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

    Active substance: Lincomycin hydrochloride (in terms of linkomycin) - 300 mg / ml;

    Excipients: disodium edetate (disodium ethylenediaminetetraacetic acid), sodium hydroxide, water for injection.

    Description:Transparent colorless or slightly yellowish liquid with a slight specific odor.
    Pharmacotherapeutic group:Antibiotic-Lincosamide
    ATX: & nbsp

    J.01.F.F   Lincosamides

    J.01.F.F.02   Lincomycin

    Pharmacodynamics:

    Antibiotic, produced Streptomyces lincolniensis, has a bacteriostatic effect. Suppress protein synthesis of bacteria due to reversible binding to 50S subunit ribosome disrupts the formation of peptide bonds.

    Active against gram-positive cocci (Staphylococcus spp., Streptococcus spp., at e.g. Streptococcus pneumoniae); Bacillus anthracis, Mycoplasma spp., Corynebacterium diphtheriae, Clostridium perfringens, Clostridium tetani.

    Effective in relation to Staphylococcus spp., resistant to penicillin, tetracyclines, chloramphenicol, streptomycin, cephalosporins (30% Staphylococcus spp., resistant to erythromycin, have cross resistance to lincomycin).

    Does not apply to Enterococcus spp. (incl. Enterococcus faecalis), Gram-negative microorganisms, fungi, viruses, protozoa; is inferior in activity to erythromycin against spore forming anaerobes, Neisseria spp., Corynebacterium spp.

    The optimum action is in alkaline medium (pH 8.0-8.5). Resistance to lincomycin develops slowly. In high doses has a bactericidal effect.

    Pharmacokinetics:

    The time required to reach a maximum concentration of 2-3 hours. It penetrates well into the tissues of the lungs, liver, kidneys, through the placental barrier, into breast milk; in high concentrations found in bone tissue and joints. Through the blood-brain barrier (BBB) lincomycin penetrates slightly, with meningitis - permeability increases.

    Partially metabolized in the liver. Half-life is 5 hours. It is excreted unchanged in the form of metabolites with bile and kidneys.

    Indications:

    Infectious-inflammatory diseases caused by sensitive microorganisms (especially staphylococci and streptococci, especially microorganisms resistant to penicillins, as well as allergic to penicillins): sepsis, subacute septic endocarditis, lung abscess, pleural empyema, pleurisy, otitis, osteomyelitis (acute and chronic), purulent arthritis, postoperative purulent complications, wound infection, skin and soft tissue infections (pyoderma, furunculosis, phlegmon, erysipelas).

    Contraindications:

    Hypersensitivity to lincosamides, pregnancy (except for cases when it is necessary for "vital" indications),severe hepatic and / or renal insufficiency; lactation period, children's age (up to 1 month).

    Carefully:

    Fungal diseases of the skin, mucous membrane of the mouth, vagina; myasthenia gravis.

    Dosing and Administration:

    Parenterally: intravenously, intramuscularly.

    The daily dose for adults with parenteral administration is 1.8 g, single dose is 0.6 g. In severe infection, the daily dose can be increased to 2.4 g (in 3 divided doses at an interval of 8 h).

    Intravenously, children older than 1 month - in a daily dose of 10-20 mg / kg, regardless of age. Intravenous - only drip, at a rate of 60-80 cap / min. Before the introduction of 2 ml of a 30% solution (0.6 g) is diluted in 250 ml of 0.9% sodium chloride solution.

    Duration of treatment, depending on the form and severity of the disease is 7-14 days (with osteomyelitis - 3 weeks or more).

    With prolonged or repeated courses, treatment should be performed under the control of liver and kidney function.

    In renal-hepatic insufficiency parenteral should be used in a daily dose not exceeding 1.8 g, with an interval between administrations of at least 12 hours.

    Side effects:

    From the digestive system: nausea, vomiting, diarrhea, epigastric pain,glossitis, stomatitis, transient hyperbilirubinemia, increased activity of "liver" transaminases; with prolonged use - candidiasis of the gastrointestinal tract, pseudomembranous colitis.

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

    Allergic reactions: urticaria, exfoliative dermatitis, angioedema, anaphylactic shock.

    Local Reactions: with intravenous injection - phlebitis, intramuscular injection - irritation, infiltration and pain at the injection site.

    With rapid intravenous administration - lowering blood pressure, dizziness, asthenia, relaxation of skeletal muscles.

    Other: fungal infections of the urinary tract.

    Overdose:

    There is no information on overdose.

    Interaction:

    Pharmaceutically incompatible with kanamycin, ampicillin, barbiturates, theophylline, calcium gluconate, heparin and magnesium sulfate.

    Antagonism - with erythromycin, chloramphenicol, synergism - with aminoglycosides. Strengthens the effect of drugs for inhalation anesthesia, muscle relaxants and narcotic analgesics, increasing the risk of neuromuscular blockade and stopping breathing.

    When used concomitantly with lincomycin, an isoenzyme inhibitor CYP 1A2 cytochrome P450, the effect of theophylline may increase (decreases its clearance), which may require a reduction in its dose.

    Special instructions:

    To avoid the development of aseptic necrosis, it is better to inject deeply intramuscularly.

    Intravenous to enter without prior dilution is impossible.

    Against the background of long-term treatment, periodic monitoring of the activity of "liver" transaminases and kidney function is necessary.

    The appointment to patients with hepatic insufficiency is permissible only for "vital" indications.

    If there are signs of pseudomembranous colitis (diarrhea, leukocytosis, fever, abdominal pain, discharge with blood and mucus calves) in mild cases, it is sufficient to discontinue the preparation and prescribe ion-exchange resinscolestramine), in severe cases, compensation for loss of fluid, electrolytes and protein, vancomycin inside in a daily dose of 0.5-2 g (for 3-4 doses) for 10 days.

    Form release / dosage:

    Solution for intravenous and intramuscular injection 300 mg / ml.

    Packaging:

    2 ml into neutral glass ampoules.

    5 ampoules with the drug in a contour cell package.

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

    In the pack, insert the ampoule knife or scarifier (when packing ampoules with a ring, a notch or a break point, the knife is ampoule or the scarifier does not put it).

    Storage conditions:

    In 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:LSR-001561/10
    Date of registration:02.03.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Company DEKO, LLC Company DEKO, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.04.2018
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