$44.00
Manufacturer: France
The drug is prescribed to cleanse the bowel before any procedure that requires it (for example, bowel imaging, including endoscopy and radiology, or surgical procedures). The drug is not a remedy for constipation.
Description
Easyclean Storage:
active substances: 1 bottle contains: anhydrous sodium sulfate 17,510 g, magnesium sulfate, heptahydrate 3,276 g, potassium sulfate 3,130 g;
Excipients: sodium benzoate (E 211), citric acid anhydrous, malic acid, sucralose, fruit and berry flavor (mixture of natural and synthetic flavors, propylene glycol (E 1520), dilute ethanol, acetic acid and benzoic acid (E 210), purified water.
Total electrolyte ion content: Content in grams Content in millimoles 1 bottle 2 bottles 1 bottle 2 bottles Sodium * 5,683 11,366 247,2 494,4 Potassium 1,405 2,81 35,9 71,8 Magnesium 0,323 0,646 13,3 26,6 Sulfate 14,844 29,688 154,5 309,0 * obtained from anhydrous sodium sulphate (active substance) and sodium benzoate (excipient).
Easyclean Dosage form.
Concentrate for oral solution.
Basic physical and chemical properties: liquid from transparent to slightly turbid with aroma of fruit mix.
Easyclean Pharmacotherapeutic group.
Osmotic laxatives. A combination of mineral salts.
ATX code A06A D10.
Pharmacological properties.
Pharmacodynamics.
The drug is an osmotic laxative. The mechanism of its action is mainly based on the limited and saturated process of active sulfate transfer. Due to saturation in the process of gastrointestinal transfer, sulfate remains in the intestine. The osmotic effect of unabsorbed ions when taken with large amounts of water causes profuse watery stools. In clinical trials, the mean time to frequent bowel movements was approximately 6.3 hours at 12-hour intervals and approximately 2.8 hours at 1-hour intervals.
Pharmacokinetics.
Sulfate absorption is a limited and saturated process of active transfer; the absorbed sulfate is excreted mainly by the kidneys. Following clinical administration of a medicinal product with the same sulphate content as Iziklin, six healthy volunteers in divided dose regimens, ie two doses at 12-hour intervals, the maximum serum sulphate concentration was observed approximately 16 hours after the first half the dose and 5 hours after the second dose [Cmax: 499.5 μmol / l (CV: 33.03%) compared to baseline 141-467 μmol / l, mean 335 μmol / l (CV: 34.4%) )]. After that, the serum concentration decreased with a half-life of 8.5 hours (CV: 53.76%). The main route of excretion of sulfate was excretion with fecal masses (about 70% of the dose).
The systemic effects (AUC and Cmax) of sulphate after drug administration were also compared in healthy volunteers, six patients with moderate renal impairment (creatinine clearance 30-49 ml / min) and six patients with mild or moderate hepatic impairment (Child score). -Pue A (N = 5) and B (N = 1)), respectively. Renal impairment led to a decrease in urinary sulfate excretion. As a result, the mean AUC and Cmax were approximately 50% higher than those in patients with normal renal function. Hepatic impairment did not affect the systemic action of sulfate. Serum sulfate concentrations returned to baseline on day 6 after drug administration in all three study groups. In this study, the use of the drug did not lead to clinically significant hypersulfatemia in patients with impaired liver or kidney function.
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