LyncoWel capsules 250mg, 40pcs

Composition

Per capsule: Active ingredient: lincomycin hydrochloride monohydrate-283.5 mg (in terms of lincomycin-250.0 mg).

Excipients: potato starch, sucrose (powdered sugar).

Composition of the gelatin capsule: lid: gelatin, sunset yellow, quinoline yellow, titanium dioxide; body: gelatin, titanium dioxide.

Pharmacological action

Pharmacotherapeutic group: antibiotic-lincosamide

ATX code: [J01FF02]

Pharmacological properties

Pharmacodynamics

The antibiotic produced by Streptomyces lincolnensis has a bacteriostatic effect. Inhibits bacterial protein synthesis due to reversible binding to the 50S subunit of ribosomes, disrupts the formation of peptide bonds.

Sensitive in vivo: Staphylococcus aureus (penicillinase-producing and non-producing strains), Staphylococcus epidermidis, Streptococcus pneumoniae.

Sensitive in vitro: aerobic gram-positive microorganisms-Streptococcus pyogenes, Streptococcus spp. of the viridans group, Corynebacterium diphtheriae; anaerobic gram-positive microorganisms-Propionibacterium acnes, Clostridium tetani, Clostridium perfrigens.

It is effective against Staphylococcus spp., resistant to penicillin, tetracycline, chloramphenicol, streptomycin, cephalosporins (30% of Staphylococcus spp., resistant to erythromycin, have cross-resistance to lincomycin).

It has no effect on Enterococcus spp. (including Enterococcus faecalis); Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, and other gram-negative bacteria, as well as fungi, viruses, and protozoa.

The optimum action is found in an alkaline environment (pH 8-8.5).

Resistance to lincomycin develops slowly. In high doses, it has a bactericidal effect.

There is cross-resistance between lincomycin and clindamycin.

Pharmacokinetics

Absorption – 30-40% (food intake slows down the rate and degree of absorption). The time to reach the maximum concentration of the drug in plasma (TCmax) is 2-3 hours. It penetrates well into the tissues of the lungs, liver, kidneys, through the placental barrier, into breast milk. It is found in high concentrations in bone tissue and joints. Lincomycin penetrates only slightly through the blood-brain barrier, with meningitis, the permeability increases. However, the concentration of lincomycin in the cerebrospinal fluid is insufficient for the treatment of meningitis. It is metabolized in the liver. It is excreted unchanged and in the form of metabolites through the gastrointestinal tract and in the urine.

The elimination half-life is about 5 hours. In liver and kidney diseases, the elimination half-life increases, and there is a significant individual variability in the dynamics of the concentration of lincomycin in blood plasma. In case of renal failure (end-stage), the half-life is 10-20 hours, in case of liver dysfunction-8-12 hours.

It is excreted unchanged and as metabolites in the bile and kidneys.

Elderly patients. Pharmacokinetics in elderly patients with normal liver and kidney function corresponds to the pharmacokinetics of adult patients.

Indications

Bacterial infections caused by lincomycin-sensitive microorganisms (primarily Staphylococcus spp. and Streptococcus spp., especially penicillin-resistant microorganisms, as well as penicillin allergy): sepsis, subacute septic endocarditis, lung abscess, pleural empyema, pleurisy, otitis media, osteomyelitis (acute and chronic), purulent arthritis, postoperative purulent complications, wound infection, skin and soft tissue infections (pyoderma, furunculosis, phlegmon, erysipelas).

Use during pregnancy and lactation

Since there are no data on the safety of the drug for the fetus, the use of the drug during pregnancy is possible only if the benefit to the mother exceeds the potential risk to the fetus.

During the period of breastfeeding, you should decide whether to stop breastfeeding for the duration of treatment with the drug.

Contraindications

Hypersensitivity to lincomycin; hypersensitivity to other components of the drug, to clindamycin; severe hepatic and/or renal failure; sucrose deficiency; pregnancy (except in cases where this is necessary for “vital” indications), breastfeeding, children under 3 years of age and body weight less than 20 kg (for this dosage form).

With caution

Fungal diseases of the skin, oral mucosa, and vagina; diabetes mellitus; moderate hepatic / renal insufficiency; diseases of the gastrointestinal tract, especially colitis, in the anamnesis; myasthenia gravis; concomitant use with drugs that block neuromuscular conduction.

Side effects

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

Skin disorders: rash, exfoliative or vesiculobullous dermatitis, erythema multiforme (Stevens-Johnson syndrome).

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

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, itchy anus, glossitis, stomatitis, jaundice, transient hyperbilirubinemia, increased activity

of “hepatic” transaminases; with prolonged use-candidiasis of the gastrointestinal tract, pseudomembranous colitis.

