The need to supplement the instructions for the use of medicinal products with the following information is revealed:
1. In the section "Pharmacological properties" the subsection "Pharmacodynamics" should be specified in the wording:
"The 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), Staphylococcus epidermidis, Streptococcus pneumoniae.
Sensitive in vitro: aerobic Gram-positive microorganisms - Streptococcus pyogenes, Streptococcus spp. groups viridans, Corynebacterium diphtheriae; anaerobic Gram-positive microorganisms - Propionibacterium acnes, Clostridium tetani, Clostridium perfringens.
Effective in relation to Staphylococcus spp., resistant to penicillin, tetracycline, 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 meningitidis, Haemophilus influenzae and others gram-negative bacteria, 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.
There is cross-resistance between lincomycin and clindamycin. "
2. In the section "Pharmacological properties" subsection "Pharmacokinetics" add:
"With a 120-minute intravenous injection of 600 mg of lincomycin, the therapeutic concentration is maintained for 14 hours"; "In diseases of the liver and kidneys, the elimination half-life increases, there is a significant individual variability in dynamics concentrations of lincomycin in the blood plasma. With renal failure (terminal stage), the half-life period is 10-20 hours, with violations of liver function - 8-12 hours ";" Hemodialysis and peritoneal dialysis ineffective ";" Pharmacokinetics in elderly people with normal liver and kidney functioncorresponds to the pharmacokinetics of adult patients. "
Information on meningitis is added: "However, concentrations Linkomycin in cerebrospinal fluid are not sufficient for the treatment of meningitis. "
3. In the section "Indications for use", the information should be indicated in "Bacterial infections caused by sensitive to lincomycin microorganisms (first of all Staphylococcus spp. and Streptococcus spp., especially microorganisms resistant to penicillins, as well as allergies to penicillin): sepsis, subacute bacterial endocarditis, lung abscess, empyema, pleural effusion, otitis media, osteomyelitis (acute and chronic), purulent arthritis, postoperative septic complications, wound infection, skin and soft tissue infections (pyoderma , furunculosis, phlegmon, erysipelas). "
4. In the section "Contraindications" the information specified in the wording: "Hypersensitivity to lincomycin, clindamycin, or to other components of the drug, severe hepatic and / or renal failure, pregnancy (except in cases when it is necessary for" real life "testimony), breastfeeding , newborns (up to 1 month). "
5. In the "Precautions" section, please indicate the information in the editorial office: "Fungal diseases of the skin, mucous membrane of the oral cavity, the vagina; myasthenia gravis; simultaneous use with drugs that block neuromuscular conduction; diabetes; hepatic / renal failure of moderate severity; diseases of the gastrointestinal tract, especially colitis, in the anamnesis. "
6. In the section "Application during pregnancy and during breastfeeding" the information should be indicated in the wording:
"It is contraindicated to use during pregnancy (except when necessary for" vital "indications) and during breastfeeding (during treatment, breastfeeding should be discontinued)."
7. In the section "Side effect" the information should be indicated in the wording:
"From the digestive system: nausea, vomiting, diarrhea, pain at abdomen, 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, purpura, neutropenia, agranulocytosis, aplastic anemia and pancytopenia.
Allergic reactions: itching, urticaria, rash, exfoliative dermatitis, vesicle-bullous dermatitis, angioedema, anaphylactic shock, erythema multiforme (Stevens-Johnson syndrome), serum sickness.
From the genitourinary system: impaired renal function (azotemia, oliguria, proteinuria), vaginitis.
From the sense organs: noise in the ears, vertigo.
Local reactions: with intravenous administration - thrombophlebitis; when administered intramuscularly - local irritation, soreness, formation of a seal and a sterile abscess at the injection site.
With rapid intravenous administration - lowering blood pressure, dizziness, headache, drowsiness, general weakness, relaxation of skeletal muscles, stopping breathing and heart. "
8. In the section "Overdose" the information should be indicated in the wording: "Symptoms: increased manifestations of dose-dependent undesirable reactions.
Treatment: symptomatic therapy, poorly removed with hemo- and peritoneal dialysis. "
9. In the section "Interaction with other medicinal products" the information should be indicated in the wording:
"Pharmaceutically incompatible with kanamycin, ampicillin, barbiturates, theophylline, calcium gluconate, heparin and magnesium sulfate.
Antagonism - with erythromycin, penicillins, cephalosporins and chloramphenicol, ampicillin and other bactericidal antibiotics, 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, an inhibitor of cytochrome P450 isoenzyme, the effectiveness of theophylline may increase, which may require a reduction in its dose. "
10. In the section "Special instructions" add:
"When using lincomycin, official national recommendations on the proper use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country, should be taken into account"; "Lincomycin should be administered with caution to patients with diseases of the gastrointestinal tract, especially colitis, in an anamnesis"; "Lincomycin is not indicated for the treatment of meningitis, since its concentration in the cerebrospinal fluid is insufficient for the treatment of meningitis"; "It is not recommended to apply lincomycin in patients with diabetes mellitus, except in the absence of alternative treatment, because there is no adequate data on the therapy of patients with endocrine or metabolic diseases. "" The half-life of lincomycin may be increased in patients with impaired liver and kidney function, so care should be taken when administering lincomycin to patients with hepatic / renal insufficiency of moderate severity and control the concentration of lincomycin in the blood during high-dose therapy with a link Icin. In such patients, the possibility of reducing the frequency of administration of the drug should be considered. Use in severe hepatic / renal failure is contraindicated. "" As with the use of other antimicrobials with lincomycin, especially prolonged, it is possible to develop a secondary infection associated with the growth of resistant to the preparation of microorganisms (especially fungi), to exclude and confirm which should be repeated assessment of the patient's condition. If a secondary infection occurs during therapy,should take the necessary measures for its treatment, "" Lincomycin should be used with caution in patients with existing fungal diseases, such patients should also prescribe antifungal therapy ";" In the application of lincomycin reported with severe bullous reactions such as Stevens-Johnson syndrome. Patients should be informed that in the development of skin reactions and / or mucosal lesions, you should immediately consult a doctor before you continue treatment lincomycin ";" In the application of lincomycin reported the development of allergic reactions, which may progress to a life-threatening condition. In these cases, the use of lincomycin should be discontinued and appropriate treatment initiated. ";" Lincomycin is characterized by neuromuscular blocking activity and may increase muscle weakness in patients with pseudo-paralytic myasthenia gravis. The use of lincomycin in patients with established diagnosis of pseudo-paralytic myasthenia is not recommended. "" There have been reports of cases of development of neutropenia and / or leukopenia during the treatment with lincomycin, therefore periodic monitoring of the blood test is recommended during therapy. "
The information on monitoring the kidney function should be supplemented: "If violations are detected, the possibility of discontinuing the drug should be considered."
11. In the section "Influence on the ability to drive vehicles, mechanisms," specify the information in the wording:
"With the use of lincomycin, it is impossible to exclude the possibility of dizziness and relaxation of skeletal muscles, so driving and other activities requiring increased attention and reaction speed are not recommended."