Universal reference book for medicines
Product name: TARGOCID (TARGOCID)

Active substance: teicoplanin

Type: Antibiotic of the glycopeptide group

Manufacturer: AVENTIS PHARMA (Great Britain) manufactured by GRUPPO LEPETIT (Italy)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous and / or injections
in the form of a porous homogeneous mass of light yellow color.

1 f.

teicoplanin 200 mg

[PRING] sodium chloride 24 mg, sodium hydroxide to pH 7.5.

The composition of the solvent: water d / and 3 ml.

200 mg - vials of colorless glass (1) complete with a solvent 3 ml of fl.
1 PC. - packs cardboard.
Lyophilizate for the preparation of a solution for intravenous and / or injections in the form of a porous homogeneous mass of light yellow color.

1 f.

teicoplanin 400 mg

[PRING] sodium chloride 24.8 mg, sodium hydroxide to pH 7.5.

The composition of the solvent: water d / and 3 ml.

400 mg - vials of colorless glass (1) complete with a solvent 3 ml of fl.
1 PC. - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Teicoplanin is an antibiotic of a glycopeptide structure demonstrating in vitro bactericidal activity against anaerobic and aerobic gram-positive microorganisms.Teicoplanin inhibits the growth of sensitive microorganisms by inhibiting the biosynthesis of the microbial cell membrane in places other than those in the envelope of a microbial cell, which are affected by beta-lactam antibiotics.

Teicoplanin has activity against Staphylococcus spp.
(including strains resistant to methicillin and other beta-lactam antibiotics). Streptococcus spp., Enterococcus spp., Listeria monocytogenes. Micrococcus spp, Corenebacterum spp. group J / K and Gram-positive anaerobes, including Clostridium difficile, Peptococcus spp. In vitro, synergism was demonstrated with respect to the bactericidal action on Staphylococcus aureus in the combination of teicoplanin with aminoglycosides or imipenem. In vitro additive and synergistic effects on Staphylococcus aureus have been shown by a combination of teicoplanin and rifampicin. With respect to Staphylococcus epidermidis synergism of teicoplanin with ciprofloxacin was observed. In vitro single-stage resistance to teicoplanin was not obtained, and only after multiple passages in vitro multistage resistance was developed. An increase in the minimum inhibitory concentrations (MIC) of teicoplanin was reported for some strains of hemolytic staphylococci. As a rule, teicoplanin does not exhibit "cross-resistance" with antibiotics of other groups, however, in Enterococcus spp. there was a slight "cross-resistance" to teicoplanin and another glycopeptide, vancomycin. When determining the sensitivity of microorganisms to teicoplanin, discs (sensidiski) containing 30 micrograms of teicoplanin are used. Strains in which the growth inhibition zone has a diameter of 14 mm or more are considered to be sensitive, the same strains whose growth inhibition zone is 10 mm in diameter or less are considered resistant.
PHARMACOKINETICS

Bioavailability after a single intramuscular injection of teicoplanin at a dose of 3-6 mg / kg body weight is about 90%.

After ingestion teikoplanin is not absorbed and in the absence of lesions of the digestive system does not enter the systemic circulation;
40% of the ingested dose is present in the feces in a microbiologically active form. The study of the profile of plasma concentrations of teicoplanin in humans after its intravenous administration at a dose of 3-6 mg / kg showed a two-phase distribution of teicoplanin (with a phase of rapid distribution with a half-life from the plasma of about 0.3 hours, followed by a phase of a slower distribution with a half-life from the plasma, which is about 3 hours), after which a slow removal of teicoplanin with a finite half-life of about 150 hours is observed. Such a long half-life period allows the drug to be administered once a day.
With the intravenous administration of Targoside at a dose of 6 mg / kg of body weight as a 30-minute infusion three times in 12 hours and then once a day (every 24 hours), the minimum plasma teicoplanin concentration of 10 mg / l could be achieved to the 4th day.
The calculated maximum and minimum plasma concentrations in the equilibrium state of 64 mg / L and 16 mg / L could be achieved by the 28th day of treatment. Teicoplanin is rapidly distributed into the skin (subcutaneous fatty tissue) and blister fluid, myocardium, lung tissue and pleural fluid, bone tissue and synovial fluid, but poorly penetrates into the cerebrospinal fluid. Weakly affinity binding with plasma proteins is 90-95%. The volume of distribution in the equilibrium state with intravenous administration of teicoplanin at a dose of 3-6 mg is 0.94-1.41 l / kg. The volume of distribution in children does not differ significantly from that in adults.
After parenteral administration of teicoplanin, its metabolism is minimal (about 3%).
97% of the administered teicoplanin is excreted unchanged. Approximately 80% of the administered dose is excreted by the kidneys. Renal clearance after intravenous administration of 3-6 mg / kg is in the range of 10.4 - 12.1 mg / h / kg. The total plasma clearance is in the range of 11.9-14.7 ml / h / kg.
INDICATIONS

