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

Active substance: cefazolin

Type: 1st generation cephalosporin

Manufacturer: SHREYA LIFE SCIENCES (India) manufactured by SERENA PHARMA (India)
Composition, form of production and packaging
Powder for the preparation of solution for iv and in / m introduction of
white or almost white color.

1 f.

cefazolin (in the form of a sodium salt) 250 mg

Glass bottles (1) - cardboard boxes.

Powder for solution for iv and in / m introduction from white to almost white.

1 f.

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

Glass bottles (1) - cardboard boxes.

Powder for solution for iv and in / m introduction from white to almost white.

1 f.

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

Glass bottles (1) - cardboard boxes.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Cephalosporin antibiotic of the first generation.
It is bactericidal.
Has a wide spectrum of antimicrobial action.
It is active both against Gram-positive (Staphylococcus spp., Not producing and producing penicillinase, Streptococcus spp., Pneumoccccus spp., C. diphtheriae, B. antracis), and Gram-negative microorganisms (N. meningitidis, N. gonorrhoeae, Shigella spp., Salmonella spp., E. coli, Klebsiella spp.). It is also active against Spirochaetaceae and Leptospiraceae.
The drug is not effective against P. aeruginosa, indolpositive strains of Proteus spp., M. tuberculosis, anaerobic microorganisms.

PHARMACOKINETICS

When ingestion is destroyed.
T C max after im / m administration 0.25, 0.5 and 1 g - 1-2 hours, C max value - 17, 38 and 64 μg / ml, respectively. After intravenous administration of 1 g of C max at the end of infusion, 188 μg / ml, after 8 hours - 4 μg / ml.
The connection with plasma proteins is 85%.
V d = 0.12 l / kg. Penetrates into the organs and tissues of the body (including joints, SSS, abdominal cavity, kidney and urinary tract, middle ear, placenta, respiratory tract, skin and soft tissues). In patients with normal bile duct function, the concentration in the gallbladder and bile tissues is significantly higher than in plasma. With obstruction of the bile ducts, the concentration in the bile is much less than in the plasma.
Metabolised in the liver.
T 1/2 - 1.4-1.8 h (in newborns under the age of 1 week - 4.5-5 h). It is excreted by the kidneys in the modified form during the first 6 hours - 60-90%, after 24 hours - 70-95%. If the kidney function T 1/2 - 3-42 h. Moderately withdrawn during hemodialysis.
INDICATIONS

Infectious-inflammatory diseases caused by drug-susceptible pathogens:

- sepsis;

- peritonitis;

- endocarditis;

- respiratory tract infections;

- infections of the genitourinary tract, including, syphilis and gonorrhea;

- infectious lesions of bones and joints.

Prevention of postoperative complications.

DOSING MODE

In / m, in / in (struyno and drip).
The average daily intake for adults is 0.25-1 g; the frequency of administration is 3-4 times / day. The maximum daily dose is 6 g (in rare cases - 12 g). The average duration of treatment is 7-10 days.
For the prevention of postoperative infection - in / in 1 g for 0.5-1 h before surgery, 0.5-1 g - for a time
operations and 0.5-1 g every 8 hours during the first 24 hours after the operation.
Patients with impaired renal function require a change in the dosage regimen in accordance with the values ​​of CC: with a CC of 55 ml / min or more, or with a plasma creatinine concentration of 1.5 mg% or less, a full dose can be administered;
with SC 54-35 ml / min or a plasma creatinine concentration of 1.6-3.0 mg%, a full dose can be administered, but the intervals between injections should be increased to 8 hours; with SC 34-11 ml / min or creatinine concentration in plasma 3.1-4.5 mg% - 1/2 dose at intervals of 12 hours; with CC 10 ml / min or less, or with a plasma creatinine concentration of 4.6 mg% or more - 1/2 of the usual dose every 18-24 hours. All recommended doses are given after the initial shock dose of 500 mg.
Children 1 month and older - 25-50 mg / kg / day;
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 correction of the dosing regimen is performed depending on the values ​​of CK: for KK 40-70 ml / min - 60% of the average daily dose and injected every 12 hours;
with KK 20-40 ml / min - 25% of the average daily dose with an interval of 12 hours; with KK 5-20 ml / min - 10% of the average daily dose every 24 hours. All recommended doses are administered after the initial shock dose.
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 injections.
For IV bolus injection, the resulting solution is diluted with 5 ml of water for injection, then injected slowly for 3-5 minutes. For intravenous administration of the drug, dilute 50-100 ml of 5% or 10% solution of dextrose, 0.9% solution of sodium chloride, Ringer's solution, 5% sodium bicarbonate solution.
During the dilution, vials should be vigorously shaken until completely dissolved.

SIDE EFFECT

Allergic reactions: urticaria, chills, fever, rash, itching;
rarely - bronchospasm, zosinophilia, exudative erythema multiforme, malignant erythema exudative (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, candidiasis of the gastrointestinal tract (including candidiasis stomatitis), impaired liver function (increased activity of hepatic transaminases, alkaline phosphatase,
hyperbilirubinemia), rarely stomatitis, glossitis, hepatitis and cholestatic jaundice, pseudomembranous enterocolitis.
From the hematopoiesis: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, a decrease in hematocrit, an increase in prothrombin time.

On the part of the genitourinary system: renal dysfunction (azotemia, increased urea levels in the blood, hypercreatininaemia), anal itching, genital itching.

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

Other: superinfection, candidiasis.

CONTRAINDICATIONS

- Pregnancy;

- lactation;

- hypersensitivity to cephalosporins and other beta-lactam antibiotics.

Do not appoint a newborn.

With caution - renal / hepatic insufficiency, pseudomembranous enterocolitis.

PREGNANCY AND LACTATION

If necessary, breast-feeding is stopped.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution - kidney failure.

Patients with impaired renal function require a change in the dosage regimen in accordance with the values ​​of CC: with a CC of 55 ml / min or more, or with a plasma creatinine concentration of 1.5 mg% or less, a full dose can be administered;
with SC 54-35 ml / min or a plasma creatinine concentration of 1.6-3.0 mg%, a full dose can be administered, but the intervals between injections should be increased to 8 hours; with SC 34-11 ml / min or creatinine concentration in plasma 3.1-4.5 mg% - 1/2 dose at intervals of 12 hours; with CC 10 ml / min or less, or with a plasma creatinine concentration of 4.6 mg% or more - 1/2 of the usual dose every 18-24 hours. All recommended doses are given after the initial shock dose of 500 mg.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution - liver failure.

APPLICATION FOR CHILDREN

Do not appoint a newborn.

SPECIAL INSTRUCTIONS

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

With caution, the drug is prescribed to patients with gastrointestinal diseases (especially with colitis).

When using cefazolin, positive direct and indirect Coombs probes may appear.

With cefazolin, a false positive reaction to glucose in the urine is possible.

The safety of the drug in preterm infants and children of the first month of life is not established.

DRUG INTERACTION

It is not recommended simultaneous reception with anticoagulants and diuretics.

Loop diuretics and drugs that block tubular secretion increase the concentration of cefazolin in the plasma.

Aminoglycosides increase the risk of kidney damage.

Pharmaceutically incompatible with aminoglycosides (mutual inactivation).
To prepare a solution for intravenous administration (jet or drip), lidocaine can not be used.
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 at a temperature of no higher than 25 ° C.
Shelf life - 2 years. Do not use after the time specified on the package.
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