Teicoplanin-Belpharm 400 mg

Medicine trade name: Teicoplanin-Belpharm
Active ingredient (INN): Teicoplanin
Medicine form: powder for preparation of injection solution 200 mg, 400 mg
Description: yellow amorphous powder
Composition for 1 bottle:
Active substance:
Teicoplanin – 200 mg or 400 mg.
Pharmaceutic group: antibiotics of glycopeptides group.
ATX Code: J01XA02

Pharmacological properties:
Pharmacodynamics
Teicoplanin – complicated glycopeptide, produced by Actinoplanes teichomyceticus. Antibiotics is a complex of six related compounds, which have different antibacterial activity. Antibacterial activity of teicoplanin is manifested a result of inhibition of bacterial cell wall biosynthesis. An antibiotic is able to change permeability resistance of the bacterial cell membrane and RNA synthesis.
Teicoplanin active with gram-positive microorganisms: Enterococcus spp., Staphylococcus spp., Streptococcus spp., Clostridium spp., Peptostreptococcus spp., Propionibacterium acnes, Corynebacterium jeikeium.
Actinomycetes, heterofermentative lactobacilli, Leuconostoc, Nocardia asteroides, Рediococcus, also gram-negative aerobes, chlamydia, mycobacteria, mycoplasmas, rickettsias, treponemas are resistant to teicoplanin. Teicoplanin is inactive with gram-negative bacteria, since the lipid layer of the outer membrane of these bacteria does not allow large antibiotic molecules to reach the valve layer. Resistance develops slowly, there is no cross-resistance with antibiotics of other groups.
Pharmacokinetics
After inner or outer administration (3-6mg/kg) the bioavailability of the teicoplanin is 90%, in the blood medicinal drug binds with proteins by 90-95%. After oral administration, teicoplanin is poorly absorbed from the gastrointestinal tract. Teicoplanin is easily goes to lungs, bones, soft tissues. Teicoplanin penetrates into the cerebrospinal fluid slowly. The period of of teicoplanin ranges from 33 to 160 hours. Up to 80% of the antibiotic is primarily by the kidneys.

Pharmacokinetics in special clinical cases
In case of renal failure treatment schemes with teicoplanin are adjusted taking into account the degree of impairment of renal excretory function. In case of moderately severe renal failure (creatinine clearance > 21-80 ml/min) the patient is administered half of the usual dose. However, in critically ill patients level of medicinal drug in blood varies and often can not be predicted based on creatinine clearance measurements. In such cases, the dosage is established by constantly monitoring the level of teicoplanin in blood.

Indications for use
Infectious-inflammatory illnesses, caused by microorganisms sensitive to teicoplanin: infections of skin and soft tissues; bones and joints, infections of upper and lower respiratory tract, hospital-acquired and community-acquired pneumonia, complicated and uncomplicated infections of urinary tract, ENT infections, septicemia. In adults, additionally used in cases of endocarditis, peritonitis associated with continuous peritoneal dialysis on outpatient basis; for the prevention of infective endocarditis in case of allergy to beta-lactam antibiotics; in dentistry and during procedures in the upper respiratory tract, when general anesthesia used; during surgical interventions on the genitourinary system and gastrointestinal tract.
Teicoplanin is used in cases of allergy to penicillin or beta-lactam antibiotics, intolerance of lack of response to treatment with other antibiotics, including penicillins and cephalosporins.

