Intrataxim - 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.

It is active against Gram-positive and Gram-negative microorganisms resistant to other antibiotics: Asinetobacter spp., Aeromonas hydrophila, Vasillus pertussis, Borrelia spp. (including some strains of Vasteroides fragilis), Bordetella pertussis, Vorelia burgdorferi, Citobacter spp., Clostridium spp. (including Clostridium perfringens), Sorynebacterium diphtheriae, Enterococcus spp., Erysipelothrix insidiosa, Egysipelothrix rhusiopathiae, Escherichia coli, Eubacterium spp., Fusobacterium spp. (including Fusobacterium nucleatum), Naemophilus influezae (including strains forming penicillinase), Naemophilus parainfluezae, Clebsiella spp. (including Klebsiella pneumoniae), Moraxella catarrhalis, Morganella morganii, Neisseria gonorrhoeae (including strains forming penicillinase), Neisseria meningitidis, Pertococcus spp., Pertostreptococcus spp., Propionibacterium spp., Proteus mirabilis, Rotrose vulgaris , Rovidencia spp. (including Rovidencia rettgeri), Pseudomonas aeruginosa, Salmonella spp., Serratia spp., some strains of Pseudomonas aeruginosa, Shigella spp., Staphylococcus epidermidis (excluding Staphylococcus epidermidis and Staphylococcus aureus, methicillin resistant), Staphylococcus spp. (incl.Staphylococcus aureus, including strains forming penicillinase), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Veillonella spp., Yersinis spp.

Most strains of Clostridium difficile are resistant.

Resistant to most beta-lactamases of gram-positive and gram-negative microorganisms.

Pharmacokinetics:

After a single intravenous (i / v) administration at doses of 1 and 2 g of time to reach maximum concentration (TSmah) - 30 min, the maximum concentration (Cmax) of 101.7 and 214 ug / ml, respectively. After intramuscular (IM) administration in a dose of 1 g, Tmax - 0.5 h and Cmax is 21 mcg / ml, respectively. The connection with plasma proteins is 30-50%. Bioavailability is 90-95%.

Creates therapeutic concentrations in most tissues (myocardium, bone tissue, skin, soft tissues) and liquids (spinal, synovial, pericardial, pleural, sputum, bile, urine) of the body. Penetrates through the blood-brain barrier. The volume of distribution is 0.25-0.39 l / kg.

Half-life (T_1/2) -1h for iv injection and 1-1.5 h for v / m administration. Excreted by the kidneys - 20-36% unchanged, the rest - in the form of metabolites (15-25% - in the form of a pharmacologically active dezatsetiltsefotaksima and 20-25% - in the form of two active metabolites - M2 and M3).

The bactericidal concentration in the blood persists for more than 12 hours.

In chronic renal failure and in the elderly T_1/2 increases by 2 times. T_1/2 in newborns - 0.75-1.5 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 grams - 3.4 hours. For repeated IV injections, a dose of 1 g every 6 hours for 14 days of cumulation is not observed. Penetrates into breast milk.

Indications:Bacterial infections of severe course caused by sensitive microorganisms: respiratory tract and ENT organs, urinary tract, septicemia, bacteremia, sepsis, endocarditis, intra-abdominal infections (including peritonitis), central nervous system (meningitis) infections, skin and soft tissue infections, bones, joints , infection of the pelvic organs, chlamydia, gonorrhea, infected wounds and burns, Lyme disease (borreliosis), salmonellosis, infection against immunodeficiency, prevention of infections after surgery (including follows urological, obstetrical, on the gastrointestinal tract).

Contraindications:

Hypersensitivity (including penicillins, cephalosporins, carbapenems).

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

Carefully:When the drug is prescribed for patients with impaired renal and hepatic function. Newborn period (for intravenous administration), diseases of the gastrointestinal tract, especially colitis, ulcerative colitis (including 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.

In small concentrations 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 administration, dissolve 1 g of Intathaxime in 4 ml of sterile water for injection, injected deeply into the gluteus muscle. As a solvent, intramuscular injection also uses a 1% solution of lidocaine (per 1 g - 4 ml).

For intravenous administration, 1 g of Intathaxime is dissolved in 4 ml of sterile water for injection. Enter slowly for 3-5 minutes.

