Vankogen

The glycopetid antibiotic for intravenous infusions, used only in inpatient departments of medical institutions. It is intended for the treatment of severe infections, the active component is vancomycin hydrochloride (producer Amycolatopsis orientalis).

Indications Vankogen

Severe clinical cases of infectious diseases provoked by microorganisms sensitized to the active ingredient, due to the lack of efficacy of penicillin, cephalosporin and other antibacterial drugs or hypersensitivity to them in the patient; bacterial sepsis; bacterial inflammation of the endocardium; preoperative antibiotic therapy for prosthetic heart valve; an inflammation (abscess) of the lung; Infectious and inflammatory diseases of bones, bone marrow and central nervous system; enterocolitis.

Release form

Dry substance for infusion solution, packaged in vials containing 500 and 1000 mg of active substance.

Pharmacodynamics

The bactericidal effect is based on inhibition of biosynthesis of the bacterial cell membrane and a decrease in its strength. Vancomycin hydrochloride modifies the synthesis of the ribonucleic acid molecule of a pathogenic microorganism.

The active ingredient exhibits activity with respect to gram-positive microbes: staphylococci, in particular, golden and epidermal (methicillin-resistant strains inclusive), streptococci - ß-hemolytic group A and group B, pneumococci (penicillin-resistant strains inclusive), green streptococci, enterococci , listeria, diphtheria rods, clostridia, actinomycetes.

Suppresses the activity of most of the sensitive to vancomycin hydrochloride microorganisms with a minimum serum content of this drug to 5 μg / ml. For tolerant staphylococcus aureus, the concentration of the preparation is from 10 μg / ml to 20 μg / ml.

Pharmacokinetics

The active ingredient is practically not absorbed in the gastroduodenal tract, as a result of which intravenous long-term (for an hour) drip infusion of vancomycin hydrochloride is used.

The highest after-infusion serum concentration is directly proportional to the administered dosage: drip infusion of 500 mg of antibiotic leads to a serum concentration of approximately 33 μg / ml (1000ml - 63μg / ml). After 12 hours, the residual level of the drug content is from 5 to 10 μg / ml. It binds to albumin by 55%.

The active ingredient penetrates well into the interstitial fluid - articular, pleural, pericardial, and others. Overcomes the blood-brain barrier only in case of inflammation of the cerebral membranes.

Approximately three quarters of the administered amount of this substance is eliminated with the urinary organs through the glomerular filter during the first day, in persons over 18 years without renal pathologies, the half-life of vancomycin hydrochloride is between four and six hours. In the presence of anuria, this time interval is extended to 7.5 days.  

Dosing and administration

Child age of the patient

The recommended dosage is 10 mg per kilogram of the child's body weight, drip the drug for an hour every six hours.

Treatment of newborns begins with a dosage of 15 mg per kilogram of the child's weight, then the dosage is reduced to 10 mg per kilogram of weight every 12 hours during the first seven days after birth. From the eighth day to the month of age, 10 mg per kilogram of weight is administered after eight hours. Introduced drip for an hour.

Schemes of dosing of Vancogene in the neonatal period

Age since early pregnancy¹ (weeks)	Chronological age (days)	Whey Creatinine² (mg / dL)	Dosage (mg / kg)
Less than 30	No more than seven	Data not informative³	15 in a day
	From the eighth day of life	Not more than 1,2	10 in 12 hours
30-36	Not more than 14	Data not informative³	10 in 12 hours
	Older than 14	Not more than 0.6	10 in 8 hours
	Older than 14	0.7-1.2	10 in 12 hours
More than 36	No more than seven	Data not informative³	10 in 12 hours
	From the eighth day of life	Not more than 0.6	10 in 8 hours
	From the eighth day of life	0.7-1.2	10 in 12 hours

¹ - age of intrauterine development plus chronological age;

² - at a serum creatinine level of more than 1.2 mg / dl, the drug is dosed at 15 mg / kg daily;

³ - such patients need to regularly monitor the serum level of the active ingredient of the drug.

Dosage for patients over 18 years of age

The recommended dosage of the drug to persons over 18 years old without renal pathologies is 2000 mg per day. It can be administered four times 500mg or twice 1000mg, maintaining equal time intervals. Drip Injection of Vancogene is performed at a rate of 10 mg / min.

For elderly patients and / or overweight, the dosage of the drug may be adjusted depending on the plasma content of the active ingredient.

Patients with pathological processes in the kidney Vankogen is dosed individually, relying on the serum creatinine.