Directions for use and dosage
Dosage and administration ways of Teicoplanin-Belpharm is established based on sensitivity of the pathogen, the severity of the illness, and also the condition of kidney function of patient.
Teicoplanin-Belpharm should be administered intramuscularly or intravenously (as a bolus injection during 3-5 minutes or as an infusion during 15-30 minutes).
Infections of upper and lower respiratory tract, infections of skin and soft tissues, infections of urinary tract ENT infections and other moderate infections: loading dose for adults and elderly people with normal renal function is 400 mg or every 12 hours for the first 1-3 injections, then 200 mg or once a day.
Septicemia, infections of bones and joints, endocarditis, complicated infections of respiratory tract and other severe infections: loading dose for adults and elderly people with normal renal function is 800 mg every 12 hours for the first 3-5 injections; the maintenance dose is up to 12 mg/kg or once a day. To prevent infectious complications during orthopedic or maxillofacial operations during anesthesia administered once 400 mg intravenously.
In maintenance therapy during treatment of septicemia and endocarditis transition to intramuscularly administration depends on clinical course of the disease.
At especially complex clinical situations, when minimal inhibiting concentrations of teicoplanin are high (4-8mg/l), considering bacterial loads or when pharmacokinetic of medicinal drug in blood serum is difficult to predict (significant buns, intensive therapy and etc.) or under conditions of low tissue distribution (bones, heart valve), recommended loading dose is – 3-5 infections each 12 mg/kg every 12 hours. In case of necessity, allowed to prescribe maintenance dose up to 12 mg/kg and higher.
To achieve optimal dose, it is necessary to determine concentration of the antibiotic in blood plasma. For maintaining loading doses, it is necessary to track residual plasma concentrations for achieving stable residual concentrations in the blood plasma within 20-30 mg/l or 30-40 mg/l, as well as during maintenance therapy, to make sure, that these concentrations are stable.
Initial dose for children at the age from 2 months to 12 years is 10 mg/kg every 12 hours 3 times, then 6-10 mg/kg once a day; at the age to 2 months – 16 mg/kg (as a 30-minute intravenous infusion) in the first day, maintenance dose is 8 mg/kg once a day.
In case of moderate or more severe complex infection for achieving loading dose, it is necessary to track residual plasma concentrations, to make sure in achievement of stable residual concentrations in the blood plasma not less than 10 mg/l or 15 mg/l, as well as during maintenance therapy, to make sure, that these concentrations are stable.
For pseudomembranous colitis, Teicoplanin-Belpharm is prescribed 100-200 mg twice a day for 7-14 days. Recommended dose of Teicoplanin-Belpharm after the dissolution goes inside.
In adults and elderly patients with impaired renal function dose correction starts from 4^th day for to maintain teicoplanin serum concentrations at 10 mg/l. when creatinine clearance is 30-80 ml/min, the maintenance dose is either reduced by half or administered once in two days.
Patients with creatinine clearance less than 30 ml/min or patients who are on hemodialysis, are administered 1/3 daily dose or once in 3 days. Teicoplanin is not eliminated by hemodialysis.
For adults and elderly patients with impaired renal function and secondary peritonitis, which caused as a result of continuous peritoneal dialysis, a dosage of 20 mg for 4 liter of dialysis fluid is recommended; the loading dosage for such patients is 200 mg.

Rules for preparing a solution
200 mg or 400 mg of Teicoplanin-Belpharm is dissolved in 3 ml of one of the following solvents: 0.9% sodium chloride solution, lactated Ringer's solution, 5% glucose solution, 0.18% sodium chloride solution and 4% glucose solution, peritoneal dialysis solution containing 1.36% or 3.86% glucose. The solvent should be introduced into the vial slowly, carefully shaking until the vial is completely dissolved, avoiding the appearance of bubbles. If foam appears, the bottle with the solution must be left in an upright position to reduce the amount.
The resulting solution can be used for intravenous injection.
To use the drug in the form of infusions, the resulting solution is diluted to 100 ml. For oral administration, 200 mg or 400 mg of Teicoplanin-Belpharm is dissolved in 10 ml of water.
To avoid administering a dose less than required, the drug must be completely dissolved. The solvent is introduced into the vial slowly to prevent the formation of bubbles. If form formation, the bottle must be left in an upright position for at least 15 minutes. The prepared solution must be carefully removed from the bottle!

