Composition, form of production and packaging
Powder for solution for injection white or white with a yellowish tint, odorless.
1 f.
cefamandol (in the form of naphtha) 500 mg
- "- 1 g
Vials with a capacity of 10 ml (1) - packs of cardboard.
Vials with a capacity of 10 ml (10) - packs of cardboard.
Vials with a capacity of 10 ml (50) - carton boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2005.
PHARMACHOLOGIC EFFECT
Cephalosporin antibiotic of the second generation. It is bactericidal. Oppresses transpeptidase, disrupts the biosynthesis of the mucopeptide of the cell wall of microorganisms, thus causing the death of the pathogen.
Cephate is active against aerobic Gram-negative bacteria: Escherichia coli, Haemophilus influenzae, Enterobacter spp. (during treatment may acquire resistance), 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
Suction
After the / m introduction of the drug at a dose of 0.5 mg or 1 g of C max is achieved after 30-120 minutes and is 13 Ојg / ml and 25 Ојg / ml, respectively.
After intravenous administration at a dose of 1 mg, 2 mg and 3 mg after 10 min, the concentration of cefamandol is 139 Ојg / ml, 240 Ојg / ml and 533 Ојg / ml and is maintained at the therapeutic level for 6 hours.
Distribution
Therapeutic concentrations of cefamandol are achieved in pleural and articular fluids, in bile and bones.
Excretion
After the / m introduction, T 1/2 is 60 minutes, after intravenous administration - 32 minutes.
Cefamandol is excreted unchanged in the urine (for 8 hours 65-85% of the administered dose is excreted). After intravenous administration of the drug at a dose of 0.5 mg and 1 g, the concentration of cefamandol in the urine is 254 Ојg / ml and 1357 Ојg / ml, respectively, after intravenous administration of the drug at a dose of 1 g and 2 g - 750 Ојg / ml and 1380 Ојg / ml, respectively.
Pharmacokinetics in special clinical cases
With renal failure, excretion of the drug slows down.
INDICATIONS
- abdominal infections;
- gynecological infections;
- sepsis;
- meningitis;
- endocarditis;
- urinary tract infections;
- respiratory tract infections;
- infections of bones and joints;
- skin and soft tissue infections;
- prevention of postoperative infectious complications.
DOSING MODE
The drug is injected in / m and / in (jet or drip).
Adults appoint 0.5-1 g every 4-8 hours.
In diseases of the urinary tract - 500 mg every 8 hours, in severe cases - 1 g every 8 hours.
In life-threatening infections - 2 g every 4 hours (daily dose - 12 g).
Children are prescribed 50-100 mg / kg 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.
In infections caused by beta-hemolytic streptococci, treatment should be continued for at least 10 days.
For the prevention of postoperative complications, the drug is administered 30-60 minutes before the operation: adults - 1-2 g; children - 50-100 mg / kg. The same dose is administered within 24-48 hours after the operation.
After eliminating the symptoms of the disease, treatment should be continued for 48-72 hours.
Patients who are on hemodialysis, the drug is administered 1 g every 12 hours IV or IM (if I / O is used, then after completion of hemodialysis, 1 / 3-1 / 2 doses are additionally administered).
In case of impaired renal function, weakened patients and elderly patients with renal dysfunction, the dosage regimen of the drug is adjusted taking into account the values ​​of creatinine clearance.
After the initial dose of 1-2 g (depending on the severity of the infection), the following maintenance doses are prescribed.
Creatinine clearance (mL / min) Severe infections Infections of moderate severity
80-50 for 2 g every 4 hours for 1.5 g every 6 hours or 2 g every 8 hours
50-25 to 1.5 g every 4 h or 2 g every 6 h to 1.5 g every 8 h
25-10 to 1 g every 6 hours or 1.25 g every 8 h to 1 g every 8 h
10-2 for 670 mg every 8 hours or 1 g every 12 hours for 500 mg every 8 hours or 750 mg every 12 hours
<2 for 500 mg every 8 hours or 750 mg every 12 hours for 500 mg every 12 hours
Rules for the preparation and administration of solutions
For the / m introduction, the powder (0.5 g or 1 g) is dissolved in 3 ml of water for injection or 0.9% of a physiological solution of sodium chloride.