Severe infections caused by drug-sensitive gram-positive bacteria, including those resistant to other antibiotics (such as penicillins, including methicillin and cephalosporins), including these infections in patients with allergy to penicillins and cephalosporins:

- endocarditis;

- septicemia;

- infections of bones and joints;

- Lower respiratory tract infection;

- skin and soft tissue infections;

- urinary tract infections;

- peritonitis, which occurred with continuous ambulatory peritoneal dialysis (NAPD).

Prevention of infectious complications in dental and orthopedic operations with the risk of developing infections caused by Gram-positive microorganisms.

For oral administration: pseudomembranous colitis caused by Clostridium difficile (associated with the use of antibacterial drugs).

DOSING MODE

Teicoplanin is administered parenterally (intravenously or intramuscularly).
Intravenous (IV) administration can be performed by either intravenous injection for 3-5 minutes, or - IV infusion for 30 minutes. In newborns, the drug should be administered only as an intravenous infusion.
Dosing regimen in adults and adolescents 16-18 years with normal renal function

Treatment of infections caused by drug-sensitive gram-positive bacteria (endocarditis, septicemia, bone and joint infections, lower respiratory tract infections, skin and soft tissue infections, urinary tract infections)

For moderately severe infections of the skin and soft tissues, urinary tracts, lower respiratory tract infections, the initial dose of teicoplanin is 400 mg once iv on the first day, followed by a maintenance dose of 200 mg once daily in / in or intramuscularly (IM).

For the treatment of severe infections of bones and joints, septicemia, endocarditis, the initial dose is 400 mg IV every 12 hours for the first three doses followed by a maintenance dose of 400 mg IV or IM once a day.
In severe infections, the minimum concentration in serum should not be less than 10 mt / l.
Maximum concentrations, determined 1 hour after iv injection of 400 mg, are usually in the range of 20 to 50 mg / l.

In some cases (in burn patients or in patients with endocarditis) the maintenance dose may be up to 12 mg / kg of body weight per day.
Standard doses of 200 mg and 400 mg correspond to doses of 3 mg / kg and 6 mg / kg of body weight. In patients with a body weight of more than 85 kg, it is recommended to adjust the dose of the drug taking into account the body weight, adhering to the same therapeutic regimen: moderately severe infections of 3 mg / kg, severe infections of 6 mg / kg.
Patients with peritonitis developed as a complication of continuous ambulatory peritoneal dialysis

After a single loading dose of 400 mg intravenously, in the first week, 20 mg / l is injected into each reservoir with peritoneal dialysis solution; in the second week, 20 mg / l is injected into each second tank with peritoneal dialysis solution; in the third week, 20 mg / l in a tank with peritoneal dialysis solution for night dialysis.

Antimicrobial prophylaxis for surgical operations in orthopedics, dental operations (for example, endocarditis prophylaxis in patients with artificial heart valves): 400 mg teicoplanin (or 6 mg / kg with a patient weight of more than 85 kg) as an I / O single injection during an introductory anesthesia.

Pseudomembranous colitis caused by C. difficile: 200 mg of teicoplanin orally two times a day.

Dosage regimen in children

Children older than 2 months to 16 years of age: for most Gram-positive infections, the recommended initial dose is 10 mg / kg body weight IV with an interval of 12 hours for the first three doses with the transition to a maintenance dose of 6 mg / kg body weight given in / m or iv / once a day.

In severe infections and neutropenia, the recommended initial dose is 10 mg / kg body weight IV with an interval of 12 hours for the first three doses with the transition to a maintenance dose of 10 mg / kg body weight administered / once a day.

Children younger than 2 months of age, including newborns: the recommended initial dose is 16 mg / kg body weight IV on the first day with a transition to a maintenance dose of 8 mg / kg body weight IV once a day.
IV administration should be carried out by iv infusion for 30 minutes.
Dosage regimen in elderly patients

With normal kidney function, dosage adjustment is not required.

