreted in the urine in a microbiologically active form. A small part is excreted with bile. T 1/2 from the plasma is about 2 hours.
Excretion

In patients with impaired renal function, T 1/2 may be longer.

INDICATIONS

Treatment of infections caused by sensitive microorganisms:

- bacterial infections of the upper and lower respiratory tract;

- urinary tract infections (including acute pyelonephritis);

- infections of the skin and soft tissues, incl.
wound and burn infections;
- endocarditis;

- septicemia;

- infections of the abdominal and biliary tract;

- infections of bone and connective tissues (including osteomyelitis);

- syphilis;

- Gonorrhea;

- mastitis.

Prevention of infection during surgical interventions.

DOSING MODE

Cefazolin Sandoz is intended for IV (in the form of injections and infusions) and in / m administration.

Doses depend on the sensitivity of the pathogens that caused the infection, and the severity of the course of the disease.

Adults

Standard doses for treatment:

Indications Dose Frequency of administration Daily dose

Infections of mild severity 500 mg 1 g every 8 h every 12 h 1.5 g 2g

Uncomplicated urinary tract infections 1g every 12 hours 2g

Infections of moderate severity and severe infections 1 g every 6-8 h 3-4 g

Infections that threaten life from 1 g to 1.5 g every 6 h 4-6 g

In rare cases, doses up to 12 g were used.

Recommendations on the regimen of dosing in patients with renal insufficiency:

CK (ml / min / 1.73 m 2 ) Serum creatinine (mg / dL) Daily dose Interval between administrations (h)

? 55? 1.5 Usual dose No change

35-54 1.6-3 0 Usual dose 12 h

11-34 3.1-4.5 50% of the usual dose 12 h

? 10? 4.6 25% of the usual dose 24 h

In order to prevent postoperative infection, the drug is administered intravenously or in / m in an initial dose of 1-2 g for 0.5-1 h before the operation.
In long-term operations (2 hours and longer) an additional 500 mg-1 g during the operation is injected into / in or / m. The dose and time of administration depend on the type and duration of the operation.
After the operation for 24 hours, enter / in or in / m for 0.5-1 g at intervals of 6-8 hours.

If potential infections pose a great danger to the patient (eg, after heart surgery or a serious orthopedic operation, such as complete joint replacement), it is recommended to continue the postoperative administration of the drug for 24-48 hours.

For
elderly patients correction of the dose is not required.
Children aged 1 month and older

In the treatment of infections of mild to moderate severity, the daily dose is 25-50 mg / kg body weight divided by 3-4 injections.

In severe infections, the daily dose can be increased to the maximum recommended dose of 100 mg / kg.

Recommendations on the regimen of dosing in the treatment of children with renal insufficiency:

KK (ml / min / 1.73 m 2 ) Cefazolin dose (mg / kg) Interval between administrations (h)

> 50 7 (up to 500 mg per administration) 6 to 8

25-50 7 12

10-25 7 from 24 to 36

<10 7 from 48 to 72

At the beginning of treatment for children who undergo hemodialysis , the drug is administered at a dose of 7 mg / kg body weight.
Because during dialysis, the concentration of cefazolin in the blood plasma is reduced by 35-65%, between the dialysis procedures the drug is administered at a dose of 3-4 mg / kg (the interval between the dialysis procedures is 72 hours).
The duration of treatment depends on the course of the disease.
In accordance with the principles of antibiotic therapy, treatment with Cefazolin Sandoz is recommended to continue for at least 2-3 days after the disappearance of the febrile condition and / or obtaining confirmation of the eradication of the pathogen.
Rules for the preparation of solutions for IM and IV administration

For intravenous administration of Cefazolin Sandoz 1 g is dissolved in 4 ml, 500 mg - in 2 ml of a 0.5% solution of lidocaine or water for injection.
The maximum dose for the / m administration of 1 g is injected deep into the muscle.
When treating children under the age of 1 year, do not use lidocaine as a solvent.

A solution of cefazolin with lidocaine is not used for IV administration.

For intravenous injection in the form of injections, Cefazolin Sandoz is dissolved in water for injection or 0.9% solution of sodium chloride: to dissolve 1 g of powder, not less than 4 ml of solution is required.
By slow intravenous injection (3-5 min), up to 1 g of cefazolin can be administered.
The drug in higher daily doses (4-6 g in 2-3 injections) is administered by intravenous infusion.

To prepare a solution for intravenous infusion, the drug is dissolved in 50-100 ml of a 0 : 9% solution of sodium chloride or 5% solution of dextrose.
The duration of the infusion is 20-30 minutes.
During the dilution, vials should be vigorously shaken until the drug is completely dissolved.
Only transparent and colorless solutions are used.
SIDE EFFECT

On the part of the digestive system: loss of appetite, diarrhea, abdominal pain, nausea and vomiting (in most cases, these symptoms are mild and disappear during or after treatment), dysbiosis;
rarely - transient hepatitis, cholestatic jaundice, pseudomembranous enterocolitis, transient increase in the level of hepatic transaminases, bilirubin and / or LDH and AF.
From the urinary system: a transient increase in the level of blood urea nitrogen and serum creatinine;
rarely - a violation of kidney function (in the treatment of high doses).
From the side of the central nervous system: dizziness, general malaise, fatigue, nightmares, nervousness or anxiety, insomnia, drowsiness, weakness, sensation of heat, changes in perception of color, confusion, encephalopathy and epileptiform seizures (in patients with kidney failure), aseptic meningitis.

