Instructions Ionika powder for oral solution sachet 4.4 g No. 20
Composition
active ingredients: 1 sachet contains: anhydrous glucose 2.7 g, sodium citrate 0.58 g, sodium chloride 0.52 g, potassium chloride 0.3 g;
excipients: sucralose, anhydrous citric acid, orange flavoring.
Dosage form
Powder for oral solution.
Main physicochemical properties: white or almost white granular powder.
Pharmacotherapeutic group
Saline formulations for oral rehydration.
ATX code A07C A.
Pharmacological properties
Pharmacodynamics.
The Ionic solution, in accordance with WHO recommendations, has a reduced osmolarity of 245 mOsm/l, pH is slightly alkaline. The solution is used to correct electrolyte and fluid loss during diarrhea. Glucose promotes salt absorption, citrates help correct the balance in metabolic acidosis.
Pharmacokinetics.
The pharmacokinetics of water, electrolytes, and glucose contained in the preparation Ionika correspond to the natural pharmacokinetics of these substances in the body.
Indication
Restoration of water and electrolyte balance, correction of acidosis in acute diarrhea (including cholera), diarrhea with mild or moderate dehydration, and thermal injuries accompanied by disturbances of water and electrolyte metabolism.
For preventive purposes: heat and physical exertion that lead to intense sweating.
Contraindication
Hypersensitivity to the active substances or to any other component of the drug, severe dehydration, loss of consciousness, hemodynamic shock, intestinal obstruction, intractable vomiting, ileus.
Interaction with other medicinal products and other types of interactions
There is no information on the interaction of Ionika with other drugs. The absorption of drugs may be altered in diarrhea, mainly of drugs absorbed in the small or large intestine, or in their enterohepatic circulation.
The pH of the drug solution is slightly alkaline, so it may affect medications whose absorption depends on the pH of the intestinal contents.
Application features
The drug should be administered orally, using water to dissolve it. The contents of 1 sachet of the drug Ionika should be dissolved in 0.2 l of water. If the dose is exceeded, the patient may develop hypernatremia. Sugar should not be added to the solution. Food intake is possible immediately after rehydration. In case of vomiting, wait 10 minutes and let the solution be drunk slowly, in small sips.
Severe dehydration (weight loss of more than 9% in children, anuria) should be treated first with intravenous rehydration agents. Ionic may then be administered 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.
Patients who develop dehydration due to renal failure, diabetes, or other chronic diseases that disrupt acid-base, electrolyte, or carbohydrate balance require close monitoring during therapy with Ionic and may require hospitalization.
The drug 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.
Caution should be exercised when treating patients with liver disease with Ionika, as well as patients on a diet with a limited content of sodium or potassium. Diarrhea can significantly affect the fluid and glucose balance in patients with diabetes, renal failure or certain other chronic diseases. Therefore, while symptoms of diarrhea persist, such patients require closer observation with laboratory evaluations and in-hospital dehydration therapy.
Ionic should be used with caution in case of renal failure during oliguria or anuria, and in case of parenteral rehydration therapy.
Situations when using the drug Ionika that require medical intervention:
the patient's speech slows down, drowsiness appears, he quickly gets tired and does not answer questions;
urine output stops;
the patient's mental state has changed (irritability, apathy, lethargy);
fever (temperature above 39 °C);
blood in the stool;
constant vomiting;
diarrhea lasts more than 2 days;
diarrhea suddenly stops, severe pain appears;
if treatment at home is unsuccessful or impossible;
severe abdominal pain.
When treating diarrhea caused by cholera bacteria and some other bacteria, the amount of salt in the medicine may not be enough to replace the excessive salt loss associated with the disease.
Ionic contains potassium, which must be taken into account when using the solution in patients with reduced kidney function who are on a potassium-controlled diet.
Ionic contains sodium, which must be taken into account when using the solution in patients with reduced kidney function who are on a sodium-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. It can also be continued immediately after rehydration.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving vehicles or other mechanisms.
Method of administration and doses
Preparation of the solution: dissolve 1 sachet of powder in 0.2 l of boiled water cooled to room temperature. Take the solution orally or administer under the supervision of a physician through a nasogastric tube.
Treatment of mild and moderate dehydration (replacement therapy): the dose depends on the patient's body weight and the degree of dehydration and is 50-100 ml of the drug solution per kg of body weight. To eliminate fluid deficiency in the body, Ionic must be taken within 4 hours.
Adults and children with mild to moderate dehydration should take the drug according to the table below:
| Volumes of Ionic solution for replacement therapy |
| Body weight | < 5 kg | 5‒7.9 kg | 8‒10.9 kg | 11‒15.9 kg | 16‒29.9 kg | > 30 kg |
| mL of solution | 200‒400 | 400‒600 | 600‒800 | 800‒1200 | 1200‒2200 | 2200‒4000 |
If diarrhea persists after replacement therapy, Ionic solution is used as maintenance therapy.
In case of nausea and vomiting, it is advisable to take the cooled solution in small repeated doses. If necessary, first use a small amount of the solution (using, for example, a teaspoon, a syringe), the dose can be increased gradually, depending on tolerance. Rapid administration of the drug is safe, but there is a possibility of vomiting.
Other fluids may be consumed during drug therapy, but fluids containing a lot of sugar should be avoided, as high sugar concentrations may worsen diarrhea.
Prevention of dehydration (maintenance therapy).
To prevent fluid loss from the body and for maintenance therapy, use lower doses. Therapy with Ionika should be started at the onset of diarrhea. Usually, the drug should be taken for no more than 3-4 days, and the administration should be stopped after the diarrhea has stopped.
The dose of the drug depends on body weight:
children weighing up to 10 kg: 50-100 ml of the drug solution after each loose stool;
adults and children weighing more than 10 kg: 100-200 ml of the drug solution after each loose stool.
You can consume other liquids and food while using Ionic.
Children.
Ionic can be used in children. There are no age restrictions from which children can use this medicine.
Overdose
Hypernatremia and hyperkalemia may occur in patients with reduced renal function.
Hypernatremia may occur with the administration of very large amounts or very concentrated solutions of Ionic. Metabolic alkalosis may occur in patients with reduced renal function. Symptoms of hypernatremia include weakness, neuromuscular excitation, drowsiness, confusion, coma, and sometimes even respiratory arrest. Metabolic alkalosis may manifest itself in decreased lung ventilation, neuromuscular excitation, and tetanic convulsions.
In case of severe overdose with severe consequences, the administration of Ionic should be discontinued. A doctor's consultation is required. Correction of electrolyte and fluid balance should be carried out on the basis of laboratory test data.
Side effects
When using recommended doses, the development of adverse reactions is unlikely.
Potentially possible development of allergic reactions.
In patients with normal renal function, the risk of hypernatremia or hyperhydration with Ionic is low. Vomiting may occur, indicating that the drug has been administered too rapidly.
The results of a meta-analysis of clinical trials indicate an association between the use of rehydration solutions with reduced osmolarity (less than 270 mOsm/L) and the development of hyponatremia and hypokalemia.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Store the prepared solution in a refrigerator at 2-8°C for 24 hours.
Packaging
4.4 g of powder per sachet; 5 or 20 sachets per carton.
Vacation category
Without a prescription.
Producer
FDS Limited.
Address
Plot No. B-8, MIDS, Industrial Area, Waluj, 431 136, Dist. Aurangabad, India.
