Lincomycin Ecolinkom® capsules 250mg

Instructions for use Lincomycin Ecolinkom® capsules 250mg

Trade name: Lincomycin Ecolinkom^®

International nonproprietary or grouping name: lincomycin

Dosage form: capsules

Composition per one capsule:

Active substance: lincomycin hydrochloride monohydrate – 283.5 mg (equivalent to lincomycin) – 250.0 mg.

Excipients: Lactitol – 300.0 mg, low molecular weight povidone (K-17) – 10.0 mg, talc – 10.0 mg, magnesium stearate – 5.0 mg, potato starch – up to a capsule content weight of 650.0 mg.

Capsule shell: gelatin, titanium dioxide.

Description:

Hard gelatin capsules size No. 00 with white body and cap. The capsule contents are a granulated white or almost white powder.

Pharmacotherapeutic group: antibiotic - lincosamide.

ATC code: J01FF02.

Pharmacological properties

Pharmacodynamics:

An antibiotic produced by Streptomyces lincolnensis, it has a bacteriostatic effect. It inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunit, disrupting 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. viridans group, Corynebacterium diphtheriae. Anaerobic Gram-positive microorganisms: Propionibacterium acnes, Clostridium tetani, Clostridium perfringens.

Effective against Staphylococcus spp. resistant to penicillin, tetracyclines, chloramphenicol, streptomycin, cephalosporins (30 % of Staphylococcus spp. resistant to erythromycin show cross-resistance to lincomycin).

Does not act on Enterococcus spp. (including Enterococcus faecalis), Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae and other Gram-negative bacteria, as well as fungi, viruses, protozoa. The optimum action is 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 the rate and extent of absorption). Time to reach maximum plasma concentration (T_max) - 2-3 hours. Penetrates well into tissues of the lungs, liver, kidneys, crosses the placental barrier, into breast milk. Found in high concentrations in bone tissue and joints. Lincomycin penetrates the blood-brain barrier poorly; permeability increases with meningitis. However, lincomycin concentrations in the cerebrospinal fluid are insufficient for treating meningitis.

Metabolized in the liver. Excreted unchanged and as metabolites via the gastrointestinal tract and urine. The half-life is about 5 hours.

In liver and kidney diseases, the half-life increases, with significant individual variability in the dynamics of lincomycin plasma concentration. In renal failure (end-stage) the half-life is 10-20 hours, in liver dysfunction - 8-12 hours.

Elderly patients

Pharmacokinetics in elderly individuals with normal liver and kidney function corresponds to that in adult patients.

Indications for use:

Bacterial infections caused by microorganisms sensitive to lincomycin (primarily Staphylococcus spp. and Streptococcus spp., especially microorganisms resistant to penicillins, as well as in cases of 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).

Contraindications:

Hypersensitivity to lincomycin or any other component of the drug, to clindamycin; severe hepatic and/or renal failure; pregnancy (except when necessary for "vital" indications), breastfeeding period, 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, vagina; diabetes mellitus; moderate hepatic/renal insufficiency; history of gastrointestinal diseases, especially colitis; myasthenia gravis; concurrent use with drugs blocking neuromuscular transmission.

Use during pregnancy and breastfeeding:

Use during pregnancy is contraindicated (except when necessary for "vital" indications). If use during lactation is necessary, breastfeeding should be discontinued.

Dosage and administration:

Orally, 1-2 hours before meals or 2-3 hours after meals, swallowed with plenty of water, 2-3 times a day at 8-12 hour intervals. For adults and children over 12 years: The daily dose is 1-1.5 g, the single dose is 0.5 g. For children from 3 to 12 years (with body weight from 20 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).

During long-term or repeated courses, treatment should be monitored for liver and kidney function.

Adverse effects:

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

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

Urinary and genital system disorders: fungal infections of the genital tract, vaginitis, impaired renal function (azotemia, oliguria, proteinuria).