For iv injection, the powder is dissolved at the rate of 1 g of the drug in 10 ml of water for injection or 0.9% of a physiological solution of sodium chloride.
For IV injections, the preparation (prepared as described above) is dissolved in a 10% solution of glucose or saline.
SIDE EFFECT
On the part of the digestive system: nausea, vomiting, pseudomembranous colitis, cholestatic jaundice, persistent hepatitis, transient increase in the activity of hepatic transaminases and alkaline phosphatase in the blood plasma.
On the part of the hematopoiesis system: leukopenia, neutropenia, thrombocytopenia.
On the part of the urinary system: violations of the excretory function of the kidneys, decreased creatinine clearance and increased urea nitrogen (in patients with renal insufficiency).
Allergic reactions: skin rash, urticaria, eosinophilia, fever; rarely - Quincke's edema, bronchospasm, anaphylactic shock.
Local reactions: with the / m introduction - pain and infiltration, with the / in the introduction - thrombophlebitis.
Other: dysbacteriosis, superinfection.
CONTRAINDICATIONS
- Hypersensitivity to cephalosporins, penicillins, carbapenems.
PREGNANCY AND LACTATION
The use of the drug during pregnancy and lactation (breastfeeding) is shown only in those cases when the expected therapeutic effect for the mother exceeds the possible negative impact on the fetus and the baby.
APPLICATION FOR FUNCTIONS OF THE LIVER
In case of impaired renal function, weakened patients and elderly patients with renal dysfunction, the dosage regimen of the drug is adjusted taking into account the values ​​of creatinine clearance.
After the initial dose of 1-2 g (depending on the severity of the infection), the following maintenance doses are prescribed.
Creatinine clearance (mL / min) Severe infections Infections of moderate severity
80-50 for 2 g every 4 hours for 1.5 g every 6 hours or 2 g every 8 hours
50-25 to 1.5 g every 4 h or 2 g every 6 h to 1.5 g every 8 h
25-10 to 1 g every 6 hours or 1.25 g every 8 h to 1 g every 8 h
10-2 for 670 mg every 8 hours or 1 g every 12 hours for 500 mg every 8 hours or 750 mg every 12 hours
<2 for 500 mg every 8 hours or 750 mg every 12 hours for 500 mg every 12 hours
APPLICATION FOR CHILDREN
With caution appoint Cephate to newborns (including premature) .
Children are prescribed 50-100 mg / kg 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 INSTRUCTIONS
Caution is prescribed for patients with severe renal dysfunction, with colitis (including ulceration), decreased coagulation, peptic ulcer and duodenal ulcer.
Use in Pediatrics
With caution appoint Cephate to newborns (including premature) .
OVERDOSE
At present, no cases of overdose of Cephate have been reported.
DRUG INTERACTION
With the simultaneous administration of cefat and "loop" diuretics, as well as antibiotics of the aminoglycoside group, the risk of developing nephrotoxic action is increased.
With simultaneous use with aminoglycosides, a synergism of antibacterial action is noted.
Probenecid with simultaneous application with Cefat slows the excretion of cefamandole, thereby increasing its concentration and duration of action.
With the simultaneous use of cefat with anticoagulants, thrombolytic drugs and NSAIDs, the risk of bleeding increases.
With the simultaneous use of cefamandol prolongs the effect of ethanol and causes a disulfiram-like reaction.
Pharmaceutical interaction
The solution of Cephate should not be mixed in the same syringe with the antibiotics of the aminoglycoside group.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a dry, protected from light at a temperature of 15 В° to 25 В° C. Shelf life - 2 years.
The freshly prepared solution is suitable for use for 24 hours when stored at 25 В° C and for 96 hours when stored in a refrigerator.
