Cefazolin, powder of, vial1g

Composition

Powder for preparing a solution for intravenous and intramuscular use.

Active ingredient:

Cefazolin (in the form of a sodium salt) 1.0 g

Pharmacological action

Cefazolin is a semi-synthetic cephalosporin antibiotic of the first generation of a broad spectrum of action for parenteral use.

It acts bactericidal, suppressing the biosynthesis of the bacterial cell wall. Active against gram-positive bacteria:  Staphylococcus spp. (excluding methicillin-resistant strains), Streptococcus spp. (excluding Streptococcus faecalis); gram-negative bacteria:  Escherichia coli, Proteus mirabilis, Klebsiella spp., Neisseria gonorrhoeae, Treponema spp., Enterobacter aerogenes, Haemophilus influenzae.

It is not effective against Pseudomonas aeruginosa, indole-positive strains of Proteus spp., Mycobacterium tuberculosis, Serratia spp., anaerobic microorganisms, methicillin-resistant strains of Staphylococcus spp.

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, syphilis, gonorrhea and other diseases caused by microorganisms sensitive to cefazolin.

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

Contraindications

Hypersensitivity to cefazolin, cephalosporin and other beta-lactam antibiotics (including penicillins and carbapenems), neonatal period (up to 1 month). Concomitant use with anticoagulants and diuretics is not recommended.

With caution

Kidney failure, bowel diseases (including colitis in the anamnesis), children aged from 1-12 months.

Side effects

Allergic reactions:  hyperthermia, skin rash, urticaria, pruritus, bronchospasm, eosinophilia, angioedema, arthralgia, anaphylactic shock, erythema multiforme, malignant exudative erythema (Stevens-Johnson syndrome).

Nervous system disorders:  convulsions.

From the urinary system:  patients with renal insufficiency may develop renal insufficiency when using the drug in large doses (6 g).

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

From the side of hematopoietic organs:  leukopenia, neutropenia, thrombocytopenia, thrombocytosis, hemolytic anemia.

Local reactions:  with intravenous use – soreness (at the injection site), with intravenous use-phlebitis.

Other services:  gastrointestinal disorders, dysbiosis, superinfection caused by antibiotic-resistant strains.

Interaction

There is a synergistic antibacterial effect when the drug is used simultaneously with aminoglycosides, vancomycin, rifampicin.

Concomitant use with anticoagulants and diuretics (furosemide, etacric acid) is not recommended.

With the simultaneous use of cefazolin, its tubular secretion is blocked. Aminoglycosides increase the risk of developing kidney damage.

Pharmacologically incompatible with aminoglycosides (mutual inactivation). Drugs that block tubular secretion increase blood concentrations, slow down excretion, and increase the risk of toxic reactions.

How to take, course of use and dosage

Cefazolin is intended only for parenteral use-intramuscularly and intravenously (jet or drip). Doses are set individually, taking into account the severity of the course and localization of infection, the sensitivity of the pathogen.

Solution preparation and application

For intravenous use,1 g of the drug is dissolved in 4 ml of water for injection.

For intravenous injection, a single dose of the drug is diluted in 10 ml of water for injection, then administered slowly for 3-5 minutes.

For intravenous drip use, the drug is diluted in 50-100 ml of 5-10% dextrose solution,0.9% sodium chloride solution, Ringer’s solution,5% sodium bicarbonate solution. The infusion is carried out for 20-30 minutes (the rate of use is 60-80 drops per minute). During dilution, the vials should be shaken vigorously until completely dissolved.

Use only freshly prepared and clear solutions. The possible yellowish color of the solution after the powder is dissolved is not an indication of any change in the properties of the drug or differences in its therapeutic effectiveness.

The average daily dose for adults is 1-4 g; the frequency of use is 3-4 times a day. The maximum daily dose is 6 g. The average duration of treatment is 7-10 days.

