Symptomatic treatment of acute and chronic diarrhea. In patients with ileum, it can be used to reduce the amount and volume of stools and to increase their consistency. The drug is indicated for use in adults and children aged 6 years and above.
Anti-diarrheal drug. Loperamide binds to the opioid receptor of intestinal wall cells, inhibiting peristaltic movements and prolonging the passage of food through the gastrointestinal tract. It increases the resting tension of the anal sphincter and reduces the pressure on the stool. After oral administration, the drug is well absorbed from the intestines. The onset of action is observed within 1 hour of a single dose. T0,5 is about 9-14 h. The elimination occurs mainly through the oxidative route of N-demethylation, which is the most important metabolic pathway of loperamide. Loperamide in unchanged form and its metabolites are mainly excreted in faeces. In patients with liver disease, the concentration of the drug in the blood may increase.
Contraindications:
Hypersensitivity to loperamide or to any of the excipients. It should not be used as an essential treatment in patients with acute dysentery who is characterized by the presence of blood in the stool and high fever, in patients with acute major ulcerative colitis, bacterial inflammation of the small intestine and colon caused by pathogenic bacteria of the genusSalmonella, Shigella andCampylobacter and with pseudomembranous enteritis associated with the administration of broad-spectrum antibiotics. Do not use the drug in children under 6 years. It should not be used in cases where gut motility should be avoided due to the possible risk of serious complications, including bowel obstruction, giant colon and toxic colonic dilation.
Precautions:
Treatment should be stopped immediately if constipation, abdominal distension or bowel obstruction occur. Treatment of diarrhea with loperamide is only symptomatic. In any case where it is possible to determine the etiology, if justified (or indicated), a causal treatment should be used. Patients with diarrhea, especially in children, may lose fluid and electrolytes; in these cases, an adequate amount of fluids and electrolytes should be added. Caution should be exercised in patients with impaired hepatic function (risk of overdose leading to toxic effects o.u.n.n.); patients with impaired hepatic function should be closely monitored. In patients with AIDS treated for lupus diarrhea, the drug should be discontinued at the first signs of abdominal distension. There are isolated reports of toxic colonic distension when loperamide is used in AIDS patients with infectious colitis caused by both bacteria and viruses. The drug contains lactose - the drug should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Although there is no indication that loperamide would be teratogenic or embryotoxic, the anticipated therapeutic benefit should be carefully weighed against the potential risks of administering the drug to pregnant women, particularly in the first trimester. Small amounts of loperamide are excreted in human milk, therefore the drug is not recommended during breastfeeding.
Side effects:
Very rare: rash, urticaria, pruritus, isolated cases of allergic reactions, sometimes severe hypersensitivity reactions, including anaphylactic shock and reactions resembling anaphylaxis, abdominal pain, intestinal obstruction, abdominal distension, nausea, constipation, vomiting, enlarged colon (including toxic) , flatulence, indigestion, isolated cases of urinary retention, dizziness, drowsiness.In single cases, vasomotor edema, bladder rash, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis, have been observed.
Dosage:
Orally. Adults and children ≥6 years. Acute diarrhea: initially 2 tabl. for adults and 1 tabl. for children; then 1 tabl. after each loose stool. Chronic diarrhea: initially 2 tabl. daily for adults and 1 tabl. daily for children, if necessary, a maintenance dose of 1-6 tabls can be used. daily, until 1-2 normal stools daily. The maximum dose in acute and chronic diarrhea is 8 tablets. daily for adults; 3 tablets / 20 kg / day for children. The drug should not be used for a long time until the cause of diarrhea has been determined. If no improvement in the clinical condition of the patient is observed after acute diarrhea within 48 hours, treatment should be discontinued and the patient's condition reviewed.
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