Diagnostin-zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIAGNOSTIN-ZDOROVYE (DIAGNOSTIN-ZDOROVYE)

Composition:

Active substances: potassium chloride; sodium chloride; sodium bicarbonate; macrogol 3350;

1 sachet contains: potassium chloride 0.185 g, sodium chloride 1.4 g, sodium bicarbonate 0.715 g, macrogol 3350 52.5 g;

Excipients: sodium saccharin; colloidal anhydrous silicon dioxide; banana flavoring containing maltodextrin, dextrin, glycerol triacetate (triacetin).

Pharmaceutical form. Oral powder for solution.

Main physicochemical properties: white, powder-like mixture of various crystalline substances with a banana flavor.

Pharmacotherapeutic group. Osmotic laxatives. Macrogol combinations.

ATC code A06AD65.

Pharmacological properties.

Pharmacodynamics.

The medicinal product is a mixture of various electrolytes and macrogol for producing an isotonic solution for bowel cleansing.

The pharmacodynamic effect consists in inducing diarrhea. The intestine is emptied and cleaned. The electrolytes contained in the ready-to-use solution are balanced to ensure the cessation of the reverse processes of absorption and secretion of water and electrolytes in the gastrointestinal tract. The addition of high-molecular-weight macrogol provides an iso-osmotic concentration characterized by a particle concentration comparable to that in blood plasma. This prevents any significant fluid shift between the intestinal lumen and the vascular compartment. Due to this type of balancing and osmolarity, the effect on the body's electrolyte or fluid balance is practically negligible.

Clinical characteristics.

Indications.

For bowel cleansing prior to colonoscopy.

Contraindications.

Hypersensitivity to the active substances, other macrogols, or to any of the excipients of the medicinal product.

Intestinal obstruction or suspicion of intestinal obstruction, gastrointestinal obstruction, gastrointestinal perforation, risk of gastrointestinal perforation, severe inflammatory bowel diseases (including ulcerative colitis, Crohn's disease), toxic megacolon, gastric emptying disorders.

The medicinal product should not be administered to patients who are unconscious or in a semi-conscious state, as well as to patients at risk of aspiration or regurgitation, or in cases of general weakness or impaired swallowing reflex.

Interaction with other medicinal products and other forms of interaction.

Medicinal products administered orally within several hours before or during administration of this product may be flushed out of the gastrointestinal tract or their absorption may be reduced or completely prevented. This particularly applies to medicinal products with delayed release. If these medicinal products are essential for life-sustaining therapy, their oral administration should be avoided and an alternative dosage form or alternative treatment should be used.

Possible interactions may occur between macrogol and certain enzymatic tests (e.g., ELISA) when analyzing expelled intestinal fluid.

The prepared solution must not be mixed with other solutions or additives.

Special precautions for use.

The medicinal product should be used only under medical supervision in elderly patients, patients with reflux esophagitis, or in patients with cardiac arrhythmia and suspected or confirmed sinoatrial block or sick sinus syndrome.

The drug should be administered with caution under physician supervision to patients with chronic inflammatory bowel diseases (except severe cases and toxic megacolon).

The medicinal product should not be used in patients with cardiac insufficiency [NYHA (New York Heart Association) class III–IV], renal insufficiency, hepatic disorders, or in patients with pronounced dehydration, as safety in these patient groups has not been adequately studied. The drug should be used with caution in patients at risk of disturbances in water-electrolyte balance (e.g., patients with impaired liver or kidney function, or those receiving concomitant diuretic therapy). Isolated cases of water-electrolyte imbalance have been reported in at-risk patients. Acute pulmonary edema may develop in patients with cardiac or renal insufficiency due to excessive intake of sodium hydroxide.

Seizures associated with the use of polyethylene glycol 3350 with electrolytes for bowel cleansing have been observed in patients both with and without a history of seizures. These cases were mostly associated with electrolyte disturbances such as severe hyponatremia (see section "Adverse reactions"). Polyethylene glycol 3350 with electrolytes should be prescribed with caution to patients with a history of seizures, those at increased risk of seizures, or those at risk of electrolyte imbalance. In the event of neurological symptoms, water-electrolyte imbalances should be corrected promptly.

