Instructions for use Regisol IS powder for oral solution sachet 18.9 g No. 10
Composition
active ingredients: sodium chloride, potassium chloride, sodium citrate, glucose;
1 sachet contains sodium chloride 3.5 g, potassium chloride 2.5 g, sodium citrate 2.9 g, glucose 10.0 g.
Dosage form
Powder for oral solution.
Main physicochemical properties: white crystalline powder.
Pharmacotherapeutic group
Electrolyte preparations with carbohydrates. Salt formulations for oral rehydration.
ATX code A07C A.
Pharmacological properties
Pharmacodynamics.
Glucose promotes the absorption of salts, citrates help correct the balance in metabolic acidosis. The osmolarity of the solution of the drug Regisol IC is 235‒255 mOsm/l, the pH is slightly alkaline - 8.2.
The medicinal product solution contains (per 1 liter of solution):
| Sodium chloride | 59.9 mmol |
| Potassium chloride | 33.5 mmol |
| Sodium citrate | 9.9 mmol |
| Glucose | 55.5 mmol |
| Na+ | 89.5 mmol |
| K+ | 33.5 mmol |
| Cl− | 93.4 mmol |
| Citrate ions | 9.9 mmol |
Pharmacokinetics.
The pharmacokinetics of water, electrolytes and glucose contained in the medicinal product correspond to the natural pharmacokinetics of these substances in the body.
Indication
Restoration of water and electrolyte balance, correction of acidosis in acute diarrhea with mild and moderate dehydration (for example, loss of 3-9% of body weight in children), in thermal injuries accompanied by impaired water and electrolyte metabolism.
For preventive purposes: during heat and physical exertion that lead to intense sweating.
Contraindication
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 types of interactions
There is no information on the interaction of the drug Regisol IC with other drugs. The pH of the drug solution is slightly alkaline, so it may affect drugs whose absorption depends on the pH of the intestinal contents. Also, the absorption of drugs may be altered by diarrhea, mainly those drugs that are absorbed in the small or large intestine, or during their enterohepatic circulation.
Application features
Severe dehydration (loss of more than 9% of body weight in children, anuria) should be treated first with intravenous rehydration agents. After this, Regisol IC may be prescribed for continued therapy.
The recommended doses of the drug should not be exceeded unless the patient's need for additional electrolyte administration is confirmed by laboratory tests.
If the dose is exceeded, the patient may develop hypernatremia.
The drug should be administered orally, using water to dissolve it. The contents of 1 sachet of the drug Regisol IS should be dissolved in 1 liter of water. Sugar should not be added to the solution. Eating is possible immediately after rehydration. In case of vomiting, wait 10 minutes and drink the solution slowly, in small sips.
Patients in whom dehydration has developed against the background of renal failure, diabetes mellitus, or other chronic diseases that disrupt acid-base, electrolyte, or carbohydrate balance require careful monitoring during therapy with the drug Regisol IS and may require hospitalization.
Diarrhea can significantly affect fluid and glucose balance in patients with diabetes, renal failure, or certain other chronic diseases. Therefore, as long as diarrhea symptoms persist, such patients require more careful monitoring with laboratory evaluations and hospital-based rehydration therapy.
Caution should be exercised when using the drug Regisol IS in patients with liver diseases.
The drug should be used with caution in case of renal failure during oliguria or anuria, in case of parenteral rehydration therapy.
The medicine should not be used in children under 6 months of age without consulting a doctor.
In infants, acute diarrhea can cause dehydration and electrolyte imbalances, leading to rapid deterioration of the patient's condition. All cases of diarrhea and dehydration in infants should be reported to a doctor as soon as possible.
Situations when using the drug Regisol IS that require a doctor's intervention:
the patient's mental state has changed (irritability, apathy, lethargy);
the patient develops speech delay, drowsiness appears, he quickly gets tired and does not answer questions;
constant vomiting;
the temperature rises above 39 °C;
urine output stops;
there are loose bloody stools;
diarrhea lasts more than 2 days;
severe abdominal pain;
diarrhea suddenly stops, severe pain appears;
1 sachet of the medicinal product Regisol IS contains 10.0 g of glucose. Patients with known intolerance to some sugars should consult their doctor before taking this medicinal product. Patients with rare hereditary problems of glucose-galactose malabsorption should not take Regisol IS.