Gastrointestinal disorders: nausea, vomiting, diarrhea,  abdominal pain, anal itching, glossitis, stomatitis, jaundice, transient hyperbilirubinemia, increased activity of "liver" transaminases; with prolonged use - gastrointestinal candidiasis, pseudomembranous colitis.

Blood and lymphatic system disorders: reversible leukopenia, thrombocytopenic purpura, neutropenia, agranulocytosis, aplastic anemia and pancytopenia.

Ear and labyrinth disorders: tinnitus, vertigo.

If any of the adverse effects mentioned in the instructions worsen, or if any other adverse effects not listed in the instructions are noticed, inform your doctor.

Overdose:

Symptoms: possible intensification of dose-dependent adverse effects.

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy. There is no specific antidote. Poorly removed by hemodialysis and peritoneal dialysis.

Drug interactions:

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

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

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

With simultaneous use with lincomycin, an inhibitor of P450, the serum concentration of theophylline may increase, which may require a dose reduction.

Special instructions:

When using lincomycin, official national recommendations on the appropriate use of antibacterial drugs, as well as the sensitivity of pathogens in a particular country, should be taken into account.

During long-term treatment, periodic monitoring of "liver" transaminase activity and kidney function is necessary (if abnormalities are detected, the possibility of discontinuing the drug should be considered).

Prescription for 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 pseudomembranous colitis appear (diarrhea, leukocytosis, fever, abdominal pain, passage of blood and mucus in stools), in mild cases, discontinuation of the drug and administration of ion-exchange resins (cholestyramine) may be sufficient; in severe cases, replacement of fluid, electrolyte and protein losses is indicated, as well as oral vancomycin at a daily dose of 0.5-2 g (in 3-4 doses) for 10 days or bacitracin.

The use of drugs that inhibit intestinal peristalsis is contraindicated.

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

It is not recommended to use lincomycin in patients with diabetes mellitus, except in cases where there is no alternative treatment, due to the lack of adequate data on therapy for 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 monitor lincomycin blood levels during high-dose therapy. In such patients, the possibility of reducing the frequency of administration should be considered. Use in severe hepatic/renal failure is contraindicated.

As with other antimicrobial drugs, during lincomycin use, especially prolonged use, the development of a secondary infection associated with the growth of drug-resistant microorganisms (especially fungi) is possible; repeated patient assessment should be performed to rule out and confirm this. If a secondary infection occurs during therapy, necessary measures for its treatment should be taken.

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

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

Allergic reactions have been reported with lincomycin use, which may progress to life-threatening conditions. In these cases, lincomycin should be discontinued and appropriate treatment initiated.

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

Cases of neutropenia and/or leukopenia during lincomycin treatment have been reported; therefore, periodic blood count monitoring is recommended during therapy.

Effect on ability to drive and operate machinery:

The possibility of dizziness and skeletal muscle relaxation during lincomycin use cannot be excluded; therefore, driving vehicles and engaging in other activities requiring increased attention and rapid reactions are not recommended.

Dosage form:

Capsules 250 mg.

5 or 10 capsules in a blister strip made of polyvinyl chloride film and printed lacquered aluminum foil.

20 capsules in polymer jars made of high-density polyethylene with screw-on lids (outer layer made of high-density polyethylene, inner layer made of low-density polyethylene).

Each jar, or 2 or 4 contour blister packs of 5 capsules, or 1 or 2 contour blister packs of 10 capsules, together with the instructions for use, are placed in a cardboard carton.

Storage conditions:

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

Shelf life:

4 years. Do not use after the expiration date.

Prescription status:

Dispensed by prescription.

Marketing Authorization Holder / Consumer claims organization

JSC "AVVA RUS", Russia, 121614, Moscow, Krylatskie Kholmy st., 30, building 9.

Tel./Fax: +7 (495) 956-75-54.

avva.com.ru

ecoantibiotic.ru

Manufacturer:

JSC "AVVA RUS", Russia, 610044, Kirov region, Kirov, Luganskaya st., 53a.

Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.