Dosage of Vancogene to persons with renal dysfunction

Creatinine clearance (ml / min)	Dosage of Vancogene (mg / 24 h)
100	1545
90	1390
80	1235
70	1080
60	925
50	770
40	620
Thirty	465
20	310
10	155

The above calculations are not applicable to persons with no urine in the bladder. They are recommended to start therapy with a dosage of 15 mg per kilogram of the patient's body weight in order to speed up the creation of optimal concentrations of vancomycin hydrochloride in the blood plasma. The maintenance serum level of its dosage is determined from the calculation of 1.9 mg per kilogram of body weight per day. Patients with severe renal dysfunction intravenous drip infusion of maintenance doses of Vancogene (250-1000 mg) are recommended once with an interval of several days, with anuria - 1000 mg once with an interval of seven to ten days.

Preparation and use

Intravenous infusion: To obtain a composition with a density of vancomycin hydrochloride 50 mg / ml, add 10ml of water for injection into the bottle with 500ml of the active ingredient; with 1000ml - 20ml. This composition should be diluted with glucose solution for infusions (5%) or isotonic (0.9% NaCl) until the density of the active substance is 5 mg / ml: dilute the composition with 500 mg of active ingredient into 100 ml of 5% glucose solution for infusions (isotonic, 0.9 % NaCl), with 1000 mg - in 200ml. Ready-made infusion solutions can be kept if necessary, observing the temperature regime of 2-8 ° C (in the refrigerator), but not more than a day.

Antibiotic-associated pseudomembranous colitis, provoked by Peptoclostridium difficile, or staphylococcal enterocolitis suggests taking the medication internally. The adult dosage is 500-1000 mg per day. The calculation of the nursery is based on 40 mg per kilogram of the child's weight per day. Single dose is divided into three or four doses. Duration of treatment - from a week to ten days.

The oral solution is prepared by dissolving the powder from the vial into 30 ml of water. It is possible to combine the resulting solution with liquid syrups or food additives to improve taste. 

[1]

Use Vankogen during pregnancy

This drug is not recommended for prescribing during the period of gestation, exceptions are vital cases. The active ingredient is determined in breast milk, therefore, for the period of the therapeutic course of vancomycin, breastfeeding is interrupted. 

Contraindications

Cochlear neuritis, hearing loss; kidney pathologies; the first three months of pregnancy, sensitization to the ingredients of the solution. 

Side effects Vankogen

A short injection of medication into the vein is associated with the risk of anaphylaxis, the flow of blood to the upper body in combination with rashes on the face, neck, arms, legs and spasmodic contractions of the thoracic and dorsal musculature. As a rule, such phenomena last no more than a third of an hour, however, not always. Occasionally such phenomena occur and with the recommended rate of infusion.

The greatest danger is the side effects of the drug on the organs of hearing and kidney function. Occurrence of symptoms of hearing loss, for example, noise in the ears, is a signal to stop treatment with Vancogen because of the possibility of irreversible changes in the ears.

Severe renal dysfunction as a result of drug therapy is rarely detected. It is manifested by an increase in the plasma creatinine concentration and azotemia. It often develops with high dosage therapy. Single cases of interstitial nephritis are known when combined use of aminoglycoside antibacterial agents or in renal failure in a patient. The termination of reception leads to restoration of normal work of kidneys.

There can be reversible hematopoietic disorders in the form of a decrease in neutrophil counts, leukocytes, platelets, an increase in the number of eosinophils.

From the skin can be observed hives, malignant exudative erythema, Lyell's syndrome, vasculitis.

Dyspeptic disorders, uncontrollable diarrhea can be considered as a symptom of the development of superinfection. 

Overdose

The symptomatology of drug overdose is expressed in exacerbation of side effects. Stop its introduction and conduct therapeutic measures according to the symptoms.

Recommended activities: fluid administration and determination of the serum density of the active substance. Hemofiltration is preferred for the elimination of an excessive amount of the drug. It is more effective than hemodialysis in this case.

Interactions with other drugs

The combination of Vancogene with drugs that can exert a toxic effect on the central nervous system and / or urinary organs (ureitis, cisplatin, antibacterial agents of the aminoglycoside series, muscle relaxants) can mutually enhance intoxication.

The combination with ototoxic drugs can mutually reinforce the negative impact on the hearing organs.

The combination with antihistamine drugs can camouflage the signs of Vancogene ototoxicity (tinnitus).

Simultaneous use with anesthetics increases the possibility of developing arterial hypotension, skin and anaphylactoid reactions.

Vancomycin hydrochloride in solution has a pronounced acidity, which can not be neglected when it is necessary to mix with other substances.

The cross-resistance of Vancogene to other antibacterial drugs is not known.

Combination with levomitsetin, synthetic steroid hormones, methicillin, eufillin, antibiotics of cephalosporin group, heparin derivatives, phenobarbital. 

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Storage conditions

Store in accordance with the temperature regime up to 25 ° C. Keep away from children.

[3]

Shelf life

Shelf life 3 years.

Ready-made solution for infusions is suitable for use within a day from the moment of preparation, under condition of storage with observance of a temperature mode 2-8 ° С.