Suvitol

Instructions for use of the drug

SUVITOL

Trade name: Suvitol

International nonproprietary name: sodium lactate and sorbitol

Dosage form : solution for infusion

Compound:

Every 100 ml of solution contains:

sorbitol	6.00 g
sodium lactate	1.9 g
sodium chloride	0.6 g
calcium chloride (Calcium chloride hexahydrate calculated on dry matter)	0.01 mg
potassium chloride	0.03 mg
magnesium chloride (Magnesium chloride hexahydrate in terms of dry matter)	0.02 mg
water for injections	Up to 100/200 and 400ml

Description: Transparent colorless or slightly yellowish liquid.

Clinical and pharmacological group : Plasma replacement drug

Pharmacotherapeutic group: Plasma replacement agent

ATX code : B05XA31

pharmachologic effect

Plasma replacement drug. It has a rheological, anti-shock, detoxifying, alkalizing effect. The main pharmacologically active substances are sorbitol and sodium lactate. In the liver, sorbitol is first converted to fructose, which is then converted to glucose and then to glycogen. Part of the sorbitol is used for immediate energy needs, the other part is stored as a reserve in the form of glycogen. An isotonic sorbitol solution has a disaggregant effect and thus improves microcirculation and tissue perfusion.

Unlike bicarbonate solution, correction of metabolic acidosis with sodium lactate occurs more slowly as it is included in the metabolism, without causing sharp fluctuations in pH. The effect of sodium lactate appears 20-30 minutes after administration.

Sodium chloride is a plasma-substituting agent that exhibits detoxification and rehydration effects. Eliminates deficiency of sodium and chlorine ions in various pathological conditions.

Calcium chloride eliminates calcium ion deficiency. Calcium ions are necessary for the transmission of nerve impulses, contraction of skeletal and smooth muscles, myocardial activity, bone tissue formation, and blood clotting. Reduces the permeability of cells and the vascular wall, prevents the development of inflammatory reactions, increases the body’s resistance to infections and can significantly enhance phagocytosis.

Potassium chloride restores water and electrolyte balance. It exhibits negative chrono- and bathmotropic effects, and in high doses — negative ino-, dromotropic and moderate diuretic effects. Takes part in the process of conducting nerve impulses. Increases the content of acetylcholine and causes excitation of the sympathetic division of the autonomic nervous system. Improves the process of skeletal muscle contraction in muscular dystrophy and myasthenia.

Pharmacokinetics

Sorbitol is quickly included in general metabolism, 80-90% of which is utilized in the liver and accumulates in the form of glycogen. 5% is deposited in brain tissue, cardiac muscle and skeletal muscle. 6-12% is excreted in urine.

When introduced into the vascular bed, sodium lactate reacts with carbon dioxide and water, forming sodium bicarbonate, which leads to an increase in the alkaline reserve of the blood. Only half of the administered sodium lactate (isomer L) is considered active, while the other half (isomer D) is not metabolized and is excreted in the urine.

Sodium chloride is quickly removed from the vascular bed, only temporarily increasing the volume of blood volume. Increases diuresis.

Indications

— to improve capillary blood flow for the purpose of prevention and treatment of traumatic, surgical, hemolytic, toxic and burn shock, with acute blood loss, burn disease;

— infectious diseases accompanied by intoxication, exacerbation of chronic hepatitis;

— sepsis;

— for preoperative preparation and in the postoperative period;

— to improve arterial and venous circulation for the prevention and treatment of thrombosis, thrombophlebitis, endarteritis;

— Raynaud’s disease.

Dosage regimen

IV stream or drip.

For adults, intravenous drip at a rate of 40–60 drops per minute. If necessary, a jet injection of the drug is allowed after the test by drip injection at a rate of 30 drops per minute. After administering 15 drops, the infusion of the drug is stopped, and after 3 minutes, if there is no reaction, Suvitol® is administered in a stream.

For chronic hepatitis — 400 ml (6–7 ml/kg body weight) drip, repeated.

For thrombus-obliterating diseases of the blood vessels — at the rate of 8-10 ml/kg body weight, drip, repeated, every other day, up to 10 infusions per course of treatment.

In the preoperative period and after various surgical interventions — at a dose of 400 ml (6-7 ml/kg body weight) dropwise, once or repeatedly, daily for 3-5 days.

For acute blood loss — 1500–1800 ml (up to 25 ml/kg body weight). In this case, Suvitol® infusions are recommended to be carried out at the prehospital stage, in a specialized ambulance.

For traumatic, burn, postoperative and hemolytic shock — 600–1000 ml (10–15 ml/kg body weight) once and repeatedly, first in a stream, then in a drip method;

Children under the age of 6 years are recommended to administer the drug at a dose of 10 ml/kg body weight, from 6 to 12 years — at a dose that is half the dose for adults. Children over 12 years old — in a dose the same as for adults.

Side effect

Alkalosis and allergic reactions (skin rashes, itching) may occur.

Contraindications for use

— alkalosis;

— in cases where the infusion of large volumes of fluid is contraindicated (cerebral hemorrhage, thromboembolism, cardiovascular decompensation, stage III arterial hypertension);

— hypersensitivity to the components of the drug.

The drug should be prescribed with caution to patients with impaired liver function, peptic ulcer disease, or hemorrhagic colitis.

Use during pregnancy and breastfeeding

There are no data on the use of Suvitol® during pregnancy and breastfeeding.

Use for liver dysfunction

The drug should be prescribed with caution to patients with impaired liver function.

Use in children

For children under 6 years of age, it is recommended to administer the drug at a dose of 10 ml/kg body weight; at the age of 6 to 12 years — at a dose that is half the dose for adults; For children over 12 years of age, the dose of the drug is the same as for adults.

special instructions

The drug is used under the control of acid-base status and blood electrolytes, as well as the functional state of the liver.

Use with caution in patients with calculous cholecystitis.

Drug interactions.

Suvitol® must not be mixed with phosphate- and carbonate-containing solutions.

Do not use as a carrier solution for other drugs.

Overdose

Symptoms : phenomena of alkalosis occur, which quickly go away on their own, subject to immediate cessation of drug administration.

Release form:

100/200/400 ml of the drug in a PET bottle

Best before date.

3 years.

Storage conditions.

Store in a cool and dry place at a temperature not exceeding 25°C.

Store protected from light and humidity.

Keep out of the reach of children.

Conditions for dispensing from pharmacies:

On prescription.

Manufacturer :

Cisen Pharmaceutical Co.,Ltd .

Tongji Sci-tech Industrial Park, High-tech Industrial

Development Zone, Jining, Shandong, China. 272000