Cefat^® (Powder) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

ATC Code

J01DC03 (Cefamandole)

Active Substance

Cefamandole (Rec.INN registered by WHO)

Dosage Forms

	Cefat®	Powder for preparation of solution for injections 1 g: vial 1, 5, 10 or 50 pcs.
		Powder for preparation of solution for injections 500 mg: vial 1, 5, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for injections white or white with a yellowish tint, odorless.

Vials with a capacity of 10 ml (1) – cardboard packs.
Vials with a capacity of 10 ml (10) – cardboard packs.
Vials with a capacity of 10 ml (50) – cardboard boxes.

Clinical-Pharmacological Group

Second generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

Cephalosporin antibiotic of the II generation. It acts bactericidally. It inhibits transpeptidase, disrupts the biosynthesis of mucopeptide of the microorganism cell wall, thereby causing the death of the pathogen.

Cefat^® is active against aerobic gram-negative bacteria Escherichia coli, Haemophilus influenzae, Enterobacter spp. (may acquire resistance during treatment), Proteus mirabilis, Proteus vulgaris (some strains), Providencia rettgeri, Morganella morganii, Neisseria gonorrhoeae, Shigella spp., Salmonella spp.; aerobic gram-positive microorganisms Staphylococcus spp., Streptococcus spp.; anaerobic microorganisms Clostridium spp., Bacteroides spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp.

Pharmacokinetics

Absorption

After intramuscular administration of the drug at a dose of 0.5 mg or 1 g, C_max is reached in 30-120 minutes and is 13 µg/ml and 25 µg/ml, respectively.

After intravenous administration at a dose of 1 mg, 2 mg and 3 mg, a cefamandole concentration of 139 µg/ml, 240 µg/ml and 533 µg/ml is reached after 10 minutes and remains at a therapeutic level for 6 hours.

Distribution

Therapeutic concentrations of cefamandole are achieved in pleural and joint fluids, in bile and bones.

Elimination

After intramuscular administration, T_1/2 is 60 minutes, after intravenous administration – 32 minutes.

Cefamandole is excreted unchanged in the urine (65-85% of the administered dose is excreted within 8 hours). After intramuscular administration of the drug at a dose of 0.5 mg and 1 g, the concentration of cefamandole in the urine is 254 µg/ml and 1357 µg/ml, respectively, after intravenous administration of the drug at a dose of 1 g and 2 g – 750 µg/ml and 1380 µg/ml, respectively.

Pharmacokinetics in special clinical cases

In renal failure, the elimination of the drug is slowed down.

Indications

• Abdominal infections;
• Gynecological infections;
• Sepsis;
• Meningitis;
• Endocarditis;
• Urinary tract infections;
• Respiratory tract infections;
• Bone and joint infections;
• Skin and soft tissue infections;
• Prevention of postoperative infectious complications.

ICD codes

Dosage Regimen

The drug is administered intramuscularly and intravenously (bolus or drip). Adults are prescribed 0.5-1 g every 4-8 hours. For urinary tract diseases – 500 mg every 8 hours, in severe cases – 1 g every 8 hours. For life-threatening infections – 2 g every 4 hours (daily dose – 12 g). Children are prescribed 50-100 mg/kg of body weight/day; the interval between administrations is 4-8 hours. In severe infections, the daily dose of the drug can be increased to 150 mg/kg. For infections caused by beta-hemolytic streptococci, treatment should be continued for at least 10 days. For prevention of postoperative complications, the drug is administered 30-60 minutes before surgery: adults – 1-2 g; children – 50-100 mg/kg. The same doses are administered within 24-48 hours after surgery. After the symptoms of the disease have been eliminated, treatment should be continued for 48-72 hours. Patients on hemodialysis are administered the drug at 1 g every 12 hours intravenously or intramuscularly (if intramuscular administration is used, then after hemodialysis is completed, an additional 1/3-1/2 dose is administered). For patients with impaired renal function, debilitated patients and elderly patients with impaired renal function, the dosage regimen of the drug is adjusted taking into account the creatinine clearance values. After an initial dose of 1-2 g (depending on the severity of the infection), the following maintenance doses are prescribed.

Rules for preparation and administration of solutions
For intramuscular administration, the powder (0.5 g or 1 g) is dissolved in 3 ml of water for injections or 0.9% physiological sodium chloride solution. For intravenous bolus administration, the powder is dissolved at the rate of 1 g of the drug in 10 ml of water for injections or 0.9% physiological sodium chloride solution. For intravenous drip administration, the drug (prepared as described above) is dissolved in a 10% glucose solution or physiological solution.

Adverse Reactions

From the digestive system nausea, vomiting, pseudomembranous colitis, cholestatic jaundice, persistent hepatitis, transient increase in the activity of hepatic transaminases and alkaline phosphatase in blood plasma.

From the hematopoietic system leukopenia, neutropenia, thrombocytopenia.

From the urinary system impaired renal excretory function, decreased creatinine clearance and increased blood urea nitrogen (in patients with renal failure).

Allergic reactions skin rash, urticaria, eosinophilia, fever; rarely – Quincke’s edema, bronchospasm, anaphylactic shock.

Local reactions with intramuscular administration – pain and infiltrate, with intravenous administration – thrombophlebitis.

Other dysbacteriosis, superinfection.

Contraindications

• Hypersensitivity to cephalosporins, penicillins, carbapenems.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation (breastfeeding) is indicated only in cases where the expected therapeutic effect for the mother outweighs the possible negative impact on the fetus and child.

Use in Renal Impairment

For patients with impaired renal function, debilitated patients and elderly patients with impaired renal function, the dosage regimen of the drug is adjusted taking into account the creatinine clearance values. After an initial dose of 1-2 g (depending on the severity of the infection), the following maintenance doses are prescribed.

Pediatric Use

Cefat^® should be prescribed with caution to newborns (including premature infants).

Children are prescribed 50-100 mg/kg of body weight/day; the interval between administrations is 4-8 hours. In severe infections, the daily dose of the drug can be increased to 150 mg/kg.

Special Precautions

Cefat^® should be prescribed with caution to patients with severe renal impairment, with colitis (including ulcerative), decreased blood clotting, gastric and duodenal ulcers.

Use in pediatrics

Cefat^® should be prescribed with caution to newborns (including premature infants).

Overdose

Currently, no cases of overdose with Cefat^® have been reported.

Drug Interactions

When Cefat^® and “loop” diuretics, as well as antibiotics of the aminoglycoside group, are prescribed simultaneously, the risk of nephrotoxic action increases.

When used simultaneously with aminoglycosides, a synergy of antibacterial action is noted.

Probenecid, when used simultaneously with Cefat^®, slows down the elimination of cefamandole, thereby increasing its concentration and duration of action.

When Cefat^® is used simultaneously with anticoagulants, thrombolytic drugs and NSAIDs, the risk of bleeding increases.

When used simultaneously, Cefamandole prolongs the effect of ethanol and causes a disulfiram-like reaction.

Pharmaceutical interaction

Cefat^® solution should not be mixed in the same syringe with antibiotics of the aminoglycoside group.

Storage Conditions

List B. The drug should be stored in a dry, light-protected place at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 years.

The freshly prepared solution is suitable for use within 24 hours when stored at a temperature of 25°C (77°F) and within 96 hours when stored in a refrigerator.

Dispensing Status

The drug is dispensed by prescription.

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.