Dosing regimen in adults with renal insufficiency

Up to 4 days of treatment with tsykoplanin, correction of the dosing regimen is not required.
Beginning on the fourth day, the administered dose should maintain the teicoplanin concentration in the serum at a level of 10 mg / L.
With moderate renal insufficiency (creatinine clearance 40-60 ml / min): the maintenance dose should be reduced by half, either by introducing the previous dose once every two days, or by introducing a half dose once a day.
In severe renal failure (creatinine clearance less than 40 ml / min) and in patients undergoing hemodialysis: the maintenance dose should be reduced threefold, either by the introduction of the previous dose every third day, or by the introduction of 1/3 of the previous dose once a day . Teikoplanin is not excreted by hemodialysis.
Duration of treatment

The response therapeutic response in most patients with infections caused by susceptible antibiotics is observed within 48-72 hours after the start of the drug administration.
The total duration of treatment is determined individually and depends on the type and severity of the infection and the clinical response of the individual patient. With endocarditis and osteomyelitis, treatment is recommended for 3 weeks or more; while Targotsid should not be administered more than 4 months.
Preparation of the solution

All the contents of the ampoule with sterile water should be slowly introduced into the tare of the drug Targoside, gently shaking the bottle until the powder completely dissolves, while avoiding the formation of foam.
It is very important that the whole preparation is dissolved, even the part that is near the cork. When the solution is shaken, a foam is formed, which makes it difficult to extract the required volume of the solution. However, if teicoplanin is completely dissolved, the foam does not change the concentration of the remaining 200 mg / 3 ml solution in the 200 mg Targogid 200 mg bottle and 400 mg / 3 ml in the Targogid 400 mg bottle. If the solution turns frothy, then leave it to stand for about 15 minutes to reduce the amount of foam.
It is necessary to slowly extract the teicoplanin solution from the vial, trying to extract it completely, piercing the middle of the rubber cork with a needle.

The resulting solution will contain 200 mg of teicoplanin in 3 ml in a 200 mg Targocid vial and 400 mg in 3 ml in a 400 mg Targogid vial.
It is important that the preparation of the solution is carried out correctly, and the solution is carefully removed from the vial; improper preparation of the solution can lead to a lower dose than required.
The prepared solution is isotonic and has a pH of 7.2-7.8.
The prepared solution can be directly injected or further diluted with 0.9% sodium chloride solution, Ringer's solution, Hartmann's solution, 5% dextrose solution, peritoneal dialysis solution containing 1.36% or 3.86% dextrose.
SIDE EFFECT

Usually, Targotsid well tolerated.
Undesirable reactions rarely require withdrawal of treatment and in most cases are mild and transient; severe unwanted reactions are rare. The undesirable reactions listed below were recorded.
Local Reactions

Erythema, pain at the injection site, thrombophlebitis, abscess in place of the / m injection.

Allergic reactions

Rash, itching, fever, chills, bronchospasm, anaphylactic reactions, anaphylactic shock, hives, angioedema, rare reports of exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.

In addition, there have been reports of infusion-related reactions, such as erythema or blood tides to the upper body, with no history of prior treatment with teicoplanin, and they did not repeat with subsequent administration of the drug at a reduced rate or concentration of the drug.
These cases were not specific for any specific concentration of the infusion solution and the rate of infusion.
From the gastrointestinal tract

Nausea, vomiting, diarrhea.

From the side of the blood

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, eosinophilia.

From the liver and biliary tract

Increased activity of "liver" transaminases and (or) alkaline phosphatase in the blood serum.

From the side of the kidneys

Increased serum creatinine concentrations, renal failure.

From the central nervous system

Dizziness;
headache, convulsions with intravenous administration.
Hearing disorders and labyrinthine disorders

Hearing loss, ringing in the ears and vestibular disorders.

Other

Superinfection (excessive reproduction of microorganisms insensitive to the drug).

CONTRAINDICATIONS

- hypersensitivity to teicoplanin and other components of the drug.

Carefully:

- in patients with increased sensitivity to vancomycin (risk of "cross" hypersensitivity);

- in patients with renal insufficiency (correction of the dosing regimen is required, see the section "Dosing and Administration", and monitoring of the hearing, hematological parameters, kidney and liver function);

- in patients undergoing long-term treatment (monitoring of hearing, hematological parameters, renal and hepatic function);

- with simultaneous treatment with other ototoxic and nephrotoxic drugs: aminoglycosides, colistin, amphotericin B, cyclosporin, cisplatinum, furosemide and ethacrynic acid.