Hematopoietic disorders: reversible leukopenia, thrombocytopenic purpura, neutropenia, agranulocytosis, aplastic anemia, and pancytopenia.

From the side of the senses: tinnitus, vertigo.

If any of the side effects listed in the instructions get worse, or you notice any other side effects that are not listed in the instructions, tell your doctor.

Interaction

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

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

Increases the effect of drugs for inhalation anesthesia, muscle relaxants and opioid analgesics, increasing the risk of neuromuscular blockage and respiratory arrest.

When used concomitantly with lincomycin, an inhibitor of P450 isoenzymes, theophylline’s potency may increase. In this case, a reduction in the dose of theophylline is required.

How to take, course of use and dosage

The daily dose for adults and children over 12 years of age is 1-1.5 g, a single dose is 0.5 g. Inside,1-2 hours before meals or 2-3 hours after meals, abundantly washed down with water,2-3 times a day with an interval of 8-12 hours.

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

Overdose

Symptoms: increased dose-dependent side effects may occur.

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

Poorly removed during hemo – and peritoneal dialysis.

Description

Solid gelatin capsules No. 0 with a white body and a yellow cap. The contents of the capsules are white powder.

Special instructions

When using lincomycin, you should take into account the official national guidelines for the proper use of antibacterial drugs, as well as the sensitivity of pathogens in a particular country.

Against the background of long-term treatment, periodic monitoring of the activity of “hepatic” transaminases and kidney function is necessary (if violations are detected, discontinuation of the drug should be considered).

use to patients with hepatic insufficiency is permissible only for “vital” indications.

Lincomycin should be used with caution in patients with a history of gastrointestinal diseases, especially colitis. If signs of pseudomembrane colitis appear (diarrhea, leukocytosis, fever, abdominal pain, excretion of blood and mucus with feces), in mild cases, it is sufficient to cancel the drug and prescribe ion exchange resins (colestyramine), in severe cases, compensation for loss of fluid, electrolytes and protein is indicated, vancomycin – inside, in a daily dose of 0.5-2 g (in 3-4 doses) for 10 days or bacitracin. The use of drugs that inhibit intestinal motility is contraindicated.

Lincomycin is not indicated for the treatment of meningitis, as its concentration in the cerebrospinal fluid is insufficient for the treatment of meningitis.

It is not recommended to use lincomycin in patients with diabetes mellitus, unless there is no alternative treatment, since there are no adequate data on the treatment of patients with endocrine or metabolic diseases.

The half-life of lincomycin may be prolonged in patients with impaired liver and kidney function, so caution should be exercised when prescribing lincomycin to patients with moderate hepatic / renal insufficiency and monitoring the concentration of lincomycin in the blood during therapy with high doses of lincomycin. In such patients, the possibility of reducing the frequency of drug use should be considered.Use in severe hepatic / renal insufficiency is contraindicated.

As with other antimicrobial agents, lincomycin may develop a secondary infection associated with the growth of microorganisms resistant to the drug (especially fungi), which should be re-evaluated to exclude and confirm the patient’s condition. If a secondary infection occurs during therapy, the necessary measures should be taken to treat it.

Lincomycin should be used with caution in patients with existing fungal diseases, such patients should also be prescribed antifungal therapy.

Severe bullous reactions, such as Stevens-Johnson syndrome, have been reported with lincomycin. Patients should be advised that if skin reactions and/or mucosal lesions develop, they should immediately consult a doctor before continuing treatment with lincomycin.

Allergic reactions that may progress to a life-threatening condition have been reported with lincomycin. In these cases, the use of lincomycin should be discontinued and appropriate treatment should be initiated.

Lincomycin is characterized by neuromuscular blocking activity and may increase muscle weakness in patients with pseudoparalytic myasthenia gravis. The use of lincomycin in patients with an established diagnosis of pseudoparalytic myasthenia gravis is not recommended.

Neutropenia and/or leukopenia have been reported during lincomycin treatment, so periodic monitoring of the blood test is recommended during therapy.

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 (with a body weight of 20 kg to 40 kg), the maximum daily dose of 2 g contains 0.0035 XE.

Influence on the ability to drive vehicles and mechanisms

When using lincomycin, it is impossible to exclude the possibility of dizziness and relaxation of skeletal muscles, so driving vehicles and other activities that require increased attention and reaction speed are not recommended.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C. Keep out of reach of children.

Shelf

life is 3 years.

Do not use after the expiration date.

Active ingredient

Lincomycin

Conditions of release from pharmacies

By prescription

Dosage form

Capsules