Active substanceCefoxytinCefoxytin
Similar drugsTo uncover
  • 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 the preparation of solution for intravenous and intramuscular injection.

    Composition:
    cefoxitin sodium (calculated as cefoxitin) - 500 mg or 1000 mg.

    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 II generation for parenteral administration. It acts bactericidal, disrupting the synthesis of the cell wall of the microorganism. Has a wide range of activities.
    It is active against Staphylococcus aureus and Staphylococcus epidermidis (including penicillinase-producing strains and producing no). Highly active against gram-negative microorganisms: Escherichia coli, Haemophilus influenzae, Enterobacter spp, Proteus mirabilis, Eikenella corrodens (producing no beta-lactamase producing strains). Neisseria gonorrhoeae (including strains producing and not producing penicillinase); Morganella morganii; Proteus vulgaris; Providencia spp .; Providencia rettgeri.
    It is active against anaerobic organisms: Peptococcus niger, Peptostreptococcus spp, Clostridium spp, Bacteroides spp... (Including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron).
    Resistant to the action of beta-lactamases.
    Activity against various species of Pseudomonas spp., Many strains of Enterobacter cloacae (metitsillinoustoychivye), Staphylococcus aureus and Staphylococcus epidermidis (metitsillinoustoychivye strains), Listeria monocytogenes.Streptococcus pneumoniae, Streptococcus hemolyticus, the majority of Enterococcus spp. (including Enterococcus faecalis) are resistant to cefoxitin.

    Pharmacokinetics:
    Time to reach the maximum concentration with intravenous administration - at the end of infusion; the maximum concentration after the administration of 1 and 2 g is about 110 and 244 μg / ml, respectively. Well penetrates into the pleural cavity, the joint cavity, in antibacterial concentrations determined in bile. The volume of distribution is 0.16 l / kg. The connection with plasma proteins is 70-80%.
    Half-life is about 0.7-1.1 hours, with renal insufficiency - about 5-6 hours. It is excreted mostly unchanged (85% due to glomerular filtration, 6% - tubular secretion), in the form of inactive metabolites - only 0 , 2-5%.
    The half-life period for newborns up to 7 days is about 5.6 hours; from 7 days to 1 month - about 2.5 hours; 1-3 months - about 1.7 hours.
    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to cefoxitin: infections of the respiratory tract, pelvic organs, urinary tract, bones and joints, skin and soft tissues, abdominal infections, sepsis, endocarditis, gonorrhea (uncomplicated).
    Prevention of postoperative infectious complications.

    Contraindications:
    Hypersensitivity to cefoxitin, drugs group cephalosporins and penicillins, as well as to other beta-lactam antibiotics, pregnancy.

    Carefully:
    Colitis in the anamnesis, hepatic and / or renal insufficiency.

    Pregnancy and lactation:
    In pregnancy, the use of cefoxitin is contraindicated. If you need to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Intravenous (bolus or infusion), intramuscularly.

    Average Adult Dose - 1-2 g every 6-8 hours.

    In uncomplicated urinary tract infections - intramuscularly, 1 g 2 times a day.

    With uncomplicated gonorrhea, incl. caused by penicillinase producing strains, intramuscularly 2 g once, simultaneously (or 1 hour later) with ingestion of 1 g of probenecid.

    In severe infections, intravenously, 2 g every 4 hours or 3 g every 6 hours. The daily dose may be increased to 200 mg / kg (but not more than 12 g).

    If there is a violation of the excretory function of the kidneys, the first dose is 1-2 g, in the future it is necessary to reduce the single dose and increase the intervals between the administrations.

    In patients with impaired renal function, the dosage regimen of cefoxitin is set depending on the creatinine clearance.

    Creatinine clearance (ml / min)

    Dosing regimen

    30-50

    1-2 g every 8-12 h

    10-29

    1-2 g every 12-24 h

    5-9

    0.5-1 g every 12-24 hours

    Less than 5

    0.5-1 g every 24-48 h

    Patients on hemodialysis are advised to add 1-2 g after each hemodialysis procedure. In children with renal dysfunction, correction of the dosing regimen (reduction of the single dose and increase in the interval between doses) is performed according to recommendations for adult patients with impaired renal function.

    Children - in a single dose of 30-40 mg / kg; the frequency of administration depends on the age: premature infants with a body weight of more than 1500 g and a newborn in the first week of life - after 12 hours; Newborns 1-4 weeks of life - after 8 hours; children, older than 1 month - after 6 or 8 hours. The maximum daily dose for children should not exceed 12 g.

    For the prevention of postoperative infections, adults are prescribed 2 g intramuscularly or intravenously 0.5-1 h before the operation; after the operation - 2 g every 6 hours for 1 day. Children - 30-40 mg / kg with the above intervals, but the newborn second and third dose is administered after 8-12 hours. When conducting cesarean section - one-time, intravenously, 2 g after clamping the umbilical cord.

    Preparation of solutions for injection:

    For intramuscular injection, 500-1000 mg of the drug is dissolved in 2 ml of water for injection or 0.5-1% of a solution of lidocaine (without epinephrine).

    For intravenous bolus administration, 500 mg of the drug is dissolved in 5 ml of water for injection, 1000 mg in 10 ml of water for injection. Introduction is carried out slowly, within 3-5 minutes.

    For intravenous infusion, 500 mg of the drug is dissolved in 50 ml of the solvent, 1000 mg in 100 ml of the solvent. As a solvent, 0.9% solution of sodium chloride or 5% solution of dextrose. The duration of the infusion is 30-60 minutes.

    Side effects:

    From the genitourinary system: interstitial nephritis, kidney failure.

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

    From the hematopoiesis: leukopenia, granulocytopenia, neutropenia, anemia, thrombocytopenia, bone marrow suppression, hemolytic anemia.

    From the cardiovascular system: lowering of blood pressure.

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

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

    Local Reactions: with intravenous injection - phlebitis, with intramuscular injection - hyperemia and soreness at the injection site.

    Other: exacerbation of myasthenia gravis gravis.

    Overdose:
    Symptoms: increased severity of side effects, except for allergic reactions.

    Treatment: symptomatic therapy.

    Interaction:
    Drugs that block tubular secretion, increase the concentration of the drug in the blood and the duration of its action.
    Aminoglycosides and other cephalosporins - the risk of developing nephrotoxicity.

    Special instructions:
    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 aspartic aminotransferase.
    Not recommended for the treatment of meningitis.
    When using the Jaffe method, falsely elevated serum creatinine concentrations are possible.
    With the use of the drug, both on the background of taking and 2-3 weeks after the treatment is stopped, the development of diarrhea caused by Clostridium difficile (pseudomembranous colitis) is possible. In mild cases, it is sufficient to cancel the treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole.
    Do not use drugs that inhibit the intestinal motility.
    Effect on the ability to drive transp. cf. and fur:
    During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular injection of 500 mg and 1000 mg.



    Packaging:
    For 500 mg or 1000 mg of active substance (cefoxitine) in 10 ml vials hermetically sealed with rubber stoppers and crimped with aluminum or combined caps.
    1 bottle with the instruction for use is placed in an individual pack;
    50 bottles with instructions for use in the amount of 10 pieces are placed in a cardboard box (for hospitals).
    Storage conditions:
    In a dry, protected from light 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 printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:PL-000907
    Date of registration:18.10.2011
    Date of cancellation:2016-10-18
    The owner of the registration certificate:Company DEKO, LLC Company DEKO, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.10.2015
    Illustrated instructions
      Instructions
      Up