Cefotaxime powder solution 1g vials, 1pc

Composition

Active ingredient:

Cefotaxime sodium salt – based on the Active ingredient) – 1.0 g

Pharmacological action

Cefotaxime is a third-generation cephalosporin antibiotic for parenteral use. It acts bactericidal. It has a wide spectrum of antimicrobial action.

It is active against gram-positive and gram-negative microorganisms resistant to others. for antibiotics: Staphylococcus spp. (including Staphylococcus aureus, including penicillinase-forming strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Enterococcus species, Enterobacter spp., Escherichia coli, Haemophilus influenzae (including strains, forming penicillinase), Haemophilus parainfluenzae, Klebssiella spp. (including Kl. pneumoniae), Morganella morganii, Neisseria gonorrhoeae (including penicillinase-forming strains), Acinetobacter species, Corynebacterium diphtheriae, Erysipelothrix insidiosa, Eubacterium spp., Propionibacterium spp., Bacillus subtilis, Clostridium spp. (including Clostridium perfringens), Escherichia coli, Citrobacter spp., Proteus mirabilis, Proteus indole, Proteus vulgaris, Providencia spp. (including 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, penicillinase of staphylococci, Clostridium difficile.

Pharmacokinetics

After a single intravenous injection of 0.5,1 and 2 g, the maximum concentration (cmax) is reached in 5 minutes and is 39 mcg / ml,100 mcg / ml and 214 mcg/ml, respectively. After intravenous use of 0.5 and 1 g, the Cmax is reached in 0.5 hours and is 11 and 21 micrograms / ml, respectively. Binding to 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, spinal fluid) of the body. The volume of distribution is 0.25-0.39 l / kg.

The half-life (half-life) of intravenous and intramuscular use is 1 hour.

Excreted by the kidneys-60% – 70% unchanged, the remaining amount – in the form of metabolites (the deacetylated derivative has bactericidal activity, and 2 other metabolites do not have).

In patients with chronic renal failure (CRF) and in the elderly, the half-life increases by 2 times. Half-life in newborns is 0.75-1.5 hours, in premature newborns it increases to 4.6 hours. With repeated intravenous use at a dose of 1 g every 6 hours for 14 days, accumulation is not observed. Penetrates into breast milk.

Indications

Severe bacterial infections caused by sensitive microorganisms:

• infections of the Central nervous system (meningitis), the respiratory tract and ENT organs, urinary tract, bones, joints, skin and soft tissue, pelvic,
• chlamydia,
• gonorrhea,
• wounds and burns,
• peritonitis,
• sepsis,
• abdominal infections,
• endocarditis,
• Lyme disease (borreliosis),
• Salmonella,
• infection due to immune deficiency,
• prevention of infections after surgery (including urology, Ob / GYN, the gastrointestinal tract).

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

Cefotaxime is excreted in breast milk, so if it is necessary to prescribe the drug during lactation, stop breastfeeding.

Contraindications

Hypersensitivity (including to penicillins, other cephalosporins, carbapenems).

In children under 2.5 years of age, intramuscular use of the drug should not be used.

With caution

Neonatal period, lactation period (excreted in small concentrations in milk); chronic renal failure, non-specific ulcerative colitis (including anamnesis).

Side effects

Allergic reactions: urticaria, chills or fever, rash, pruritus, bronchospasm, eosinophilia, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), angioedema, anaphylactic shock.

From the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbiosis, impaired liver function (increased activity of “liver” transaminases, alkaline phosphatase, hypercreatininemia, hyperbilirubinemia), stomatitis, glossitis, pseudomembranous enterocolitis.

Hematopoietic disorders: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation.

From the urinary system: impaired renal function (azotemia, increased urea content in the blood, oliguria, anuria, interstitial nephritis).

Nervous system disorders: headache, dizziness.

Laboratory parameters: false positive Coombs test.

From the cardiovascular system: potentially life-threatening arrhythmias after rapid bolus injection into the central vein.

Local reactions: phlebitis, soreness along the vein, soreness and infiltration at the site of intravenous injection.

Other: superinfection (in particular, candida vaginitis).

Interaction

Increases the risk of bleeding when combined with antiplatelet agents, nonsteroidal anti-inflammatory drugs.

It does not lead to the development of disulfiram-like reactions when combined with ethanol.

The likelihood of kidney damage increases when taken concomitantly with aminoglycosides, polymyxin B, and loop diuretics.

Drugs that block tubular secretion increase plasma concentrations of cefotaxime and slow its elimination.

Pharmacologically incompatible with other solutions. antibiotics in a single syringe or dropper.

How to take, course of use and dosage

Intramuscularly and intravenously. For intramuscular injection,0.5 g of the drug is dissolved in 2 ml (respectively 1 g in 4 ml) of sterile water for injection. It is inserted deep into the gluteal muscle. As a solvent for intramuscular use, a 1% solution of lidocaine is also used (0.5 g-2 ml,1 g-4 ml).

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

For drip use (within 50-60 minutes),2 g of the drug is dissolved in 100 ml of an isotonic sodium chloride solution or 5% glucose solution.

The usual dose of cefotaxime for adults and children over 12 years of age 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. 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 of age is 50-100 mg / kg of body weight per day with intervals of use from 6 to 12 hours. For premature infants, the daily dose should not exceed 50 mg / kg.

In case of impaired renal function, the dose is reduced. With a creatinine clearance of 10 ml / min or less, the daily dose of the drug is halved.

Overdose

Symptoms: convulsions, encephalopathy (in the case of high doses, especially in patients with renal insufficiency), tremor, increased neuromuscular excitability.

Treatment: symptomatic therapy.

Special instructions

In the first weeks of treatment, pseudomembranous colitis may 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, it is necessary to collect an allergic history, especially with regard to beta-lactam antibiotics. There is a known cross-allergy between penicillins and cephalosporins. In individuals 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 fatal outcome, should be taken into account).

If the duration of treatment with the drug is 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, the Benedict method), false positive results are possible.

Use caution when prescribing to people who manage vehicles and engage in activities that require increased concentration of attention and rapid motor response.

Product form

powder for solution preparation for intravenous and intramuscular use

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Cefotaxime

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Purpose

For adults as directed by your doctor

Indications

Burns, Urinary Tract Infections, Osteomyelitis, Salmonellosis, Pneumonia, Bronchitis, Otitis media, Urethritis, Skin infections, Purulent wounds, Chlamydia, Infectious diseases