Re-sol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RE-SOL (RE-SOL)

Composition:

Active substances: potassium chloride, sodium chloride, sodium citrate, glucose;

1 sachet contains potassium chloride 2.5 g, sodium chloride 3.5 g, sodium citrate 2.9 g, anhydrous glucose 10 g.

Pharmaceutical form. Powder for oral solution.

Main physicochemical properties: white crystalline odourless powder.

Pharmacotherapeutic group. Electrolyte preparations with carbohydrates. Oral rehydration salts. ATC code A07CA.

Pharmacological properties.

Pharmacodynamics.

Re-sol solution is used to correct electrolyte and fluid losses in cases of diarrhea and vomiting. Glucose promotes salt absorption, while citrates help correct the imbalance in metabolic acidosis. The osmolarity of Re-sol solution is

235–255 mOsm/L, pH is slightly alkaline – 8.2.

Re-sol solution contains (per 1 L of solution):

Compared to standard oral rehydration solutions recommended by the WHO, the osmolarity of the Re-sol preparation is slightly lower (it has been demonstrated that rehydration solutions with reduced osmolarity are more effective), and the potassium content is higher (to accelerate restoration of potassium levels).

Pharmacokinetics.

The pharmacokinetics of water, electrolytes, and glucose contained in Re-sol corresponds to the natural pharmacokinetics of these substances in the body.

Clinical characteristics.

Indications.

Restoration of water-electrolyte balance, correction of acidosis in acute diarrhea with mild to moderate dehydration (e.g., loss of 3–9% body weight in children), and in heat-related illnesses associated with disturbances in water-electrolyte metabolism.

For prophylactic use: heat exposure and physical exertion leading to excessive sweating.

Contraindications.

Hypersensitivity to the components of the drug, severe dehydration, hemodynamic shock, intractable vomiting, loss of consciousness, intestinal obstruction, ileus.

Interaction with other medicinal products and other forms of interaction.

There is no information available on interactions between Re-sol and other drugs. The pH of the drug solution is slightly alkaline; therefore, it may affect medicinal products whose absorption depends on the pH of intestinal contents. Additionally, drug absorption may be altered during diarrhea, particularly for drugs absorbed in the small or large intestine, or those undergoing enterohepatic circulation.

Special precautions for use.

Severe dehydration (loss of more than 9% of body weight in children, anuria) must first be treated using intravenous rehydration solutions. After that, Re-sol may be prescribed for continuation of therapy.

Recommended doses of the drug should not be exceeded unless the patient's need for additional electrolyte supplementation is confirmed by laboratory tests.

The drug should be administered orally, using water for its dissolution. The contents of 1 packet of Re-sol should be dissolved in 1 L of water. Sugar must not be added to the solution. Food intake is possible immediately after rehydration. In case of vomiting, wait 10 minutes and then administer the solution slowly, in small sips.

Overdose may lead to the development of hypernatremia in patients.

Patients in whom dehydration has developed against a background of renal failure, diabetes mellitus, or other chronic diseases affecting acid-base, electrolyte, or carbohydrate balance require careful monitoring during Re-sol therapy and may require hospitalization.

Caution should be exercised when treating patients with Re-sol who have liver disease or who are on a diet restricted in sodium or potassium. Diarrhea may significantly affect fluid and glucose balance in patients with diabetes mellitus, renal failure, or certain other chronic diseases. Therefore, while diarrhea symptoms persist, such patients require more careful monitoring with laboratory assessments and hospital-based rehydration therapy.

Re-sol should be used with caution in patients with renal failure during periods of oliguria or anuria, and during parenteral rehydration therapy.

The drug should not be administered to children under 6 months of age without prior medical consultation.

In infants, acute diarrhea may cause dehydration and electrolyte imbalances, leading to rapid deterioration of the patient's condition. All cases of diarrhea and dehydration in infants must be reported to a physician as soon as possible.

Situations during Re-sol use requiring medical intervention:

• change in the patient's mental state (irritability, apathy, lethargy);
• the patient develops slowed speech, drowsiness, rapid fatigue, and does not respond to questions;
• persistent vomiting;
• body temperature rises above 39 °C;
• urine output ceases;
• watery bloody stools occur;
• diarrhea lasts more than 2 days;
• severe abdominal pain;
• diarrhea suddenly stops and severe pain appears;
• if home treatment is unsuccessful or impossible.

Re-sol contains potassium and sodium, which must be taken into account when administering the solution to patients with impaired renal function or those on a diet controlling potassium or sodium intake.

The medicinal product contains glucose. If the patient has been diagnosed with intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding.

The drug is permitted for use at recommended doses during pregnancy or breastfeeding. Breastfeeding can be continued as long as necessary, even during oral rehydration, or may be resumed immediately after rehydration.

Ability to affect reaction rate while driving or operating machinery.

The drug does not affect reaction rate while driving or operating machinery.

Dosage and Administration.

Dissolve the powder from 1 sachet of Re-sol in 1 liter of boiled, cooled to room temperature water. Do not add any other components to the solution to avoid interfering with the drug's action. The solution should be taken orally or administered under medical supervision via a nasogastric tube.

Before starting treatment, the patient should be weighed to determine body weight loss and degree of dehydration.

Fatty foods and foods high in simple sugars should be avoided.

Therapy with Re-sol should be initiated after the onset of diarrhea.

The prepared solution should be taken in small sips after each loose stool. Within 6–10 hours, the dose of Re-sol solution may amount to 30–60 mL/kg body weight. The drug is usually taken for no longer than 3–4 days; administration should be discontinued after diarrhea resolves. In case of nausea or vomiting, it is advisable to take the cooled solution in small, repeated doses.

Rehydration. To correct dehydration, the drug should be taken during the first 6–10 hours in an amount twice exceeding the body weight loss due to diarrhea; for example, if the loss is 400 g, the amount of the drug should be 800 mL. During Re-sol therapy, there is no need to use other fluids.

Subsequent use. If diarrhea persists, after correction of dehydration, Re-sol and other fluids may be administered according to the table below during the following 24 hours:

Children.

Re-sol can be used in children. There are no age restrictions for the use of this medicinal product in children.

Overdose.

Administration of a very large amount or a highly concentrated solution of Re-sol may lead to hypernatremia. In patients with impaired renal function, metabolic alkalosis and hyperkalemia are possible. Symptoms of hypernatremia include weakness, neuromuscular irritability, drowsiness, confusion, coma, and sometimes even respiratory arrest. Metabolic alkalosis may manifest as decreased lung ventilation, neuromuscular excitability, and tetanic seizures.

In case of severe overdose with pronounced adverse effects, administration of Re-sol must be discontinued. Medical consultation is required. Correction of fluid and electrolyte balance should be performed based on laboratory test results.

Side effects.

When the recommended doses are followed, the development of adverse reactions is unlikely. Allergic reactions are potentially possible. In patients with normal kidney function, the risk of developing hypernatremia or hyperhydration when using Re-sol is low. Vomiting may occur, indicating that the drug was administered too quickly.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

The prepared solution should be stored in a refrigerator at 2–8 °C for 24 hours.

Keep out of reach of children.

Packaging. 18.9 g of powder in a sachet; 10 or 20 sachets per box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of business activity.

22 Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.