Normohydron powder for solution for oral administration in bags No. 10

Name:
Normohydron por. d/preparation.r-ra d/vn.prim.in pak.in unitary enterprise No. 10
Description:
White odorless crystalline powder. During storage, the formation of lumps is allowed, which are destroyed when lightly pressed. The prepared solution is clear, colorless, odorless, with a salty-sweet taste. Main active ingredient Dextrose + potassium chloride + sodium chloride + sodium citrate Product form Powder Pharmacological action Normohydron is used to correct dehydration and loss of electrolytes caused by diarrhea. Glucose promotes the absorption of salts, citrate helps to eliminate metabolic acidosis and regulate the acid-base state. The osmolarity of the solution is 282 mOsm/l, the pH of the solution is slightly alkaline – 8.2. Indications for use Oral rehydration (replenishment of body fluids) for acute diarrhea accompanied by mild to moderate dehydration (dehydration) and prevention of dehydration. The solution is designed to replenish the loss of water and salts in the body. Dosage and administration To prepare the solution, dissolve the contents of 1 sachet in 1 liter of boiled chilled drinking water. Stir before use. The solution is taken orally (orally), if necessary, the solution can be administered through a nasogastric tube (in a hospital setting). The prepared solution should be stored at +2°C to +8°C and 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 weight loss and degree of dehydration. The patient’s nutrition should not be interrupted during oral rehydration therapy 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 drug should be started as soon as diarrhea begins. Usually the drug is used for no more than 3-4 days, treatment is stopped with the end of diarrhea. In case of nausea or vomiting, it is advisable to take the solution chilled in small portions (for example, teaspoons). For rehydration, the drug should be taken during 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 amount of drug is 800 ml. During this phase of treatment, the use of other fluids is not required. Eating during the first 4 hours of fluid replenishment is not recommended. Large doses may cause vomiting. For the prevention of dehydration: in case of continued diarrhea after correction of dehydration, it is recommended to administer the drug, water and other fluids within 24 hours according to the following scheme: Body weight (kg) – Total amount of fluid required (ml) – Normohydron (solution, ml) – Water (ml) – Other liquids (ml) 40-49 – 2100 – 900 – 540 – 660 50-59 – 2300 – 1000 – 600 – 700 60-69 – 2500 – 1100 – 660 – 740 70-79 – 2700 – 1200 – 720 – 780 80-89 – 3200 – 1400 – 800 – 1000 90-99 – 3600 – 1500 – 900 – 1200 100 and more – 4000 – 1700 – 1000 – 1300 Use during pregnancy and lactation during pregnancy and lactation. Precautions Do not add sugar to the solution. Severe dehydration (weight loss > 10%, anuria) should be corrected with intravenous agents, after which Normohydron can be prescribed. Do not exceed the recommended doses of the drug, unless the need for additional administration of electrolytes is confirmed by laboratory tests. Patients who develop dehydration on the background of renal failure, diabetes mellitus or other chronic diseases in which the acid-base, electrolyte or carbohydrate balance is disturbed require careful monitoring during Normohydron therapy. When using the drug in patients with diseases accompanied by impaired excretion of potassium from the body, the development of hyperkalemia cannot be excluded. In children, solutions with a lower sodium content and osmolarity should be used. Given 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 diet low in salt (sodium and (or) potassium). In patients with diabetes mellitus, renal insufficiency, and some other chronic diseases, diarrhea can cause significant impairment of fluid or glucose balance. In this regard, the treatment of diarrhea in such patients may require laboratory monitoring and hospitalization. The drug contains glucose, and therefore it is not recommended for use in patients with glucose / galactose malabsorption syndrome. When using Normohydron, a doctor’s consultation is required in the following cases: rapid fatigue, drowsiness, speech slowdown, the patient does not answer questions, body temperature rises over 39 ° C, cessation of urine output, the appearance of loose bloody stools, diarrhea lasting more than 48 hours, sudden cessation of diarrhea and the appearance of severe pain if home treatment is ineffective and impossible. Interaction with other drugs Interactions with other drugs have not been studied. Normohydron solution has a slightly alkaline reaction, therefore, it can affect the effectiveness of drugs, the absorption of which depends on the pH of the intestinal contents. Diarrhea itself can alter the absorption of many drugs that are absorbed in the small or large intestine, or drugs that are metabolized by intrahepatic circulation. Contraindications Hypersensitivity to the components of the drug, severe dehydration, hemodynamic shock, hyperkalemia, impaired renal function, insulin-dependent and non-insulin-dependent diabetes mellitus, unconsciousness, intestinal obstruction, severe vomiting, diarrhea caused by cholera, glucose-galactose malabsorption, severe forms of arterial hypertension. Composition 1 package (18.9 g) contains: sodium chloride 3.5 g sodium citrate 2.9 g potassium chloride 2.5 g glucose 10 g The solution obtained by dissolving 1 sachet in 1 liter of water contains the following concentrations of active ingredients: sodium chloride – 59 .9 mmol potassium chloride – 33.5 mmol sodium citrate – 9.9 mmol dextrose – 55.5 mmol Na + – 89.6 mmol K + – 33.5 mmol Cl- – 93.4 mmol Citrate – 9.9 mmol Osmolarity solution – 282 mOsm / l. Overdose Hypersensitivity to the components of the drug, severe dehydration, hemodynamic shock, hyperkalemia, impaired renal function, insulin-dependent and non-insulin-dependent diabetes mellitus, unconsciousness, intestinal obstruction, severe vomiting, diarrhea caused by cholera, glucose-galactose malabsorption, severe forms of arterial hypertension. Side effects If the recommended doses of the drug are followed, side effects are unlikely. Allergic reactions, hypernatremia, hyperhydration, vomiting are potentially possible. In the event of the above adverse reactions or adverse reactions not listed in these instructions for medical use of the drug, you should consult a doctor. Storage conditions Store in a place protected from moisture and light at a temperature of 15°C to 25°C. Keep out of the reach of children. The prepared solution should be stored at a temperature of 2°C to 8°C for no more than 24 hours. 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