Universal reference book for medicines
Product name: CEFOTAXIM SANDOZ ® (CEFOTAXIM SANDOZ)

Active substance: cefotaxime

Type: Third generation cephalosporin

Manufacturer: SANDOZ (Austria)
Composition, form of production and packaging
Powder for the preparation of solution for iv and in / m introduction from white to light yellow color.
1 f.
cefotaxime (in the form of the sodium salt) 1 g
sodium content 48 mg
Vials of colorless glass (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Cephalosporin antibiotic III generation for parenteral administration. It is bactericidal. The mechanism of action is associated with a violation of the synthesis of mucopeptide of the cell wall of microorganisms. Has a wide spectrum of antimicrobial action.
The drug is active against Gram-positive and Gram-negative microorganisms resistant to other antibiotics: Staphylococcus spp. (including Staphylococcus aureus, including penicillinase-producing strains, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes (group A beta-hemolytic streptococci), Streptococcus agalactiae (group B Streptococcus), Enterococcus spp., Enterobacter spp., Escherichia coli , Haemophilus influenzae (including strains forming penicillinase), Haemophilus parainfluenzae, Moraxella catarrhalis, Klebsiella spp. (Including Klebsiella pneumoniae, Klebsiella oxytoca), Morganella morganii, Neisseria gonorrhoeae (including strains, Formation of Penicillinase), Acinetobacter spp., Corynebacterium diphtheriae, Erysipelothrix insidiosa, Eubacter spp., Propionibacterium spp., Bacillus subtilis, Clostridium spp. (including Clostridium perfringens), Citrobacter spp., Proteus mirabilis, Proteus vulgaris, Providencia spp (in vol. . Providencia rettgeri), Serratia spp. , Pseudomonas aeruginosa, Neisseria meningitidis, Bacteroides spp. ( Including some strains of Bacteroides fragilis), Fusobacterium spp. (including Fusobacterium nucleatum), Peptococcus spp., Peptostreptococcus spp.
Resistant to most beta-lactamases of Gram-positive and Gram-negative microorganisms, Clostridium difficile.
PHARMACOKINETICS
Suction
After a single IV injection at doses of 500 mg, 1 g and 2 g of T max is 5 min, C max is 39, 100 and 214 μg / ml, respectively.
After a / m administration at doses of 500 mg and 1 g of T max - 0.5 h, C max is 11 and 21 μg / ml, respectively.
Distribution
Binding to plasma proteins - 25-40%. Bioavailability is 90-95%. Therapeutic concentrations are achieved in most tissues (myocardium, bones, gall bladder, skin, soft tissues) and fluids (synovial, pericardial, pleural, sputum, bile, urine, spinal fluid) of the body.
V d = 0.25-0.39 l / kg.
With repeated iv introduction in a dose of 1 g every 6 hours for 14 days of cumulation is not observed.
Cefotaxime in small concentrations is excreted in breast milk.
Excretion
T 1/2 for IV and IM for 1 hour. It is excreted by the kidneys: 60-70% - unchanged, the rest - in the form of metabolites (the deacetylated derivative has bactericidal activity, and 2 other metabolites do not possess).
Pharmacokinetics in special clinical cases
In chronic renal failure and in the elderly, T 1/2 increases by a factor of 2. T 1/2 in newborns is 0.75-1.5 h, in preterm infants it increases to 4.6 h.
INDICATIONS
Bacterial infections of severe course caused by susceptible microorganisms:
- CNS infection (meningitis);
- respiratory tract infections and ENT organs;
- urinary tract;
- infections of bones and joints;
- skin and soft tissue infections;
- infection of the pelvic organs;
- Chlamydia;
- Gonorrhea;
- infected wounds and burns;
- peritonitis;
- sepsis;
- abdominal infections;
- endocarditis;
- Lyme disease (borreliosis);
- salmonellosis;
- infection on the background of immunodeficiency.
Prevention of infections after surgical operations (including urological, obstetric-gynecological, GIT).
DOSING MODE
For intravenous injection, Cefotaxim Sandoz ® 1 g is dissolved in 4 ml of sterile water for injection. Enter deep into the gluteal muscle. A 1% solution of lidocaine is also used as a solvent in the / m administration (per 1 g of the drug, 4 ml).
For intravenous administration of Cefotaxime Sandoz ® 1 g is dissolved in 10 ml of sterile water for injection. Enter slowly for 3-5 minutes.
For intravenous administration drop Cefotaxim Sandoz ® 2 g in 100 ml of 0.9% sodium chloride solution or 5% glucose solution. Infusion is carried out for 50-60 minutes.
For adults and children over 12 years, the average dose of Cefotaxim Sandoz ® is 1 g every 12 hours. In severe cases, the dose is increased to 3 g or 4 g per day - 1 g 3-4 times / day. Depending on the severity of the disease, the daily dose can be increased to a maximum of 12 g.
The usual dose for newborns and children under 12 years is 50-100 mg / kg / day at intervals of 6 to 12 hours. For premature infants, the daily dose should not exceed 50 mg / kg.
In patients with impaired renal function with CC 10 ml / min or less, the daily dose of the drug is reduced by a factor of 2.
SIDE EFFECT
On the part of the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbiosis, impaired liver function (increased activity of hepatic transaminases, alkaline phosphatase, hypercreatininaemia, hyperbilirubinemia), stomatitis, glossitis, pseudomembranous enterocolitis.
On the part of the hematopoiesis system: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation.
On the part of the urinary system: a violation of the kidneys (azotemia, increased urea in the blood, oliguria, anuria, interstitial nephritis).
From the side of the central nervous system: headache, dizziness.
From the cardiovascular system: potentially life-threatening arrhythmias after a rapid bolus injection into the central vein.
Allergic reactions: urticaria, chills or fever, rash, itching, bronchospasm, eosinophilia, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), angioedema, anaphylactic shock.
Laboratory indicators: false positive test of Coombs.
Local reactions: phlebitis, pain along the vein, soreness and infiltration at the site of the / m introduction.
Other: superinfection (in particular, candidal vaginitis).
CONTRAINDICATIONS
- Children's age to 2.5 years (for the / m introduction);
- hypersensitivity to the components of the drug;
- Hypersensitivity to penicillins, other cephalosporins, carbapenems.
Caution should be used during the period of neonatal period, during lactation (in small concentrations is excreted with milk), with chronic renal failure, NNC (including anamnesis).
PREGNANCY AND LACTATION
The use of the drug during pregnancy is possible only if the intended benefit for 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 patients with impaired renal function with CC 10 ml / min or less, the daily dose of the drug is reduced by a factor of 2

