Cefamabol^® (Powder) Instructions for Use

Marketing Authorization Holder

PFC Prebend, LLC (Russia)

ATC Code

J01DC03 (Cefamandole)

Active Substance

Cefamandole (Rec.INN registered by WHO)

Dosage Form

Cefamabol®

Powder for solution for intravenous and intramuscular administration 1000 mg: vial 1 or 5 pcs. with or without solvent

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, crystalline, odorless.

Excipients: sodium carbonate.

Solvent: water for injections.

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 10 ml (1) in a set with solvent (amp. 1 pc.) – cardboard packs.
Glass vials with a capacity of 10 ml (1) in a set with solvent (amp. 1 pc.) – contour cell packs (1) – cardboard packs.
Glass vials with a capacity of 10 ml (5) – cardboard packs.
Glass vials with a capacity of 10 ml (5) in a set with solvent (amp. 5 pcs.) – contour cell packs (1) – cardboard packs.

Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, crystalline, odorless.

Excipients: sodium carbonate.

Solvent: water for injections.

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 10 ml (1) in a set with solvent (amp. 1 pc.) – cardboard packs.
Glass vials with a capacity of 10 ml (1) in a set with solvent (amp. 1 pc.) – contour cell packs (1) – cardboard packs.
Glass vials with a capacity of 10 ml (5) – cardboard packs.
Glass vials with a capacity of 10 ml (5) in a set with solvent (amp. 5 pcs.) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Second generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

Cephalosporin antibiotic of the second generation for parenteral use. It acts bactericidally (disrupts the synthesis of the microbial cell wall). It has a broad spectrum of action.

Highly active against gram-positive microorganisms – Staphylococcus aureus (including strains producing and not producing penicillinase), Staphylococcus epidermidis, Streptococcus spp. (including beta-hemolytic strains, Streptococcus pneumoniae); gram-negative microorganisms – Escherichia coli, Klebsiella spp., Enterobacter spp., Hemophilus influenzae, Providencia rettgeri, Morganella morganii, Proteus mirabilis et vulgaris; anaerobic microorganisms – gram-positive and gram-negative cocci (including Peptococcus, Peptostreptococcus), gram-positive rods (including Clostridium spp.), gram-negative rods (including Fusobacterium spp., Bacteroides spp.).

It is resistant to the action of beta-lactamases. It is not active against various species of Pseudomonas, most strains of Enterococcus spp. (including Enterococcus faecalis), Enterobacter cloacae spp., Bacteroides fragilis, Staphylococcus spp. (methicillin-resistant strains) and Listeria monocytogenes, Serratia spp.

It has a disulfiram-like effect.

Pharmacokinetics

After intramuscular administration of 0.5 or 1 g, the time to reach maximum concentration (T_Cmax) is 30-120 min, the C_max value is 13 and 25 µg/ml, respectively. After intravenous administration of 1, 2 or 3 g, after 10 min C_max is 139, 240 and 533 µg/ml and remains at a therapeutic level for 6 hours. Therapeutic concentration is achieved in pleural and joint fluids, bile and bones.

Does not accumulate. T_1/2 after intravenous administration is 30-35 min, after intramuscular administration is 60 min.

It is excreted by the kidneys unchanged (65-85% is excreted within 8 hours and provides high concentrations of the drug in the urine). After intramuscular administration of 0.5 and 1 g, the urine content is 254 and 1357 µg/ml, respectively; after intravenous administration of 1 and 2 g – 750 and 1380 µg/ml, respectively.

In chronic renal failure, excretion is slowed. In patients on hemodialysis, T_1/2 increases to 6 hours.

Indications

Infectious and inflammatory diseases caused by pathogens sensitive to the drug, including

• Abdominal and 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 or intravenously.

For intramuscular administration, the drug (0.5 g or 1.0 g) is dissolved in 3 ml of water for injections or in 3 ml of 0.9% sodium chloride solution.

For intravenous bolus administration, the drug is dissolved at the rate of 1 g of the drug in 10 ml of water for injections or in 10 ml of 0.9% sodium chloride solution.

