Rehydron^® (Powder) Instructions for Use

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

Manufactured By

Recipharm Parets, S.L.U. (Spain)

Packaging and Quality Control Release

RECIPHARM PARETS, S.L.U. (Spain)

PHARMACOR PRODUCTION, LLC (Russia)

VALENTA PHARM, JSC (Russia)

Contact Information

VALENTA PHARM JSC (Russia)

ATC Code

A07CA (Oral rehydrating salt preparations)

Dosage Form

Rehydron^®

Powder for oral solution preparation: pouch 18.9 g 4, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution crystalline, white, odorless; the appearance of the solution obtained after preparation according to the instructions for medical use: colorless transparent solution.

	1 pouch	1 L of prepared solution*
Sodium chloride	3.5 g	59.9 mmol
Potassium chloride	2.5 g	33.5 mmol
Sodium citrate dihydrate	2.9 g	9.9 mmol
Dextrose	10 g	55.5 mmol
Including
Na⁺		89.6 mmol
K⁺		33.5 mmol
Cl^–		93.4 mmol
Citrate		9.9 mmol

* concentrations of active substances in the solution obtained by dissolving 1 pouch in 1 L of water.

Primary packaging

18.9 g of the drug in sachets made of paper/polyethylene/aluminum/Surlyn^® laminate.

Secondary packaging

4, 10 or 20 sachets in a cardboard carton together with the instructions for use.

Clinical-Pharmacological Group

Oral rehydration drug

Pharmacotherapeutic Group

Rehydrating agent for oral administration

Pharmacological Action

Agent for rehydration for oral administration.

Rehydron^® is used to correct the loss of electrolytes and fluid in diarrhea. Dextrose promotes the absorption of electrolytes, which helps correct metabolic acidosis.

The osmolarity of the solution is 282 mOsm/L, pH – 8.2.

Pharmacokinetics

The pharmacokinetic properties of water, electrolytes, and dextrose, which are part of the drug, are similar to those contained in the human body.

Indications

Oral rehydration (fluid replenishment in the body) and prevention of dehydration in acute diarrhea accompanied by mild to moderate dehydration.

The medicinal product replenishes water and salt reserves.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A09	Other and unspecified gastroenteritis and colitis of infectious origin
E86	Volume depletion (including dehydration, hypovolemia)
K59.1	Functional diarrhea

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

The contents of one sachet are dissolved in 1 L of freshly boiled cooled drinking water. The resulting colorless solution is taken orally. If necessary, the solution can be administered via a nasogastric tube (in a hospital setting).

The prepared solution should be stored in a refrigerator (at a temperature from 2°C (35.6°F) to 8°C (46.4°F)); it should be consumed within 24 hours. To not disrupt the action of the drug, no other components should be added to the solution.

Before starting treatment, the patient should be weighed to assess weight loss and the degree of dehydration.

The patient’s nutrition or breastfeeding during oral rehydration therapy should not be interrupted, or they should be resumed immediately after rehydration. During treatment with the drug, it is recommended to avoid eating food rich in fats and simple carbohydrates (this may worsen diarrhea).

For preventing dehydration, the use of the drug Rehydron^® should be started as soon as diarrhea begins. Usually, the drug is required to be used for no more than 3-4 days, treatment stops with the end of diarrhea.

If nausea or vomiting occurs, it is advisable to take the solution chilled in small portions (for example, with teaspoons).

Fluid replenishment

For fluid replenishment, Rehydron^® is taken within the first 6-10 hours in an amount that is twice the weight loss caused by diarrhea. For example, if the weight loss is 400 g, the volume of Rehydron^® solution is 800 ml. During this phase, the use of other fluids is not required. Eating in the first 4 hours of fluid replenishment is not recommended. When taking large volumes, vomiting may occur.

Prevention of dehydration

If diarrhea continues, after correction of dehydration, it is advisable to take Rehydron^® and water for 24 hours according to the following scheme

Body weight (kg)	Total amount of required fluid (L)	Rehydron^® (ml)	Water (ml)	Other fluids (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

Adverse Reactions

In patients with normal renal function, the risk of developing hypernatremia (increased sodium content in the blood) or excessive water intake is low.

If taken too quickly, vomiting may occur.

Contraindications

Hypersensitivity to the components of the drug;
Severe dehydration;
Coma (unconscious state);
Intestinal obstruction;
Severe vomiting;
Diarrhea due to cholera;
Glucose-galactose malabsorption.

Use in Pregnancy and Lactation

In recommended doses, Rehydron^® can be used during pregnancy and lactation.

Use in Hepatic Impairment

Caution should be exercised in patients with impaired liver function.

Use in Renal Impairment

Caution should be exercised in patients with impaired renal function.

Patients with renal failure should take into account that the drug contains potassium.

Pediatric Use

In children, other solutions with lower sodium content and osmolarity should be used.

Special Precautions

Considering the composition of the medicinal product, caution should be exercised in patients with diabetes mellitus, impaired liver or kidney function, as well as in patients on a salt-restricted diet (sodium and/or potassium).

In patients with diabetes mellitus, renal failure, and some other chronic diseases, diarrhea can cause a significant disruption in maintaining fluid or glucose balance. Therefore, 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 doses of the drug should not be exceeded.

Severe dehydration (weight loss >10%, cessation of urine output) should be treated with intravenous rehydration drugs, after which it is permissible to start using Rehydron^® solution.

If intravenous administration of drugs is necessary, or in case of severe dehydration or severe vomiting, with decreased or ceased urine output, Rehydron^® should be used with caution.

In case of vomiting, wait 10 minutes after the end of the vomiting episode and give the solution to drink slowly, in small sips.

The patient should consult a doctor if the following situations occur during the use of the drug Rehydron^®

Slurred speech, irritability, rapid fatigue, drowsiness, stupor occur;
Temperature rises above 39°C (102.2°F);
Bloody stools;
Persistent vomiting;
Diarrhea lasts more than 2 days;
Severe abdominal pain.

In diarrhea developing with cholera and a number of other severe intestinal infections, the use of Rehydron^® solution to replenish electrolyte loss may be insufficient.

Persons with renal failure or on a potassium-restricted diet should take into account that the drug contains potassium.

In children, other solutions with lower sodium content and osmolarity should be used.

Effect on ability to drive vehicles and operate machinery

Rehydron^® does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

When administering a large volume or a highly concentrated solution of Rehydron^® (in case of violation of the rules for preparing the solution), hypernatremia (increased sodium content in the blood) may occur. Symptoms of hypernatremia include weakness, neuromuscular excitation, drowsiness, confusion, coma, and sometimes respiratory arrest. In patients with reduced renal function, hyperkalemia (increased potassium content in the blood) may occur, manifested by heart rhythm disturbances and weakness.

If symptoms of overdose occur, it is necessary to consult a doctor. Correction of water-electrolyte balance should be carried out based on laboratory test data.

Drug Interactions

Interaction with other medicinal products has not been studied.

The drug solution has a weakly alkaline reaction, so it may affect medicinal products whose absorption depends on the pH of the intestinal contents.

Diarrhea itself can alter the absorption of many medicinal products that are absorbed in the small or large intestine, or drugs whose metabolism involves enterohepatic circulation.

Storage Conditions

Keep out of reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use the drug after the expiration date indicated on the packaging.

After dilution, the solution is stored in the refrigerator for 24 hours.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer