Active substanceClindamycinClindamycin
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    Composition of 1 ampoule: 2 ml of solution contain:

    active substance: clindamycin 300 mg (in the form of clindamycin phosphate);

    Excipients: benzyl alcohol 18.00 mg, disodium edetate 1.00 mg, water for injection up to 2.0 ml.

    Description:Solution for intravenous and intramuscular injection: clear, colorless or slightly yellowish solution.
    Pharmacotherapeutic group:Antibiotic-Lincosamide
    ATX: & nbsp

    J.01.F.F.01   Clindamycin

    Pharmacodynamics:

    Clindamycin is a drug from the group of antibiotics - lincosamides, has a wide spectrum of action, bacteriostatic, binds to 50Sthe subunit of the ribosome and inhibits protein synthesis in microorganisms. Active with respect to Staphylococcus spp. (incl. Staphylococcus epidermidis, producing penicillinase), Streptococcus spp. (excluding Enterococcus spp.), Streptococcus pneumoniae, anaerobic and microaerophilic Gram-positive cocci (including Peptococcus spp. and Peptostreptococcus spp.), Corynebacterium diphtheriae, Clostridium perfringens, Clostridium tetani, Mycoplasma spp., Bacteroides spp. (including Bacteroides fragilis and Bacteroides melaninogenicus), anaerobic Gram-positive, non-spore, bacilli (including Propionibacterium spp., Eubacterium spp., Actinomyces spp.).

    Most strains Clostridium perfringens sensitive to clindamycin, but other species of clostridia (Clostridium sporogenes, Clostridium tertium) are resistant to the action of the drug, therefore, for infections caused by Clostridium spp., the definition of antibioticogram is recommended.

    The mechanism of action and antimicrobial spectrum is close to that of lincomycin (for some microorganisms, especially for bacteroids and non-spore forming anaerobes, it is 2-10 times more active).

    Pharmacokinetics:

    Quickly and completely absorbed in the gastrointestinal tract, simultaneous ingestion slows down absorption, without changing the concentration of the drug in the plasma.Easily penetrates into biological fluids and tissues (tonsils, muscle and bone tissue, bronchi, lungs, pleura, bile ducts, appendix, fallopian tubes, prostate, synovial fluid, saliva, sputum, wound surfaces); through the blood-brain barrier passes badly (with inflammation of the meninges, the permeability of the blood-brain barrier is increased). The maximum concentration in the blood is achieved by oral intake through 0.75-1 hour, after intramuscular injection (in / m) - after 1 hour in children and 3 hours in adults, with intravenous administration (in / in) - at the end of infusion.

    The therapeutic concentration circulates in the blood for 8-12 hours, the half-life is about 2.4 hours; is metabolized primarily in the liver (70-80%) with the formation of active (N-dimethyl-clindamycin and clindamycin sulfoxide) and inactive metabolites; is excreted for 4 days by kidneys (10%) and through the intestine (3.6%) as an active drug, the rest - in the form of inactive metabolites.

    Indications:

    Infectious-inflammatory diseases caused by microorganisms sensitive to clindamycin:

    - infections of the upper respiratory tract and infection of the ENT organs (pharyngitis, tonsillitis, sinusitis, otitis), lower respiratory tract (pneumonia, incl.aspiration, lung abscess, pleural empyema, bronchitis), scarlet fever, diphtheria;

    - infection of the urogenital tract (chlamydia, endometritis, vaginal infections, tubo-ovarian inflammation);

    - infections of the skin and soft tissues (infected wounds, abscesses, boils, panariciums);

    - infection of the abdominal cavity (peritonitis, abscess);

    - oral infection;

    - Acute and chronic osteomyelitis;

    - septicemia (primarily anaerobic);

    bacterial endocarditis.

    Prevention of peritonitis and intra-abdominal abscess after perforation of the intestine or as a result of traumatic infection (in combination with aminoglycosides).

    Contraindications:

    - Hypersensitivity;

    - Myasthenia gravis;

    - bronchial asthma;

    - Ulcerative colitis (in the anamnesis);

    - diarrhea;

    - pregnancy, lactation period;

    - Children's age up to 3 years - for a solution for intravenous and intramuscular administration (due to the lack of safety data for the use of benzyl alcohol).

    Carefully:

    Clindamycin is used with caution in patients with severe hepatic and / or renal insufficiency, in elderly patients.

