Vancor 1g vial

VANCOR General characteristics: Non-proprietary international name: Vancomycin; Main physical-chemical properties: White, off-white or cream to brown powder. Composition: 1 vial contains: Vancomycin hydrochloride, equivalent to 1 g vancomycin. Dosage form: Sterile powder for preparation of infusion solution, 1 g. Pharmacological group: Glycopeptide group antibacterial agents. Vancomycin. Pharmacological properties: Pharmacodynamics: Vancomycin is a tricyclic glycopeptide produced by Amycolatopsis orientalis. The antibacterial action of vancomycin is manifested by inhibition of bacterial cell wall synthesis. In addition, the antibiotic alters the permeability of the bacterial cell membrane and RNA synthesis. Vancomycin is active against the following Gram-positive aerobic and anaerobic bacteria: Staphylococcus aureus, coagulase-negative staphylococci, Streptococcus spp. (group B, C, G), Streptococcus pneumonia, Streptococcus pyogenes, Viridans streptococci, Corynebacterium spp. Enterococcus spp. (Enterococcus faecalis, Enterococcus faecium), Clostridium difficile. Vancomycin does not exhibit cross-resistance with other antibiotics. Pharmacokinetics: Absorption After intravenous administration of 1 g Vancor, the peak plasma antibiotic concentration (Cmax) is approximately 63 mcg/mL at 1 hour and approximately 23 mcg/mL at 2 hours. Plasma protein binding is 55%. Distribution After intravenous administration, the antibiotic is found at therapeutic concentrations in pleural, synovial, pericardial, and ascitic fluids, as well as in atrial appendage tissue, urine, and peritoneal fluid. Vancor penetrates the cerebrospinal fluid slowly, and therapeutic concentrations are observed in the cerebrospinal fluid during meningitis. It crosses the placental barrier and is excreted in breast milk. Metabolism and excretion The drug is practically not metabolized. 75-90% is excreted by the kidneys through glomerular filtration within 24 hours. Insignificant amounts may be excreted with bile. Small amounts are excreted by hemodialysis or peritoneal dialysis. In patients with normal renal function, the half-life (T 1/2) is 4-6 hours in adults, 2-3 hours in older children, and 4 hours in infants. Pharmacokinetics in special clinical cases In patients with impaired renal function, the excretion of Vancor is slowed. In patients with anuria, the half-life is 7.5 days. The total systemic and renal clearance of Vancor may be reduced in elderly patients due to a decrease in glomerular filtration rate. Indications: Infectious-inflammatory diseases caused by microorganisms sensitive to the drug: • Sepsis; • Endocarditis; • CNS infections (including meningitis); • Lower respiratory tract infections (pneumonia, lung abscess); • Skin and soft tissue infections; • Bone and joint infections (including osteomyelitis); • Vancor is used in case of penicillin allergy, intolerance to other antibiotics, or their ineffectiveness (including penicillins and cephalosporins). • Vancor can only be taken orally for the treatment of staphylococcal enterocolitis and pseudomembranous colitis caused by Clostridium difficile. Dosage and administration: Vancor cannot be administered intramuscularly or intravenously as a bolus. The drug is administered only by infusion! The following daily doses are recommended: For adults, the dose is 500 mg every 6 hours or 1 g every 12 hours intravenously. The drug is administered by slow infusion at a rate not exceeding 10 mg/min for 60 minutes or longer. The concentration of the prepared Vancor solution should not exceed 5 mg/mL. The maximum daily dose is 2 g. For newborns up to 7 days old, the initial dose is 15 mg/kg, then 10 mg/kg every 12 hours during the first week, and once every 8 hours until 1 month of age. In children from 1 month and older, the recommended daily dose is 40 mg/kg, divided into doses every 6 hours. Infusion is carried out for 60 minutes or longer. In premature newborns, vancomycin clearance decreases with decreasing postconceptional age. Therefore, in this category of patients, it is necessary to increase the interval between doses and intensively monitor the vancomycin concentration in serum. In patients with renal failure, individual dose selection is necessary. The initial dose is 15 mg/kg body weight, and subsequent dosing is determined according to creatinine clearance. Creatinine clearance mL/min Vancor dose mg/day 100 1,545 90 1,390 80 1,235 70 1,080 60 925 50 770 40 620 30 465 20 310 10 155 In elderly patients, due to decreased renal function, dose reduction or increased interval between infusions may be necessary. Oral use: For the treatment of staphylococcal enterocolitis and pseudomembranous colitis caused by Clostridium difficile, Vancor is administered orally. For adults and the elderly, the average daily oral dose is 500 mg, divided into 3-4 doses. The course of treatment is 7-10 days. The daily dose should not exceed 2 g. For children, the average daily oral dose is 40 mg/kg, divided into 3-4 doses; the course of treatment is 7-10 days. The daily dose should not exceed 2 g. Preparation and administration of the solution Preparation of the solution for intravenous administration. The contents of the Vancor 1 g vial are dissolved in 20 ml of water for injection, and the resulting solution is diluted in 200-400 ml of diluent. 