APPLICATION FOR CHILDREN
Contraindication: children's age to 2.5 years (for the / m introduction).
APPLICATION IN ELDERLY PATIENTS
In the elderly, T 1/2 increases by a factor of 2

SPECIAL INSTRUCTIONS
In the first weeks of treatment, pseudomembranous colitis can occur, which is manifested by severe prolonged diarrhea. At the same time, stop taking the drug and prescribe adequate therapy, including vancomycin or metronidazole.
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. In persons who have a history of allergic reactions to penicillin, the drug is used with extreme caution (the possibility of developing severe anaphylactic reactions, up to a lethal outcome) should be considered.
With a duration of treatment with the drug for more than 10 days, it is necessary to monitor the picture of peripheral blood.
When determining glucose in the urine by a non-enzymatic method (for example, by the method of Benedict), false-positive results are possible.
OVERDOSE
Symptoms: seizures, encephalopathy (in case of administration in high doses, especially in patients with renal insufficiency), tremor, increased neuromuscular excitability.
Treatment: symptomatic therapy.
DRUG INTERACTION
Cefotaxim Sandoz ® increases the risk of bleeding when combined with antiaggregants, NSAIDs.
Does not lead to the development of disulfiram-like reactions when combined with ethanol.
The probability of kidney damage increases with simultaneous administration with aminoglycosides, polymyxin B and "loop" diuretics.
Drugs that block tubular secretion, increase plasma concentrations of cefotaxime and slow its elimination.
Pharmaceutical interaction
Pharmaceutically incompatible with solutions of other antibiotics in one syringe or dropper.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C. Shelf life - 2 years.
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