Composition, form of production and packaging
Powder for solution for iv and in / m introduction white or white with a yellowish hue, crystalline, odorless.
1 f.
cefamandol (in the form of naphtha) 500 mg
Excipients: sodium carbonate.
Solvent: water d / and.
Vials with a capacity of 10 ml (1) - packs cardboard.
Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.
Vials of glass with a capacity of 10 ml (1) complete with a solvent (1 pc.) - packings of cellular contour (1) - packs of cardboard.
Vials with a capacity of 10 ml (5) - packs of cardboard.
Vials of glass with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular outline (1) - packs of cardboard.
Powder for solution for iv and in / m introduction white or white with a yellowish hue, crystalline, odorless.
1 f.
cefamandol (in the form of naphtha) 1 g
Excipients: sodium carbonate.
Solvent: water d / and.
Vials with a capacity of 10 ml (1) - packs cardboard.
Vials with a capacity of 10 ml (1) complete with a solvent (amp 1 pc.) - packs of cardboard.
Vials of glass with a capacity of 10 ml (1) complete with a solvent (1 pc.) - packings of cellular contour (1) - packs of cardboard.
Vials with a capacity of 10 ml (5) - packs of cardboard.
Vials of glass with a capacity of 10 ml (5) complete with a solvent (amp 5 pcs.) - packings of cellular outline (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Cephalosporin antibiotic II generation for parenteral use. It acts bactericidal (it breaks the synthesis of the cell wall of microorganisms). Has a wide range of activities.
Highly active against Gram-positive microorganisms - Staphylococcus aureus (including strains that produce and do not produce penicillinase), Staphylococcus epidermidis, Streptococcus spp. (including beta-hemolytic strains, Streptococcus pneumoniae); Gram-negative microorganisms - Echerichia 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.).
Resistant to the action of beta-lactamases. 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.
Has disulfiramoid action.
PHARMACOKINETICS
After the / m introduction of 0.5 or 1 g, the time to reach the maximum concentration (T Cmax ) is 30-120 min, the C max value is 13 and 25 Ојg / ml, respectively. After intravenous injection of 1, 2 or 3 g after 10 min C max is 139, 240 and 533 Ојg / ml and is maintained at the therapeutic level for 6 hours. Therapeutic concentration is achieved in pleural and joint fluids, bile and bones.
Do not cumulate. T 1/2 after IV, 30-35 minutes, after IM for 60 minutes.
It is excreted by the kidneys in the unchanged form (in 8 hours 65-85% is output and provides high concentrations of the drug in the urine). After an / m introduction of 0.5 and 1 g, the urine content is 254 and 1357 Ојg / ml, respectively; with intravenous injection of 1 and 2 g - 750 and 1380 mkg / ml, respectively.
With chronic renal failure, excretion slows down. In patients on hemodialysis, T 1/2 increases to 6 h
INDICATIONS
Infectious-inflammatory diseases caused by drug-susceptible pathogens, including:
- abdominal and gynecological infections;
- sepsis;
- meningitis;
- endocarditis;
- urinary tract infections;
- respiratory tract infections;
- infections of bones and joints, skin and soft tissues.
Prevention of postoperative infectious complications.
DOSING MODE
The drug is given in / m or / in.
For the / m introduction, the preparation (0.5 g or 1.0 g) is dissolved in 3 ml of water for injection or in 3 ml of 0.9% sodium chloride solution.
For intravenous administration of the drug, dissolve the drug at a rate of 1 g of the drug in 10 ml of water for injection or in 10 ml of a 0.9% solution of sodium chloride.
For intravenous drip administration, dissolved as described above, the preparation is mixed with 10% dextrose solution or 0.9% sodium chloride solution.
Adults appoint 500 mg-1 g every 4-8 hours, with diseases of the urinary tract - 500 mg (in severe cases - 1 g) every 8 hours, with life-threatening infections - up to 2 g every 4 hours (12 grams per day ).
Children -50-100 mg / kg ( with severe infections - up to 150 mg / kg) per day with intervals between administrations 4-8 hours.
In 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 IV or IM (if I / O is used, then after the completion of hemodialysis, 1 / 3-1 / 2 doses are additionally administered).
For the prevention of postoperative infectious complications for 30-60 minutes before the intervention, adults are given - 1-2 g, children - 50-100 mg / kg, followed by the same doses for 24-48 hours.
