Composition, form of production and packaging
Capsules в„–00 with a white casing and a yellow lid, the contents of capsules - a granular powder of white or almost white color.
1 caps.
lincomycin (in the form of hydrochloride monohydrate) 250 mg
Excipients: lactulose - 300 mg, povidone low molecular weight - 10 mg, talc - 10 mg, magnesium stearate - 5 mg, potato starch - up to 650 mg.
Composition of the capsule shell: gelatin, water, titanium dioxide, dye quinoline yellow, dye sunset yellow.
5 pieces. - packings cellular planimetric (2) - packs cardboard.
5 pieces. - packings cellular planimetric (4) - packs cardboard.
20 pcs. - plastic bottles (1) - packs of cardboard.
20 pcs. - polymer cans (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The antibiotic produced by Streptomyces lincolniensis has a bacteriostatic effect. Suppress protein synthesis of bacteria due to reversible binding to the 50S subunit of ribosomes, disrupts the formation of peptide bonds.
It is active against gram-positive cocci (Staphylococcus spp., Streptococcus spp., Including Streptococcus pneumoniae); Haemophilus influenzae; Bacillus anthracis, Mycoplasma spp., Bacteroides spp., Corynebacterium diphtheriae, Clostridium perfringens, Clostridium tetani.
Effective against Staphylococcus spp., Resistant to penicillin, tetracyclines, chloramphenicol streptomycin, cephalosporins (30% Staphylococcus spp., Resistant to erythromycin, have cross resistance to lincomycin).
Does not affect Enterococcus spp. (including 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
Absorption - 30-40% (eating slows down speed and degree of absorption). The time to reach C max is 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, lincomycin penetrates only slightly, with meningitis - the permeability increases.
Partially metabolized in the liver. T 1/2 - 5 hours. It is excreted unchanged in the form of metabolites with bile and kidneys.
INDICATIONS
Infectious-inflammatory diseases caused by sensitive microorganisms (primarily, staphylococci and streptococci, especially microorganisms resistant to penicillins, as well as allergic to penicillins):
- sepsis;
- subacute septic endocarditis;
- chronic pneumonia;
- abscess of the lung;
- empyema of the pleura;
- pleurisy;
otitis media;
- osteomyelitis (acute and chronic);
- purulent arthritis;
- postoperative purulent complications;
- wound infection;
- infections of the skin and soft tissues (pyoderma, furunculosis, phlegmon, erysipelas).
DOSING MODE
Inside, 1-2 hours before or 2-3 hours after meals, 2-3 times a day at intervals of 8-12 hours. For adults, the daily dose is 1-1.5 g, single-dose 0.5 g. For children aged 3 to 14, the daily dose is 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).
With prolonged or repeated courses, treatment should be performed under the control of liver and kidney function.
SIDE EFFECT
On the part of the digestive system: nausea, vomiting, diarrhea, epigastric pain, abdominal pain, glossitis, stomatitis, transient hyperbilirubinemia, increased activity of "liver" transaminases; at long application - a candidiasis GASTROINTESTINAL TRACT, a pseudomembranous enterocolitis.
Other fungal infections of the genital tract.
From the hematopoiesis: reversible leukopenia, thrombocytopenia, neutropenia.
Allergic reactions: urticaria, exfoliative dermatitis, angioedema, anaphylactic shock.
CONTRAINDICATIONS
hypersensitivity;
- Pregnancy (except for cases when it is necessary for "vital" indications),
- lactation period;
- severe hepatic and / or renal insufficiency;
- Children under 3 years old.
With caution: fungal diseases of the skin, mucous membrane of the mouth, vagina.
PREGNANCY AND LACTATION
Contraindicated during pregnancy, except when necessary for "vital" indications.
Contraindicated in the period of lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure.
Against the background of long-term treatment, periodic monitoring of the activity of "liver" transaminases and kidney function is necessary.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency.
The appointment to patients with hepatic insufficiency is permissible only for "vital" indications.
APPLICATION FOR CHILDREN
Contraindicated for children under 3 years.
SPECIAL INSTRUCTIONS
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 of ion-exchange resins (colestyramine), in severe cases, compensation for loss of fluid, electrolytes and protein, vancomycin - inside, in a daily dose of 0.5-2 g (3-4 times) for 10 days or bacitracin.
OVERDOSE
There is no evidence of an overdose of the drug.
DRUG 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, an inhibitor of P450, the serum concentration of theophylline may increase and this will require a reduction in its dose.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
List B. In a dry, the dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 4 years.
