Composition, form of production and packaging
Powder for solution for injection from white to pale yellow.
1 f.
cefotaxime sodium (equivalent to anhydrous cefotaxime) 500 mg
Glass bottles (1) - cardboard packs.
Powder for solution for injection from white to pale yellow.
1 f.
cefotaxime sodium (equivalent to anhydrous cefotaxime) 1 g
Glass bottles (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Cephalosporin antibiotic III generation for parenteral use. It is bactericidal. Has a wide spectrum of antimicrobial action.
Highly active against gram-negative microorganisms resistant to other antibiotics: E. coli, Citrobacter spp., Proteus mirabilis, Proteus indole, Providencia spp., Klebsiella spp., Serratia spp., Some strains of Pseudomonas spp., Haemophlus influenzae. Less active against gram-positive cocci, mainly staphylococci. The drug has a high resistance to beta-lactamases of gram-positive and gram-negative bacteria.
PHARMACOKINETICS
With the / m introduction the drug is absorbed quickly. C max in the blood plasma is observed 30 minutes after the injection. Bactericidal concentration in the blood remains more than 12 hours.
The drug penetrates well into the tissues and body fluids; is found in effective concentrations in the pleural, peritoneal, synovial fluids. In contrast to earlier cephalosporins, it penetrates the blood-brain barrier.
As a result of biotransformation, an active metabolite is formed.
It is produced in significant quantities from urine in unchanged form (about 30%) and in the form of active metabolites (about 20%). Partially excreted with bile.
INDICATIONS
Infections caused by microorganisms sensitive to cefotaxime (mainly Gram-negative):
- respiratory tract infections;
- Urinary tract infection, kidney infection;
- infections of the ear, throat, nose;
- septicemia, endocarditis, meningitis;
- infections of bones and soft tissues;
- infection of the abdominal cavity;
- infectious and inflammatory diseases of the pelvic organs, gonorrhea;
- wound and burn infections.
DOSING MODE
Apply Cefatoxime in / m and / in. For the / m injection, dissolve 0.5 g of the drug in 2 ml (1 g in 4 ml, respectively) of sterile water for injection, injected deep into the gluteal muscle. As a solvent, in v / m administration, 1% lidocaine is also used (for 0.5 g - 2 ml, for 1 g - 4 ml).
For drip administration (within 50-60 minutes), dissolve 2 g of the drug in 100 ml of isotonic sodium chloride solution or 5% glucose solution.
The usual dose of Cefotaxime for adults and children over 12 years is 1 g every 12 hours. In severe cases, the dose is increased to 3 or 4 g / day, the drug is administered 3 or 4 times at 1 g. The maximum daily dose, depending on the severity of the disease , can be increased to 12 g.
The usual dose for newborns and children under 12 years is 50-100 mg / kg of body weight / day with intervals of administration from 6 to 12 hours. For premature babies, the daily dose should not exceed 50 mg / kg.
In the case of impaired renal function, the dose is reduced. With QC 10 ml / min and less than the daily dose of the drug is reduced by half.
SIDE EFFECT
With the use of cefotaxime, allergic reactions are possible (skin rash, fever, anaphylactic shock), digestive disorders (dyspeptic phenomena, pseudomembranous colitis (rarely), impaired functional liver tests), an increase in the number of eosinophils, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, increased alkaline levels phosphatase and the content of nitrogen in the urine; pain, redness and swelling at the injection site; may increase body temperature.
CONTRAINDICATIONS
- Hypersensitivity to cephalosporin antibiotics.
A cross-allergy between penicillins and cephalosporins is possible.
Caution is necessary when prescribing the drug to patients with impaired renal and hepatic function.
Children under 2.5 years of age should not be given an IV injection.
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.
Cefotaxime excreted in breast milk, so if you need to prescribe the drug during lactation should stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
In the case of impaired renal function, the dose is reduced. With QC 10 ml / min and less than the daily dose of the drug is reduced by half.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution is necessary when prescribing the drug to patients with impaired liver function.
APPLICATION FOR CHILDREN
Children under 2.5 years of age should not be given an IV injection.
SPECIAL INSTRUCTIONS
Before prescribing the drug, you need to collect an allergic medical history, especially with regard to beta-lactam antibiotics. There is a cross-allergy between penicillins and cephalosporins. People who have a history of indicating allergic reactions to penicillin, the drug is used with extreme caution.
When there are reactions of hypersensitivity (which are severe and even lead to death), the drug is canceled.
With a duration of treatment with the drug for more than 10 days, it is necessary to monitor the picture of peripheral blood.
Possible detection of false positive Coombs test.
When determining glucose in the urine by a non-enzymatic method (for example, by the method of Benedict), false-positive results are possible.
DRUG INTERACTION
With the simultaneous use of Cefotaxim with potentially nephrotoxic drugs (aminoglycoside antibiotics, furosemide), it is necessary to monitor kidney function (the risk of nephrotoxic action of the latter).
Solutions cefotaxima incompatible with solutions of other antibiotics in a single syringe or dropper.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Keep out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years. Do not use after the expiry date printed on the package.
