Teicoplanin-Farmex (teicoplanin) lyophilisate for solution for injection 400 mg. vial №1 + solvent 3.2 ml.

Description

Teicoplanin-Farmex (teicoplanin) lyophilisate for solution for injection 400 mg. vial №1 + solvent 3.2 ml.

Composition

active substance: teicoplanin;

1 vial contains teicoplanin 200 mg or 400 mg;

excipient: sodium chloride;

solvent – water for injections.

Dosage form

Lyophilisate for solution for injection.

Basic physical and chemical properties:

• vial with lyophilisate: lyophilized porous mass or yellowish powder;
• solvent vial: clear colorless liquid.

Pharmacotherapeutic group

Glycopeptide antibiotics.
ATX code J01X A02.

Pharmacological properties

It is an antibacterial agent with a glycopeptide structure. The bactericidal effect is manifested due to the ability to inhibit the biosynthesis of the cell wall in areas other than those on which beta-lactams act. Active against anaerobic, aerobic gram-positive microorganisms: Streptococcus spp., Staphylococcus spp., Enterococcus spp., Micrococcus spp., Listeria monocytogenes, Corynebacterium spp., Peptostreptococcus spp., Clostridium difficile.

Indications

Teicoplanin-Farmex is used to treat an infectious process triggered by gram-positive flora sensitive to this antibiotic, including those resistant to other antibiotics:

• with endocarditis;
• with infection of bones, joints;
• with lower respiratory tract infections;
• with infections of the skin, soft tissues;
• with urinary tract infection;
• with peritonitis caused by continuous ambulatory peritoneal dialysis;
• for the prevention of infectious complications during dental, orthopedic surgery.

To take the solution inside:

– with pseudomembranous colitis caused by Clostridium difficile.

Contraindications

Teicoplanin-Farmex does not apply:

• with an allergy to an active ingredient;
• with intolerance to auxiliary components.

It is used with caution:

• with renal failure;
• if you are allergic to vancomycin (since cases of cross-hypersensitivity have been reported);
• with long-term drug treatment;
• while taking other ototoxic, nephrotoxic drugs (aminoglycosides, amphotericin B, colistin, cyclosporine, furosemide, ethacrynic acid, cisplatin);
• during pregnancy;
• during breastfeeding.

Application during pregnancy and lactation

Women should stop breastfeeding.
Application during pregnancy is allowed only for health reasons.

Method of administration and dosage

Teicoplanin-Farmex is used parenterally (intravenously or intramuscularly) or inside.
The standard dose for adults, children over 16 years old is 400 mg once intravenously on the first day, then a maintenance dose of 200 mg is applied once a day intravenously or intramuscularly.
For severe infections, the initial dose is 400 mg intravenously every 12 hours for the first three doses, followed by a maintenance dose of 400 mg intravenously or intramuscularly once a day.
The standard dose for children from 2 months to 16 years is 10 mg / kg intravenously with an interval of 12 hours for the first three doses, then a maintenance dose is used – 6 mg / kg once a day intravenously or intramuscularly. In severe infections, febrile neutropenia, the initial dose is 10 mg / kg intravenously with an interval of 12 hours for the first three doses, the maintenance dose is 10 mg / kg intravenously once a day.
The standard dose for children under 2 months of age is 16 mg / kg IV on the first day, followed by a switch to a maintenance dose of 8 mg / kg IV once a day.
Intravenous administration is carried out by infusion over a period of 30 minutes.
A therapeutic response is usually observed within 48 to 72 hours after the first dose. The total duration of treatment depends on the type, severity of the infection, and the clinical response of the individual patient. With osteomyelitis, endocarditis, the duration of therapy is three weeks or more.
The drug should not be used for more than 4 months.
With pseudomembranous colitis caused by C. difjicille, 200 mg orally (orally) twice a day is shown, the course is 7-14 days.
For patients with kidney failure, in the elderly, dose adjustment is required.

Overdose

Symptoms: agitation.
Treatment: dynamic observation, maintenance of adequate glomerular filtration, symptomatic therapy.

Side effects:

• Reactions at the injection site: pain, erythema at the injection site, aseptic abscess, thrombophlebitis.
• Immune disorders: rash, chills, pruritus, fever, bronchospasm, anaphylactic reactions, urticaria, anaphylactic shock, angioneurotic edema, exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme.
• Hematological disorders: agranulocytosis, thrombocytopenia, leukopenia, neutropenia, eosinophilia.
• Digestive disorders: nausea, diarrhea, vomiting, increased activity of “liver” enzymes, alkaline phosphatase in blood serum.
• Urinary disorders: hypercreatininemia, renal failure.
• Neurological disorders: dizziness, convulsions, headache.
• Perceptual disorders: hearing loss, tinnitus (ringing in the ears), vestibular disorders.
• Others: superinfection.