ANAEROTSEF

Active material: cefoxitin
When ATH: J01DC01
CCF: Cephalosporin II generation
ICD-10 codes (testimony): A40, A41, A54, J15, J85, J86, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, M00, M86, N10, N11, N30, N34, N41, N70, N71, N72, N73.0, Z29.2
When CSF: 06.02.02
Manufacturer: ABOLmed Ltd. (Russia)

Pharmaceutical form, composition and packaging

Powder for solution for I / O, and the / m white or white with a yellowish tint.

Solvent: water d / and (5 ml).

Bottles (1) – packs cardboard.
Bottles (1) together with the solvent (amp. 1 PC.) – packs cardboard.
Bottles (1) together with the solvent (amp. 1 PC.) – packings Valium planimetric.
Bottles (5) – packings Valium planimetric (1) – packs cardboard.
Bottles (5) together with the solvent (amp. 5 PC.) – packings Valium planimetric (2) – packs cardboard.

Pharmacological action

Cephalosporin antibiotic II Group cephamycin generation of parenteral administration. The bactericidal effect caused by blocking bacterial transpeptidase, which leads to violation of the final stages of cell wall synthesis microorganisms. It has a wide spectrum of antimicrobial activity both in terms of aerobic, and anaerobic bacteria. Molecular structure cefoxitin determines its high stability to bacterial β-lactamases.

It is active against gram-positive aerobes: Staphylococcus aureus, Staphylococcus epidermidis (including strains, produciruûŝie and neproduciruûŝie penicillinazu), Beta-hemolytic streptococci group A (Streptococcus pyogenes), Beta-hemolytic streptococci Group B (Streptococcus agalactiae), Streptococcus pneumoniae; Gram-negative aerobic: Escherichia coli, Haemophilus influenzae, Eikenella corrodens (strains, not producing β-laktamazu), Klebsiella pneumoniae, Neisseria gonorrhoeae (including strains, produciruûŝie and neproduciruûŝie penicillinazu), Morganella morganii, Proteus is wonderful, Proteus vulgaris, providencia spp. (including Providencia rettgeri), Salmonella spp., Shigella spp.; anaerobes: Actinomyces spp., Clostridium spp. (other than Clostridium difficile), Peptococcus niger, Peptostreptococcus spp., microaerophilic streptococci, Bacteroides spp. (incl. Bacteroides distasonis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron), Prevotella crossroads.

Tsefoksytyn are not active against metitsillinoustoychivyh Staphylococcus spp., Enterococcus spp., Listeria monocytogenes, Enterobacter cloacae, Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Mycobacterium spp., Rickettsia spp., Chlamydia spp., Mycoplasma spp., Ureaplasma spp.

Pharmacokinetics

Distribution

Through 5 min after bolus on / in a dose of cefoxitin in 1 and g 2 г C_max up 110 mg/l and 244 mg / l, respectively. Through 4 hours after / in a dose of 1 g serum concentration is less than 1 mg / l.

After the / m at a dose tsefoksitina 1 г C_max achieved through 20 and m is 30 mg / l.

Well into the various fluids and tissues: in plevralynuyu, ascites and synovial fluid; bactericidal concentration determined in bile. V_d – 0.16 l / kg. Plasma protein binding – 70-80%. Excreted in breast milk in low concentrations.

Deduction

Excreted mainly by the kidneys unchanged as (85% due to glomerular filtration, 6% – due to tubular secretion), wherein in urine are high concentrations of the drug. In the form of inactive metabolites derived only 0.2-5% of the administered dose. T_1/2 with a / in the introduction of 41-59 m.

Pharmacokinetics in special clinical situations

T_1/2 at / in the introduction in elderly patients is 51-90 m.

Testimony

Infection, caused by susceptible microorganisms:

- Infections of the lower respiratory tract (incl. pneumonia, empyema, lung abscess);

- abdominal cavity infection (incl. peritonitis, abdominal abscess);

- Infectious and inflammatory diseases of the pelvic organs (incl. endometritis, pelvioperitonit, salpingo-oophoritis);

- Urinary tract infections (pyelitis, pyelonephritis);

- Infections of the skin and soft tissues;

- Bone and joint infections;

- Neoslojnennaya gonorrhea;

- Septicemia.

Prevention of postoperative infectious complications.

Dosage regimen

Depending on the dose and severity of the infection, Anaérocef^® may be administered in / in (bolus or infusion) or / m.

To Adult sredneterapevticheskih dose is 1-2 g every 6-8 no.

At uncomplicated urinary tract infections the drug is prescribed in / m 1 g 2 times / day.

At uncomplicated gonorrhea, incl. caused by penicillinase-producing strains of Neisseria gonorrhoeae, preparation is administered once / m at a dose 2 g; simultaneously or 1 hours later designate the interior 1 g probenecid.

At severe infections in / in preferred route of administration. Assign 2 g every 4 or h 3 g every 6 no. The daily dose should not be more 12 g.

Cefoxitin is excreted mainly by the kidneys, why Patients with renal insufficiency requires correction mode depending on the creatinine clearance values ​​of.

Patients, hemodialysis, It recommended after each hemodialysis procedure further administered 1-2 g Anaérocefa^®.

