Active substanceCefamandolCefamandol
Similar drugsTo uncover
  • Cefamabol®
    powdersolution w / m in / in 
    PREBAND PFC, LLC     Russia
  • Cefat®
    powdersolution for injections 
    SYNTHESIS, OJSC     Russia
  • Dosage form: & nbspPowder for the preparation of solution for intravenous and intramuscular injection.
    Composition:
    Composition per one bottle: 1000 mg

    cefamandola naphtha

    Comprises:

    cefamandole nafat

    (in terms of cefamandol) 1000 mg

    sodium carbonate 60 mg
    Description:White or white with a yellowish tint powder.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.C.03   Cefamandol

    Pharmacodynamics:

    Cephalosporin antibiotic II generation for parenteral use. It acts bactericidal (it breaks the synthesis of cellular, walls, microorganisms). Has a wide range of antimicrobial effects. Highly active against gram-positive aerobes - Staphylococcus aureus, including penicillinase-producing and non-penicillinase-producing strains, Staphylococcus epidermidis, Streptococcus spp., incl. beta-hemolytic streptococcus serogroups A (Streptococcus pyogenes) and Streptococcus pneumoniae; gram-negative aerobes - Escherichia coli, Klebsiella spp., Enterobacter spp., Haemophilus influenzae, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Morganella morganir, anaerobic bacteria - Gram-positive and Gram-negative cocci (including Peptococcus spp. and Peptostreptococcus spp.), Gram-positive rods (including Clostridium spp.), Gram-negative rods (including Bacteroides spp. and Fusobacterium spp.). Resistant to the action of beta-lactamases. Not active against most strains Enterococcus spp., methicillin-resistant strains Staphylococcus spp., Listeria monocytogenes, Acinetobacter calcoaceticus, different types of Pseudomonas spp., most strains Serratia spp., Clostridium difficile, most strains Bacteroides fragilis, Mycobacterium tuberculosis.

    Pharmacokinetics:
    After intramuscular (IM) administration of 0.5 g or 1.0 g of cefamandol, the maximum serum concentrations (Cmax) are reached after 30-120 minutes and are 13 μg / ml and 25 μg / ml, respectively. After intravenous (iv) administration, 1 g, 2 g or 3 g of C max are observed after 10 minutes and are 139 μg / ml, 240 μg / ml and 533 μg / ml, respectively; after 4 hours, the serum concentrations decrease to 0.8 μg / ml, 2.2 μg / ml, and 2.9 μg / ml, respectively. After iv and / m injections, therapeutic cefamandol concentrations exceeding the minimum inhibitory concentrations for drug-sensitive pathogens are achieved in pleural and articular fluids, bile and bones. With multiple injections does not cumulate.
    The half-life (T1 / 2) after IV injection is 30-35 minutes; after the / m introduction-60 min. It is excreted by the kidneys unchanged. For 8 hours of renal excretion 85% of the administered dose is exposed, while in the urine high concentrations of the drug are created: after the / m administration of 0.5 g and 1.0 g, the urine content is 254 μg / ml and 1357 μg / ml,respectively; with iv injection of 1 g and 2 g - 750 mcg / ml and 1380, mcg / ml, respectively. In patients with renal insufficiency, excretion of cefamandol slows down. In the terminal stage of renal failure and in patients on hemodialysis, T1 / 2 increases to 6 hours.
    Cefamandol inhibits the enzyme acetaldehyde dehydrogenase (has a disulfiram-like action), which can lead to the accumulation of acetaldehyde with simultaneous intake of ethanol.