PREGNANCY AND LACTATION

Pregnancy

Do not use Targoside during pregnancy or with suspicion of it, except when the potential benefit to the mother prevails over the possible harm to the fetus.
Studies in animals have not revealed teratogenic effects in teicoplanin.
Breastfeeding period

Information on the excretion of teicoplanin in breast milk is absent.
If it is necessary to use the drug during the lactation period, the question of temporary cessation of breastfeeding should be resolved.
APPLICATION FOR FUNCTIONS OF THE LIVER

Until the 4th day of treatment with teicoplanin, correction of the dosing regimen is not required.
Beginning on the fourth day, the administered dose should maintain the teicoplanin concentration in the serum at a level of 10 mg / L.
With moderate renal insufficiency (creatinine clearance 40-60 ml / min): the maintenance dose should be reduced by half, either by introducing the previous dose once every two days, or by introducing a half dose once a day.
In severe renal failure (creatinine clearance less than 40 ml / min) and in patients undergoing hemodialysis: the maintenance dose should be reduced threefold, either by the introduction of the previous dose every third day, or by the introduction of 1/3 of the previous dose once a day . Teikoplanin is not excreted by hemodialysis.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The hepatic toxicity of teicoplanin has been reported.
Therefore, it is necessary to monitor the functional state of the liver, especially in patients with long-term treatment with teicoplani.
APPLICATION FOR CHILDREN

Children older than 2 months to 16 years of age: for most Gram-positive infections, the recommended initial dose is 10 mg / kg body weight IV with an interval of 12 hours for the first three doses with the transition to a maintenance dose of 6 mg / kg body weight given in / m or iv / once a day.

In severe infections and neutropenia, the recommended initial dose is 10 mg / kg body weight IV with an interval of 12 hours for the first three doses with the transition to a maintenance dose of 10 mg / kg body weight administered / once a day.

Children younger than 2 months of age, including newborns: the recommended initial dose is 16 mg / kg body weight IV on the first day with a transition to a maintenance dose of 8 mg / kg body weight IV once a day.
B / in the introduction method must be carried on / in infusion for 30 minutes.
APPLICATION IN ELDERLY PATIENTS

In normal renal function in elderly patients correct dosing regimen is required.
SPECIAL INSTRUCTIONS

Targotsid be administered with caution in case of known hypersensitivity to vancomycin, since it is possible the development of "cross" allergy.
It reported toxic effects on the hearing organ, hematologic, hepatic and renal toxicity of teicoplanin. Therefore it is necessary to monitor the status of hearing, haematological indices, functional state of the liver and kidney, especially in patients with renal failure, patients who are treated teykoplanivom held permanently and in patients treated simultaneously oto- and other nephrotoxic drugs (aminoglycosides, colistin, amphotericin B , cyclosporine, tsisplatanom, ethacrynic acid and furosemide).
Superinfection: as is the case with other antibiotic teicoplanin use, especially if it is prolonged, may result in excessive reproduction insensitive to the drug microorganisms (bacteria or fungi); in the case of superinfection during treatment with the drug, it is necessary to take appropriate measures.
The effect on the ability to drive or do other potentially dangerous activities
During treatment, care must be taken when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions, since the drug mozheg cause dizziness et al. Side Effects which may affect these abilities.
OVERDOSE

Experience of overdose in humans

have been reported cases, the introduction of excessively high doses of error pediatric patients. In one report observed excitation arising from the 29-day neonate, to which 400 mg of teicoplanin / v (95 mg / kg body weight) was introduced. In all other cases, there were no symptoms or laboratory abnormalities associated with overdose of teicoplanin. The age of patients with an overdose ranged from 1 month to 8 years. Mistakenly injected dose of 35.7 mg / kg to 104 mg / kg.
Treatment of overdose
Teicoplanin does not rely on hemodialysis. Treatment of overdose should be symptomatic.
DRUG INTERACTION

With nephrotoxic and ototoxic drugs (streptomycin, neomycin, kanamycin, gentamycin, amikacin, tobramycin, tsefaloridinom, kopistinom, amphotericin B, cyclosporine, cisplatin, furosemide, ethacrynic acid)
In combination with the above drugs may increase the risk of side effects while simultaneously or following successive application of teicoplanin with these drugs.
Teicoplanin pharmaceutically incompatible with aminoglycosides.
TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

At temperatures above 25 ° C.
Keep out of the reach of children! Shelf-life of the drug - 3 years, solvent - 5 years.
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