Contraindications of Loperamide in the treatment of Diarrhea

1.

Elsevier ClinicalKey Drug Monograph

Content last updated: April 2, 2024.

Contraindications And Precautions Loperamide is contraindicated in cases of acute dysentery, which is characterized by blood in stools and high fever (elevated temperature/fever greater than 38.3 degrees C). Loperamide is contraindicated in cases of diarrhea caused by pseudomembranous colitis (e.g., Clostridium difficle ) associated with the use of broad-spectrum antibiotics. Loperamide is contraindicated in patients with bacterial gastroenteritis or enterocolitis caused by infection with invasive organisms including Salmonella , Shigella , and Campylobacter. Patients with fever, blood, or mucus in the stool should not self-treat but should seek medical professional evaluation and advice prior to use. Patients with fever may also be at increased risk for developing a prolonged QT interval with loperamide use.

Contraindications And Precautions Loperamide is contraindicated in patients with abdominal pain in the absence of diarrhea. Loperamide should not be used in patients with acute ulcerative colitis. In general, loperamide should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loperamide must be discontinued promptly when constipation, abdominal distention, or ileus develop. Patients with acquired immunodeficiency syndrome (AIDS) treated with loperamide for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide. Treatment of diarrhea with loperamide is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated). In patients with acute diarrhea, inform the patient that if clinical improvement is not observed in 48 hours, they should discontinue loperamide and contact their health care provider.

Contraindications And Precautions Medique Diamode is contraindicated in cases of acute dysentery, which is characterized by blood in stools and high fever (elevated temperature/fever greater than 38.3 degrees C). Medique Diamode is contraindicated in cases of diarrhea caused by pseudomembranous colitis (e.g., Clostridium difficle ) associated with the use of broad-spectrum antibiotics. Medique Diamode is contraindicated in patients with bacterial gastroenteritis or enterocolitis caused by infection with invasive organisms including Salmonella , Shigella , and Campylobacter. Patients with fever, blood, or mucus in the stool should not self-treat but should seek medical professional evaluation and advice prior to use. Patients with fever may also be at increased risk for developing a prolonged QT interval with medique diamode use.

Contraindications And Precautions Loperamide is contraindicated for use in neonates, infants, or children less than 2 years of age due to variable responses in this age group, and an increased risk for respiratory depression and serious cardiac events. Serious cardiac events (i.e., syncope, hypoventilation, ventricular tachycardia) have been reported to the FDA Adverse Event Reporting System (FAERS) following off-label use in pediatric patients less than 2 years of age.

2.

Elsevier ClinicalKey Drug Monograph

Content last updated: April 2, 2024.

Contraindications And Precautions Loperamide is contraindicated in cases of acute dysentery, which is characterized by blood in stools and high fever (elevated temperature/fever greater than 38.3 degrees C). Loperamide is contraindicated in cases of diarrhea caused by pseudomembranous colitis (e.g., Clostridium difficle ) associated with the use of broad-spectrum antibiotics. Loperamide is contraindicated in patients with bacterial gastroenteritis or enterocolitis caused by infection with invasive organisms including Salmonella , Shigella , and Campylobacter. Patients with fever, blood, or mucus in the stool should not self-treat but should seek medical professional evaluation and advice prior to use.

Contraindications And Precautions Loperamide; simethicone is contraindicated in patients with abdominal pain in the absence of diarrhea. Loperamide should not be used in patients with acute ulcerative colitis. In general, loperamide should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loperamide must be discontinued promptly when constipation, abdominal distention, or ileus develop. Patients with acquired immunodeficiency syndrome (AIDS) treated with loperamide for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide. Treatment of diarrhea with loperamide is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated). In patients with acute diarrhea, inform the patient that if clinical improvement is not observed in 48 hours, they should discontinue loperamide and contact their health care provider.

3.

Food and Drug Administration (DailyMed).

Publish date: February 4, 2024.

Contraindications CONTRAINDICATIONS Loperamide hydrochloride capsules are contraindicated in: • pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see WARNINGS ). • patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. • patients with abdominal pain in the absence of diarrhea. • patients with acute dysentery, which is characterized by blood in stools and high fever. • patients with acute ulcerative colitis. • patients with bacterial enterocolitis caused by invasive organisms including Salmonella , Shigella , and Campylobacter . • patients with pseudomembranous colitis (e.g., Clostridium difficle ) associated with the use of broad-spectrum antibiotics.

Dosage And Administration DOSAGE AND ADMINISTRATION Loperamide hydrochloride capsules are contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see CONTRAINDICATIONS ). Avoid loperamide hydrochloride capsules dosages higher than recommended in adult or pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (see WARNINGS and OVERDOSAGE ). (1 capsule = 2 mg): Patients should receive appropriate fluid and electrolyte replacement as needed. Acute Diarrhea Adults and Pediatric Patients 13 Years and Older The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. The maximum daily dose is 16 mg (eight capsules). Clinical improvement is usually observed within 48 hours. Pediatric Patients 2 to 12 Years of Age In pediatric patients 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation of loperamide (1 mg/5 mL) should be used; for ages 6 to 12, either loperamide hydrochloride capsules or the non-prescription liquid formulation of loperamide may be used. For pediatric patients 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements: Recommended First Day Dosage Schedule Two to five years (13 kg to 20 kg): 1 mg three times daily (3 mg total daily dosage) Six to eight years (20 kg to 30 kg): 2 mg twice daily (4 mg total daily dosage) Eight to twelve years (greater than 30 kg): 2 mg three times daily (6 mg total daily dosage) Recommended Subsequent Daily Dosage Following the first treatment day, it is recommended that subsequent loperamide hydrochloride capsules doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.

Warnings • patients with risk factors for QT prolongation, including patients with congenital long QT syndrome, with a history of cardiac arrhythmias or other cardiac conditions, elderly patients and those with electrolyte abnormalities. Dehydration Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of loperamide hydrochloride capsules does not preclude the need for appropriate fluid and electrolyte therapy. Gastrointestinal Disorders In general, loperamide hydrochloride capsules should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loperamide hydrochloride capsules must be discontinued promptly when constipation, abdominal distention or ileus develop. Treatment of diarrhea with loperamide hydrochloride capsules is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated). Patients with AIDS treated with loperamide hydrochloride capsules for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride. Variability in Pediatric Response Loperamide hydrochloride capsules should be used with special caution in pediatric patients because of the greater variability of response in this age group. Dehydration, particularly in pediatric patients less than 6 years of age, may further influence the variability of response to loperamide hydrochloride capsules. Loperamide hydrochloride capsules are contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions.