Active substanceCefoxytinCefoxytin
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  • Anaerocef®
    powder w / m in / in 
    PREBAND PFC, LLC     Russia
  • Cefoxytin
    powdersolution w / m in / in 
    Company DEKO, LLC     Russia
  • Dosage form: & nbsp
    powder for solution for intravenous and intramuscular administration
    Composition:

    active substance:

    sodium cefoxitin

    (in terms of cefoxytin) 0.5 g and 1.0 g.

    Description:The powder is white or white with a yellowish hue.
    Pharmacotherapeutic group:Antibiotic-cephalosporin
    ATX: & nbsp

    J.01.D.C.01   Cefoxytin

    Pharmacodynamics:

    Cephalosporin antibiotic of the second generation from the group of cefamycins for parenteral administration. Bactericidal action is due to the blocking of bacterial transpeptidases, which leads to a violation of the final stages of the synthesis of the cell wall of microorganisms. It has a wide spectrum of antimicrobial action in both aerobic and anaerobic bacteria. The unique molecular structure of cefoxitin determines its high resistance to bacterial beta-lactamases.

    Active with gram-positive aerobes - Staphylococcus aureus and Staphylococcus epidermidis (including penicillinase-producing and non-producing penicillinase strains), beta-hemolytic streptococci of group A (Streptococcus pyogenes), beta-hemolytic streptococcus group B (Streptococcus agalactiae), Streptococcus pneumoniae, gram-negative aerobes - Escherichia coli, Haemophilus influenzae, Eikenella corrodens (non-beta-lactamase-producing strains), Klebsiella pneumoniae, Neisseria gonorrhoeae (including penicillinase-producing and non-producing penicillinase strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri), as well as clinically significant anaerobes - Clostridium spp. (Besides Clostridium difficile), Peptococcus niger, Peptostreptococcus spp., microaerophilic streptococci, Bacteroides distasonis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides spp., Prevotella bivia.

    Cefoxytin inactive at respect methicillin-resistant Staphylococcus spp., Enterococcus spp., Listeria monocytogenes, Enterobacter cloacae, Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Mycobacterium spp., Rickettsia spp., Chlamydia spp., Mycoplasma spp., Ureaplasma spp.

    Pharmacokinetics:

    Five minutes after the bolus intravenous (iv) administration of 1 g and 2 g of cefoxitin, the maximum serum concentrations (Cmax) are 110 and 244 mg / L, respectively. 4 hours after intravenous administration at a dose of 1 g, the serum concentrations are less than 1 mg / L. After intramuscular (intramuscular) administration, 1 g of cefoxytin C max is observed after 20 minutes and is 30 mg / l.

    It penetrates well into various body fluids and tissues: into the pleural, ascitic and synovial fluids; bactericidal concentrations are determined in bile. The volume of distribution is 0.16 l / kg. The connection with plasma proteins is 70-80%. It is excreted in breast milk in low concentrations.

    Excreted mainly by the kidneys in the unchanged in the form (85% due to glomerular filtration, 6% - tubular secretion), while in the urine high concentrations of the drug are created. In the form of inactive metabolites only 0.2-5% of the administered dose is excreted. The half-life (T1 / 2) for intravenous administration is 41 to 59 minutes, in the elderly, from 51 to 90 minutes.

    Indications:

    Infections caused by susceptible microorganisms:

    - infections of the lower respiratory tract, including pneumonia, pleural empyema, lung abscess;

    - infections of the abdominal cavity, including peritonitis, abscess of the abdominal cavity;

    - Infectious and inflammatory diseases of the pelvic organs, including endometritis, pelvic peritonitis, salpingoophoritis;

    - urinary tract infection (pyelitis, pyelonephritis);

    - infections of the skin and soft tissues,

    - infection of bones and joints;

    - uncomplicated gonorrhea;

    - septicemia.

    Prevention of postoperative infectious complications.

    Contraindications:Hypersensitivity to cefoxitin and other cephalosporin antibiotics.
    Carefully:In patients with allergic reactions on penicillins in the anamnesis,since a cross-allergy between penicillins and cephalosporins is possible; with a history of nonspecific ulcerative colitis; renal insufficiency.
    Pregnancy and lactation:The use of Anaerocepha in pregnant women is possible in cases where the intended benefit to the mother exceeds the potential risk to the fetus, and should be carried out under the supervision of a specialist. For the period of cefoxytin treatment, breastfeeding should be discontinued.
    Dosing and Administration:

    Depending on the chosen dose and the severity of the infection, Anaerocef® can be administered intravenously (either jetwise or intravenously) or in / m.

    For adults, the average therapeutic dose is 1-2 g every 6-8 hours. In uncomplicated urinary tract infections - in / m, 1 g 2 times a day. With uncomplicated gonorrhea, incl. caused by penicillinase-producing strains Neisseria gonorrhoeae, injected once / in a dose of 2 g; At the same time (or 1 hour later) 1 g of probenecid is ingested. In severe infections, the IV route is preferred; appoint 2 g every 4 hours or 3 g every 6 hours. The daily dose should not be more than 12 g. Cefoxytin is excreted from the body mainly by the kidneys, therefore, in patients with renal insufficiency, correction of the administration regimen is required depending on the values ​​of creatinine clearance (see Fig.table):

    Dosing of Anaerocepha in patients with renal insufficiency

    Creatinine clearance, ml / min

    Dose, g

    Interval between doses

    30-50

    1-2

    8-12 hours

    10-29

    1-2

    12-24h

    5-9

    0,5-1

    12-24h

    <5

    0,5-1

    24-48 h

    Patients, to the on hemodialysis, it is recommended that after each procedure of hemodialysis additionally introduce 1 -2 g of Anaeroceph®.

    Children over 1 month Anaerocef® is administered at a rate of 30-40 mg / kg every 6-8 hours (the maximum daily dose should not exceed 12 g). With mild and moderate infections, intramuscular injection is possible, with severe infections, intravenous injections or infusion of the drug are preferred. In children under 3 months, Anaerocef® is administered only intravenously.

    Newborns of the first week of life and premature newborns weighing more than 1500 g are administered intravenously in a single dose of 30-40 mg / kg every 12 hours; newborns 1-4 weeks of life at 30-40 mg / kg intravenously every 8 hours.

    Adults for the prevention of postoperative infectious complications is administered iv in a dose of 2 g for 30 min before the operation; according to the indications, in the first day of the postoperative period, 2 g every 6 hours.

    In the operation of a cesarean section, 2 g of Anaerosceph® is administered IV immediately after the umbilical cord is clamped.

    Newborns and children up to 12 years, Anaerocef® is administered iv 30 minutes before the start of the operation at a dose of 30-40 mg / kg. According to the indications, in the first day of the postoperative period, the drug is additionally administered in a dose of 30-40 mg / kg every 6-8 hours (in newborns - 8-12 hours).

    Preparation of solutions, methods of administration

    Do not use solutions containing preservatives (for example, benzyl alcohol in bacteriostatic water for injection) for the preparation of Anaerocetef® solutions used in neonates. For IV injection, it is recommended to dissolve 1 g of Anaerocepha ® in 10 ml of water for injection. The resulting solution should be administered intravenously slow within 3-5 minutes; it is possible to administer a system for intravenous infusion through the injection unit for transfusion of compatible solutions (see "Interaction with Other Drugs"). When using a long intravenous infusion 1 g Anaerocef® is dissolved in 3-5 ml of sterile water for injection; after complete dissolution, the resulting solution is added to 200-400 ml of a compatible infusion medium: 0.9% sodium chloride solution, 5% dextrose solution, an aqueous solution containing 5% dextrose and 0.9% sodium chloride; injected intravenously drip using a system for intravenous infusion.To prepare the solution for intramuscular injection, 1 g of Anaerotsefa® is dissolved in 2-3 ml of one of the following solvents: water for injection, 0.5% lidocaine hydrochloride solution, 1% lidocaine hydrochloride solution. Enter by a deep injection into the area with a pronounced muscle layer (upper-outer quadrant of the buttock), after having conducted an aspiration test to avoid insertion into the blood vessel.

    Side effects:

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

    Local Reactions: thrombophlebitis after intravenous administration; pain, compaction in places with / m injections.

    From the side of the urinary system: increased serum creatinine concentration, interstitial nephritis, renal failure.

    From the digestive system: nausea, vomiting, dry mouth, decreased appetite, diarrhea, pseudomembranous colitis.

    On the part of the blood system: leukopenia, granulocytopenia, neutropenia, anemia, thrombocytopenia, bone marrow suppression, hemolytic anemia,eosinophilia (the use of high doses in children is accompanied by an increase in the frequency of eosinophilia).

    From the side of the cardiovascular system: lowering blood pressure.

    Laboratory indicators: in patients with azotemia, a false-positive Coombs reaction is possible, an increase in the activity of "liver" transaminases.

    Other: aggravation of the current myastenia gravis.

    Interaction:

    With simultaneous use with aminoglycosides, a synergism of the antimicrobial effect is observed, mainly with respect to Enterobacteriaceae.

    Simultaneous intravenous administration of the solution of Anaeroceph® is possible with the following infusion solutions: 0.9% sodium chloride solution, 5% dextrose solution, 10% dextrose solution, 5% dextrose aqueous solution and 0.9% sodium chloride, Ringer's solution, 2, 5%, 5% and 10% mannitol solution.

    Due to pharmacological incompatibility, do not mix Anaerocef® and aminoglycoside solutions in a single syringe or one infusion medium.

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

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

    Special instructions:

    Anaerocef® is used as the sole antibiotic (monotherapy) for the treatment of mixed aerobic-anaerobic infections of a variety of localizations, including those caused by strains of bacteria resistant to penicillins, other cephalosporins, lincosamides and aminoglycosides.

    Patients who had a history of allergic reactions to penicillins, may have increased sensitivity to cephalosporin antibiotics.

    For the treatment of newborns, use a solvent without preservatives. The use of high doses in children is accompanied by an increase in the frequency of eosinophilia and an increase in the activity of aspartate aminotransferase.

    Anaeroscef® is not recommended for the treatment of bacterial meningitis.

    When using the Jaffe method, falsely elevated serum creatinine concentrations are possible, therefore it is not recommended to take blood samples for the determination of creatinine within 2 hours after the administration of cefoxitine.

    Form release / dosage:
    Powder for solution for intravenous and intramuscular injection 0.5 g and 1.0 g.
    Packaging:

    0.5 g; 1.0 g of the active substance is placed in 10 ml glass bottles.

    The solvent is "Water for Injection" in 5 ml ampoules.

    1. 1 bottle with the drug and instructions for use are placed in a pack of cardboard.

    2. 1 bottle with the drug, 1 ampoule with a solvent and instructions for use are packed in a cardboard box. <

    3. 1 bottle with the drug and 1 ampoule with solvent are packaged in a contour mesh box made of polyvinyl chloride film and aluminum foil or without foil. One outline package and instructions for use are put in a cardboard pack.

    4. Five vials of the drug are packed in contour mesh packages made of polyvinyl chloride film and aluminum foil or without foil. One outline package and instructions for use are put in a cardboard pack.

    5. 5 vials with the preparation complete with 5 ampoules of the solvent are packed in contoured cell packs made of polyvinylchloride film and aluminum foil or without foil. One outline package with the preparation, one outline package with a solvent and instruction for use is put in a cardboard pack.

    Storage conditions:In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N003297 / 01
    Date of registration:18.10.2011 / 12.09.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:PREBAND PFC, LLCPREBAND PFC, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp01.09.2017
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