Symptomatic treatment of acute and chronic diarrhea.
Composition:
1 capsule contains 2 mg of Loperamide hydrochloride. The preparation contains lactose.
Action:
A drug that inhibits intestinal peristalsis. Loperamide binds to the opioid receptors in the intestinal wall, as a result of which the release of acetylcholine from the nerve endings and intramural ganglions is reduced, which causes inhibition of intestinal peristalsis. The intestinal passage is slowed down, the frequency and number of bowel movements decreases, and the anal sphincter voltage increases. The colon is absorbed from the large intestine, which changes the consistency of the stool. The excretion of water and electrolytes is reduced. The onset of the therapeutic effect of loperamide occurs 1-3 hours after admission. T0,5 loperamide is 9-14 h (average approx. 11 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.
Contraindications:
Hypersensitivity to loperamide hydrochloride or to any of the excipients. Conditions in which the intestinal motility is undesirable because of the possible risk of serious complications, including intestinal obstruction, giant colon (megacolon) and toxic colonic distension (megacolon toxicum). Treatment with the product should be discontinued immediately if constipation, abdominal distension or bowel obstruction occur. Bowel obstruction. Acute ulcerative colitis, acute hemorrhagic colitis, pseudomembranous colitis, especially associated with the administration of broad-spectrum antibiotics. Acute dysentery with blood in the stool and running with increased body temperature. Bacterial inflammation of the small intestine and colon caused by pathogenic bacteria of the genusSalmonella, Shigella andCampylobacter. Do not use the drug in children under 6 years.
Precautions:
Treatment of diarrhea with the preparation is only symptomatic. In any case where it is possible to determine the etiology, if justified (or indicated), a causal treatment should be used. In patients with diarrhea, especially in children, dehydration and electrolyte deficiency may occur - diarrhea should be supplemented with water and mineral salts. Administration should be discontinued in the event of constipation, bloating, developing obstruction, and if, after administration of acute diarrhea within 48 hours, no improvement in the clinical condition of the patient is observed. In patients with AIDS treated with the product for diarrhea, the treatment should be discontinued if the earliest signs of abdominal distension occur. In patients with AIDS and concomitant infectious colitis caused by both viruses and bacteria treated with loperamide hydrochloride, isolated cases of toxic colonic distension have been reported with loperamide. The drug should be used with caution in patients with impaired liver function; these patients should be carefully monitored for signs of toxicity from o.u.n. In patients who have fever and blood in the stool, the cause of diarrhea should be determined before initiating loperamide. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
There was no teratogenic effect of loperamide. However, it is not recommended to take the product in the first trimester of pregnancy, and in the second and third trimester, the preparation can be used only in cases where in the doctor's opinion the expected benefit to the mother outweighs the potential risk to the mother and fetus. Loperamide passes into breast milk in a small amount - it is not recommended to use the product during breastfeeding.
Side effects:
Very rare: pain and dizziness, fatigue, drowsiness, abdominal pain, abdominal distension, constipation, nausea and vomiting, intestinal obstruction, enlargement of the colon (megacolon), including toxic dilation of the colon (megacolon toxicum), flatulence and indigestion, dry mouth, rash, hives and pruritus. Isolated cases: angioneurotic edema, bullous rash (including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis), allergic reactions (sometimes severe hypersensitivity reactions including anaphylactic shock and anaphylaxis-like reactions), urinary retention. Many adverse events associated with the use of loperamide are common symptoms of diarrheal syndrome (discomfort and pain in the abdomen, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness, constipation, flatulence) - often these symptoms are difficult to distinguish from the side effects of the drug used.
Dosage:
Orally.Adults and children over 12 years. Acute diarrhea: first dose of 2 capsules (4 mg) followed by 1 capsule (2 mg) after each loose bowel movement; do not use a dose greater than 8 capsules (16 mg) per day. Chronic diarrhea: initially 1 capsule 2 times a day, if necessary, the dose can be increased to 4-6 capsules per day. In children, the dose should be adjusted to body weight (3 capsules / 20 kg).Children from 9 to 12 years old. Acute diarrhea: 1 capsule after each loose bowel movement; Do not use a dose of more than 3 capsules a day. Chronic diarrhea: 1 capsule after each loose bowel movement; Do not use a dose of more than 3 capsules a day.Children from 6 to 8 years old: Acute diarrhea: 1 capsule after each loose bowel movement; Do not use a dose of more than 3 capsules a day. Chronic diarrhea: 1 capsule after each loose bowel movement; Do not use a dose greater than 2 capsules per day. No dosage adjustment is necessary in the elderly or in patients with impaired renal function. In patients with impaired liver function, use caution. Diarrhea may disappear after one dose - then the drug should no longer be used.
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