Chlosol (Solution) Instructions for Use
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. It 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, and tears.
In the body, acetate is activated to acetyl-coenzyme A (acetyl-CoA). The main amount of active acetate is then 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 a minor oxidation pathway with the formation of fatty acids, keto acids, and cholesterol.
Indications
Dehydration; intoxication (dysentery, food toxicoinfection, El Tor cholera).
ICD codes
| ICD-10 code | Indication |
| A00 | Cholera |
| A03 | Shigellosis |
| A05 | Other bacterial food poisonings, not elsewhere classified |
| A09 | Other and unspecified gastroenteritis and colitis of infectious origin |
| E86 | Volume depletion (including dehydration, hypovolemia) |
| R54 | Acute intoxication |
| ICD-11 code | Indication |
| 1A00 | Cholera |
| 1A02 | Intestinal infections due to Shigella |
| 1A1Z | Bacterial foodborne intoxications, unspecified |
| 1A40.Z | Infectious gastroenteritis or colitis, unspecified |
| 5C70.Z | Decrease of volume of fluid [hypovolemia], unspecified |
| MG2A | Frailty syndrome |
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. |
Administer intravenously only.
Determine the infusion rate and total volume based on the severity of dehydration and the patient’s clinical condition.
For severe forms of disease, administer as an intravenous bolus over 1 to 3 hours.
For mild to moderate forms, administer as an intravenous drip infusion at a rate of 40 to 120 drops per minute.
Continue the drip infusion for a duration of 24 to 48 hours as required.
Calculate the total infusion volume to correct the existing fluid deficit and maintain adequate water-electrolyte balance.
Adjust the dosage based on the patient’s body weight, serum electrolyte levels, and hematocrit values.
Warm the solution to approximately 37°C (98.6°F) prior to administration.
Monitor cardiovascular status and renal function continuously during therapy.
Discontinue the potassium-containing formulation immediately upon signs of hyperkalemia.
Adverse Reactions
Systemic reactions edema, tachycardia, chills, hyperkalemia.
Contraindications
Hypersensitivity; hyperkalemia; alkalosis; chronic renal failure; presence of contraindications to the introduction of a large amount of fluid into the body.
Use in Pregnancy and Lactation
Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding should be avoided during use due to the lack of relevant clinical data.
Use in Renal Impairment
Contraindicated in chronic renal failure.
Special Precautions
Before use, the solution must be warmed to body temperature. Treatment is carried out under the control of hematocrit and blood electrolyte concentration.
In case of hyperkalemia development, the drug containing this combination is replaced with a drug containing the combination of sodium acetate + Sodium chloride until the electrolyte balance normalizes.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Infusion solution 4.75 g+1.5 g+3.6 g/1 L: fl. 200 ml, 400 ml
Marketing Authorization Holder
Nesvizh Medical Products Plant OJSC (Republic Of Belarus)
Dosage Form
| Chlosol | Infusion solution 4.75 g+1.5 g+3.6 g/1 L: fl. 200 ml, 400 ml |
Dosage Form, Packaging, and Composition
| Infusion solution | 1 L |
| Sodium chloride | 4.75 g |
| Potassium chloride | 1.5 g |
| Sodium acetate trihydrate | 3.6 g |
200 ml – blood substitute bottles (40) – cardboard boxes.
400 ml – blood substitute bottles (24) – cardboard boxes.
400 ml – blood substitute bottles.
Infusion solution 4.75 g+1.5 g+3.6 g/1 L: fl. 200 ml 1, 24, or 28 pcs., 400 ml 1, 12, or 15 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Dosage Form
| Chlosol | Infusion solution 4.75 g+1.5 g+3.6 g/1 L: fl. 200 ml 1, 24, or 28 pcs., 400 ml 1, 12, or 15 pcs. |
Dosage Form, Packaging, and Composition
| Infusion solution | 1 L |
| Sodium chloride | 4.75 g |
| Potassium chloride | 1.5 g |
| Sodium acetate trihydrate | 3.6 g |
200 ml – blood substitute bottles (1) – cardboard packs.
400 ml – blood substitute bottles (1) – cardboard packs.
200 ml – blood and blood substitute bottles (for hospitals).
400 ml – blood and blood substitute bottles (for hospitals).
200 ml – blood and blood substitute bottles (28) (for hospitals) – cardboard boxes.
400 ml – blood and blood substitute bottles (15) (for hospitals) – cardboard boxes.
200 ml – blood substitute bottles (24) – cardboard boxes.
200 ml – blood substitute bottles (28) – cardboard boxes.
400 ml – blood substitute bottles (12) – cardboard boxes.
400 ml – blood substitute bottles (15) – cardboard boxes.
