Instructions for Xylat solution for infusions, 200 ml bottle
Composition
active ingredients:
1 ml of solution contains xylitol 50 mg, sodium acetate trihydrate (calculated as sodium acetate) 2.6 mg, sodium chloride 6 mg, calcium chloride dihydrate (calculated as calcium chloride) 0.1 mg, potassium chloride 0.3 mg, magnesium chloride hexahydrate (calculated as magnesium chloride) 0.1 mg;
excipient: concentrated hydrochloric acid, water for injection.
Dosage form
Solution for infusion.
Main physicochemical properties: transparent, colorless liquid. Ionic composition of the drug:
Na+ − 134.4 mmol/l, K+ − 4 mmol/l, Ca++ − 0.9 mmol/l, Mg++ − 1.1 mmol/l, Cl- − 110.6 mmol/l, СН3СОО- − 31.7 mmol/l. Energy value – 200 kcal/l. Theoretical osmolarity 611 mosmol/l, pH 6.0‒7.6.
Pharmacotherapeutic group
Blood substitutes and perfusion solutions. Electrolyte solutions. Electrolytes in combination with other drugs. ATX code B05X AZ1.
Pharmacological properties
Pharmacodynamics
The main active ingredients of the drug are xylitol and sodium acetate.
Xylitol is a pentaatomic alcohol that, when administered intravenously, is quickly incorporated into the general metabolism, 80% is absorbed in the liver and accumulates in the form of glycogen.
It has a pronounced anti-ketogenic effect and is a source of energy with insulin-independent metabolism.
Xylitol is a natural intermediate product of carbohydrate metabolism in humans, therefore it has low toxicity and good tolerance. Unlike fructose, it does not cause a decrease in nucleotides (adenosine triphosphate, adenosine diphosphate, adenosine monophosphate) in the liver, and is also safe for administration to patients who have a deficiency of the enzyme fructose-1,6-diphosphatase or who are intolerant to fructose.
Sodium acetate belongs to the slow-acting alkalizing agents. It causes the accumulation of bases due to the metabolism of the buffered drug and is indicated for types of metabolic acidosis in which the accumulation of excess H+ occurs slowly (for example, in renal and deficient non-respiratory acidosis). When using sodium acetate, in contrast to sodium bicarbonate solution, the correction of metabolic acidosis occurs more slowly, therefore it does not cause sharp fluctuations in pH.
Pharmacokinetics
Sodium acetate is completely metabolized into an equivalent amount of sodium bicarbonate within 1.5–2 hours, does not cause intracellular interstitial edema of the brain and does not increase platelet and erythrocyte aggregation. It is important that oxygen consumption during acetate metabolism is significantly lower than during lactate metabolism, which is of great importance for the treatment of severe shock of various origins.
Xylat® belongs to the group of multicomponent multifunctional hyperosmolar solutions and has antiketogenic, hemodynamic, detoxification, rheological, energetic, alkalizing and osmodiuretic effects.
Indication
To reduce intoxication, improve microcirculation, to partially cover the need for carbohydrates that occurs in diabetes mellitus and other disorders of glucose utilization, in traumatic, surgical, hemolytic and burn shock (taking into account blood and urine osmolarity), in preoperative preparation and in the postoperative period, in acute blood loss, as well as in burn disease, in prolonged purulent processes, in various infectious diseases and chronic toxic hepatitis.
Contraindication
Hyperosmolar coma, anuria. Xylat® should not be administered in cases where fluid infusion is contraindicated (edema, cerebral hemorrhage, thromboembolism, cardiovascular decompensation, stage III arterial hypertension). The use of the drug is not recommended for general dehydration and disorders of water and electrolyte metabolism.
Interaction with other medicinal products and other types of interactions
The drug cannot be mixed with phosphate- and carbonate-containing solutions. Xylat® cannot be a carrier solution for other drugs. Adding drugs may lead to physicochemical changes.
Application features
To achieve a hemodynamic effect, Xylat® should be administered intravenously to adults at a rate of 40–60 drops/min.
If necessary, it is allowed to administer the drug by jet injection after the test by drip injection at a rate of 30 drops/min. First, administer 15 drops of the drug, and after 3 minutes, if there is no reaction, administer the drug by jet injection.
The antiketogenic properties of the drug are manifested at a rate of administration equal to the rate of xylitol utilization.
In case of liver diseases, the drug should be used while monitoring liver function indicators. The drug should be used with caution in case of chronic renal failure; during the administration of the drug, kidney function should be monitored.
Since Xylat® has choleretic properties, its administration in cholelithiasis should be carried out under the close supervision of a physician. The administration of Xylat® to patients with diabetes mellitus should be carried out while controlling the blood sugar content.
The use of the drug is not recommended in cases of general dehydration and disorders of water and electrolyte metabolism.
Use during pregnancy or breastfeeding
No studies have been conducted on the use of Xylat® in pregnant women or women during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug should be used exclusively in a hospital setting.
Method of administration and doses
Adults should be administered intravenously by drip, at a rate of 50–70 drops per minute, i.e. 2.1–3 ml/kg/h or 150–210 ml/h.
The maximum dose for adults is 2100 ml per day or 1.5 g xylitol/kg body weight/day. The maximum infusion rate is 210 ml/h (70 drops per minute) = 0.15 g xylitol/kg body weight/h.
In chronic and toxic hepatitis, adults should be administered 400 ml (5-6 ml/kg) per day, drip (monitoring of liver function indicators is necessary) once or twice a day (the daily dose can be divided into 2 administrations).
For parenteral nutrition of patients, including patients with diabetes mellitus, adults should be administered 600–1000 ml (10–15 ml per 1 kg of patient body weight) per day, once or twice a day (the daily dose can be divided into 2 administrations).
In traumatic, burn, postoperative and hemolytic shock - adults should be administered 600-1000 ml (10-15 ml per 1 kg of patient's body weight) per day, once or twice a day (the daily dose can be divided into 2 administrations).
In the preoperative period and after various surgical interventions, adults should be administered dropwise at a dose of 400–600 ml (6–10 ml/kg) per day, once or twice a day (the daily dose can be divided into 2 administrations), daily, for 3–5 days.
In case of acute blood loss, adults should be administered 1000-1400 ml (up to 20 ml/kg). In this case, infusions of Xylat® are also recommended to be carried out at the pre-hospital stage in a specialized ambulance.
Children
No studies have been conducted on the possibility of use in children.
Overdose
In case of an overdose of the drug, nausea, bloating, diarrhea, abdominal pain, and disturbances in water and electrolyte balance (in the form of a hypertensive reaction; in this case, antihypertensive agents should be administered while controlling blood pressure) may occur.
Side effects
Allergic reactions, including rash, itching, urticaria, rarely - tachycardia, fever, irritation of peripheral veins at the injection site. Hypertensive reaction may occur (in this case, antihypertensive agents should be administered, controlling blood pressure); nausea, chills.
Electrolyte disturbances, lactic acidosis, hyperhydration, edema, hyperoxaluria, hyperuricemia, changes in liver function tests, acidosis (including lactic acidosis).
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.
Incompatibility
The drug should not be mixed with phosphate- and carbonate-containing solutions. The addition of drugs may lead to physicochemical changes. If addition is necessary, sterility, thorough mixing, and drug compatibility should be monitored.
Packaging
200 or 400 ml in glass bottles. 200 ml or 400 ml in polymer bottles.
Vacation category
According to the recipe.
Producer
LLC "Yuria-Pharm".
Address
Ukraine, 18030, Cherkasy region, Cherkasy city, Kobzarska st., 108. Tel.: (044) 281-01-01.
