Regidraton

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT REHYDRATON (REHYDRATON)

Composition:

Active substances: 1 sachet (9.45 g of powder) contains: potassium chloride 1.25 g, sodium chloride 1.75 g, sodium citrate 1.45 g, anhydrous glucose 5.0 g.

Pharmaceutical form. Oral rehydration powder.

Main physicochemical properties: white crystalline odourless powder.

Pharmacotherapeutic group.

Electrolyte preparations with carbohydrates. Oral rehydration salts.

ATC code A07C A.

Pharmacological properties.

Pharmacodynamics.

Regidraton medicinal solution is used to compensate for losses of electrolytes and fluids in cases of diarrhea and vomiting. Glucose promotes the absorption of salts; citrates help correct the imbalance in metabolic acidosis. The osmolarity of Regidraton medicinal solution is 235–255 mOsm/L, and the pH is weakly alkaline — 8.2.

Regidraton medicinal solution contains the following concentrations of active substances:

Compared to standard oral rehydration solutions recommended by the WHO, the osmolarity of the medicinal product Regidraton is slightly lower (reduced osmolarity rehydration solutions have been proven to be more effective), and the potassium content is higher (to accelerate the restoration of potassium levels).

Pharmacokinetics.

The pharmacokinetics of water, electrolytes, and glucose contained in the medicinal product Regidraton corresponds to the natural pharmacokinetics of these substances in the body.

Clinical characteristics.

Indications.

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

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

Contraindications.

Hypersensitivity to any component of the drug, severe dehydration, hemodynamic shock, uncontrollable 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 the medicinal product Regidraton and other drugs. The solution is slightly alkaline and therefore may affect drugs whose absorption depends on the pH of intestinal contents. In addition, 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 (weight loss exceeding 9% of body weight in children, anuria) should be treated first using intravenous rehydration solutions. After that, Regidraton may be prescribed for continuation of therapy.

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

The medicinal product is administered orally, using water for its dissolution. The contents of 1 sachet should be dissolved in 500 ml of water; if a larger volume of solution is required, dissolve the contents of 2 sachets in 1000 ml 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 hypernatremia in the patient.

If dehydration develops against a background of renal insufficiency, diabetes mellitus, or other chronic diseases affecting acid-base, electrolyte, or carbohydrate balance, the patient's condition should be carefully monitored during treatment with Regidraton — hospitalization may be required.

Caution should be exercised when treating patients with liver disorders, or patients on a diet restricted in sodium or potassium, with Regidraton. Diarrhea may significantly affect fluid and glucose balance in patients with diabetes mellitus, renal insufficiency, or certain other chronic diseases. Therefore, as long as diarrhea symptoms persist, such patients require more careful monitoring, including laboratory assessments and, if necessary, hospital-based rehydration therapy.

Regidraton should be used with caution in cases of renal insufficiency during periods of oliguria or anuria, or when parenteral rehydration therapy is administered.

The medicinal product should not be used in 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 quickly as possible.

Situations during use of Regidraton requiring medical intervention:

• Changes in the patient's mental status (irritability, apathy, lethargy);
• Slurred speech, drowsiness, rapid fatigue, and unresponsiveness to questions;
• Persistent vomiting;
• Body temperature rises above 39 °C;
• Urine output ceases;
• Frequent loose stools containing blood occur;
• Diarrhea lasts more than 2 days;
• Severe abdominal pain;
• Diarrhea suddenly stops and is followed by severe pain;
• If home treatment is ineffective or impossible.

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

Since the medicinal product contains glucose, it should not be administered to patients with the rare hereditary condition glucose-galactose malabsorption.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction speed when driving or operating machinery.

The medicinal product does not affect reaction speed when driving or operating machinery.

Dosage and administration.

Dissolve the contents of 1 sachet of Regidraton medicinal product in 500 ml of boiled, cooled to room temperature water. If it is necessary to prepare a larger volume of solution, dissolve the contents of 2 sachets in 1000 ml of water. No other components should be added to the solution in order to avoid interference 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.

Treatment with Regidraton should be initiated after the onset of diarrhea.

The prepared solution should be taken orally in small sips after each loose stool. Within 6–10 hours, the dose of Regidraton solution may range from 30 to 60 ml/kg body weight. Usually, the drug should be administered no longer than 3–4 days; treatment should be discontinued after diarrhea resolves. In case of nausea or vomiting, it is advisable to take the cooled solution in small, frequent doses.

Rehydration: to correct dehydration, the medicinal product should be administered during the first 6–10 hours in an amount twice the body weight loss caused by diarrhea; for example, if weight loss is 400 g, the required volume of the drug is 800 ml. During Regidraton therapy, there is no need to use other fluids.

Subsequent use: if diarrhea persists, after correction of dehydration, administration of Regidraton and other fluids may continue over the next 24 hours according to the table:

Children.

Rehydron 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 the medicinal product Rehydron may lead to hypernatraemia. In patients with impaired renal function, metabolic alkalosis and hyperkalaemia are possible. Symptoms of hypernatraemia include weakness, neuromuscular excitability, 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 consequences, administration of Rehydron must be discontinued. Medical consultation is required. Electrolyte and fluid balance correction should be performed based on laboratory test results.

Side effects.

When 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 with the use of Regidraton is low. Vomiting may occur, indicating administration of the preparation too rapidly.

Shelf life. 2 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

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

Packaging. 9.45 g of powder in sachets; 20 sachets per cardboard pack.

Dispensing category. Over-the-counter.

Manufacturer/Marketing Authorization Holder. Ternopharm LLC.

Manufacturer’s address / Marketing Authorization Holder’s address.

4 Fabrychna St., Ternopil, 46010, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua