INTRATAKSIM

Active material: Cefotaxime
When ATH: J01DD01
CCF: III generation cephalosporins
When CSF: 06.02.03
Manufacturer: LDP – Laboratories TORLAN (Spain)

Pharmaceutical form, composition and packaging

Bottles (1) – cardboard boxes.

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

Zefalosporinovy antibiotic III generation of broad-spectrum. Has bactericidal activity through inhibition of the synthesis of cell walls of bacteria. The mechanism of action is due to membranosvazannah transpeptidaz and acetylation violation cross stitching peptidoglikanov, necessary to ensure strength and rigidity of the cell wall.

Vsokoakteven against gramotricationah bacteria (resistant to other antibiotics): Escherichia coli, Citrobacter spp., Proteus is wonderful, Providencia spp., Klebsiella spp., Serratia spp., some strains of Pseudomonas spp., Haemophilus influenzae.

Less active against Streptococcus spp. (incl. Streptococcus pneumoniae), Staphylococcus spp., Neisseria meningitidis, Neisseria gonorrhoeae, Bacteroides spp.

Resistant to most of the β-lactamases.

Pharmacokinetics

Rapidly absorbed from the injection site. Plasma protein binding is 40%. Widely distributed in tissues and body fluids. Reaches therapeutic concentrations in cerebrospinal fluid, especially with meningitis. It penetrates through the placenta, out of breast milk in low concentrations. Partially metabolized in the liver. 40-60% dose presented with urine in an unmodified form via 24 no, 20% – as metabolites.

Testimony

Infectious and inflammatory diseases heavy currents, caused by susceptible to zefotaksimu microorganisms, incl. peritonitis, sepsis, abdomen infection and pelvic infection, infections of the lower respiratory tract, urinary tract, bone and joint infections, skin and soft tissue, infected wounds and burns, gonorrhea, meningitis, Lyme disease.

Prevention of infections after surgery.

Dosage regimen

Adults and children weighing more than 50 kg – by 1-2 g every 4-12 h in/m or/in (bolus or infusion). Babies weighing less than 50 kg – 50-180 mg / kg / day; multiplicity of introduction – 2-6 time.

The maximum dose: for adults – 12 g / day, for infants weighing less than 50 kg – 180 mg / kg / day.

Side effect

From the digestive system: nausea, vomiting, diarrhea, transient increase in liver transaminases, cholestatic jaundice, hepatitis, psevdomembranoznыy colitis.

Allergic reactions: skin rash, itch, eozinofilija; rarely – angioedema.

From the hematopoietic system: with long-term use at high doses can change picture peripheral blood (leukopenia, neutropenia, thrombocytopenia, gemoliticheskaya anemia).

From the blood coagulation: gipoprotrombinemii.

With urinary system: interstitial nephritis.

Effects, caused by chemotherapeutic action: candidiasis.

Local reactions: phlebitis (at / in the introduction), soreness at the injection site (when i / m administration).

Contraindications

Hypersensitivity to zefotaksimu and other zefalosporynam.

Pregnancy and lactation

We do not recommend the use of cefotaxime in the first trimester of pregnancy.

In II and III trimestrah pregnancy and lactation is possible only in cases, when the intended benefits to the mother outweighs the potential risk to the fetus or infant.

It will be appreciated, that after the on/in the introduction of the zefotaksima dose 1 g in 2-3 h the maximum concentration of the active substance in breast milk averaged 0.32 ± 0.09 μg/ml. At such concentrations may have a negative impact on flora orofaringeal′nuû child.

IN experimental studies on animals teratogenic and embryotoxic effects detected zefotaksima.

Cautions

Be wary cefotaxime with human kidney function, guidance on colitis in history, as well as the newborn.

In patients with hypersensitivity to penicillin allergic reaction to cephalosporin antibiotics.

During treatment, it is possible to direct positive kumbsa and lozhnopolojitelnaya reaction of urine for glucose.

Be cautious when used in conjunction with “loop” Diuretics.

Drug Interactions

Cefotaxime, suppressing intestinal flora, inhibits the synthesis of vitamin k. Therefore, while the use of drugs, reduces platelet aggregation (NSAIDs, salicilaty, sulfinpirazon), It increases the risk of bleeding. For the same reason, together with the use of anticoagulants increasing antikoagulântnogo action.

Together with the application aminoglikozidami, polimiksinom (B) and “loop” dioretikami increased risk of kidney failure.

In an application with drugs, reducing kanalzevu secretion, increases concentration in the blood plasma of cefotaxime.

Probenecid slows excretion of cefotaxime by reducing kanalzeva secreta last.