Description
Trade name:
Stoprrhea
Compound:
Each lozenge contains:
Loperamide hydrochloride 2 mg
Properties:
Loperamide, by binding to opioid receptors in the intestinal wall, suppresses the release of acetylcholine and prostaglandins, thereby slowing peristalsis and increasing the time it takes for contents to pass through the intestines. Increases the tone of the anal sphincter, thereby reducing fecal incontinence and the urge to defecate.
A clinical study showed that the antidiarrheal effect occurs within one hour after taking a single dose (4 mg).
Indications:
Symptomatic treatment of acute and chronic diarrhea (allergic, emotional, medicinal, radiation-induced, with changes in diet and quality of food, with metabolic and absorption disorders);
as an adjuvant drug for diarrhea of infectious origin;
for the purpose of regulating stool in patients with ileostomy.
Method of administration and dosage:
The drug is taken orally. The tablet is placed on the tongue, it dissolves within a few seconds, after which it is swallowed with saliva, without washing it down with water.
Adults and children over 12 years old:
For acute diarrhea, the initial dose is 2 tablets (4 mg), then 1 tablet (2 mg) after each bowel movement in case of loose stools.
For chronic diarrhea, the initial dose is 2 tablets (4 mg)/day; then the initial dose should be adjusted so that the frequency of normal stool is 1–2 times/day, which is usually achieved with a maintenance dose of 1 to 6 tablets (2–12 mg)/day.
The maximum daily dose should not exceed 6 tablets (12 mg);
When stool returns to normal or if there is no stool for more than 12 hours, the drug is discontinued.
Contraindications:
Hypersensitivity to loperamide and/or other components of the drug;
children under 12 years of age;
phenylketonuria;
1st trimester of pregnancy;
lactation period (breastfeeding). Stopreya cannot be used as the main therapy:
in patients with acute dysentery, which is characterized by bloody stools and high fever;
in patients with ulcerative colitis in the acute phase;
in patients with bacterial enterocolitis caused by pathogenic microorganisms, including Salmonella spp., Shigella spp. and Campylobacter spp.);
in patients with pseudomembranous colitis associated with broad-spectrum antibiotic use.
Precautions:
Treatment of diarrhea with Stopreya is symptomatic only. In cases where the cause of diarrhea can be determined, appropriate therapy should be administered.
In patients with diarrhea, especially in children and elderly patients, fluid and electrolyte loss may occur. In such cases, appropriate replacement therapy (fluid and electrolyte replacement) should be performed.
If there is no effect after 2 days of treatment, it is necessary to stop taking the drug, clarify the diagnosis and exclude the infectious genesis of diarrhea.
Patients with AIDS taking Stopreya for the treatment of diarrhea should discontinue the drug at the first sign of abdominal distension, as well as signs of intestinal obstruction. There have been isolated reports of constipation with an increased risk of toxic megacolon in patients with AIDS and infectious colitis of viral and bacterial etiology who were treated with loperamide.
Stopreya should be used with caution in patients with liver failure, as it may lead to CNS toxicity due to relative overdose.
Prolongation of the QT interval and ventricular arrhythmia, including torsades de pointes, have been reported in association with loperamide overdose, in some cases with fatal outcome. Stopreya should not be used for prolonged periods of time without medical supervision, and patients should not exceed the recommended dose and/or recommended duration of treatment.
Side effects:
Symptoms: Overdose (including relative overdose due to liver dysfunction) may cause urinary retention, paralytic ileus, constipation, signs of CNS depression (respiratory depression, airway obstruction, vomiting with impaired consciousness, stupor, impaired coordination, drowsiness, miosis, muscle hypertonicity). Children and patients with liver dysfunction may be more sensitive to the effects of loperamide on the CNS than adults.
In individuals who have intentionally taken excessive doses (40 mg to 240 mg/day) of loperamide hydrochloride, prolongation of the QT interval and QRS complex and/or serious ventricular arrhythmias, including torsades de pointes; cardiac arrest, syncope, have been reported.
Abuse, misuse and/or overdose of high doses of loperamide may result in the clinical manifestation of Brugada syndrome.
Storage method:
Store in a cool, dry place at a temperature not exceeding 30 degrees.
Package:
The cardboard pack contains 3 blisters of 10 tablets and paper instructions.