    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to cephamandol:
    - Lower respiratory tract infection, incl. pneumonia, empyema of the pleura and lung abscess;
    -infections of the abdominal organs, including peritonitis, cholangitis and cholecystitis;
    - bacterial endocarditis;
    - meningitis;
    - infectious and inflammatory diseases of the pelvic organs in women;
    - urinary tract infections, incl. acute and exacerbation of chronic pyelonephritis, pyelitis;
    - skin and soft tissue infections;
    - infections of bones and joints, incl. osteomyelitis, septic arthritis;
    - sepsis.
    It is indicated for the prophylaxis of postoperative infectious complications.
    Contraindications:Hypersensitivity to cefamandol, other cephalosporins, penicillins, carbapenems; the period of newborns (up to 1 month). It is not used to prevent postoperative infectious complications in children under 3 months of age. (efficiency and safety not established).
    Carefully:Chronic renal failure, pseudomembranous colitis (in the anamnesis).
    Pregnancy and lactation:
    The use of the drug Cefamabol ® during pregnancy is possible in cases where the intended benefit to the mother exceeds the possible risk to the fetus, and should be carried out under the supervision of a physician.
    If necessary, the appointment of cefamandol during lactation should stop breastfeeding.
    Dosing and Administration:
    Cefamabol ® is administered intramuscularly or intravenously.
    Adults appoint 0.5 to 1 g every 4-8 hours for infections of the skin and soft tissues appoint 0.5 g every 6 hours; for the treatment of uncomplicated community-acquired pneumonia, 0.5-1 g every 6 hours; with uncomplicated urinary tract infections - 0.5 g every 8 hours; with complicated infections of the urinary tract - 1 g every 8 hours. For the treatment of severe and life-threatening infections, 2 g every 4-6 hours (the maximum daily dose should not exceed 12 g) is administered.Given the predominantly renal pathway for the elimination of cefamandol, in patients with impaired renal function the dosing regimen is set taking into account the value of creatinine clearance. After intravenous or intravenous injection, 1-2 g as a loading dose are switched to a maintenance regimen (see table):

    Clearance

    Severe infections

    Moderately severe infections

    creatinine (ml / min)

    -

    50-80

    2 g every 6 hours or 1.5 g every 4 hours

    0.75 - 1.5 g every 6 hours

    25-50

    1.5 g every 6 hours or 2 g every 8 hours

    0.75 - 1.5 g every 8 hours

    10-25

    1 g every 6 hours or 1.25 g every 8 hours

    0.5 - 1 g every 8 hours

    2-10

    0.67 g every 8 hours or 1 g

    0.5-0.75 g each

    every 12 hours

    12 hours

    Less than 2

    0.5 g every 8 hours or 0.75 g

    0.25-0.5 g every

    every 12 hours

    12 hours

    Patients on hemodialysis are given intravenous / intravenous / 1 g every 12 hours (if an intravenous injection is used, then after the completion of the hemodialysis session, 1 / 2-1 / 3 doses are additionally given).

    In children older than 1 month. The daily dose is 50-100 mg / kg body weight, which is divided into 3-6 injections at intervals of 4-8 hours. In severe infections, the daily dose can be increased to 150 mg / kg / day, but should not exceed 12 g.

    The duration of therapy with Cefamabol® depends on the severity, localization, features of the course of the infectious process, the patient's response to treatment, and is determined individually by the treating physician.The administration of the drug is continued, at least for another 48-72 hours after the normalization of body temperature. When treating infections caused by group A beta-hemolytic streptococci, the duration of therapy should be at least 10 days.

    For the prevention of postoperative infectious complications in adults

    Cefamabol® is administered iv at a dose of 1 g or 2 g together with premedication or anesthesia, but not earlier than one hour before the operation; then (if necessary) in / in or / m 1 g or 2 g every 6 hours for 24-48 hours after the operation. Children over 3 months. administered in / in the same regimen as in adults, at a rate of 50-100 mg / kg per day with intervals between administrations of 6 hours.

    Rules for the preparation of solutions and administration

    For intravenous injection of 1 g of dry sterile powder of the drug Cefamabol ® is dissolved in 3 ml of sterile water for injection, 0.9% sodium chloride solution or 0.5% lidocaine solution. Enter deeply intramuscularly into areas of the body with a pronounced muscular layer (upper-outer quadrant of the buttock or lateral surface of the thigh). It is recommended that an aspirate test be performed to avoid the unwanted introduction of the solution into the blood vessel.The use as a solvent of 0.5% lidocaine solution is contraindicated in persons with increased sensitivity to local anesthetics of the amide type (for more information refer to the instructions for use of lidocaine).

    For IV injection 1 g of Cefamabol® is dissolved in 10 ml of sterile water for injection, 0.9% sodium chloride solution or 5% dextrose solution. Enter intravenously slowly, for 3-5 minutes; it is possible to administer through a special node or port for injection of a system for intravenous infusions if the patient receives parenterally compatible fluids with Cefamabol.

