Active substanceLincomycinLincomycin
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  • Dosage form: & nbspcapsules
    Composition:

    Per one capsule:

    Lincomycin hydrochloride monohydrate

    283.5 mg

    in terms of linkomycin

    250.0 mg

    Auxiliary substances:

    Sucrose

    52.5 mg

    Potato starch

    10.5 mg

    Magnesium stearate

    3.5 mg

    Capsule body composition

    titanium dioxide

    2,0 %

    gelatin

    up to 100%

    Composition of cap capsule

    dye azorubin

    0,0016 %

    dye diamond black

    0,0958 %

    dye blue patented

    0,1642 %

    quinoline yellow dye

    1,1496 %

    titanium dioxide

    1,3333 %

    gelatin

    up to 100%

    Description:

    Hard gelatin capsules № 0: the case of white color is opaque, The lid of green color is opaque.

    The contents of capsules are a mixture of powder and granules of white or almost white color with a weak characteristic odor. It is allowed to compact the contents of the capsules into lumps that are easily disintegrating when pressed.

    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 of ribosomes, disrupts the formation of peptide bonds.

    To lincomycin are sensitive:

    - in vivo: Staphylococcus aureus (penicillin-producing and non-producing strains), Staphylococcus epidermidis, Streptococcus pneumoniae;

    - in vitro: Streptococcus pyogenes, Streptococcus spp. groups viridans, Corynebacterium diphtheriae, Propionibacterium acnes, 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), Neisseria gonorrhoeae, Neisseria meningitides, Haemophilus influenzae and other gram-negative microorganisms, as well as fungi, viruses, protozoa.

    The optimum action is in alkaline medium (pH 8-8.5). Resistance to lincomycin develops slowly.In high doses has a bactericidal effect.

    Pharmacokinetics:

    Absorption - 30-40% (eating slows down speed and degree of absorption). Time to reach the maximum concentration of the drug in plasma (TCmAh) 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. The half-life of the drug (T1/2) is 5 hours, but this period may be prolonged if there is a violation of the liver and / or kidney function. It is excreted unchanged in the form of metabolites with bile and kidneys.

    Indications:

    Bacterial infections caused by sensitive to lincomycin microorganisms (especially with allergies to penicillins): abscess of the lung, empyema of the pleura, 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 lincomycin, clindamycin, other components of the drug;

    - deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption (since the preparation contains sucrose);

    - Pregnancy (except for cases when it is necessary for "vital" indications);

    - severe hepatic and / or renal insufficiency;

    - the period of breastfeeding;

    - Children under 3 years of age and body weight less than 20 kg (for this dosage form).

    Carefully:

    In fungal diseases of the skin, mucous membranes of the oral cavity and vagina, diabetes mellitus, hepatic / renal failure of moderate severity, gastrointestinal tract diseases, especially colitis, in the anamnesis.

    Pregnancy and lactation:

    The use during pregnancy is contraindicated (except when it is necessary for "vital" indications). If it is necessary to use during lactation, breastfeeding should be abolished.

    Dosing and Administration:

    Inside, 1-2 hours before meals or 2-3 hours after eating, drink plenty of water, 2-3 times a day at intervals of 8-12 hours. For adults and children over 12 years of age, the daily dose is 1-1.5 g, single-dose 0.5 g.

    For children from 3 years to 12 years (with a body weight of 20 kg to 40 kg) daily dose of 30-60 mg / kg. Duration of treatment, depending on the form and severity of the disease is 7-14 days (with osteomyelitis - 3 weeks or more).

    Side effects:

    From the gastrointestinal tract: nausea, vomiting, diarrhea, epigastric pain. abdominal pain, glossitis, stomatitis, transient hyperbilirubinemia, impaired liver function, including increased activity of "hepatic" transaminases, jaundice, pruritus anus; with prolonged use - candidiasis of the gastrointestinal tract, colitis, including pseudomembranous colitis.

    On the part of the organs of hematopoiesis: reversible leukopenia, neutropenia, thrombocytopenic purpura, agranulocytosis, aplastic anemia, pancytopenia.

    Allergic reactions: urticaria, angioedema, anaphylactic shock, serum sickness.

    From the skin: rash, exfoliative or vesicle-bullous dermatitis, erythema multiforme (including Stevens-Johnson syndrome).

    From the genitourinary system: fungal infections of the genital tract, impaired renal function (azotemia, oliguria, proteinuria).

    Other: noise in the ears, vertigo.

    Overdose:

    Symptoms: may increase dose-related side effects.

    Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy. There is no specific antidote.

    Interaction:

    Antagonism - with erythromycin, chloramphenicol, ampicillin and other bactericidal antibiotics, synergism with aminoglycosides.

    Antidiarrhoeal drugs reduce the effect of lincomycin (the interval between their use should be at least 4 hours).

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

    When used simultaneously with lincomycin, inhibitor of isoenzymes P450, the effect of theophylline may increase. In this case, a reduction in the dose of theophylline is required.

    Special instructions:

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

    Use in patients with hepatic insufficiency is permissible only for "vital" indications.

    When there are signs of pseudomembranous colitis (diarrhea, leukocytosis, fever, abdominal pain,excretion with mucous masses of blood and mucus) in mild cases, it is sufficient to discontinue the preparation and assign ion-exchange resinscolestramine), in severe cases, compensation for loss of fluid, electrolytes and protein, vancomycin - Inward, in a daily dose of 0.5-2 g (for 3-4 doses) for 10 days or bacitracin. Contraindicated use of drugs that inhibit intestinal peristalsis.

    One capsule contains 0.004375 XE. For adults and children over 12 years of age, the maximum daily dose of 1.5 g contains 0.02625 XE. For children from 3 years to 12 years (with a body weight of 20 kg to 40 kg), the maximum daily dose of 2 g contains 0.035 XE.

    Effect on the ability to drive transp. cf. and fur:Data on the effect of lincomycin on the ability to drive vehicles, mechanisms, engage in other activities that require concentration and speed of psychomotor reactions are not.
    Form release / dosage:

    Capsules 250 mg.

    Packaging:

    For 5, 6, 10 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 10, 20, 30, 40, 50 or 100 capsules in cans of polyethylene terephthalate for medicines, sealed with caps screwed on with controlthe first opening or the "push-turn" system of polypropylene or polyethylene or polypropylene cans for drugs sealed with lids pulled with the control of the first opening from polyethylene or cans of polypropylene for drugs sealed with lids pulled with the control of the first opening of high pressure polyethylene.

    One jar or 1, 2, 3, 4 or 5 contour squares, together with the instruction for use, is placed in a cardboard package (bundle).

    Storage conditions:

    In a dark place at a temperature of no higher than 25 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:LP-003680
    Date of registration:14.06.2016
    Expiration Date:14.06.2021
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.04.2018
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