For intravenous drip administration, the drug dissolved as described above is mixed with a 10% dextrose solution or 0.9% sodium chloride solution.

Adults are prescribed 500 mg-1 g every 4-8 hours, for urinary tract infections – 500 mg (in severe cases – 1 g) every 8 hours, for life-threatening infections – up to 2 g every 4 hours (12 g per day).

Children – 50-100 mg/kg ( for severe infections – up to 150 mg/kg) per day with intervals between administrations of 4-8 hours.

For infections caused by beta-hemolytic streptococcus, treatment should be continued for at least 10 days. Patients on hemodialysis are administered 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 prevention of postoperative infectious complications, 30-60 minutes before the intervention, adults are administered – 1-2 g, children – 50-100 mg/kg, followed by the same doses within 24-48 hours.

For patients with impaired renal function, the dosage regimen is established taking into account creatinine clearance values.

After an initial dose of 1-2 g (depending on the severity of the infection), the following maintenance doses are prescribed

Adverse Reactions

Allergic reactions: urticaria, chills or fever, rash, itching, rarely bronchospasm, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), angioedema, anaphylactic shock.

From the digestive system: nausea, vomiting, diarrhea or constipation, dysbacteriosis, impaired liver function (increased activity of hepatic transaminases, alkaline phosphatase, hyperbilirubinemia, cholestatic jaundice, hepatitis), rarely – stomatitis, glossitis, pseudomembranous enterocolitis.

From the hematopoietic organs: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation.

From the urinary system: azotemia, increased blood urea, hypercreatininemia, impaired renal function.

From the nervous system: headache, dizziness.

Local reactions: phlebitis, pain along the vein, pain and infiltration at the intramuscular injection site.

Other: superinfection.

Contraindications

• Hypersensitivity (including to cephalosporins, penicillins, carbapenems);
• Early childhood (up to 6 months).

With caution: renal failure, pseudomembranous colitis (in history).

Use in Pregnancy and Lactation

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

If it is necessary to prescribe cefamandole during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

Use with caution in renal failure.

For patients with impaired renal function, the dosage regimen is established taking into account 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

The drug is contraindicated in early childhood (up to 6 months). In children over 6 months, it is used according to indications and in established doses.

Geriatric Use

In elderly and debilitated patients with vitamin K deficiency, there is an increased risk of hypoprothrombinemia with or without bleeding (in these cases, administration of vitamin K is indicated).

Special Precautions

Patients with a history of allergic reactions to penicillins may have increased sensitivity to cephalosporin antibiotics.

During treatment with cefamandole, a false-positive direct Coombs test and a false-positive urine test for glucose and proteinuria are possible.

In elderly and debilitated patients with vitamin K deficiency, there is an increased risk of hypoprothrombinemia with or without bleeding (in these cases, administration of vitamin K is indicated).

During treatment, one should refrain from taking ethanol – effects similar to the action of disulfiram (facial flushing, abdominal and stomach cramps, nausea, vomiting, headache, decreased blood pressure, tachycardia, shortness of breath) are possible.

The freshly prepared solution is suitable for use within 24 hours when stored at room temperature and within 96 hours when stored in the refrigerator.

Overdose

Symptoms: convulsions (especially in patients with chronic renal failure).

Treatment: symptomatic therapy, including diazepam and short-acting barbiturates, in severe cases – hemodialysis.

Drug Interactions

Nephrotoxicity is increased by aminoglycosides, “loop” diuretics, drugs that reduce tubular secretion.

It is incompatible with ethanol (inhibits acetaldehyde dehydrogenase), disulfiram-like reactions develop (abdominal pain, facial skin hyperemia, headache, decreased blood pressure, nausea, vomiting, palpitations, increased sweating).

Pharmaceutically incompatible with aminoglycosides.

Storage Conditions

List B. In a dry, light-protected place at a temperature from 15 to 25°C (77°F). Store the drug out of the reach of children.

Shelf Life

Shelf life 2 years. Do not use after the expiration date printed on the package. The freshly prepared solution of the drug is suitable for use within 24 hours at a temperature not exceeding 25°C (77°F) and within 96 hours when stored in the refrigerator.

Dispensing Status

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.