Cefazolin - instructions for use, dose, side effects, contraindications

It has a wide spectrum of antimicrobial action. It is active both against Gram-positive (Staphylococcus spp., Gnath producing and producing penicillinase, Streptococcus spp, Pneumococcus, C.diphtheriae, B.antracis), and Gram-negative microorganisms (N.Meningitidis, N. gonorrhoeae, Shigella, Salmonella, E.Coli , Klebsiella). It is also active against Spirochaetaceae and Leptospiraceae.

The drug is not effective against P. aeruginosa, indolpositive strains of Proteus, M. tuberculosis, anaerobic microorganisms.

Pharmacokinetics:

When ingestion is destroyed. T C max after im / m introduction 0.25, 0.5 and 1 g - 1-2 hours, the value of Cmax - 17, 38 and 64 μg / ml, respectively. After intravenous administration of 1 g of C max to the end of infusion, 188 μg / ml, after 8 hours -4 μg / ml. The connection with plasma proteins is 85%.The volume of distribution is 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 unchanged during the first 6h - 60-90%, after 24 hours - 70-95%. If the kidney T1 / 2 is disturbed, 3-42 hours. It is moderately withdrawn during hemodialysis.

Indications:Cefazolin sodium salt is used for infectious and inflammatory diseases caused by susceptible pathogens (sepsis, peritonitis, endocarditis, respiratory tract infections, genito-urinary tract, including syphilis and gonorrhea, infections of the bones and joints), as well as for the prevention of postoperative complications .

Contraindications:

Hypersensitivity to cephalosporins and other beta-lactam antibiotics.

Pregnancy and lactation.If necessary, breast-feeding is stopped. Do not appoint a newborn.

Carefully:With caution - renal / hepatic insufficiency, pseudomembranous enterocolitis.

Dosing and Administration:

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 a 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 - during the operation and for 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 dosing regimen in accordance with the values of CC: with a CC of 55 ml / min or more, or at a plasma creatine concentration of 1.5 mg% or less, a full dose can be administered; with SC 54-35 ml / min or creatine concentration in plasma 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 creatine concentration in plasma 3.1-4.5 mg% - 1/2 dose at intervals of 12 hours; with CC 10 ml / min or less, or at a plasma creatine concentration of 4.6 mg% and more - 1/2 of the usual dose every 18-24 4 All recommended doses are given after the initial shock dose of 0.5 g.

Children 1 month and older - 25-50 mg / kg / day; In severe infection, the dose may be increased to 100 mg / kg / day. Multiplicity of administration - 3-4 times a day. In children with impaired renal function, the correction of the dosing regimen is performed depending on the values of the CC: with a CK of 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 injection. For IV bolus injection, the resulting solution is diluted with 5 ml of water for injection, then injected slowly, within 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 effects:

Allergic reactions: urticaria, chills, fever, rash, itching, rarely - bronchospasm, zosinophilia, exudative erythema multiforme, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), angioedema,anaphylactic shock.

Co side of the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbacteriosis, candidiasis of the gastrointestinal tract (including candidal stomatitis), impaired liver function (increased activity of "liver" 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.

From the genitourinary system: impaired renal function (azotemia, increased urea levels in the blood, hypercreatininaemia), anal itching, genital itching.

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

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 (inkjet or drip), you can not use lidocaine.

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 diseases of the gastrointestinal tract (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.

Form release / dosage:Powder for solution for injection for 250 mg, 500 mg and 1.0 g.

Packaging:Powder for the preparation of a solution for injection of 250 mg, 500 mg and 1.0 g in glass bottles of 10 ml or 20 ml. One bottle in a cardboard box.

Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015271 / 01

Date of registration:15.12.2008

The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India

Manufacturer: & nbsp

SHREYA LIFE SCIENCES, Pvt.Ltd. India

Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India

Information update date: & nbsp14.10.2015

Illustrated instructions

Instructions

Cefazolin (Cefazolin)