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

    Active substance: lincomycin hydrochloride monohydrate in terms of lincomycin base - 300 mg / ml.

    Excipients: disodium edetate (disodium ethylenediamine-tetraacetic acid), water for injection.

    Description:Transparent colorless or with a yellowish tinge of 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 lincolnensis, has a bacteriostatic effect. Suppress protein synthesis of bacteria due to reversible binding to 50S subunit of ribosomes, disrupts the formation of peptide bonds.

    Sensitive in vivo: Staphylococcus aureus (penicillin-producing and non-producing strains), Streptococcus pneumoniae. Sensitive in vitro: aerobic gram-positive cocci - Streptococcus pyogenes, Streptococcus spp. groups viridans; aerobic Gram-positive sticks - Corynebacterium diphtheriae; anaerobic Gram-positive spore-forming sticks - Propionibacterium acnes; anaerobic gram-positive spore-forming sticks - Clostridium tetani, Clostridium perfringens. Ineffective in most strains Enterococcus faecalis; does not apply to Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae and other gram-negative bacteria, as well as fungi and viruses. The optimum action is in alkaline medium (pH 8-8.5). Resistance to lincomycin develops slowly. In high doses has a bactericidal effect.

    Pharmacokinetics:

    With a single intramuscular injection at a dose of 600 mg, the maximum concentration in the blood plasma is reached after 30 minutes. 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 lincomycin penetrates slightly, with meningitis - permeability increases. Partially metabolized in the liver. The half-life (T1 / 2) is 5 hours. It is excreted unchanged in the form of metabolites with bile and kidneys.

    Indications:

    Bacterial infections caused by microorganisms sensitive to lincomycin (primarily Staphylococcus spp. and Streptococcus spp., 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 infections and soft tissues (pyoderma, furunculosis, phlegmon, erysipelas).

    Contraindications:

    Hypersensitivity to lincomycin; hypersensitivity to other components of the drug, to clindamycin; severe hepatic and / or renal insufficiency; pregnancy (with the exception of cases,when it is necessary for "vital" indications), the period of breastfeeding, newborns (up to 1 month).

    Carefully:Fungal diseases of the skin, mucous membrane of the mouth, vagina; myasthenia gravis.
    Pregnancy and lactation:

    It is contraindicated to use during pregnancy (except for cases when it is necessary for "vital" indications) and during breastfeeding (during treatment breastfeeding should be discontinued).

    Dosing and Administration:

    Parenterally: intramuscularly and intravenously.

    The daily dose for adults with parenteral administration is 1.8 g, single dose - 0.6 g. In severe infection, the daily dose can be increased to 2.4 g. The drug is administered 3 times a day at intervals of 8 hours.

    Children over 1 month. prescribe intravenously in a daily dose of 10-20 mg / kg, regardless of age.

    Intravenous - only drip, at a speed of 60-80 drops per minute. Before the introduction of 2 ml of the drug (0.6 g) diluted with 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.

    Patients with renal and hepatic impairment lincomycin are administered parenterally in a daily dose not exceeding 1.8 g, with intervals between administrations of at least 12 hours.

    Side effects:

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

    From the hematopoiesis: reversible leukopenia, thrombocytopenic purpura, neutropenia, agranulocytosis, aplastic anemia and pancytopenia. Allergic reactions: urticaria, rash, exfoliative dermatitis, vesiculobullous dermatitis, angioedema, anaphylactic shock, erythema multiforme (Stephen-Johnson syndrome), serum sickness.

    On the part of the genitourinary system: renal dysfunction (azotemia, oliguria, proteinuria), vaginitis.

    From the sense organs: noise in the ears, vertigo.

    Local reactions: with intravenous injection - phlebitis, with intramuscular injection - soreness and compaction at the injection site.

    With rapid intravenous administration - lowering blood pressure, dizziness, general weakness, relaxation of skeletal muscles, stopping breathing and heart.With the use of the drug, candidiasis may occur, due to the chemotherapeutic effect of the drug.

    Overdose:

    Symptoms: increased manifestation of manifestations of dose-dependent adverse reactions. Treatment: symptomatic therapy, poorly removed with hemo- and peritoneal dialysis.

    Interaction:

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

    Antagonism - with erythromycin, penicillins, cephalosporins and chloramphenicol, synergism with aminoglycosides.

    Strengthens the effect of drugs for inhalation anesthesia, muscle relaxants and opioid analgesics, increasing the risk of neuromuscular blockade and stopping breathing.

    With the simultaneous use of theophylline with lincomycin, inhibitors of cytochrome P450 isoenzymes, the effectiveness of theophylline may increase, 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 mucous masses of blood and mucus) in mild cases, it is enough to cancel the drug and prescribe the appropriate treatment.

    Effect on the ability to drive transp. cf. and fur:When using lincomycin, it is impossible to exclude the possibility of dizziness and relaxation of skeletal muscles, so driving and other activities that require increased attention and reaction speed are not recommended.
    Form release / dosage:

    Solution for intravenous and intramuscular injection 300 mg / ml.

    Packaging:

    1 ml or 2 ml in ampoules. For 10 ampoules with instructions for use, with an ampoule or ampoule ampoule knife in a pack or box of cardboard.

    When packaging ampoules that have a break ring or an opening point, the ampoule knife or the ampoule scapegrator is not put in.

    5 ampoules in a cassette outline package.2 cassette contour packs with instructions for use in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of 18 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002309 / 01
    Date of registration:05.03.2009 / 10.02.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.09.2016
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