    For IV injection 1 g of Cefamabol® is dissolved in 10 ml of sterile water for injection. The resulting solution is transferred to a vial containing 50-100 ml of a compatible infusion medium. Enter intravenously drip, the duration of administration depends on the volume of the solution and can be 10-30 minutes or more. Cefamabol® solution is compatible with 5% dextrose solution, 0.9% sodium chloride solution, 10% dextrose solution, an aqueous solution containing 0.2% sodium chloride and 5% glucose; aqueous solution,containing 0.45% sodium chloride and 5% glucose; an aqueous solution containing 0.9% sodium chloride and 5% glucose, M / 6 sodium lactate solution.

    Side effects:

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

    From the digestive system: nausea, vomiting, diarrhea or constipation, dysbiosis, impaired liver function (increased activity of "liver" transaminases, alkaline phosphatase, hyperbilirubinemia, cholestatic jaundice, hepatitis), stomatitis, glossitis, pseudomembranous colitis.

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

    From the urinary system: azotemia, an increase in urea in the blood, hypercreatininaemia, impaired renal function.

    From the nervous system: headache, dizziness.

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

    Other: superinfection.

    Overdose:
    Symptoms: when prescribed in unreasonably high doses, seizures may develop (especially in patients with renal insufficiency).
    Treatment: symptomatic therapy, including diazepam and short-acting barbiturates; in severe cases - hemodialysis.
    Interaction:
    Incompatible with ethanol (inhibits acetaldehyde dehydrogenase). With the simultaneous use of ethyl alcohol or preparations containing ethanol, it is possible to develop a disulfiram-like reaction (abdominal pain, facial skin hyperemia, headache, lowering blood pressure, nausea, vomiting, palpitation, increased sweating).
    With simultaneous application with aminoglycosides, pronounced synergistic and additive effects are observed.
    Pharmaceutically incompatible with aminoglycosyls. When used simultaneously with aminoglycosides, they should not be mixed in one syringe or one infusion medium; with the / m introduction to enter into different parts of the body; when administered intravenously, it is recommended to administer separately, observing a certain sequence with as long a time interval between injections (infusions), or use separate intravenous catheters.
    The risk of side effects from the urinary system increases with the simultaneous use of the drug Cefamabol ® with drugs that have a nephrotoxic effect (including aminoglycosides and loop diuretics).
    Special instructions:
    During treatment with cefamandol, a false positive Coombs reaction and a false positive urine reaction to glucose and protein are possible. In elderly and debilitated patients with vitamin K deficiency, there is an increased risk of developing hypoprothrombinemia with or without bleeding (in these cases, vitamin K administration is indicated).
    During treatment should refrain from taking ethanol - possible effects similar to the action of disulfiram (red face, abdominal pain, nausea, vomiting, headache, arterial hypotension, tachycardia, dyspnea).
    If diarrhea occurs during treatment with Cefamabol ®, caution should be exercised in view of the possible development of pseudomembranous colitis. If a diagnosis of antibiotic-associated diarrhea or pseudomembranous colitis is established, cefamabol® should be discontinued immediately and appropriate treatment should be prescribed.
    Effect on the ability to drive transp. cf. and fur:Studies on the effect of the drug Cefamabol ® on the ability to drive vehicles and to engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions have not been conducted. Given the possible development of dizziness and encephalopathy, with the use of the drug Cefamabol ®, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular administration of 1000 mg.


    Packaging:
    1000 mg of active substance into 10 ml glass vials, hermetically sealed with rubber stoppers, crimped with aluminum caps or crimped caps with combined caps (aluminum with safety plastic caps).

    The solvent - "Water for injection" in glass ampoules of 5 ml:

    1. 1 bottle of the drug and instructions for use are placed in a pack of cardboard.
    2.1 bottle with the drug and 1 ampoule with solvent are packed in a contour mesh box made of polyvinyl chloride film and foil of aluminum lacquered or without foil. One outline package and instructions for use are put in a pack of cardboard.
    3. 5 bottles of the drug are packed in a contour mesh box made of polyvinyl chloride film and aluminum foil foil or without foil. One outline package and instructions for use are put in a pack of cardboard.
    4. 5 Vials with a preparation complete with 5 ampoules of solvent are packed in contour mesh packages from a polyvinylchloride film and foil of aluminum varnished, or without a foil. One outline package with the preparation, one outline package with a solvent and instructions for use are put in a pack of cardboard.
    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:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000030 / 01
    Date of registration:18.05.2012
    The owner of the registration certificate:PREBAND PFC, LLCPREBAND PFC, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.10.2015
    Illustrated instructions
      Instructions
      Up