    Dosing and Administration:

    With the / m and / in the introduction of the recommended dose for adults - 300 mg 2 times a day. In severe infections - up to 1.2-2.7 g / day, divided into 3-4 injections.

    It is not recommended to appoint a single dose in excess of 600 mg.

    The maximum single dose for intravenous administration is 1.2 g for 1 hour.

    Children over 3 years old - 15-25 mg / kg / day, divided into 3-4 equal doses. In severe infections, the daily dose can be increased to 25-40 mg / kg body weight, divided into 3-4 identical injections.

    Patients with severe hepatic and / or renal insufficiency Do not need to adjust the dosage regimen in the case of prescribing the drug with an interval of at least 8 hours.

    For intravenous administration, the drug is diluted to a concentration of no more than 6 mg / ml; the diluted solution is injected / dripped for 10-60 minutes.

    It is not recommended to administer the drug intravenously.

    Dilution and duration of infusion is recommended to be performed according to the "dose-volume of solvent-infusion duration" (respectively): 300 mg-50 ml-10 min; 600 mg-100 ml-20 min; 900 mg-150 ml-30 min; 1200 mg-200 ml-45 min. The following solutions can be used as the solvent: 0.9% sodium chloride solution and 5% dextrose solution.

    Side effects:

    From the gastrointestinal tract: dyspepsia (abdominal pain, nausea, vomiting, diarrhea), esophagitis, jaundice, liver dysfunction, hyperbilirubinemia,dysbacteriosis, pseudomembranous enterocolitis.

    From the side of the musculoskeletal system: rarely - a violation of neuromuscular conduction.

    On the part of the organs of hematopoiesis: leukopenia, neutropenia, agranulocytosis, thrombocytopenia.

    Allergic reactions: rarely - maculopapular rash, hives, itching; in some cases, exfoliative and vesiculobullous dermatitis, eosinophilia, anaphylactoid reactions.

    From the cardiovascular system: with rapid intravenous injection - lowering blood pressure, down to collapse; dizziness, weakness.

    At the injection site, the following are possible: irritation, soreness (at the site of the IM injection), thrombophlebitis (at the site of IV injection).

    Other: development of superinfection.

    Overdose:

    Overdose may increase the side effects.

    Treatment: symptomatic therapy, there is no specific antidote. Hemodialysis and peritoneal dialysis are ineffective.

    Interaction:

    Clindamycin increases (mutually) the effect of rifampicin, aminoglycosides streptomycin, gentamicin (especially in the treatment of osteomyelitis and the prevention of peritonitis after intestinal perforation).

    Strengthens the action of competitive muscle relaxants, and also enhances the muscle relaxation caused by n-holinoblokatorami.

    Incompatible with ampicillin, barbiturates, aminophylline, calcium gluconate and magnesium sulfate.

    It shows antagonism with erythromycin and chloramphenicol.

    It is not recommended simultaneous use with solutions containing a complex of B vitamins, aminoglycosides, phenytoin.

    Simultaneous administration with antidiarrheal drugs increases the risk of developing pseudomembranous colitis.

    With simultaneous use with opioid (narcotic) analgesics, it is possible to intensify the respiratory depression caused by them (up to apnea).

    Special instructions:

    Pseudomembranous colitis can occur both with the use of clindamycin, and 2-3 weeks after discontinuation of treatment (3-15% of cases); is manifested by diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by discharge with mucous masses of blood and mucus).

    If these phenomena occur 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 inwards or metronidazole.

    Do not use drugs that inhibit the intestinal motility.

    The safety of the drug in children under 3 years is not established.

    With prolonged therapy, children need periodic monitoring of the blood formula and the functional state of the liver.

    When prescribing the drug in high doses, it is necessary to monitor the concentration of clindamycin in the plasma.

    Patients with severe hepatic insufficiency need to monitor the function of the liver ("liver" enzymes).

    Form release / dosage:

    Solution for intravenous and intramuscular injection, 150 mg / ml.

    Packaging:

    2 ml of solution in a vial of colorless glass I of hydrolytic class.

    On the ampoule are painted: with a white paint - the first ring, with a blue paint - the second ring and a point for breaking the ampoule.

    By 5 ampoules per contour mesh PVC - a package with a coating of aluminum foil.

    2 contour mesh packages together with instructions for use in a cardboard pack.

    Storage conditions:

    Store in a dark place at a temperature of 15 to 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:П N014781 / 01
    Date of registration:10.06.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia
    Manufacturer: & nbsp
    Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia
    Information update date: & nbsp28.01.2018
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