Loperamide STELLA

OTC

Indications

• For the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease.
• For reducing the volume of discharge from ileostomies, colostomies.

Dosage

Acute diarrhea

• Adults: initial dose is 4 mg followed by 2 mg after each unformed stool. Daily dosage should not exceed 16 mg. Clinical improvement is usually observed within 48 hours.
• Children: recommended first day dosage: 6 – 8 years (20 – 30 kg) 2 mg twice daily, 8 – 12 years (> 30 kg) 2 mg 3 times daily. Recommended subsequent daily dosage: 1 mg/10 kg only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.

Chronic diarrhea

• Adults: initial dose is 4 mg followed by 2 mg after each unformed stool until diarrhea is controlled, after which the dosage should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.
• The daily maintenance dosage was 4 – 8 mg. A dosage of 16 mg was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Loperamide administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.

Usage

• Drug is administered orally. Patients should receive appropriate fluid and electrolyte replacement as needed.

• Known hypersensitive to any of the active substance or excipients.
• Patients with abdominal pain without diarrhoea.
• Children under 2 years of age.
• Patients with abdominal distention.
• First loperamide avoided use in acute dysentery, ulcerative colitis in phase bleed acute, pseudomembranous colitis, bacterial enterocolitis caused as Salmonella, Shigella and Campylobacter.
• Acute ulcerative colitis, pseudomembranous colitis (may induce toxic megacolon) caused by antibiotic use.

Common

• Headache, dizziness;
• Constipation, nausea, flatulence.

Uncommon

• Somnolence, abdominal pain, abdominal discomfort, dry mouth, abdominal pain upper, vomiting, dyspepsia,
• Rash.

• Avoid using in pregnancy and breast-feeding women.
• It is advisable to use caution when driving a car or operating machinery.
• Treatment of diarrhoea with loperamide is only symptomatic. Need to find cause (if applicable) and responding appropriate.
• Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important.
• In some patients with acute ulcerative colitis, and in pseudomembranous colitis associated with broad – spectrum antibiotics, agents which inhibit intestinal motility or delay intestinal transit time have been reported to induce toxic megacolon.
• Loperamide therapy should be discontinued promptly if abdominal distention, constipation, or ileus occurs.
• Loperamide should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to loperamide.
• In acute diarrhea, if clinical improvement is not observed in 48 hours, the administration of loperamide should be discontinued.
• Should not be used for prolonged periods. Indicated only for the symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome.
• Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity because of the apparent large first pass biotransformation.
• Patients should be advised to check with their physician if their diarrhea does not improve after a couple of days or if they note blood in their stools or develop a fever.