Regidron

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT REHYDRON (REHYDRON)

Composition:

Active substances:

1 sachet contains: potassium chloride 2.5 g; sodium chloride 3.5 g; sodium citrate 2.9 g; glucose 10 g.

Pharmaceutical form. Dosage powder.

Main physicochemical properties: white crystalline odourless powder.

Pharmacotherapeutic group.

Electrolyte preparations with carbohydrates. Oral rehydration salts.

ATC code A07CA.

Pharmacological properties.

Pharmacodynamics.

Regidron solution is used to compensate for losses of electrolytes and fluids during diarrhea and vomiting. Glucose facilitates the absorption of salts, while citrates help correct the imbalance in metabolic acidosis. The osmolarity of Regidron solution is 235–255 mOsm/L, and the pH is slightly alkaline – 8.2.

Regidron solution contains (per 1 liter of solution):

Compared to standard oral rehydration solutions recommended by the WHO, the osmolarity of Regidron is slightly lower (it has been proven that rehydration solutions with reduced osmolarity are 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 Regidron corresponds to the natural pharmacokinetics of these substances in the body.

Clinical characteristics.

Indications.

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

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

Contraindications.

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

Interaction with other medicinal products and other forms of interactions.

There is no information available on interactions between Regidron and other drugs. The pH of the solution is weakly 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 (weight loss exceeding 9% of body weight in children, anuria) should be treated first using intravenous rehydration solutions. After that, Regidron 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 is administered orally, using water for its dissolution. The contents of 1 Regidron packet should be dissolved in 1 L of water. Sugar must not be added to the solution. Food intake is allowed 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.

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

Caution should be exercised when treating patients with liver disorders, patients on a sodium- or potassium-restricted diet, with Regidron.

Diarrhea may significantly affect fluid and glucose balance in patients with diabetes mellitus, renal insufficiency, or certain other chronic diseases. Therefore, while diarrhea symptoms persist, such patients require closer monitoring, including laboratory assessments and possible in-hospital rehydration therapy.

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

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

In infants, acute diarrhea may cause dehydration and electrolyte disturbances, 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 Regidron use requiring medical intervention:

• change in the patient's mental status (irritability, apathy, lethargy);
• 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 develops;
• home treatment is unsuccessful or impossible.

1 Regidron sachet contains 1.3 g of potassium (33.5 mmol potassium per 1 L of solution) and 2.1 g of sodium (89.5 mmol sodium per 1 L of solution), which should be taken into account when administering the solution to patients with impaired renal function or those on a diet restricting potassium or sodium intake. 17 mmol (391 mg) represents approximately 20% of the WHO recommended maximum daily dietary sodium intake of 2 g for adults and is considered a high sodium dose.

1 Regidron sachet contains 10.0 g of glucose. Patients with rare hereditary disorders such as glucose-galactose malabsorption should not take this medication.

Use during pregnancy or breastfeeding.

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

Effect on the ability to drive or operate machinery.

Regidron does not affect the ability to drive or operate machinery.

Dosage and Administration.

Dissolve the powder from 1 sachet of Regidron in 1 liter of boiled, cooled to room temperature water. No other components should be added 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.

Regidron therapy should be initiated at the onset of diarrhea.

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

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

Subsequent use: if diarrhea persists, after correction of dehydration, Regidron and other fluids may be taken during the following 24 hours according to the data in the table:

Children.

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

Overdose.

When administering a very large amount or a highly concentrated solution of Rehydron, hypernatremia may occur. In patients with impaired renal function, metabolic alkalosis and hyperkalemia are possible. Symptoms of hypernatremia 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 of Rehydron administration, the drug should be discontinued immediately. Medical consultation is required. Correction of electrolyte and fluid 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 fluid overload with the use of Regidron is low. Vomiting may occur, which may indicate too rapid administration of the preparation.

Shelf life. 3 years.

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

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

Packaging. 18.9 g of powder in a sachet; 20 sachets in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer. Orion Corporation.

Manufacturer's address.
Orionintie 1, 02200 Espoo, Finland.

Manufacturer. Recipharm Parets, S.L.U.

Manufacturer's address.
C/Ramon y Cajal, 2, Parets del Valles, 08150 Barcelona, Spain.