Side effects
Allergic reactions: rash, itching, erythema, fever, anaphylactic reactions (angioedema, bronchospasm, anaphylactic shock), urticaria, exfoliative dermatitis.
From the skin and subcutaneous tissues: severe bullous skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, in exceptional cases, erythema multiforme).
From the liver: temporary increase in the level of transaminases and/or alkaline phosphatase. From the circulatory and lymphatic system: eosinophilia, leukopenia, thrombocytopenia, neutropenia (rarely severe) or agranulocytosis (reversible after discontinuation of treatment), which most often develops when receiving high doses and in the first month of therapy.
From the digestive system: nausea, vomiting, diarrhea.
From the urinary system: temporary increase in creatinine levels, renal failure, usually occurring in patients with severe infection, with the presence underlying disease and/or in patients receiving other medications, having nephrotoxic effects.
From the nervous system: dizziness, headache, hearing loss, ringing in the ears, disorders of the vestibular system, cases of seizures have been reported.
Local reactions: pain at the injection site, phlebitis, erythema, abscess.
Other: superinfection (increase in the number of insensitive microorganisms).

Contraindications
Hypersensitivity to teicoplanin.



Drug interactions
Simultaneous use of Teicoplanin-Belpharm and aminoglycosides in the form of injections is not allowed. Their combined use is possible in a dialysis solution in the treatment of peritonitis associated with continuous ambulatory peritoneal dialysis.
With the simultaneous use of Teicoplanin-Belpharm and other potentially non-protoxic and/or nephrotoxic and/or ototoxic drugs (aminoglycosides, amphotericin B, cyclosporine, furosemide, colistin, cisplatin, ethacrynic acid), mutual enhancement of the toxic effect is possible.

Special instructions
Use during pregnancy and lactation
The use of Teicoplanin-Belpharm is possible only for health reasons in cases where the expected benefit of therapy for the mother exceeds the potential risk for the fetus. In this case, the hearing function of the newborn should be checked due to the possible ototoxic effect of teicoplanin.
If necessary, use of the drug during lactation breast-feeding should be discontinued.
Special instructions
Prescribe with caution in case of hypersensitivity to vancomycin (non-cross allergization is possible).
Dose adjustment is necessary for patients with renal failure. Long-term therapy and treatment with high doses require constant monitoring of function of liver, kidneys, hematopoiesis, hearing (especially with a history of disorders), effects on the hematopoietic system, hepato- and nephrotoxicity.
When using Teicoplanin-Belpharm, cases of ototoxicity, toxic effects on the hematopoietic system, hepato- and nephrotoxicity.
Simultaneous use of Teicoplanin-Belpharm with oto-, nephro- and neurotoxic drugs (aminoglycosides, colistin, amphotericin, cyclosporine, cisplatin, furosemide and ethacrynic acid) is not recommended. If necessary, simultaneous use with these drugs, it is necessary to conduct repeated studies of kidney and hearing functions.
A history of “red man syndrome” associated with vancomycin use is not a contraindication to the use of teicoplanin.
Use in pediatrics
When using the drug in children, it is necessary to monitor the concentration of teicoplanin in the blood plasma.
Impact on the ability to drive vehicles or operate machinery
While using Teicoplanin-Belpharm, it is recommended to refrain from driving vehicles and working with complex mechanisms due to the risk of dizziness.

Overdose
Symptoms: increased severity of side effects
Treatment: symptomatic. Teicoplanin-Belpharm is not eliminated from the organism by hemodialysis.

Release form
200 mg or 400 mg vial for injection volume of 10 ml or 20 ml.
By 1 or 5 vials together with instructions of use in a cardboard box.
Packaging for hospitals: 36 vials with corresponding amount of instructions of use in group boxes.

Storage conditions
Store in dry place, protected from light at the temperature from 2 C to 8C
Store in a place out of reach of children.
Expiration date
Expiration date is 2 years
Do not use after expiration date, shown at the packaging.

Conditions for release from pharmacies
On prescription

Manufacturer/ name and address od organization, accepting claims (offers) regarding the quality of medicinal product in the territory of Republic of Uzbekistan
FC BELPHARM LLC,
100084, Republic of Uzbekistan, Tashkent,
Chingiza Aitmatova str., 37.
+998 (55) 506-28-28
www.belpharm.uz