Cefotaxime Elfa - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Cephalosporin antibiotic III generation for parenteral administration. It acts bactericidal, disrupting the synthesis of the cell wall of the microorganism. Has a wide range of action. Highly active against Gram-positive and Gram-negative microorganisms resistant to other antibiotics: Staphylococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Corynebacterium diphtheriae, Erysipelothrix insidiosa, Eubacterium spp., Propionibacterium spp., Bacillus subtilis, Clostridium perfringens, Escherichia coli, Citrobacter spp., Proteus mirabilis; Proteus indole, Providencia spp., Klebssiella spp., Serratia spp., Some strains of Pseudomonas spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Bacteroides spp. (including some strains of Bacteroides fragilis), Fusobacterium spp. (including Fusobacterium nucleatum), Peptococcus spp., Peptostreptococcus spp. Stable against most beta-lactamases of gram-positive and gram-negative microorganisms.

Pharmacokinetics:The time to reach the maximum concentration (TCmax) is 5 min after a single intravenous injection of 0.5, 1 and 2 g, while the maximum concentration (C max) in the blood serum is 39 μg / ml,101 μg / ml and 214 μg / ml, respectively; TCmax after w / m 0.5 and 1 g - 0.5 h and Cmax is 11 and 20.5 μg / ml, respectively. Relationship with plasma proteins is 25-40%. Creates therapeutic concentrations in most tissues (myocardium, bones, gallbladder, skin, soft tissues) and fluids (synovial, pericardial, pleural, sputum, bile, urine, cerebrospinal fluid) of the body. The volume of distribution is 0.25-0.39 l / kg.

The half-life period (T1 / 2) with IV and I / im administration is 1 hour. It is excreted by the kidneys -20-36% unchanged, the rest is in the form of metabolites (the diacetylated derivative has bactericidal activity, and the other two metabolites do not possess activity). With renal failure and in the elderly, T1 / 2 increases by 2 times. In newborns, T1 / 2 - 0.75-1.5 h, in preterm infants up to 4.6 h. For repeated intravenous doses of 1 g every 6 hours for 14 days of cumulation is not observed. Penetrates into breast milk.

Indications:Bacterial infections of the severe course caused by sensitive microorganisms: peritonitis, sepsis, abdominal infections, pelvic infections, chlamydia, gonorrhea, central nervous system infections (meningitis), respiratory tract infections and ENT organs, urinary tract, bones, joints,skin and soft tissues, infected wounds and burns, endocarditis, Lyme disease (borreliosis), salmonellosis. Prevention of infections after surgery (including on the gastrointestinal tract, urological and obstetric-gynecological).

Contraindications:

The drug is contraindicated in cases of hypersensitivity to cephalosporin antibiotics. A cross-allergy between penicillins and cephalosporins is possible.

Children under 2.5 years of age should not use intramuscular injection.

Carefully:patients with impaired renal and hepatic function, newborns; nonspecific ulcerative colitis (in the anamnesis).

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.

Dosing and Administration:

Intramuscularly and intravenously.

The usual dose of cefotaxime for adults and children over 12 years of age (body weight over 50 kg) is 1 g every 12 hours.In severe cases, the dose is increased to 3 or 4 g per day, the drug is administered 3 or 4 times 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 per day with intervals of administration from 6 to 12 hours. For premature babies, the daily dose should not exceed 50 mg / kg. In severe infections, incl. meningitis, the daily dose is increased to 100-200 mg / kg IM or IV, 4-6 times a day.

Use in adults: with uncomplicated acute gonorrhea - in / m, once, 1 g. For infections of moderate severity - IM or IV, 1 -2 g every 12 hours. For very serious infections, for example, meningitis - in / in, 2 g every 6-8 hours.

The duration of the course of treatment is set individually. With the purpose of preventing the development of infections before surgery - during the initial anesthesia once - 1 g. If necessary, the administration is repeated after 6-12 hours. When performing cesarean section, at the time of application of the clips to the umbilical vein - iv, 1 g, then after 6 h and 12 h after the first dose - in addition to 1 g. When creatinine clearance (CK) is 20 ml / min or less, the daily dose is halved.

Before use, dilute as follows:

For intramuscular injection, dissolve 0.5 g of the drug in 2 ml.(1 g in 4 ml, respectively) of sterile water for injection is injected deep into the gluteus muscle. As a solvent, intramuscular injection also uses 1% lidocaine (0.5 g-2 ml, 1 g-4 ml).

For intravenous administration, 0.5-1 g of cefotaxime is dissolved in 10 ml of sterile water for injection. Enter slowly for 3-5 minutes.

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.

Side effects:

Allergic reactions (urticaria, fever, pruritus, rash, bronchospasm, eosinophilia, Stevens-Johnson syndrome, Lyell syndrome, angioedema, anaphylactic shock);

On the part of hemopoiesis: hemolytic anemia, granulocytopenia, neutropenia, thrombocytopenia, leukopenia, agranulocytosis, hypocoagulation;

On the part of the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, glossitis, stomatitis, pseudomembranous enterocolitis, impaired liver function (increased activity of "liver" transaminases and alkaline phosphatase);

From the side of the nervous system: migraine, dizziness, confusion, paresthesia, encephalopathy (in the case of large doses, especially in patients with renal insufficiency);

On the part of the urinary system: a violation of kidney function (increased urea, dysuria, oliguria, anuria, interstitial nephritis);

Laboratory indicators: false positive test of Coombs;

From the side of the cardiovascular system: potentially life-threatening arrhythmias after a rapid bolus injection into the central vein;

Local reactions: with iv injection, phlebitis; with the / m introduction - soreness, burning, compaction at the injection site. Other: superinfection (in particular, candidal vaginitis).

Overdose:Symptoms: seizures, encephalopathy (in the case of high doses, especially in patients with renal insufficiency), tremor, neuromuscular excitability. Treatment: symptomatic.

Interaction:

Increases the risk of bleeding when combined with antiaggregants, non-steroidal anti-inflammatory drugs.

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.

Pharmaceutically incompatible with solutions of other antibiotics in one syringe or dropper.

Special instructions:

In the first weeks of treatment, pseudomembranous colitis can occur, 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. 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.

When treating the drug for more than 10 days, it is necessary to control the number of blood cells. Possible positive direct Coombs reaction and false positive urine reaction to glucose.

Form release / dosage:Powder for solution for intramuscular and intravenous injection, 1.0 g.

Packaging:For 1.0 g of the drug in a bottle of clear glass, sealed with a plug of chlorobutyl rubber, crimped aluminum ring with a protective plastic cap, which indicates the logo "Elfa". 1 bottle together with instructions for medical use in a cardboard box. For 50 bottles along with instructions for medical use in a cardboard box (for hospitals).

Storage conditions:Store at a temperature of no higher than 25 ° C, in a dry place, protected from light and out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000048

Date of registration:26.04.2007

The owner of the registration certificate:Elfa LaboratoriesElfa Laboratories India

Manufacturer: & nbsp

ELFA LABORATORIES India

Representation: & nbspZAO NPC ELFA ZAO NPC ELFA Russia

Information update date: & nbsp05.11.2015

Illustrated instructions

Instructions

Cefotaxime Elves (Cefotaxime Elfa)