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

It is active against gram-positive and gram-negative microorganisms resistant to other 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 strains forming penicillinase), 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.

It is 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 (C_max) is achieved after 5 minutes and is 39 μg / ml, 100 μg / ml and 214 μg / ml, respectively. After w / m 0.5 and 1 g of C_max is achieved after 0.5 h and is 11 and 21 mcg / ml, respectively. The connection 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.

Half-life (T_1/2) with iv and in / m introduction - 1h.

It is excreted by the kidneys - 60% - 70% unchanged, the rest is in the form of metabolites (the deacetylated derivative has bactericidal activity, and 2 other metabolites do not possess).

In chronic renal failure (CRF) and in the elderly T_1/2 increases by 2 times. T_1/2 in newborns - 0,75-1,5 h, in preterm newborns it increases to 4,6 hours. For repeated intravenous injections in a dose of 1 g every 6 hours during 14 days of cumulation is not observed. Penetrates into breast milk.

Indications:Bacterial infections of severe course,Sensitive microorganisms: infections of the central nervous system (meningitis), respiratory tract and ENT organs, urinary tract, bones, joints, skin and soft tissues, 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 surgery (including urological, obstetric-gynecological, on the gastrointestinal tract).

Contraindications:

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

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

Carefully:Newborn period, lactation period (in small concentrations is excreted with milk); chronic renal failure, nonspecific ulcerative colitis (including anamnesis).

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 excreted in breast milk, so if you need to prescribe the drug during lactation should stop breastfeeding.

Dosing and Administration:

Intramuscularly and intravenously. For intramuscular injection, dissolve 0.5 g of the drug in 2 ml (respectively 1 g in 4 ml) of sterile water for injection. Enter deep into the gluteal muscle. As a solvent, intramuscular injection also uses a 1% solution of 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.

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 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 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 the case of impaired renal function, the dose is reduced. With a creatinine clearance of 10 ml / min and a lesser daily dose of the drug is reduced by half.

Side effects:

Allergic reactions: urticaria, chills or fever, rash, itching, bronchospasm, eosinophilia, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell 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, hypercreatininaemia, hyperbilirubinemia), stomatitis, glossitis, pseudomembranous enterocolitis.

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

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

From the nervous system: headache, dizziness.

Laboratory indicators: false positive test of Coombs.

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

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, increased neuromuscular excitability. Treatment: symptomatic therapy.

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, 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.

Form release / dosage:Powder for the preparation of a solution for injection of 0.5 g or 1 g of active substance in a vial.

Packaging:

The bottle with the drug together with the instruction in the pack.

5 vials with the drug in a contour squamous packaging.

1, 2 contour squares with instructions in a pack of cardboard.

10 contour mesh packages with instructions in a pack of cardboard.

Storage conditions:List B. In a place protected from light, inaccessible to children, at a temperature of no higher than 25 ° C.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000677 / 01-2001

Date of registration:31.07.2008

Expiration Date:Unlimited

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Information update date: & nbsp25.01.2018

Illustrated instructions

Instructions

Clafbrin® (Clafobrin)