Dardum (Powder) Instructions for Use

Marketing Authorization Holder

Lisapharma, S.p.A. (Italy)

ATC Code

J01DD12 (Cefoperazone)

Active Substance

Cefoperazone (Rec.INN registered by WHO)

Dosage Form

Dardum

Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 or 50 pcs.

Dosage Form, Packaging, and Composition

Vials (1) – cardboard packs.
Vials (50) – cardboard boxes.

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

Cephalosporin antibiotic of the third generation with a broad spectrum of action. It exerts a bactericidal effect by inhibiting the synthesis of the bacterial cell wall. Cefoperazone acetylates membrane-bound transpeptidases, disrupting the cross-linking of peptidoglycans, which is necessary for providing strength and rigidity to the cell wall.

It is active against gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus faecalis, β-hemolytic streptococci; gram-negative bacteria: Escherichia coli, Klebsiella spp., Enterobacter spp., Citrobacter spp., Haemophilus influenzae, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia spp., Serratia spp., Salmonella spp., Shigella spp., Pseudomonas aeruginosa, Acinetobacter calcoaceticus, Neisseria gonorrhoeae, Neisseria meningitidis, Bordetella pertussis, Yersinia enterocolitica. It is also active against anaerobic microorganisms: Peptococcus spp., Peptostreptococcus spp., Veillonella spp., Clostridium spp., Eubacterium spp., Lactobacillus spp., Fusobacterium spp., Bacteroides spp.

It is resistant to the action of most β-lactamases.

Pharmacokinetics

High concentrations of cefoperazone are achieved in blood serum, bile, and urine after a single application. Therapeutic concentrations are achieved in all studied body fluids and tissues, including ascitic and cerebrospinal fluid (in meningitis), urine, bile and gallbladder wall, sputum and lungs, palatine tonsils and sinus mucosa, atrial appendages, kidneys, ureter, prostate, testicles, uterus and fallopian tubes, bones, umbilical cord blood and amniotic fluid. It poorly penetrates the blood-brain barrier, penetrates the placental barrier, and is excreted in breast milk. It is eliminated with bile and urine.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to cefoperazone, including diseases of the upper and lower respiratory tract, infections of the genitourinary system, peritonitis, cholecystitis and other abdominal infections, sepsis, meningitis, infections of the skin and soft tissues, infections of the pelvic organs.

Prophylaxis of infectious complications after abdominal, gynecological, cardiovascular and orthopedic surgeries.

ICD codes

Dosage Regimen

It is administered intravenously or intramuscularly. The dosage regimen is established individually, taking into account the severity and location of the infection, the sensitivity of the pathogen, and the patient’s age.

The single dose for intravenous administration for adults is 1-4 g/day, the interval between administrations is 12 hours. Depending on the etiology of the disease, intramuscular administration of 500 mg once is possible.

The dosage regimen for children is established taking into account age, body weight and the severity of the disease. The recommended dose is 50-200 mg/kg/day, the frequency of administration is 2 times/day.

Adverse Reactions

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

Allergic reactions hypersensitivity reactions, drug fever, anaphylactic shock, anaphylactic reactions, anaphylactoid reactions.

From the skin and subcutaneous tissues maculopapular rash, urticaria, skin itching, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis.

From laboratory parameters: eosinophilia, decrease in hemoglobin or hematocrit, neutropenia, positive direct Coombs test, increased activity of ALT, AST, ALP, transient increase in blood urea nitrogen, plasma creatinine, hypoprothrombinemia, thrombocytopenia, coagulopathy.

From the cardiovascular system severe bleeding.

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

Contraindications

Hypersensitivity to cephalosporins and other β-lactam antibiotics; history of allergic reactions to cephalosporins.

With caution

Biliary tract obstruction, severe hepatic insufficiency, renal insufficiency, simultaneous impairment of liver and kidney function.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Use in Hepatic Impairment

Cefoperazone should be used with caution in biliary tract obstruction, severe hepatic insufficiency, and with simultaneous impairment of liver and kidney function.

Use in Renal Impairment

Cefoperazone should be used with caution in renal insufficiency and with simultaneous impairment of liver and kidney function.

Pediatric Use

It can be used in children according to indications, in recommended doses and regimens. It is necessary to strictly follow the instructions for medical use of cefoperazone drugs in children.

Special Precautions

Before starting the use of cefoperazone, the patient’s allergy history should be collected due to the possibility of developing cross-hypersensitivity reactions between cephalosporins and penicillins or other β-lactam antibiotics.

Particularly careful monitoring is necessary for patients with a tendency to allergic reactions (allergic rhinitis, bronchial asthma), as against the background of such conditions, the risk of hypersensitivity reactions increases.

During the use of cefoperazone, false-positive reactions for the determination of glucose in urine are possible when using Benedict’s or Fehling’s reagent.

With prolonged use of cefoperazone, monitoring of the peripheral blood picture is necessary.

Long-term use of cefoperazone may provoke the emergence of resistant strains of bacteria. The condition of patients should be carefully monitored for the possibility of developing superinfection and appropriate measures should be taken in case of its development.

Due to the possibility of developing disulfiram-like reactions during the use of cefoperazone, patients should refrain from consuming alcohol during the treatment period and for 5 days after the end of therapy.

Drug Interactions

Cefoperazone, by suppressing the intestinal flora, prevents the synthesis of vitamin K. Therefore, when co-administered with drugs that reduce platelet aggregation (NSAIDs, salicylates, sulfinpyrazone), the risk of bleeding increases. For the same reason, when used concomitantly with anticoagulants, an enhancement of the anticoagulant effect is noted.

Solutions of cefoperazone and an aminoglycoside should not be mixed directly, as there is a physical incompatibility between them.

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.