Composition, form of production and packaging
Solution for peritoneal dialysis 1 liter
dextrose monohydrate 25 g
calcium chloride dihydrate 183.8 mg
magnesium chloride hexahydrate 101.7 mg
sodium lactate 3.925 g
Sodium chloride 5.786 g
2 l - plastic systems "Stay Safe" (4) - cardboard boxes.
2.5 l - plastic systems "Stay Safe" (4) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
KAPD / DPKA 19 is a solution of electrolytes containing glucose and a lactate buffer administered intraperitoneally for the treatment of the terminal stage of chronic renal failure and acute renal failure of various genesis by peritoneal dialysis (PD).
The method of permanent ambulatory peritoneal dialysis (CAPD) is characterized by a more or less constant presence of dialysis solution (usually 2 liters) in the abdominal cavity, which is replaced with fresh solution from 3 to 5 times a day.
The basic principle underlying any technique of peritoneal dialysis is the use of the peritoneum as a semipermeable membrane through which it is possible to exchange dissolved substances and water between the blood and the dialysis solution by diffusion in accordance with their physico-chemical properties.
The electrolyte composition of the solution basically does not differ from the physiological, although it is adapted (the solution does not contain potassium) for use in patients with uremia in order to make possible renal replacement therapy by the method of intraperitoneal metabolism and fluid.
During the dialysis procedure, substances normally excreted in the urine, such as the products of nitrogen metabolism (urea, creatinine), inorganic phosphates, uric acid, other solutes and water, are removed from the body with dialysate.
Water balance can be maintained by applying solutions with different concentrations of glucose, providing liquid removal (ultrafiltration). Secondary metabolic acidosis is compensated by the presence of lactate in the dialysis solution. Lactate is completely metabolized to bicarbonate.
PHARMACOKINETICS
Kinetics of the products of nitrogen metabolism. The ratio of the urea concentration in the dialysate to the plasma concentration (D / P) achieves equilibrium after a 4-hour interaction with both 1.5% and 4.25% glucose solutions. The ratio (D / P) for creatinine is 0.6 to 0.7 by the 4th hour, and not reaching equilibrium. The same is true for other low molecular weight toxins, such as uric acid and inorganic phosphate, whose D / P ratio is 0.6 and 0.4-0.5, respectively.
Kinetics of sodium. With constant (stable) ultrafiltration, the removal of sodium correlates with the serum sodium concentration. An increase in serum sodium concentration is accompanied by an increase in the sodium content in the "spent" dialysate solutions. In the case of an increase in the extracellular volume and the maintenance of the same concentrations of sodium in both plasma and dialysate, the removal of sodium can be divided into two phases. The sodium concentration in the ultrafiltrate remains lower than the concentration in the extracellular fluid. In the second phase of the exposure period, sodium diffuses into the dialysate solution.
Kinetics of potassium. Potassium is removed like sodium, primarily by diffusion. Excretion of approximately 30 mmol of potassium is achieved by four 2-liter exchanges.
Kinetics of calcium. The ratio of calcium concentration in dialysate to plasma concentration (D / P) achieves equilibrium with any standard concentrations of glucose solution and calcium content of 1.75 mmol / l in the dialysis solution.
Magnesium kinetics. The ratio of magnesium concentration in dialysate to plasma concentration (D / P) does not reach equilibrium when using any standard concentrations of glucose solution and a magnesium content of 0.75 mmol / l in the dialysis solution.
Kinetics of glucose and liquid . Glucose dialysate, used as an osmotic agent, is absorbed slowly, i.e. decreasing the osmotic gradient between the dialysis solution and the extracellular fluid. About 70-80% of the glucose received during the day with the dialysis solution is absorbed. Ultrafiltration is maximum at the beginning of the exposure and reaches a maximum after about 2-3 hours. By the end of the exposure, in connection with the absorption of glucose, the rate of ultrafiltration decreases.
Kinetics of lactate. The rate of excretion of lactate is maximal at the beginning of exposure, and decreases in accordance with the decrease in lactate diffusion. Lactate is absorbed almost completely after a 6-hour exposure. When carrying out standard procedures for peritoneal dialysis, D- and L-lactate is metabolized within 30 minutes after absorption.
INDICATIONS
- terminal (decompensated) stage of chronic renal failure;
- Acute renal failure of various genesis.
DOSING MODE
The solution, after heating to body temperature, is introduced into the abdominal cavity through a surgically installed peritoneal catheter. The administration time is from 5 to 20 minutes. The solution is in the abdominal cavity for 4-8 hours, as prescribed by the doctor, and then merged and replaced with fresh. Usually within a day apply 4-fold exchanges of 2000 ml with equal intervals of time between the exchange of solution in the abdominal cavity. Treatment is carried out every day, according to the dose established by the doctor and lasts as long as required for renal replacement therapy. KAPD / DPKA 19, the solution for peritoneal dialysis is used both separately when the desired ultrafiltration and electrolyte composition is achieved, and in combination with other solutions for peritoneal dialysis. Regularly monitor the concentrations of creatinine and urea.
