Lincomycin hydrochloride-Vial - instructions for use, dose, side effects, contraindications

Composition:Active substance: Lincomycin hydrochloride monohydrate (in terms of lincomycin base) - 300 mg, Excipients: water for injection - up to 1.0 ml.

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 of ribosomes, disrupts the formation of peptide bonds.

Active against gram-positive cocci (Staphylococcus spp., Streptococcus spp., in t.ch. Streptococcus pneumoniae); Haemophilus influenzae; Bacillus anthracis, Mycoplasma spp., Bacteroides 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 - 8.5). Resistance to lincomycin develops slowly. In high doses has a bactericidal effect.

Pharmacokinetics:

Time required to achieve the maximum concentration is 2 to 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 lincomycin penetrates slightly, with meningitis - permeability increases.

Partially metabolized in the liver. The 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, chronic pneumonia, 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, severe hepatic and / or renal insufficiency; children's age (up to 1 month).

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

Pregnancy and lactation:

The use of the drug during pregnancy is possible only in cases where the intended use for the mother exceeds the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be solved.

Dosing and Administration:

Parenteral: intravenously (intravenously), intramuscularly (IM).

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 - in a daily dose 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 the drug (0.6 g) diluted with 250 ml of 0.9% sodium chloride solution.

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

From the hematopoiesis: reversible leukopenia, thrombocytopenia, neutropenia.

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

Local reactions: with iv introduction - phlebitis, with the / m introduction - soreness and compaction at the injection site.

Rarely: agranulocytosis, aplastic anemia, pancytopenia.

With a rapid on / in the introduction - lowering blood pressure (BP), dizziness, general weakness, relaxation of skeletal muscles.

Interaction:

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

Antagonism - with erythromycin, synergism - with aminoglycosides.

Strengthens the neuromuscular blockade caused by muscle relaxants (especially with parenteral administration).

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.

When there are signs of pseudomembranous enterocolitis (diarrhea, leukocytosis, fever, abdominal pain, discharge with mucous masses of blood and mucus) in mild cases, it is sufficient to cancel the drug and the appointment ion exchange resins (colestramine), in severe cases, compensation for loss of fluid, electrolytes and protein, vancomycin - inside, at a daily dose of 0.5-2 g (for 3 to 4 doses) for 10 days or bacitracin.

Form release / dosage:

Solution for intravenous and intramuscular injection 300 mg / ml.

Packaging:

1 ml of the drug into neutral glass ampoules with a notch.

10 ampoules of the drug are placed in a contour mesh package made of a polyvinyl chloride film. 1 circuit cell pack together with the instruction for use is placed in a cardboard pack.

Storage conditions:

In a dry, protected from light 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 expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000590/09

Date of registration:29.01.2009 / 20.12.2013

Expiration Date:Unlimited

The owner of the registration certificate:VIAL, LLC VIAL, LLC Russia

Manufacturer: & nbsp

SHANDONG SHENGLU PHARMACEUTICAL, Co.Ltd China

Information update date: & nbsp10.04.2018

Illustrated instructions

Instructions

Lincomycin hydrochloride-Vial (Lincomycin hydrochloride-Vial)