1 sachet of the drug Regisol IC contains 89.5 mmol (or 2059 mg) of sodium. The drug should be used with caution in patients on a controlled sodium diet.
1 sachet of the drug Regisol IC contains 33.5 mmol (or 1307 mg) of potassium. Caution should be exercised when using the drug in patients with reduced kidney function or in those patients who are on a potassium-controlled diet.
Use during pregnancy or breastfeeding
The drug is approved for use in recommended doses during pregnancy or breastfeeding. Breastfeeding can be continued as long as necessary, even during oral rehydration, or it can be continued immediately after rehydration.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Dissolve the contents of 1 sachet of the drug Regisol IS in 1 liter of boiled water cooled to room temperature. No other components can be added to the solution, so as not to disrupt the effect of the drug. The solution should be taken orally or administered under the supervision of a physician through a nasogastric tube.
Before starting treatment, the patient should be weighed to determine body weight loss and the degree of dehydration.
During treatment, fatty foods and foods high in simple sugars should be avoided.
Therapy with the drug Regisol IC should be started after the onset of diarrhea. The finished solution of the drug Regisol IC should be taken in small sips after each loose stool. In 6-10 hours, the dose of the solution can be 30-60 ml/kg of body weight. Usually, the drug should be taken for no longer than 3-4 days, the use of the drug should be discontinued after the end of diarrhea. In case of nausea or vomiting, it is advisable to take the cooled solution in small doses.
Rehydration: to correct dehydration, the drug should be taken during the first 6-10 hours in an amount that is twice the weight loss during diarrhea, i.e. if the loss is 400 g, the amount of the drug is 800 ml. During therapy with the drug Regisol IS, there is no need to use other fluids.
Further use: if diarrhea continues, after correction of dehydration, the drug Regisol IC and other fluids can be taken within the next 24 hours according to the table:
| Body weight (kg) | Total liquid amount (ml) | Regisol IS (ml) | Water (ml) | Other liquids (ml) |
| 5 | 830 | 350 | 210 | 270 |
| 6 | 1000 | 420 | 250 | 330 |
| 7 | 1050 | 440 | 260 | 350 |
| 8 | 1100 | 460 | 280 | 360 |
| 9 | 1150 | 480 | 290 | 380 |
| 10 | 1200 | 500 | 300 | 400 |
| 12 | 1300 | 540 | 320 | 440 |
| 14 | 1400 | 580 | 350 | 470 |
| 16 | 1500 | 620 | 370 | 510 |
| 18 | 1600 | 660 | 400 | 540 |
| 20 | 1700 | 700 | 420 | 580 |
| 25 | 1800 | 750 | 450 | 600 |
| 30 | 1900 | 800 | 480 | 620 |
| 40 | 2100 | 900 | 540 | 660 |
| 50 | 2300 | 1000 | 600 | 700 |
| 70 | 2700 | 1200 | 720 | 780 |
Children.
Regisol IS can be used in children. There are no restrictions on the age from which children can use this medicine.
Children under 6 months of age should use the medicine under the supervision of a physician.
Overdose
When administering a very large amount or a very concentrated solution of the drug Regisol IC, hypernatremia may occur. Symptoms of hypernatremia include weakness, neuromuscular excitation, drowsiness, confusion, coma, and sometimes even respiratory arrest.
In patients with reduced renal function, metabolic alkalosis and hyperkalemia may occur. Metabolic alkalosis may manifest as decreased pulmonary ventilation, neuromuscular excitability, and tetanic convulsions.
In case of severe overdose with pronounced consequences, the administration of the drug Regisol IS should be discontinued. A doctor's consultation is necessary. Correction of electrolyte and fluid balance should be carried out on the basis of laboratory test data.
Side effects
If the recommended doses are followed, the development of adverse reactions is unlikely.
Potentially possible development of allergic reactions.
Vomiting may occur, indicating that the drug was administered too rapidly.
In patients with normal renal function, the risk of hypernatremia or hyperhydration when using the drug Regisol IC is low.
Expiration date
3 years.
Storage conditions
Keep out of reach of children.
Store the prepared solution in a refrigerator at a temperature of +2 °C to +8 °C for 24 hours.
Packaging
Powder for oral solution 18.9 g in a sachet; 10 sachets in a cardboard pack.
Vacation category
Without a prescription.
Producer
Additional Liability Company "INTERCHEM".
Address
Ukraine, 65025, Odessa, 21st km. Starokyivska Road, 40-A.