For drip (for 50-60 minutes), dissolve 2 g of the drug in 100 ml of a 0.9% solution of sodium chloride or 5% solution of dextrose, Ringer's solution, sodium lactate,Dextrans with a molecular mass of 50-70 kD and 30-40 kDa.

With the purpose of preventing the development of infections before the surgical operation, enter 1 g during the initial general anesthesia. If necessary, the administration is repeated after 6-12 hours.

At caesarean section - at the time of application of the clamps on the umbilical vein - in / in 1 g, then 6 and 12 hours after the first dose - an additional 1 g.

With the clearance of creatinine (CC) 20 ml / min / 1.73 m2 or less, the daily dose is reduced by 2 times.

Adults and children weighing 50 kg or more: for uncomplicated infections, as well as for infections of the urinary tract - in / m or / in 1 g every 8-12 hours; with uncomplicated acute gonorrhea - in / m 1 g once; at infections of average gravity-in / m or iv in 1-2 g every 12 h; in severe infections, for example, with meningitis - iv 2 g every 4-8 hours, maximum daily dose - 12 g. Duration of treatment is set individually.

Children with body weight up to 50 kg - 50-180 mg / kg body weight per day.

For preterm and newborn children up to 1 week - IV 50 mg / kg every 12 hours;

At the age of 1-4 weeks - in / in 50 mg / kg every 8 hours.

Side effects:

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

From the nervous system: headache, dizziness.

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

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

From the digestive systemNausea, vomiting, diarrhea or constipation, bloating, abdominal pain, goiter, liver dysfunction, rarely - stomatitis, glossitis, pseudomembranous colitis.

On the part of the organs of hematopoiesis: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hypocoagulation.

Laboratory indicators: Azotemia, increased concentration of urea in the blood, increased activity of "liver" transaminases and alkaline phosphatase (AP), hypercreatininemia, hyperbilirubinemia, a positive Coombs' test. Other: superinfection (in particular, candidal vaginitis).

Overdose:

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

Treatment: symptomatic.

Interaction:

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

The probability of kidney damage increases with simultaneous administration with aminoglycosides, polymyxin B and "loop" diuretics.

Drugs that block tubular secretion increase the plasma concentrations of Intra-Taxim and slow its elimination.

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

Special instructions:

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.

With a duration of treatment with the drug for more than 18 days, you need to monitor the picture of peripheral blood.

Possible false positive test Coombs.

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 solution for intravenous and intramuscular injection of 1 g of active substance.

Packaging:

Powder for the preparation of a solution for intravenous and intramuscular injection of 1 g of active substance per 10 ml vial, of colorless glass type I, or capacity 12 ml, of colorless glass type II, corked with butyl cork and coated with an aluminum cap. A plastic cap type FLIPP-OPP is put on top. One bottle with instructions for use is placed in a cardboard box.

For hospital: 10 or 100 bottles with a capacity of 12 ml with the application of 10 instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C in a dark place.

Keep out of the reach of children.

List B.

After breeding:

For intravenous injections: sterile powder Introtoxime after dilution in water or lidocaine solution is chemically stable for 8 hours (at room temperature not above +25 ° C) or for 24 hours (at a temperature of 2 to 8 ° C, in a place , protected from light).

For injections or infusions when dissolved with water for injection: for 12 hours (at room temperature not higher than +25 ° C) or for 24 hours (at a temperature of 2-8 ° C, in a place protected from light). The pale yellow shade of the solution does not mean a decrease in the activity of the antibiotic.

For infusions in infusion solutions: sterile Intathaxime powder is chemically stable for 8 hours after dilution in a solution of Hemakcele, Yonosteril and within 6 hours after dilution in a 10% dextrose solution, dextrans with a molecular weight of 50-70 kD and 30-40 kDa.

Note: it is necessary to ensure aseptic conditions for the dilution of the preparation and preparation of solutions (especially if the diluted Intra-Taxim is not administered immediately).

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013197 / 01

Date of registration:01.08.2008

Expiration Date:Unlimited

The owner of the registration certificate:LDP - Laboratories TorlanLDP - Laboratories Torlan Spain

Manufacturer: & nbsp

LDP - Laboratorios TORLAN Spain

Representation: & nbspSazhefarm, Open CompanySazhefarm, Open Company

Information update date: & nbsp26.10.2017

Illustrated instructions

Instructions

Intra-Taxim (Intrataxime)