Acesol (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

B05BB01 (Electrolytes)

Active Substances

Sodium chloride (Ph.Eur.)

Potassium chloride (Ph.Eur.)

Sodium acetate (BP)

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Rehydrating agent

Pharmacological Action

A combined drug that has detoxifying, plasma-substituting, rehydrating, diuretic, anti-shock, and antiplatelet effects.

It reduces hypovolemia, prevents blood thickening and the development of metabolic acidosis, enhances diuresis, and improves microcirculation.

Pharmacokinetics

K⁺ and Na⁺ ions are not retained in the vascular bed for long and are quickly distributed throughout all body tissues.

They are excreted primarily by the kidneys, and in small amounts through the intestines, sweat, tears, etc.

In the body, acetate is activated into acetyl-coenzyme A; then, the main amount of active acetate is completely oxidized in the Krebs cycle to carbon dioxide and water.

The process of acetate oxidation occurs in muscle cells, so the body’s ability to metabolize it mainly depends on body muscle mass.

The metabolism of acetyl-CoA can also proceed via the minor oxidation pathway with the formation of fatty acids, keto acids, and cholesterol.

Indications

Dehydration;
Intoxication (acute shigellosis, foodborne toxicoinfection, cholera).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A00	Cholera
A02	Other salmonella infections
A03	Shigellosis
A05.9	Bacterial foodborne intoxication, unspecified
A09	Other and unspecified gastroenteritis and colitis of infectious origin
E86	Volume depletion (including dehydration, hypovolemia)

ICD-11 code	Indication
1A00	Cholera
1A02	Intestinal infections due to Shigella
1A09.Z	Salmonella infection, unspecified
1A1Z	Bacterial foodborne intoxications, unspecified
1A40.Z	Infectious gastroenteritis or colitis, unspecified
5C70.Z	Decrease of volume of fluid [hypovolemia], unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

The drug is used only in moderate and severe conditions when oral rehydration solutions cannot be taken; it is administered intravenously by bolus (1-3 hours).

Before administration, the solution is warmed to 36-38°C (96.8-100.4°F).

The volume of the solution administered is selected individually, in the amount necessary to restore the water-electrolyte balance (in severe forms of the disease, within 1 hour, the solution is administered by bolus in an amount corresponding to 7-10% of the patient’s body weight; then bolus administration is replaced by drip administration, at a rate of 40-120 drops/min (24-48 hours)), under the control of laboratory parameters.

The balance of administered and lost fluid is determined every 6 hours.

The total amount of solution administered should correspond to the volume of fluid excreted with stools, vomit, urine, and sweat.

Adverse Reactions

Edema, tachycardia, chills, hyperkalemia.

Contraindications

Hyperkalemia;
Alkalosis;
Chronic renal failure;
Presence of contraindications to the administration of large amounts of fluid into the body;
Hypersensitivity.

Use with caution in patients with impaired renal excretory function.

Use in Pregnancy and Lactation

Possible if the expected therapeutic effect in the mother outweighs the potential risk to the fetus and child (adequate and strictly controlled studies on the safety of use in pregnant and breastfeeding women have not been conducted).

Use in Renal Impairment

Use with caution in patients with impaired renal excretory function.

Contraindicated in chronic renal failure.

Special Precautions

Treatment is carried out under the control of hematocrit and blood electrolyte concentrations.

In case of hyperkalemia development, the drug is replaced with “Disol” solution until the electrolyte balance normalizes.

Freezing of the drug is not a contraindication to its use.

Non-wettability of the inner surface of the bottle or polymer container is not a contraindication to the use of the drug.

Effect on the ability to drive vehicles and mechanisms

Studies to assess the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions have not been conducted.

In general, in case of dehydration, the administration of special solutions orally is indicated, and only if such administration is impossible (intractable vomiting, severe degree of dehydration, severity of general condition, etc.), the drug is administered parenterally.

Overdose

Symptoms: in patients with chronic kidney diseases or any conditions accompanied by impaired potassium excretion from the body, or with too rapid intravenous administration of the drug, hyperkalemia may develop, which can potentially be fatal.

Early clinical manifestations of hyperkalemia (peaking of the T wave, disappearance of the U wave, depression of the ST segment, and prolongation of the QT interval) usually appear at a serum potassium concentration of 7 to 8 mEq/L.

More severe symptoms (including muscle paralysis and cardiac arrest) develop at a potassium concentration of 9-10 mEq/L.