Cases of esophageal rupture (Boerhaave syndrome) associated with excessive vomiting after intake of polyethylene glycol 3350 with electrolytes for bowel cleansing have been reported in the post-marketing period, primarily in elderly patients (see section "Adverse reactions"). Patients should be advised to discontinue the medicinal product and seek immediate medical attention if they experience intractable vomiting followed by chest, neck, or abdominal pain, dysphagia, hematemesis, or dyspnea.

Ischemic colitis

During post-marketing use, cases of ischemic colitis, including severe cases, have been reported in patients receiving polyethylene glycol for bowel preparation. The medicinal product should be used with caution in patients with risk factors for ischemic colitis or when used concomitantly with stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients who develop sudden abdominal pain, rectal bleeding, or other symptoms suggestive of ischemic colitis should be evaluated immediately.

No other solutions or additives (including sugar or flavorings incompatible with the medicinal product solution) should be added to the ready-to-use oral solution of the drug, as this may alter its osmolarity and electrolyte composition or cause formation of gas mixtures in the intestine.

Water-electrolyte balance should be monitored in at-risk patients, including elderly and debilitated patients.

One sachet contains 32.7 mmol (752 mg) of sodium. This should be taken into account if the patient is on a sodium-controlled diet.

One sachet contains 2.5 mmol (97 mg) of potassium. This should be taken into account if the patient is on a potassium-controlled diet.

Use during pregnancy or breastfeeding.

Pregnancy.

There is no experience with the use of the medicinal product during pregnancy.

Breastfeeding period.

There are no data on the excretion of polyethylene glycol 3350 into breast milk.

Polyethylene glycol 3350 is poorly absorbed. The medicinal product may be used during breastfeeding if the benefit to the woman outweighs the potential risk to the infant.

Ability to affect reaction speed when driving or operating machinery.

Has no effect or has negligible influence on the ability to drive a vehicle or operate machinery.

Method of Administration and Dosage

To achieve complete bowel cleansing, it is necessary to drink up to 3 (maximum up to 4) liters of the solution. One sachet corresponds to ½ liter of solution.

The solution should be taken in portions of 200–300 ml every 10 minutes until rectal effluent becomes clear.

Usually, the administration of the drug should be completed 4 hours before the start of the procedure. The total required volume of solution may also be taken the evening before the procedure, or partially the evening before and the remainder the following morning on the day of the procedure.

Patients should not consume any solid food 2–3 hours before taking the drug and until completion of the procedure.

Preparation of the Solution

The solution should be prepared immediately before use by dissolving the contents of 2 sachets in 500 ml of warm or cooled boiled water, then adding water to make up the total volume to 1 liter. The freshly prepared solution, ready for use, may be stored in a refrigerator, as it is preferable to administer it chilled.

Children

The drug should not be used in children, as its safety in this age group has not been adequately studied.

Overdose

In case of overdose, severe diarrhea may occur. With significant overdose, disturbances in fluid, electrolyte, and acid-base balance may be expected. Adequate fluid replacement and monitoring of serum electrolytes and pH levels are required.

If fluid, electrolyte, or acid-base imbalance occurs, electrolyte replacement and corrective measures to restore acid-base balance should be initiated.

In case of aspiration, toxic pulmonary edema may develop, requiring immediate intensive therapeutic interventions, including positive-pressure ventilation.

Adverse Reactions

The most commonly observed adverse effects during the use of the drug were bloating and nausea (very common).

These symptoms are mostly due to the ingestion of a relatively large volume of fluid within a short period of time. If gastrointestinal symptoms such as nausea and vomiting occur, the dosing frequency should be temporarily reduced or administration of the drug discontinued until symptoms resolve.

Undesirable effects reported during the use of bowel cleansing agents, such as this medicinal product or similar products containing macrogol, either spontaneously or in clinical trials, are listed in the table below, grouped by system organ class and frequency.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

The prepared solution is suitable for use within 3 hours if stored at a temperature not exceeding 25 °C, or within 48 hours if stored at 2 °C–8 °C (in the refrigerator).

Keep out of reach of children.

Packaging. 55.318 g of powder in a sachet; 6 sachets in a box.

Availability. Over-the-counter (without prescription).

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of its business activities.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.