If there are no other prescriptions, use 2000 ml of solution for 1 treatment. If at the beginning of the procedure, if the patient has a tension of the anterior abdominal wall, the dose can be temporarily reduced to 500-1500 ml per procedure. For children it is recommended to use a dose between 500 and 1500 ml (30-40 ml per kg of body weight) per procedure. For patients with excessive body weight and / or resistant to large volumes of filling, 2500 or 3000 ml of solution can be used.
In cases where the prescribed infusion is performed through the apparatus for peritoneal dialysis, intermittent or cyclic method, it is recommended to use 5000 ml bags. The concentration of glucose and infusion volumes depend on the body weight, tolerability and residual function of the kidneys and are prescribed by the treating physician.
Duration of use: according to the doctor's prescription.
SIDE EFFECT
The relative loss of proteins (5-15 g / day) and amino acids (1.2-3.4 g / day) with peritoneal dialysis is unavoidable, and loss of water-soluble vitamins is also possible.
Hypokalemia.
Deficiency of these substances must be supplemented by an adequate diet. In case of insufficient compensation of protein losses with food, hypoproteinemia may occur.
A sensation of swelling is also possible; abdominal pain in the administration and removal of dialysate; pain in the shoulder joint and shortness of breath due to the elevation of the diaphragm; diarrhea or constipation; hernia.
With concomitant diabetes, the development of hyperglycemia is possible due to the additional glucose load. Therefore, it is necessary to regularly monitor the concentration of glucose in the blood.
CONTRAINDICATIONS
Contraindications for peritoneal dialysis as a method:
- Diseases affecting the integrity of the abdominal wall or abdominal cavity, such as: fresh wound, burns or extensive inflammatory skin lesions (dermatitis) at the site of the catheter outlet, peritonitis; perforation of the hollow organs of the abdominal cavity; abdominal surgery in history with the development of fibrous adhesions, inflammatory bowel disease (Crohn's disease, ulcerative colitis, diverticulosis), intra-abdominal tumors, recent surgery on the abdominal cavity, paralytic intestinal obstruction, abdominal hernia; internal or external abdominal fistulas;
- Diseases of the respiratory system, especially pneumonia;
- sepsis;
lactate acidosis;
- cachexia and a significant decrease in body weight, especially if adequate nutrition is not possible;
- in cases when uremia, it is not amenable to therapy with peritoneal dialysis;
- severe hyperlipidemia;
- use in patients who are physically or mentally (psychosis, dementia) are unable to comply with the doctor's instructions for peritoneal dialysis procedures.
Contraindications only for CAPD / DPKA 19:
severe hypokalemia.
PREGNANCY AND LACTATION
The pharmacological composition of the drug does not pose a risk with respect to the development of the fetus or the course of pregnancy, as well as in relation to the infant breastfed.
However, peritoneal dialysis solution should be used in pregnant women and breastfeeding women only after careful comparison of the possible benefits for the mother and the risk to the fetus and the baby.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is used in the terminal (decompensated) stage of chronic renal failure, with acute renal failure of various genesis.
APPLICATION FOR CHILDREN
For children it is recommended to use a dose between 500 and 1500 ml (30-40 ml per kg of body weight) per procedure
SPECIAL INSTRUCTIONS
A single volume of dialysate administered in children should be calculated according to body weight.
In order to prevent dehydration or hyperhydration, it is necessary to constantly monitor the ratio of fluid and body weight of the patient.
Regular monitoring of physical parameters, concentrations of electrolytes, creatinine and urea, total plasma protein, blood glucose, and in some cases other laboratory parameters (for example, blood gases, acid-base state) is mandatory.
In patients with diabetes, it is necessary to monitor the concentration of glucose in the blood and, if necessary, to correct the daily dose of insulin in accordance with the increasing load of glucose.
The choice of solutions for peritoneal dialysis, different in the concentration of glucose and Ca 2+ , should be carried out individually in each specific case.
To reduce the risk of infection, aseptic conditions should be maintained during the replacement of the solution. It is necessary to pay attention to the transparency and appearance of the withdrawn solution. If the withdrawn solution is cloudy, dialysis should be stopped immediately and consulted by your doctor. Pay attention to the absence of damage to the package, even minor ones. Use a solution for peritoneal dialysis only if the package is not damaged.
Never use packages with opaque content.
All unused portions of the solution should be destroyed.
Solutions for peritoneal dialysis can not be used intravenously.
Because of the existing risk of incompatibility and microbial contamination, other drugs can be added to the peritoneal solution only for the purpose of the attending physician. In this case, the solution should be used immediately (without storage) after thorough mixing and checking for transparency.
OVERDOSE
To date, there have been no reported cases of overdose.
DRUG INTERACTION
Not registered.
It should be remembered that the medications taken can enter dialysate and, together with it, be excreted from the body, which may require correction of their dose.
Simultaneous use of diuretics can be useful for maintaining residual excretion by the kidneys, but, at the same time, can cause disturbances in the water-electrolyte balance. The concentration of potassium should be monitored particularly carefully with concomitant therapy with cardiac glycosides, as the sensitivity to these drugs increases with hypokalemia.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 25 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 2 years.
