Composition, form of production and packaging
? Powder for solution for ingestion white, crystalline; the prepared solution is transparent, colorless.
1 pack. 1 liter of finished product
sodium chloride 3.5 g 59.9 mmol
potassium chloride 2.5 g 33.5 mmol
sodium citrate 2.9 g 9.9 mmol
dextrose 10 g 55.5 mmol
in t.ch.
Na + 89.6 mmol
K + 33.5 mmol
Cl = 93.4 mmol
citrate 9.9 mmol
18.9 g - packs multilayered laminated (4) - packs cardboard.
18.9 g - packs multilayered laminated (20) - packs cardboard.
? Powder for solution for ingestion white, crystalline; the prepared solution is transparent, colorless.
1 pack. 1 liter of finished product
sodium chloride 3.5 g 59.9 mmol
potassium chloride 2.5 g 33.5 mmol
sodium citrate 2.9 g 9.9 mmol
dextrose 10 g 55.5 mmol
in t.ch.
Na + 89.6 mmol
K + 33.5 mmol
Cl = 93.4 mmol
citrate 9.9 mmol
18.9 g - packs multilayered laminated (4) - packs cardboard.
18.9 g - packs multilayered laminated (20) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Means for rehydration for oral administration.
Regidron В® is used to correct the imbalance of electrolytes and fluid in diarrhea. Dextrose promotes the absorption of electrolytes, which contributes to the correction of metabolic acidosis.
Osmolarity of the solution is 282 mosm / l, pH - 8.2.
PHARMACOKINETICS
The pharmacokinetic properties of water, electrolytes and dextrose that make up the drug are similar to those found in the human body.
INDICATIONS
- oral rehydration and prevention of dehydration in acute diarrhea, accompanied by mild and moderate dehydration.
DOSING MODE
The contents of one sachet are dissolved in 1 liter of freshly boiled chilled drinking water, the prepared colorless solution is taken orally. If necessary, the solution can be administered through a nasogastric tube (in a hospital).
The prepared solution should be stored in the refrigerator (at a temperature of 2 В° to 8 В° C); the solution should be consumed within 24 hours. In order not to disrupt the effect of the drug, no other components should be added to the solution.
Before starting treatment, the patient should be weighed to assess the loss of body weight and the degree of dehydration.
Nutrition or breastfeeding during oral rehydration therapy should not be interrupted or should be continued immediately after rehydration. During treatment with the drug it is recommended to avoid eating foods rich in fats and simple carbohydrates (this can aggravate diarrhea).
To prevent dehydration, the use of Regiodron В® should be started as soon as diarrhea has started. Usually the drug should be used no more than 3-4 days, the treatment is terminated with the end of diarrhea.
If nausea or vomiting occurs, it is advisable to take the solution in chilled form in small portions (eg, tea spoons).
Replenishment of liquid
To replenish the fluid, Regidron В® is taken within the first 6-10 hours in an amount that is twice the weight loss caused by diarrhea. For example, if the body weight loss is 400 g, the volume of the Regidron В® solution is 800 ml. During this phase, the use of other liquids is not required. Take food in the first 4 hours of replenishing the fluid is not recommended. When large amounts are taken, vomiting may occur.
Prevention of dehydration
If diarrhea continues, after correcting the dehydration, it is desirable to take Regidron В® and water for 24 hours according to the following scheme:
Body weight (kg) Total amount of liquid required (liters) Regidron (ml) Water (ml) Other liquids (ml)
40-49 2.1 900 540 660
50-59 2.3 1000 600 700
60-69 2.5 1100 660 740
70-79 2.7 1200 720 780
80-89 3.2 1400 800 1000
90-99 3.6 1500 900 1200
100 and more 4 1700 1000 1300
SIDE EFFECT
In patients with normal renal function, the risk of hypernatremia or excess water intake is low.
If you receive too quickly, you may experience vomiting.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
severe dehydration;
- coma;
- intestinal obstruction;
severe vomiting;
- diarrhea due to cholera;
glucose-galactose malabsorption.
PREGNANCY AND LACTATION
In recommended doses, Regidron В® can be prescribed during pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be exercised in patients with impaired renal function.
Patients with renal failure should be aware that the drug contains potassium.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution should be exercised in patients with impaired hepatic function.
APPLICATION FOR CHILDREN
Children should use other solutions with a lower sodium content and osmolarity.
SPECIAL INSTRUCTIONS
Given the composition of the drug, caution should be exercised in patients with diabetes mellitus, impaired liver or kidney function, as well as in patients who follow a diet low in salt (sodium and / or potassium).
In patients with diabetes mellitus, renal insufficiency and some other chronic diseases, diarrhea can cause a significant disturbance in the balance of fluid or glucose. In this regard, the treatment of diarrhea in such patients may require laboratory monitoring and hospitalization. If the patient's need for additional electrolyte administration is not confirmed by laboratory tests, the recommended dose of the drug should not be exceeded.
Severe dehydration (loss of body weight> 10%, discontinuation of urine output) should be treated with IV reconstitution formulations, after which it is allowed to start using the Regidron В® solution.
If necessary, / in the administration of drugs or in severe dehydration or severe vomiting, with a decrease or discontinuation of urine output, use of Regidron В® should be carried out with caution.
When vomiting should wait for 10 minutes after the end of the attack of vomiting and give a drink of the solution slowly, in small sips.
The patient should consult a doctor if, during the application of the Regidron В® preparation, the following situations occur:
- Slow speech, irritability, rapid fatigue, drowsiness, stupor;
- the temperature rises above 39 В° C;
bloody stools;
- incessant vomiting;
- diarrhea lasts more than 2 days;
- severe pain in the abdomen.
With diarrhea that develops with cholera and a number of other serious intestinal infections, the use of the Regidron В® solution to compensate for the loss of electrolytes may not be enough.
Persons with renal insufficiency or a diet low in potassium should take into account that the preparation contains potassium.
Use in Pediatrics
Children should use other solutions with a lower sodium content and osmolarity.
Impact on the ability to drive vehicles and manage mechanisms
Regidron В® does not affect the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms: with the introduction of a large volume or highly concentrated solution of Regidron В® (in violation of the rules for the preparation of the solution), hypernatremia may occur. Symptoms of hypernatremia include weakness, neuromuscular excitation, drowsiness, confusion, coma, sometimes - stopping breathing. In patients with impaired renal function, hyperkalemia may occur, manifested by a disturbance in the rhythm of the heart, and weakness.
Treatment: In case of symptoms of overdose, see a doctor. Correction of water-electrolyte balance should be carried out on the basis of laboratory data.
DRUG INTERACTION
Interaction with other drugs has not been studied.
The solution of the preparation has a slightly alkaline reaction, so it can affect the drugs, the absorption of which depends on the pH of the contents of the intestine.
Diarrhea itself can alter the absorption of many drugs that are absorbed in the small or large intestine, or drugs in the metabolism of which has intestinal hepatic circulation.
TERMS OF RELEASE FROM PHARMACY
The drug is dispensed without a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of 15 В° to 25 В° C. Shelf life - 3 years. Do not use after the expiry date printed on the package.
The prepared solution should be stored in the refrigerator for 24 hours.