It should be borne in mind that hyperkalemia leading to death can develop rapidly and be asymptomatic.

Treatment: discontinuation of the drug; in case of hyperkalemia manifestations – the drug is replaced with “Disol” solution until the electrolyte balance normalizes.

If necessary, hemodialysis and peritoneal dialysis are performed.

Drug Interactions

If necessary, it can be combined with infusion of blood, plasma, polyglucin, etc.

Storage Conditions

Store the drug at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Acesol [Biosintez, PJSC (Russia)]
Infusion solution 5 g+1 g+2 g/1 l: bottle 200 ml or 400 ml 1 pc.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Acesol

Infusion solution 5 g+1 g+2 g/1 l: bottle 200 ml or 400 ml 1 pc.

Dosage Form, Packaging, and Composition

Infusion solution	1 L
Sodium chloride	5 g
Potassium chloride	1 g
Sodium acetate trihydrate	2 g

200 ml – vials for blood substitutes (1) – cardboard packs.
400 ml – vials for blood substitutes (1) – cardboard packs.
200 ml – vials for blood substitutes (24) – cardboard boxes.

Acesol [Grotex, LLC (Russia)]
Infusion solution 5 g+1 g+2 g/L: 100 mL, 200 mL, 250 mL, 400 mL, 500 mL or 1000 mL vials

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Acesol

Infusion solution 5 g+1 g+2 g/L: 100 mL, 200 mL, 250 mL, 400 mL, 500 mL or 1000 mL vials

Dosage Form, Packaging, and Composition

Infusion solution transparent, colorless.

	1 L
Sodium chloride	5 g
Sodium acetate trihydrate	2 g
Potassium chloride	1 g

Infusion solution	1 L
Sodium chloride	5 g
Potassium chloride	1 g
Sodium acetate trihydrate	2 g

200 ml – bottles for blood and blood substitutes (1) – cardboard packs.
200 ml – bottles for blood and blood substitutes (24) – boxes.
200 ml – bottles for blood and blood substitutes (28) – cardboard boxes.
400 ml – bottles for blood and blood substitutes (1) – cardboard packs.
400 ml – bottles for blood and blood substitutes (12) – cardboard boxes.
400 ml – bottles for blood and blood substitutes (15) – cardboard boxes.
100 ml – bottles (1) – cardboard packs.
100 ml – bottles (56) – boxes.
100 ml – bags (56) – boxes.
200 ml – bags (24) – boxes.
200 ml – bags (28) – boxes.
400 ml – bags (15) – boxes.
400 ml – bags (12) – boxes.
1000 ml – bags (12) – boxes.
250 ml – bags (24) – boxes.
250 ml – bags (28) – boxes.

Acesol [Mir Chemical and Pharmaceutical Concern, LLC (Russia)]
Infusion solution 2 g+5 g+1 g/1 L: bottles or vials 25 mL, 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL or 500 mL, containers 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, 500 mL, 750 mL, 800 mL or 1000 mL

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Manufactured By

NPC Eskom, PJSC (Russia)

Medpolymer Firm, JSC (Russia)

KFK Mir, LLC (Russia)

Dosage Form

Acesol

Infusion solution 2 g+5 g+1 g/1 L: bottles or vials 25 mL, 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL or 500 mL, containers 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, 500 mL, 750 mL, 800 mL or 1000 mL

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a colorless, transparent liquid.

	1 L
Sodium acetate trihydrate	2 g
Sodium chloride	5 g
Potassium chloride	1 g
Ionic composition
Sodium ion	100.3 mmol/L
Chloride ion	99 mmol/L
Acetate ion	14.7 mmol/L
Potassium ion	13.4 mmol/L

Excipients : water for injections – up to 1 L.

Theoretical osmolarity 227 mOsm/L.

25 mL, 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, or 500 mL – bottles (1) – cardboard packs.
25 mL, 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, or 500 mL – vials (1) – cardboard packs.
25 mL, 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, or 500 mL – vials (1) – polymer bags.
50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, 500 mL, 750 mL, 800 mL, or 1000 mL – single-use polymer containers for infusion solutions (1) with SFC type injection ports (1) – bags (1) – cardboard boxes.
50 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, 500 mL, 750 mL, 800 mL, or 1000 mL – single-use polymer containers for infusion solutions (1) with SFC type injection ports (2) – bags (1) – cardboard boxes.

Medixlife (Author)

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