Trihydrosol^® (Powder) Instructions for Use

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

ATC Code

A07CA (Oral rehydrating salt preparations)

Dosage Form

Trihydrosol^®

Powder for oral solution: sachet 9.45 g 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Granulated powder for preparation of oral solution, white, odorless; the presence of crystals and easily crumbling lumps is allowed.

	1 sachet	1 L of prepared solution
Dextrose	5 g	55.5 mmol
Potassium chloride	1.25 g	33.5 mmol
Sodium chloride	1.75 g	59.8 mmol
Sodium citrate dihydrate (calculated as sodium citrate)	1.45 g (1.27 g)	9.8 mmol
Including
Na⁺		89.5 mmol
K⁺		34 mmol
Cl^–		94 mmol
Citrate		9.8 mmol

9.45 g – thermowelded sachets made of combined material (10) – cardboard packs.
9.45 g – thermowelded sachets made of combined material (20) – cardboard packs.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for oral use

Pharmacotherapeutic Group

Rehydrating agent for oral administration

Pharmacological Action

Rehydrating agent. Prevents or reduces body dehydration by replenishing sodium and potassium salts, creates conditions leading to normalization of the acid-base state.

Indications

Dehydration: diarrhea (including in children).

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

ICD-11 code	Indication
1A40.Z	Infectious gastroenteritis or colitis, unspecified
5C70.Z	Decrease of volume of fluid [hypovolemia], unspecified
DD91.2	Functional diarrhea
DD93.Y	Other specified functional gastrointestinal disorders in infants, toddlers and school-age children
DD9Z	Functional gastrointestinal disorders, unspecified

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.

Dissolve the entire contents of one sachet in one liter of freshly boiled and cooled drinking water.

Prepare the solution immediately before use; discard any unused solution after 24 hours.

For mild to moderate dehydration, administer the solution in small, frequent volumes.

Calculate the dosage based on the patient’s body weight and clinical condition.

For outpatient treatment, administer an average dose of 60 ml per kg of body weight.

For initial rehydration, administer a minimum dose of 30 ml per kg over a period of 6 to 10 hours.

Adjust the total volume administered according to fluid loss, continuing until diarrhea subsides.

In the presence of vomiting, wait 10 minutes after an episode ends, then administer the solution slowly, in small sips.

For severe dehydration, initiate therapy with intravenous rehydration before switching to the oral solution.

Do not exceed recommended doses unless directed by a physician and confirmed by laboratory data.

Adverse Reactions

Systemic reactions risk of hypernatremia (increased sodium content in the blood).

Contraindications

Severe dehydration; coma (unconscious state); intestinal obstruction; severe vomiting; diarrhea due to cholera; glucose-galactose malabsorption; hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

In recommended doses, it can be used during pregnancy and lactation.

Pediatric Use

If it is necessary to use in children, the instructions should be carefully studied.

Special Precautions

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 on a low-salt diet (sodium and/or potassium).

In patients with diabetes mellitus, renal failure and some other chronic diseases, diarrhea can cause significant disruption of fluid or glucose balance maintenance. 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 should not be exceeded.

Severe dehydration (weight loss >10%, cessation of urination) should be treated with intravenous rehydration drugs, after which the use of the solution can be started.

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 use

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.

The use of this combination to replenish salt loss in diarrhea developing in cholera and a number of other severe intestinal infections may be insufficient.

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

Drug Interactions

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

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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