Fortazim (Powder) Instructions for Use

ATC Code

J01DD02 (Ceftazidime)

Active Substance

Ceftazidime (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

A broad-spectrum third-generation cephalosporin antibiotic. It exerts a bactericidal effect by inhibiting bacterial cell wall synthesis. Ceftazidime acetylates membrane-bound transpeptidases, thereby disrupting the cross-linking of peptidoglycans necessary for providing strength and rigidity to the cell wall.

It is active against aerobic, anaerobic, gram-positive and gram-negative bacteria, including Pseudomonas aeruginosa. Ceftazidime is active against strains of pathogens resistant to ampicillin, methicillin, aminoglycosides, and many cephalosporins.

It is resistant to the action of beta-lactamases.

Pharmacokinetics

Plasma protein binding is 10-17%. It is distributed in body tissues and fluids. Therapeutic concentrations are achieved in the cerebrospinal fluid. It crosses the placental barrier and is excreted in breast milk. It is excreted in small amounts in the bile. The main part (80-90%) is excreted unchanged in the urine.

Indications

Severe infectious and inflammatory diseases caused by microorganisms sensitive to ceftazidime, including peritonitis, sepsis; cholangitis, gallbladder empyema; pelvic organ infections; pneumonia, lung abscess, pleural empyema; pyelonephritis, kidney abscess; infections of bones, joints, skin and soft tissues, infected wounds and burns. Infectious processes caused by hemodialysis and peritoneal dialysis. Severe infectious and inflammatory diseases in patients with reduced immunity.

ICD codes

Dosage Regimen

Powder

The dosage is set individually depending on the location and severity of the infection, and the sensitivity of the pathogen. It is administered intramuscularly or intravenously. For adults – 0.5-2 g every 8 or 12 hours. For children aged 1 month-12 years – 30-50 mg/kg/day, frequency of administration 2-3 times/day; for children under 1 month – 30 mg/kg/day at 12-hour intervals.

In patients with impaired renal function, the dosing regimen is adjusted based on creatinine clearance values.

The maximum daily dose for adults and children is 6 g.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, transient increase in liver transaminase activity, cholestatic jaundice, hepatitis, pseudomembranous colitis.

Allergic reactions: skin rash, itching, eosinophilia; rarely – angioedema.

From the hematopoietic system: with prolonged use in high doses, changes in the peripheral blood picture are possible (leukopenia, neutropenia, thrombocytopenia, hemolytic anemia).

From the blood coagulation system: hypoprothrombinemia.

From the urinary system: interstitial nephritis.

Effects due to chemotherapeutic action: candidiasis.

Local reactions: phlebitis (with intravenous administration), pain at the injection site (with intramuscular administration).

Contraindications

Hypersensitivity to ceftazidime and other cephalosporins.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the safety of ceftazidime during pregnancy have not been conducted.

The use of ceftazidime during pregnancy and lactation is possible in cases where the intended therapeutic benefit for the mother outweighs the potential risk to the fetus.

Ceftazidime is excreted in breast milk in low concentrations.

In experimental studies on animals, no teratogenic or embryotoxic effects of ceftazidime were detected.

Use in Renal Impairment

Use with caution in patients with severe renal impairment.

Pediatric Use

Use with caution in newborns.

Special Precautions

Use with caution in patients with severe renal impairment, as well as in newborns.

In patients with hypersensitivity to penicillins, allergic reactions to cephalosporin antibiotics are possible.

During the use of ceftazidime, a positive direct Coombs test and a false-positive urine glucose reaction are possible.

Use with caution concomitantly with “loop” diuretics, aminoglycosides.

Ceftazidime should not be mixed in the same syringe with aminoglycosides.

Drug Interactions

With simultaneous use with drugs that may have a nephrotoxic effect (including antibiotics of the aminoglycoside group), an increase in the nephrotoxic effect is possible; with furosemide – the risk of developing a nephrotoxic effect increases.

In vitro, chloramphenicol acts as an antagonist of ceftazidime and other cephalosporins. The clinical significance of this phenomenon has not been established, but in case of simultaneous use of ceftazidime and chloramphenicol, a possible antagonistic effect should be taken into account.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.