REGIDRON OPTIM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT REHYDRON OPTIM (REHYDRON OPTIM)

Composition:

Active substances:

1 sachet contains: potassium chloride 0.75 g; sodium chloride 1.3 g; sodium citrate 1.45 g; anhydrous glucose 6.75 g;

Excipients: acesulfame potassium (E 950), lemon flavoring.

Pharmaceutical form. Oral powder for solution.

Main physicochemical properties: crystalline powder of white or light-yellow color with a characteristic lemon odor.

Pharmacotherapeutic group. Oral rehydration salts.

ATC code A07C A.

Pharmacological Properties

Pharmacodynamics

According to WHO recommendations, the Regidron Optima solution has reduced osmolarity of 245 mOsm/L and a weakly alkaline pH. The solution is used to compensate for losses of electrolytes and fluids in diarrhea. Glucose facilitates salt absorption, while citrates help correct the imbalance in metabolic acidosis.

Pharmacokinetics

The pharmacokinetics of water, electrolytes, and glucose contained in Regidron Optima 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 (including cholera), diarrhea with mild to moderate dehydration, and heat-related conditions associated with disturbances in water-electrolyte metabolism.

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

Contraindications.

Hypersensitivity to the active substances or to any other component of the medicine, severe dehydration, loss of consciousness, hemodynamic shock, intestinal obstruction, uncontrollable vomiting, ileus.

Interaction with other medicinal products and other forms of interaction.

There is no information available on interactions between Regidron Optima and other medicinal products. The absorption of medicinal products may be altered during diarrhea, particularly for drugs absorbed in the small or large intestine, or those undergoing enterohepatic circulation.

The pH of the solution is slightly alkaline; therefore, it may affect medicinal products whose absorption depends on the pH of intestinal contents.

Special precautions for use.

The drug should be taken orally, dissolving it in water. The contents of 1 sachet of Regidron Optima should be dissolved in 0.5 L of water. Overdosing may lead to hypernatremia in the patient. Sugar must not be added to the solution. Food intake is allowed immediately after rehydration. In case of vomiting, wait 10 minutes, then administer the solution slowly, in small sips.

Severe dehydration (loss of over 9% of body weight in children, anuria) should first be treated using intravenous rehydration solutions. After this, Regidron Optima 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.

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 treatment with Regidron Optima and may require hospitalization.

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

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.

Caution should be exercised when treating patients with liver disorders, as well as patients on a diet with restricted sodium or potassium intake, using Regidron Optima. 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, if necessary, inpatient rehydration therapy.

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

Situations during use of Regidron Optima requiring medical intervention:

• the patient develops slowed speech, drowsiness, rapid fatigue, or fails to respond to questions;
• cessation of urine output;
• changes in the patient's mental status (irritability, apathy, lethargy);
• fever (temperature above 39 °C);
• blood in stool;
• persistent vomiting;
• diarrhea lasting more than 2 days;
• sudden cessation of diarrhea accompanied by severe pain;
• failure or impossibility of home treatment;
• severe abdominal pain.

When treating diarrhea caused by cholera bacteria and certain other bacteria, the salt content in the drug may be insufficient to replace the excessive salt loss associated with the disease.

One sachet of Regidron Optima contains 6.75 g of glucose. This product should not be taken by patients with glucose-galactose malabsorption.

One sachet of Regidron Optima contains 0.019 g of potassium (20 mmol potassium per 1 L of solution), which should be taken into account when administering the solution to patients with impaired renal function who are on a potassium-controlled diet.

One sachet of Regidron Optima contains 0.851 g of sodium (75 mmol sodium per 1 L of solution), which should be taken into account when administering the solution to patients with impaired renal function who are on a sodium-controlled diet. 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.

Use during pregnancy or breastfeeding.

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

Effect on ability to drive or operate machinery.

The drug does not affect the ability to drive or operate machinery.

Dosage and Administration.

Solution preparation: dissolve the powder from 1 sachet in 0.5 L of boiled, cooled to room temperature water. The solution should be taken orally or administered under medical supervision via a nasogastric tube.

Treatment of mild to moderate dehydration (replacement therapy): the dose depends on the patient's body weight and degree of dehydration and amounts to 50–100 mL of the solution per 1 kg of body weight. To correct fluid deficit, Regidron Optima should be taken within 4 hours.

Adults and children with mild to moderate dehydration should take the medication according to the data provided in the table:

If diarrhea symptoms persist after replacement therapy, continue using the Regidron Optim solution as supportive therapy.

In cases of nausea and vomiting, it is advisable to take the cooled solution in small, repeated doses. If necessary, start with a small amount of solution (e.g., using a teaspoon or syringe), gradually increasing the dose depending on tolerance. Rapid administration of the drug is safe, but there is a possibility of vomiting.

During treatment with the drug, other fluids may be consumed; however, fluids high in sugar should be avoided, as high sugar concentration may worsen diarrhea.

Prevention of dehydration (supportive therapy).

To prevent fluid loss and as supportive therapy, smaller doses should be used. Treatment with Regidron Optim should be initiated at the onset of diarrhea. The drug is usually taken for no more than 3–4 days; treatment should be discontinued after diarrhea resolves.

The dose of the drug depends on body weight:

• Children with body weight up to 10 kg: 50–100 mL of the drug solution after each loose stool;
• Adults and children with body weight over 10 kg: 100–200 mL of the drug solution after each loose stool.

Other fluids and food may be consumed during treatment with Regidron Optim.

Children.

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

Overdose.

Hypernatremia and hyperkalemia may occur in patients with impaired renal function.

Hypernatremia may occur when administering a very large volume or a highly concentrated solution of Regidron Optim. Metabolic alkalosis may develop in patients with impaired renal function. Symptoms of hypernatremia include weakness, neuromuscular excitability, drowsiness, confusion, coma, and sometimes even respiratory arrest. Metabolic alkalosis may manifest as reduced lung ventilation, neuromuscular excitability, and tetany.

In case of severe overdose with pronounced adverse effects, administration of Regidron Optim must be discontinued. Medical consultation is required. Electrolyte and fluid balance correction should be based on laboratory test results.

Side effects.

When the recommended doses are followed, the development of side effects is unlikely.

Potential development of allergic reactions is possible.

In patients with normal kidney function, the risk of developing hypernatremia or hyperhydration with Regidron Optim is low. Vomiting may occur, which may indicate too rapid administration of the solution.

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 a refrigerator at 2–8 °C for up to 24 hours.

Packaging. 10.7 g of powder in a sachet; 20 sachets in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer. Orion Corporation.

Manufacturer's location and address of operations. Orionintie 1, 02200 Espoo, Finland / Orionintie 1, 02200 Espoo, Finland.

Manufacturer. Recipharm Parets, S.L.U.

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