Pharmacologic class: Piperidine derivative
Therapeutic class: Antidiarrheal
Pregnancy risk category B
Inhibits peristalsis of intestinal wall musculature and intestinal contents. Also reduces fecal volume, increases fecal bulk, and minimizes fluid and electrolyte loss.
Capsules: 2 mg
Solution: 1 mg/5 ml
Tablets: 2 mg
Tablets (chewable): 2 mg
Indications and dosages
➣ Acute diarrhea
Adults: Initially, 4 mg P.O., then 2 mg after each loose stool. Usual maintenance dosage is 4 to 8 mg P.O. daily in divided doses, not to exceed 16 mg daily.
Children ages 8 to 12 or weighing more than 30 kg (66 lb): Initially, 2 mg P.O. t.i.d., then 1 mg/10 kg after each loose stool, not to exceed 6 mg daily
Children ages 6 to 8 or weighing 20 to 30 kg (44 to 66 lb): Initially, 2 mg P.O. b.i.d., then 1 mg/10 kg after each loose stool, not to exceed 4 mg daily
Children ages 2 to 5 or weighing 13 to 20 kg (29 to 44 lb): Initially, 1 mg P.O. t.i.d., then 1 mg/10 kg after each loose stool, not to exceed 3 mg daily
➣ Acute diarrhea (treated with over-the-counter loperamide)
Adults and children ages 12 and older: Two caplets with 4 to 8 oz water after first loose stool, then one caplet (with 4 to 8 oz water) after each subsequent loose stool. Don't exceed four caplets in 24 hours. Or give equivalent dosage in liquid form.
Children ages 9 to 11 who weigh 27 to 43 kg (60 to 95 lbs): One caplet with 4 to 8 oz water after first loose stool, then ½ caplet (with 4 to 8 oz water) after each subsequent loose stool. Don't exceed three caplets in 24 hours. Or give equivalent dosage in liquid form.
Children ages 6 to 8 who weigh 22 to 27 kg (48 to 59 lbs): One caplet with 4 to 8 oz water after first loose stool, then ½ caplet with 4 to 8 oz water after each subsequent loose stool. Don't exceed two caplets in 24 hours. Or give equivalent dosage in liquid form.
Children younger than age 6: Consult physician.
➣ Chronic diarrhea
Adults: Initially, 4 mg P.O., then 2 mg after each loose stool; reduce dosage as tolerated. Don't exceed 16 mg daily for more than 10 days.
• Hypersensitivity to drug
• Abdominal pain of unknown cause (especially with fever)
• Acute diarrhea caused by enteroinvasive Escherichia coli, Salmonella, or Shigella
• Acute ulcerative colitis
• Bloody diarrhea with temperature above 38.3 °C (101 °F) (with OTC product)
• Pseudomembranous colitis associated with broad-spectrum anti-infectives
• Children younger than age 6
Use cautiously in:
• hepatic disease
• elderly patients
• pregnant or breastfeeding patients
• Use patient's weight to determine appropriate dosage (especially in children).
CNS: drowsiness, dizziness
GI: nausea; vomiting; constipation; abdominal pain, distention, ordiscomfort; dry mouth; toxic megacolon (in patients with acute ulcerative colitis)
Other: allergic reactions
Drug-drug. Antidepressants, antihistamines, other anticholinergics: additive anticholinergic effects
CNS depressants (including antihistamines, opioid analgesics, sedative-hypnotics): additive CNS depression
Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression
Drug-behaviors. Alcohol use: increased CNS depression
☞ Watch for signs and symptoms of abdominal distention, which may signal toxic megacolon in patient with ulcerative colitis.
• Assess bowel movements to evaluate drug efficacy and determine need for repeat doses.
• Monitor stool cultures as indicated.
• Check stool for occult blood as indicated.
• Evaluate fluid intake and output.
• Stay alert for CNS effects, especially in children.
• Stress importance of maintaining high fluid intake to prevent dehydration.
☞ Instruct patient or parents to report fever, mucus in stool, or history of hepatic disease before using drug.
☞ Caution patient or parents to discontinue drug if symptoms worsen or diarrhea lasts longer than 2 days.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, herbs, and behaviors mentioned above.