For patients with impaired renal function , the dosing regimen is set 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 Moderate infections
50-80 for 2g every 4 hours for 1.5 g every 6 hours or 2 g every 8 hours
25-50 to 1.5 g every 4 h or 2 g every 6 h to 1.5 g every 8 h
10-25 to 1 g every 6 hours or 1.25 g every 8 h to 1 g every 8 h
2-10 to 670 mg every 8 hours or 1 g every 12 hours 500 mg every 8 hours or 750 mg every 12 hours
Less than 2 to 500 mg every 8 hours or 750 mg every 12 hours to 500 mg every 12 hours
SIDE EFFECT
Allergic reactions: urticaria, chills or fever, rash, itching, rarely bronchospasm, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), angioedema, anaphylactic shock.
On the part of the digestive system: nausea, vomiting, diarrhea or constipation, dysbiosis, impaired liver function (increased activity of hepatic transaminases, AF, hyperbilirubinemia, cholestatic jaundice, hepatitis), rarely - stomatitis, glossitis, pseudomembranous enterocolitis.
From the hematopoiesis: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation.
On the part of the urinary system: azotemia, increased urea in the blood, hypercreatininaemia, impaired renal function.
From the nervous system: headache, dizziness.
Local reactions: phlebitis, pain along the vein, soreness and infiltration at the site of the / m introduction.
Other: superinfection.
CONTRAINDICATIONS
- hypersensitivity (including to cephalosporins, penicillins, carbapenems);
- Early childhood (up to 6 months).
With caution : renal failure, pseudomembranous colitis (in history).
PREGNANCY AND LACTATION
The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.
If necessary, the appointment of cefamandol during lactation should stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in renal failure.
For patients with impaired renal function , the dosing regimen is set 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 Moderate infections
50-80 for 2g every 4 hours for 1.5 g every 6 hours or 2 g every 8 hours
25-50 to 1.5 g every 4 h or 2 g every 6 h to 1.5 g every 8 h
10-25 to 1 g every 6 hours or 1.25 g every 8 h to 1 g every 8 h
2-10 to 670 mg every 8 hours or 1 g every 12 hours 500 mg every 8 hours or 750 mg every 12 hours
Less than 2 to 500 mg every 8 hours or 750 mg every 12 hours to 500 mg every 12 hours
APPLICATION FOR CHILDREN
The drug is contraindicated in early childhood (up to 6 months). In children older than 6 months used according to indications and in prescribed doses.
APPLICATION IN ELDERLY PATIENTS
In elderly and debilitated patients with vitamin K deficiency, there is an increased risk of developing hypoprothrombinemia with or without bleeding (in these cases, vitamin K administration is indicated).
SPECIAL INSTRUCTIONS
Patients who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics.
During treatment with cefamandol, a false positive Coombs reaction and a false positive urine reaction to glucose and proteinuria are possible.
In elderly and debilitated patients with vitamin K deficiency, there is an increased risk of developing hypoprothrombinemia with or without bleeding (in these cases, vitamin K administration is indicated).
During treatment should be refrained from taking ethanol-possible effects similar to the action of disulfiram (red face, stomach and stomach spasms, nausea, vomiting, headache, lowering blood pressure, tachycardia, dyspnea).
The freshly prepared solution is suitable for use for 24 hours when stored at room temperature and for 96 hours when stored in a refrigerator.
OVERDOSE
Symptoms: seizures (especially in patients with CRF).
Treatment: symptomatic therapy, including diazepam and short-acting barbiturates, in severe cases - hemodialysis.
DRUG INTERACTION
Nephrotoxicity increases aminoglycosides, "loop" diuretics, drugs that reduce tubular secretion.
It is not compatible with ethanol (inhibits acetaldehydrogenase), disulfiram-like reactions develop (abdominal pain, facial hyperemia, headache, lowering of arterial pressure, nausea, vomiting, palpitation, increased sweating).
Pharmaceutically incompatible with aminoglycosides.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
List B. In a dry, the dark place at a temperature of 15 to 25 В° C. Keep the drug out of the reach of children.
Shelf life 2 years. Do not use after the date specified on the package. A freshly prepared solution of the preparation is suitable for use for 24 hours at a temperature of no higher than 25 В° C and for 96 hours when stored in a refrigerator.