0.9% sodium chloride or 5% glucose infusion solutions can be used as diluents. The concentration of vancomycin in the infusion solution should not exceed 5 mg/mL. The prepared solution is stable for 24 hours at 25°C and for 48 hours at 2-8°C, however, use is recommended immediately after preparation of the solution. Preparation of the solution for oral administration. The recommended dose of Vancor is dissolved in 30 ml of water. The prepared solution is used for drinking or administration via a tube. Syrups can be used to improve the taste of the solution. Side effects: Post-infusion reactions (due to rapid administration of the drug): anaphylactoid reactions (hypotension, dizziness, dyspnea, rash, itching), "red man" syndrome (hyperpigmentation of the upper torso), spasm of chest and back muscles. When infusion is stopped, these symptoms usually disappear within 20 minutes, but can sometimes persist for several hours. In case of rapid bolus injection, hypotension, bradycardia, cardiogenic shock, and rarely cardiac arrest may develop. Urinary system: Rarely - renal failure, manifested by increased plasma creatinine concentration or blood urea nitrogen (when using high doses of Vancor); interstitial nephritis (more often in combination with aminoglycosides or in patients with a history of impaired renal function). After discontinuation of treatment, renal function normalizes in most patients and azotemia resolves. Digestive system: Nausea, pseudomembranous colitis. Auditory organ: Ototoxicity – hearing loss, vertigo, tinnitus. Hematopoietic organs: Reversible neutropenia, transient thrombocytopenia; rarely - agranulocytosis. Central and peripheral nervous system: Headache, dizziness, paresthesia, insomnia or drowsiness, anxiety, depression, impaired consciousness, hallucinations, epileptoid seizures, convulsions. Local reactions: In case of violation of infusion rules - thrombophlebitis, pain at the injection site, tissue necrosis at the injection site. Allergic reactions: Hypersensitivity reactions, rash (including exfoliative dermatitis), anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, linear IgA-dependent bullous dermatosis. In case of any side effect not listed in the instructions for use, the patient should consult their doctor. Contraindications: Hypersensitivity to vancomycin, first trimester of pregnancy, lactation, auditory nerve neuritis. Drug interactions and other types of interactions: Concomitant administration of Vancor and other potentially neurotoxic and/or nephrotoxic drugs (aminoglycosides, amphotericin B, bacitracin, polymyxin B, cisplatin, colistin, viomycin, loop diuretics) may enhance toxic effects, requiring intensive monitoring for the possible development of these symptoms. Due to the possibility of enhanced ototoxic effects, concomitant use of Vancor and ototoxic drugs is not recommended. Simultaneous use of vancomycin and anesthetics increases the risk of anaphylactoid reactions. Vancor is not recommended for use with chloramphenicol, glucocorticosteroids, methicillin, heparin, aminophylline, cephalosporins, and phenobarbital. Overdose: Symptoms: Exacerbation of side effects. Treatment: Reduction of the dose of the drug or discontinuation of treatment. Symptomatic therapy is carried out. Fluid administration and monitoring of vancomycin concentration in plasma are recommended. Hemoperfusion is more effective than hemodialysis for rapid elimination of Vancor overdose from the body. Pregnancy and lactation: In the second and third trimesters of pregnancy, Vancor is prescribed only when the expected benefit to the mother outweighs the risk of adverse effects on the fetus. Administration of the drug in the first trimester of pregnancy is not allowed. Vancomycin passes into breast milk, so breastfeeding should be discontinued when prescribing the drug during lactation. Special instructions: Vancor use is recommended only in inpatient settings. Slow administration of the drug by infusion (not less than 60 minutes) is necessary. Rapid administration of Vancor can be accompanied by a sharp decrease in blood pressure and, in rare cases, cardiac arrest. Also, Vancor cannot be administered intramuscularly or intravenously as a bolus due to painful injection and possible tissue necrosis. The incidence and severity of thrombophlebitis can be reduced by proper dilution of the initial solution and alternating injection sites. In case of long-term therapy with Vancor, it is necessary to monitor the peripheral blood count, renal function (urinalysis, creatinine and urea nitrogen levels). Vancor is used with caution in patients over 60 years of age, as the risk of hearing damage is high in this category. Therefore, this age group requires monitoring of vancomycin concentration in serum. Due to the possible development of ototoxic and nephrotoxic effects, Vancor should be prescribed with caution in cases of hearing impairment and renal failure. In such patients, monitoring of vancomycin levels in serum is necessary to prevent toxic concentrations. Caution should be exercised when prescribing Vancor to patients with increased sensitivity to teicoplanin due to the risk of cross-allergy. Prolonged use of Vancor increases the risk of antibiotic-associated diarrhea and the growth of resistant strains of microorganisms. Pediatric use In premature and infant infants, it is necessary to monitor vancomycin concentration in plasma when using the drug. Simultaneous use with anesthetics may cause erythematous rash and facial hyperemia. Effect of the drug on the ability to drive vehicles and operate machinery: Not identified. Packaging: Sterile powder for preparation of infusion solution, 1g in a vial. 50 vials in a cardboard box. Storage conditions: Store at a temperature not exceeding 25°C in a dry, protected from light, and inaccessible place for children. Shelf life: 3 years. The drug is not allowed to be used after the expiry date indicated on the packaging. The drug is not allowed to be used in case of any defect found during visual inspection. Dispensing category: Pharmaceutical product group II, dispensed with prescription form #3.