Hydrolyte oral solution is indicated as a source of water and electrolytes in mild or moderate diarrhea in infants and children.

Children below 2 years of age:  As directed by the physician.

Children over 2 years of age: Give hydrolyte at every 3-4 hours.    

Hydrolyte solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature below 30°C , brief exposure up to 40°C does not adversely affect the product.

Administration:

The administration is performed by oral route.

Care is advised if used in patients with impaired liver or kidney function. Repeated dose should not be given to children under age of 1 year except on medical advice. Consult your doctor in all cases of infant diarrhea.                                                                                                   

In cases of dehydration resulting from severe diarrhea or conditions producing large fluid loss parenteral therapy is usually required initially. Oral rehydration may accompany or follow parenteral treatment at the doctor’s discretion.

None known

May be used during pregnancy and lactation as there are no known adverse effects.

None known

None

Non known

Hydrolyte solution consists of physiological salts and glucose which are used synergistically in solution to aid rehydration. The pharmacodynamic effect is to counter the drop in the extracellular fluid volume and electrolytes in mild to moderate diarrhoea. Hydrolyte solution provides electrolytes and calories and is a source of water for hydration. Sodium, the major action of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and citrate in the regulation of the acid-base equilibrium of body fluid. Potassium, the principal action of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

It is metabolized via pyruvic or lactic acid to carbon dioxide and water with the release of energy. All body cells are capable of oxidizing dextrose and it forms the principal source of energy in cellular metabolism. Excess sodium is mainly excreted by the kidney, and small amounts are lost in the faeces and sweat.

Not known

Citric acid

Purified water

Not stated

Store unopened at temperature not exceed 30°C.

Do not use if solution is not clear or container is leaking.

After opening store the product in refrigerator (2-8°C).

Primary Packing Material - Bottle Polycarbonate and the cap made from Polyethylene. The cap & bottle are mechanically sealed with LDPE sleeve to prevent from any foreign contamination, Secondary Packing material is white colour corrugated box.

Does not use unless solution is clear and the container is undamaged.

Discard any unused portion after 48hrs of first opening.