Resibelakta - instructions for use, dose, side effects, contraindications

Cephalosporin antibiotic - III generation for parenteral administration. It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Has a wide range of action.

Active in relation gram-positive and gram-negative microorganisms resistant to other antibiotics: Staphylococcus spp. (incl.Staphylococcus aureus, including strains forming penicillinase), Staphylococcus epidermidis (with the exception of Staphylococcus epidermidis and Staphylococcus aureus, resistant to methicillin), Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic group streptococci A), Streptococcus agalactiae (Group B Streptococcus), Enterococcus spp., Enterobacter spp., Escherichia coli, Haemophilus influenzae (including strains that form penicillinase), Haemophilus parainfluenzae, Moraxella catarrhalis, Klebsiella spp. (incl. Klebsiella pneumoniae), Morganella morganii, Neisseria gonorrhoeae (including strains that form penicillinase), Acinetobacter spp.,Corynebacterium dihtheriae, Erysipelothrix rhusiopathiae, Eubacter spp., Propionibacterium spp.; Clostridium spp. (at t.h. Clostridium perfringens), Citrobacter spp., Proteus mirabilis, Proteus vulgaris, Providencia spp. (at t.h. Providencia rettgeri), Serratia spp., some strains Pseudomonas aeruginosa, Neisseria meningitidis, Bacteroides spp. (at t.h. some strains Bacteroides fragilis), Fusobacterium nucleatum), Peptococcus spp., Peptostreptococcus spp. Most strains Clostridium difficile - are stable. Resistant to most beta-lactamases of gram-positive and gram-negative microorganisms.

Pharmacokinetics:

After a single intravenous (IV) dose of 1 g, the time to reach the maximum concentration (TCmax) is 5 minutes, the maximum concentration of the drug (Cmax) is about 101.7 μg / ml. After intramuscular (IM) administration in a dose of 1 g of TCmax-0.5 h and is 21 μg / ml. The connection with plasma proteins is 30-50%. Bioavailability of 90-95%. 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 of the drug (T1 / 2) is 1 hour with IV injection and 1-1.5 hours with the IM injection.

It is excreted by the kidneys - 20% - 36% unchanged, the rest - in the form of metabolites (15-25% in pharmacologically active deacetylcefotaxime and 20-25% in the form of 2 inactive metabolites).

In chronic renal failure and in the elderly, T1 / 2 increases by 2 times.T1 / 2 in newborns - 0.75-G, 5 h, in preterm infants (body weight less than 1500 g) increases to 4.6 h, in children with a body weight of more than 1500 g - 3.4 h. For repeated intravenous doses 1 g every 6 hours for 14 days of cumulation is not observed. Cefotaxime passes through the placenta, in small concentrations penetrates into breast milk.

Indications:

Infectious-inflammatory diseases caused by microorganisms that are sensitive to the drug: central nervous system (meningitis), lower respiratory tract and ENT

- organs, urinary tract, bones, joints, skin and soft tissues, pelvic organs; peritonitis, sepsis, endocarditis, gonorrhea, infected wounds and burns, intra-abdominal infections, salmonellosis, Lyme disease (borreliosis), infections with immunodeficiency. Prevention of infections after surgical operations (including urological, obstetric-gynecological, on the organs of the gastrointestinal tract).

Contraindications:

- hypersensitivity (including penicillins, other cephalosporins, carbapenems);

- children's age to 2.5 years (for the / m introduction);

Carefully:

- in the period of neonatal (for intravenous administration);

- with chronic renal failure;

- with ulcerative colitis (including anamnesis).

Pregnancy and lactation:

During pregnancy, the drug is contraindicated.

