INTRAZOLIN

Active material: Tsefazolyn
When ATH: J01DB04
CCF: I generation Cephalosporin
When CSF: 06.02.01
Manufacturer: LDP – Laboratories TORLAN (Spain)

Pharmaceutical form, composition and packaging

Powder for solution for injection1 fl.
tsefazolyn (sodium salt)1 g

Bottles (1) – cardboard boxes.

 

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

I generation cephalosporin antibiotic broad spectrum. It has bactericidal activity.

Active against gram-positive bacteria: Staphylococcus spp. (strains, producing and not producing penicillinase), Streptococcus spp. (incl. Streptococcus pneumoniae), Corynebacterium diphtheriae, Bacillus anthracis; Gram negative bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Escherichia coli, Klebsiella spp.

It is also active against Spirochaetoceae, Leptospira spp.

Inactive against Pseudomonas aeruginosa, indole-positive strains of Proteus spp., Mycobacterium tuberculosis, Anaerobic bacteria.

 

Pharmacokinetics

Cefazolin is poorly absorbed from the gastrointestinal tract and is therefore used in the / m or /. After the / m dose 500 mg Cmax plasma achieved through 1-2 h is 30 ug / ml.

Plasma protein binding is about 85%.

Cefazolin penetrates into the bone tissue, ascitic fluid, pleural fluid and synovial, but not detected in the CNS.

T1/2 cefazolin plasma is about 1.8 no.

Cefazolin is excreted in the urine in unchanged form, mainly, by glomerular filtration, and to a small extent – by tubular secretion. After the / m, at least, 80% dose after the / m output through 24 no. After the / m of doses 500 mg 1 г Cmax urine is respectively 1 mg / ml 4 mg / ml.

There is evidence that high concentrations of cefazolin in bile, Although it appears that by a small amount.

T1/2 plasma is increased in patients with impaired renal function.

 

Testimony

Infectious-inflammatory diseases, caused by organisms susceptible to cefazolin, incl. diseases of the upper and lower respiratory tract, urinary and biliary tract, pelvic, skin and soft tissue, bone and joints, endokardit, sepsis, peritonitis, otitis media, osteomyelitis, mastitis, Wound, burns and postoperative infections, syphilis, gonorrhea.

 

Dosage regimen

Establish individually, taking into account the severity and localization of infection, susceptibility.

Enter the / m or / (bolus or infusion). The average daily dose for adults is 1 g, the frequency of administration – 2-4 times / day.

For the prevention of post-operative infection is administered in a dose of 1 d for 30 minutes before the operation, 0.5-1 g during operation and 0.5-1 g every 6-8 hours within a day after surgery.

The maximum dose: 6 g / day.

For children, the average daily dose is 20-40 mg / kg; in severe infections the dose can be increased to 100 mg / kg / day. The duration of treatment is 7-10 days.

 

Side effect

From the digestive system: nausea, vomiting, diarrhea; rarely – transient increase in liver transaminases.

Allergic reactions: possible urticaria, itching, eozinofilija, fever; in a few cases – angioedema, artralgii, anaphylactic shock.

Effects, caused by chemotherapeutic action: candidiasis, psevdomembranoznыy colitis.

From the hematopoietic system: rarely – reversible leukopenia, neutropenia, thrombocytopenia.

From the urinary system: rarely – impairment of renal function.

Local reactions: possible pain at the / m injection.

 

Contraindications

Children up to age 1 of the month, Hypersensitivity to cephalosporins.

 

Pregnancy and lactation

It penetrates through the placental barrier.

In breast milk it is determined by low concentrations of cefazolin.

Use in pregnancy and lactation is justified only in cases, the expected benefit to the mother outweighs the potential risk to the fetus or child.

 

Cautions

To use caution in renal impairment.

In patients with hypersensitivity to penicillin allergic reaction to cephalosporin antibiotics.

During treatment possible false positive reaction of urine for sugar.

Cefazolin appear in hemodialysis.

 

Drug Interactions

Together with the application “loop” diuretics block tubular secretion occurs cefazolin (this combination is not recommended).

Cefazolin may cause disulfiramopodobnye reactions while the use of ethanol.

Probenecid excretion violates cefazolin.

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