Allergic reactions: hyperthermia, urticaria, skin itching, rash, angioedema;
rarely - exudative erythema multiforme (including Stevens-Johnson syndrome), Lyell's syndrome, bronchospasm, anaphylactic shock.
Laboratory parameters: transient - leukocytosis, granulocytosis, monocytosis, lymphocytopenia, basophilia, eosinophilia, granulocytopenia, neutropenia, leukopenia, thrombocytopenia, increased prothrombin time;
rarely - reduction of hemoglobin and / or hematocrit, anemia, agranulocytosis, aplastic anemia, pancytopenia, hemolytic anemia.
Local reactions: phlebitis in the place of intravenous injection, soreness in the injection site with the / m introduction.

Other: chest pain, effusion to the pleural cavity, cough, rhinitis, hypoglycemia, hyperglycemia, vaginitis, thrombophlebitis, superinfection, candidiasis.

CONTRAINDICATIONS

- newborns up to 1 month (safety of use not established);

- hypersensitivity to the components of the drug;

- Hypersensitivity to other cephalosporin antibiotics.

Caution should be given to patients with kidney failure, with bowel disease (including colitis).

PREGNANCY AND LACTATION

The appointment of cefazolin in pregnancy is permissible only if the expected benefit for the mother exceeds the potential risk to the fetus.

Cefazolin in small amounts is excreted in breast milk.
If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be resolved.
APPLICATION FOR FUNCTIONS OF THE LIVER

Caution should be given to patients with renal insufficiency.

APPLICATION FOR CHILDREN

Contraindicated in newborns under 1 month of age (safety of use not established).

SPECIAL INSTRUCTIONS

When appointing Cefazolin Sandoz, it is necessary to consider the possibility of developing a cross-allergy with other cephalosporins and occasionally encountering cross-allergic reactions to penicillins (especially in patients with allergic diathesis, bronchial asthma or pollinosis).

In the presence of severe persistent diarrhea, it is necessary to consider the likelihood of developing pseudomembranous colitis associated with antibiotic therapy.Since this condition may pose a threat to the life of the patient, cefazolin should be discontinued immediately and appropriate treatment should be prescribed.
The use of drugs that affect peristalsis is contraindicated.
When treating patients with arterial hypertension and heart failure, it is necessary to take into account the sodium content in injectable solutions (48 mg per g of cefazolin).

Athletes should take into account that if during treatment a solution of cefazolin with lidocaine was used, doping tests can give positive results.

If a urinalysis test for glucose is performed using Benedict's solution, Fehling's solution or Klinist®, the results may be false-positive, although cefazolin does not affect the urine's glucose test results using the enzyme method.

Both indirect and direct Coombs reaction can be false positive, incl.
in newborns whose mothers received cephalosporins.
Impact on the ability to drive vehicles and manage mechanisms

The drug does not affect the ability to drive vehicles and other mechanisms.

OVERDOSE

Symptoms: pain, inflammatory reactions and phlebitis at the injection site;
dizziness headache, paresthesia, possibly the development of seizures (especially in patients with kidney disease). Laboratory indicators: elevated levels of creatinine, blood urea nitrogen, liver enzymes and bilirubin; a positive Coombs reaction; thrombocytosis and thrombocytopenia, eosinophilia, leukopenia, increased prothrombin time.
Treatment: immediately stop the injection, carefully monitor vital body functions and appropriate laboratory parameters.
Conduction of symptomatic therapy. In severe cases, hemodialysis is possible. Peritoneal dialysis is not effective.
DRUG INTERACTION

Do not use cefazolin along with antibacterial drugs that have a bacteriostatic mechanism of action (tetracyclines, sulfonamides, erythromycin, chloramphenicol), since in vitro studies have shown that antagonism exists between them.

In vitro studies, it has been shown that antagonism exists between cefazolin and antibacterial drugs with a bacteriostatic mechanism of antimicrobial action (tetracyclines, sulfonamides, erythromycin, chloramphenicol) (should not be used simultaneously).

With the concomitant use of probenecid, the renal clearance of cefazolin decreases (co-administration is not recommended).

With the simultaneous use of cefazolin with oral anticoagulants or high doses of heparin, it is necessary to monitor the parameters of blood coagulability.

At simultaneous application with aminoglycosides and diuretics the risk of development of toxic reactions increases (the control of parameters of function of kidneys is necessary).

Pharmaceutical interaction

Cefazolin is pharmaceutically incompatible with aminoglycosides (mutual inactivation).

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
Ready solutions should be stored for no more than 24 hours in a dark place at a temperature of 2 ° to 8 ° C.

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