Dosage instructions for adults Mild infections caused by sensitive gram-positive cocci 0.5-1 g After 8 hours Pneumococcal pneumonia 0.5 g After 12 hours Acute uncomplicated urinary tract infections 1 g After 12 hours Moderate or severe 0.5-1 g After 6-8 hours Severe, life-threatening infections: endocarditis, septicemia 1-1.5 g After 6 hours

Use in children with normal renal function

Children aged 1 month and older are prescribed cefazolin at a dose of 25-50 mg / kg of body weight per day. The frequency of use is 3-4 times a day. In severe cases of infection, the daily dose of cefazolin can be increased to 100 mg / kg of body weight. The frequency of use is 3-4 times a day.

Use in adult patients with impaired renal function

In patients with impaired renal function requires the modification of the dosing regimen in accordance with the values of creatinine clearance (CC):

• at KK 55 ml/min or more, or when the concentration of creatinine in the blood plasma of 1.5 mg% or less can enter the total daily dose;
• in QA 54-35 ml/min or creatinine concentration in blood plasma 3-1,6 mg%, you can enter the total daily dose, the interval between injections should be increased to 8 hours;
• in QA 34-11 ml/min or creatinine concentration in blood plasma of 4.5 and 3.1 mg% – 1/2 the usual dose at intervals of 12 hours;
• in QA 10 ml/min. or less or when the concentration of creatinine in the blood plasma of 4.6 mg% or more to 1/2 the usual dose every 18 to 24 hours.

All recommended doses are applied after the initial dose is administered, corresponding to the severity of the infection.

Use in children with impaired renal function

Correction of the dosage regimen is made depending on the values of KK:

• when KK 70-40 ml/min/1.73 m 2 – 60% of the average daily dose after 12 hours;
• in QA 40-20 ml/min/1.73 m 2 – 25% of the average daily dose after 12 hours;
• in QA 20-5 ml/min/1.73 m 2 – 10% of the average daily dose in 24 hours.

All recommended doses should be administered after the initial dose corresponding to the severity of the infection.

Perioperative prevention

To prevent infections during surgical procedures, the dosage of cefazolin depends on the type and duration of the operation.

• 1 g intravenously or intramuscularly 30 min – 1 hour before the start of surgery (dose is sufficient for minor surgical interventions of short duration);
• prolonged surgery (>2 hours) is further added 0.5 to 1 g intravenously or intramuscularly during the operation itself (you can enter the drug and during surgery, depending on its duration through a certain period of time);
• during the postoperative period after the initial dose administered 0.5 g to 1 g intravenously or intramuscularly with an interval of 6-8 hours for 24 hours;
• if a potential infection can pose a threat to the patient (for example after heart surgery or after major orthopedic operations such as arthroplasty), it is recommended to continue postoperative introduction of Cefazolin during the period from 3 to 5 days.

It is important to observe the above deadlines so that sufficient concentrations of the antibiotic are already present in the patient’s serum and tissues during the surgical incision.

Special instructions

Patients who have had a history of allergic reactions to penicillins, carbapenems, may have an increased sensitivity to cephalosporin antibiotics. If allergic reactions develop, the drug should be discontinued and appropriate desensitizing therapy should be prescribed.

With the development of renal failure, the dose of the drug should be reduced and further treatment should be carried out under the control of the dynamics of urea nitrogen and creatinine in the blood.

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

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

When thawed, the solution remains stable for 10 days when stored in the refrigerator (5 deg. C) or 48 hours at room temperature.

The safety of use in premature infants and infants of the first year of life has not been established.

Storage conditions

Store in a dry place protected from light at a temperature not exceeding 5°C.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Cefazolin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Purpose

Children older than 1 month, Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Otitis media, Inflammation of the female genital organs, Osteomyelitis, Skin infections, Bronchitis, Purulent wounds, Biliary tract infections, Urinary tract infections, Sinusitis, Burns, Tonsillitis, Pneumonia