If it is necessary to prescribe "the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Adults and children with a body weight of 50 kg or more: for uncomplicated infections in / m or / in, 1 g every 12 h; with uncomplicated acute gonorrhea - in / m, 0.5-1 g once; with infections of medium severity - in / m or / in 1-2 g every 8 hours; with sepsis - in / in, 2 g every 6-8 hours, with life-threatening infections (with meningitis) - iv, 2 g every 4 hours, maximum daily dose - 12 g. Duration of treatment is set individually. With the purpose of preventing the development of infection before the surgery, one is injected at the time of the initial general anesthesia, 1 g. If necessary, the administration is repeated after 6-12 hours. In cesarean section (at the time of application of the clamps on the umbilical vein) - iv, 1 g, 6 and 12 hours after the first dose - an additional 1 g. With creatinine clearance of 20 ml / min 1.73 m2 or less, the daily dose is reduced by 2 times.

Premature and newborn before 1 week - in / in, 50 mg / kg every 12 hours; at the age of 1-4 weeks - in / in, 50 mg / kg every 8 hours; children weighing up to 50 kg - in / in or / m 50-180 mg / kg in 4-6 receptions, the maximum daily dose - 12 g.

Rules for the preparation of injection solutions:

- for intravenous injection as a solvent used water for injection (1 g diluted in 4 ml of solvent)

- for intravenous infusion, 0.9% sodium chloride solution or 5% dextrose solution is used as the solvent (1-2 g diluted in 50-100 ml of the solvent). The duration of the infusion is 50-60 minutes.

- for the / m introduction, water for injection or 1% lidocaine solution (1 g - 4 ml) is used.

Side effects:

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

From the central nervous system: headache, dizziness.

From the urinary system: disturbance of kidney function, oliguria, interstitial nephritis.

From the hematopoiesis: hemolytic anemia, leukopenia, granulocytopenia, neutropenia, thrombocytopenia, agranulocytosis, hypocoagulation.

From the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbiosis, impaired liver function, stomatitis, glossitis, pseudomembranous colitis.

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

Laboratory indicators: azotemia, increased urea concentration in the blood, increased activity of "liver" transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, false positive Coombs test.

Local reactions: phlebitis, soreness along the vein, soreness and infiltration at the site of the / m introduction.

Other: Superinfection (in particular, candidal vaginitis).

Overdose:

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

Treatment: symptomatic, there is no specific antidote.

Interaction:

- increases the risk of bleeding when combined with antiaggregants and non-steroidal anti-inflammatory drugs;

- 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:

- During 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;

- patients who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics;

- when treating with a drug for more than 10 days, peripheral blood control is necessary;

- during treatment with cefotaxime, it is possible to obtain a false positive Coombs test and a false positive urine reaction to glucose;

- during treatment can not be used ethanol - Disulfiramoid-like effects are possible (flushing of the face, spasm in the abdomen and in the stomach, nausea, vomiting, lowering of blood pressure, headache, tachycardia, shortness of breath).

According to the effect of the drug on the ability to drive vehicles and occupy other potentially dangerous activities that require increased concentration of data, there is no data, but taking into account the possibility of developing side effects from the central nervous system, care should be taken.

Form release / dosage:

Powder for the preparation of solution for intravenous and intramuscular injection.

Packaging:By 1.0 g in a bottle of colorless glass 10 ml, closed with a rubber stopper, crimped with an aluminum lid and capped with a plastic cap.

Each bottle is placed in a cardboard box along with the instructions for use. 50 bottles together with 50 instructions for use are placed in a box with separating partitions from cardboard box, (for hospitals)

10 boxes are placed in a box of cardboard box, (for hospitals).

Storage conditions:In a dry, dark place at a temperature of 15 ° C to 25 ° C. Keep out of reach of children.

Shelf life:2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:PL-000539

Date of registration:12.05.2011

Expiration Date:12.05.2016

The owner of the registration certificate:Laboratorios Atral SALaboratorios Atral SA Portugal

Manufacturer: & nbsp

Laboratorios ATRAL, S.A. Portugal

Representation: & nbspESCO PHARMA, LLCESCO PHARMA, LLC

Information update date: & nbsp01.11.2015

Illustrated instructions

Instructions

Resibalactone (Resibelacta)