Children over 1 Months Anaérocef^® administered at the rate of 30-40 mg / kg every 6-8 no (the maximum daily dose should not exceed 12 g). At mild and moderate infections possible / m administering drug, at severe infections preferred in / or injection / infusion of the drug. In Children up to 3 Months Anaérocef^® administered alone / in.

First week of life the newborn and premature infants weighing more 1500 g administered on / in a single dose 30-40 mg / kg every 12 no; newborn 1-4 weeks of life – in / on 30-40 mg / kg every 8 no.

Adults to prevention of postoperative infectious complications introduced in / dose 2 d for 30 minutes prior to surgery; by indications on the first day postoperative period – by 2 g every 6 no.

At In step cesarean Anaérocef^® introduced in / dose 2 g immediately after cord clamping.

Infants and children up to 12 years Anaérocef^® introduced into / in for 30 minutes before the start of the operation in a dose 30-40 mg / kg. According to the testimony, during the first postoperative day additionally administered drug dose 30-40 mg / kg every 6-8 no (in newborns - 8-12 no).

Terms of preparation and administration solutions

Do not use solutions, containing preservatives (eg, benzyl alcohol as bacteriostatic water for injection), for the preparation of solutions Anaerotsefa^®, used in newborns.

For in / bolus is recommended to dissolve 1 g Anaérocefa^® in 10 ml water for injection. The resulting solution should be administered in / in slowly over 3-5 m; possible introduction through the node for a system for injection / in infusion solutions compatible transfusion.

When using a long / infusion 1 g Anaérocefa^® dissolved in 3-5 ml of sterile water for injection; after complete dissolution the resulting solution is added to 200-400 ml compatible infusion medium: 0.9% sodium chloride solution, 5% Dextrose (Glucose), water solution, comprising 5% dextrose (Glucose) and 0.9% sodium chloride. Enter / drip, Using the system for the on / in infusions.

To prepare the solution for the / m, 1 g Anaérocefa^® dissolved in 2-3 ml of one of the following solvents: water for injection, 0.5% lidocaine hydrochloride, 1% lidocaine hydrochloride. Injected deep into / m portion with pronounced muscle layer (the upper-outer quadrant of the buttock), Having conducted pre aspirate, to avoid introducing into a blood vessel.

Side effect

From the urinary system: increase in serum creatinine, interstitial nephritis, renal failure.

From the digestive system: nausea, vomiting, dry mouth, decreased appetite, diarrhea, pseudomembranous enterocolitis, increase in liver transaminases.

From the hematopoietic system: leukopenia, granulocytopenia, neutropenia, anemia, thrombocytopenia, bone marrow suppression, gemoliticheskaya anemia.

Cardio-vascular system: hypotension.

Allergic reactions: rash, exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome), eozinofilija, fever, breathlessness; rarely – anaphylactic reactions, angioedema.

Local reactions: thrombophlebitis after the on / in the; pain, seal places in / m injections.

Other: worsening current myastenia gravis, azotemia in patients with possible false-positive Coombs' test.

Contraindications

- hypersensitivity to cefoxitin and other cephalosporin antibiotics.

FROM caution preparation should be administered to patients with allergic reactions to penicillins history, as possible cross-allergy between penicillins and cephalosporins; When specifying a history of ulcerative colitis; in renal failure.

Pregnancy and lactation

Application Anaerotsefa^® in pregnant women is possible in cases, when the intended benefits to the mother outweighs the potential risk to the fetus, and should be administered under the supervision of a specialist.

During treatment, cefoxitin should stop breastfeeding.

Cautions

Anaérocef^® used for monotherapy for the treatment of mixed aerobic-anaerobic infections of different localizations, incl. caused by strains of bacteria, resistant to penicillin, other cephalosporins, lincosamides and aminoglycosides.

Patients, had a history of allergic reactions to penicillins, may be sensitive to cephalosporin antibiotics.

For the treatment of infants should use a solvent with no preservatives.

Use of the drug at high doses for children accompanied by increased frequency of eosinophilia and increased AST activity.

Anaérocef^® not recommended for the treatment of bacterial meningitis.

When using the method of Jaffe can false excessive concentration of serum creatinine, it is not recommended to collect blood samples for determining serum creatinine during 2 hours after administration tsefoksitina.

Overdose

Data on drug overdose Anaerotsef^® not provided.

Drug Interactions

While the use of aminoglycosides observed synergistic antimicrobial action, predominantly, against Enterobacteriaceae.

Drugs, block tubular secretion, increase in the blood concentration of the drug and the duration of its validity.

Simultaneous use of aminoglycosides and other cephalosporins increases the risk of nephrotoxicity.

Simultaneous / in a solution Anaerotsefa^® perhaps with the following infusion solutions: 0.9% sodium chloride solution, 5% dextrose (Glucose), 10% dextrose (Glucose), aqueous solution, contains 5% dextrose (Glucose) and 0.9% sodium chloride, Ringer, 2.5%, 5% and 10% mannitol solution.

In view of the pharmacological incompatibility, not be mixed in the same syringe or medium audio infusion solutions Anaerotsefa^® and aminoglikozidov.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 2 year.