Cefanorm (Powder) Instructions for Use

ATC Code

J01DE02 (Cefpirome)

Active Substance

Cefpirome (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Fourth generation cephalosporin

Pharmacotherapeutic Group

Systemic antibacterial agents; other beta-lactam antibacterial agents; fourth-generation cephalosporins

Pharmacological Action

An antibiotic of the cephalosporin series of the IV generation. It exerts a bactericidal effect by inhibiting the synthesis of mucopeptides of the bacterial cell wall during the mitosis phase.

It has a broad spectrum of activity against gram-positive and gram-negative bacteria, strains resistant to aminoglycosides or third-generation cephalosporin antibiotics.

Active against gram-positive bacteria Staphylococcus aureus, Staphylococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Corynebacterium spp., Peptostreptococcus spp.; gram-negative bacteria Pseudomonas aeruginosa, Escherichia coli, Enterobacter spp., Klebsiella spp., Proteus spp., Morganella morganii, Providencia spp., Citrobacter spp., Serratia spp., Haemophilus influenzae, Moraxella catarrhalis, Acinetobacter spp., Bacteroides spp.

Pharmacokinetics

Cefpirome is not absorbed from the gastrointestinal tract. After intravenous administration of a 1 g dose over 5 minutes, the average plasma concentration is 81 mg/l. Plasma protein binding is about 10%.

The T_1/2 of cefpirome in patients with normal renal function is about 1.8-2.2 hours. Accumulation upon repeated administration is not observed. Cefpirome is excreted mainly by the kidneys via glomerular filtration. Excretion in urine within the first 24 hours is 80-90%.

In patients over 65 years of age, within 5 minutes after intravenous administration of a 1 g dose, the average plasma concentration is 127.1 mg/l, T_1/2 increases to 4.5 hours. Accumulation upon multiple administration is not observed.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms: respiratory tract infections (including pneumonia, lung abscess, pleural empyema); complicated infections of the upper and lower urinary tract; gynecological infections (including adnexitis, endometritis, parametritis, pelvic peritonitis, Douglas pouch abscess, Bartholin’s gland abscess); skin and soft tissue infections; bacteremia, septicemia; infections in patients with neutropenia and weakened immunity.

ICD codes

Dosage Regimen

Powder

Administered intravenously only.

The dosage regimen is individual, depending on the severity of the infection, susceptibility of microorganisms, and renal function.

For patients with normal renal function (CrCl>50 ml/min) with severe infections, a single dose is 1 g, the daily dose is 2 g, the interval between administrations is 12 hours.

For patients with complicated, life-threatening infections, a single dose is 2 g, the daily dose is 4 g, the interval between administrations is 12 hours.

Adverse Reactions

From the digestive system diarrhea, nausea, vomiting, pseudomembranous colitis, abdominal pain, constipation, taste alteration, increased ALT, AST, ALP, total bilirubin.

From the CNS dizziness, headache, confusion, insomnia, reversible encephalopathy.

From the cardiovascular system cardiac arrhythmia.

From the urinary system interstitial nephritis, renal failure.

From the blood coagulation system increased prothrombin time or aPTT, hemorrhages.

From the hematopoietic system eosinophilia, transient thrombocytopenia, transient leukopenia and neutropenia, anemia.

From metabolism temporary increase in blood urea nitrogen and/or serum creatinine.

Allergic reactions rash, itching, urticaria, anaphylactic reactions.

Local reactions phlebitis, inflammation or pain at the injection site.

Contraindications

Hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics.

Use in Pregnancy and Lactation

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided.

Special Precautions

Use with caution in patients with any form of allergy, especially with a history of allergic reactions to drugs. If allergic reactions develop, treatment should be discontinued.

With prolonged use of cefpirome, measures should be taken to prevent the development of dysbiosis, and blood counts and renal function should be monitored. Pseudomembranous colitis may develop during the first weeks of treatment.

Drug Interactions

With simultaneous use of cefpirome with aminoglycosides, furosemide and other “loop” diuretics, an increase in nephro- and ototoxicity is possible.

Probenecid slows down the excretion of cefpirome from the body and thereby increases its plasma concentration.

With simultaneous administration of cefpirome solution with solutions of metronidazole, vancomycin, gentamicin, pharmaceutical interaction is possible (each antibiotic should be administered separately).

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.