Anti-Diarrheal Tablets - Loperamide 2mg

02212005

2 years from date of manufacture

Loperamide HCI 2mg

Cornstarch, D & C yellow #10 aluminum lake, lactose, magnesium stearate and microcrystalline cellulose.

56:08 Antidiarrhea Agents

Light green, capsule-shaped tablet, scored and engraved "APO" over "2" on one side.

Diameter: 0.2500 x 0.6085 capsule
Thickness: 0.190" - 0.210"

Store at room temperature (15 to 30°C). Protect from light and high humidity.

For rapid relief of diarrhea, often with just one dose.

Adults and children over 12 years of age: Take two loperamide hydrochloride caplets initially and one caplet every time you have another loose bowel movement, to a maximum of 8 caplets a day.

While diarrhea is not normally a serious condition, you should consult your physician immediately if it is associated with high fever (102°F or 39°C) or if blood is present in the stools. If diarrhea does not resolve within 48 hours, discontinue the medication and consult your physician.

None.

Contraindicated for use in children under 6 years of age, patients with known hypersensitivity to the drug and in those in whom constipation must be avoided.

The adverse effects reported in adults during clinical trials are difficult to distinguish from symptoms associated with the diarrheal syndrome. In adults, they were generally of a minor and self-limiting nature e.g., abdominal pain, distension or discomfort; constipation; drowsiness or dizziness; dry mouth; nausea and vomiting; hypersensitivity, including skin rash. Opiate-like effects (CNS) have been observed in young children (under 3 years of age).

Loperamide should not be used in the case of acute dysentery which is characterized by blood in stools and elevated temperature. Fluid and electrolyte depletion may occur in patients who have diarrhea. The use of loperamide does not preclude the administration of appropriate fluid and electrolyte therapy.

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 distension occurs or if other untoward symptoms develop.

Loperamide should be used with special caution in young children and those with compromised blood brain barrier (e.g. meningitis) because of the greater variability of response in these groups. Dehydration, particularly in young children, may further influence the variability of response to loperamide.

Do not exceed the recommended dose. In case of accidental overdosage, consult a physician immediately.

Clinical trials have demonstrated that a slurry of activated charcoal administered promptly after ingestion of loperamide can reduce the amount of drug which is absorbed into the systemic circulation by as much as ninefold.

If vomiting has not occurred, gastric lavage should be performed followed by administration of 100 g of the activated charcoal slurry through the gastric tube. In the event of overdosage, patients should be monitored for signs of CNS depression for at least 24 hours. If CNS depression is observed, naloxone may be administered. If responsive to naloxone, vital signs must be monitored carefully for recurrence of symptoms of drug overdose for at least 24 hours after the last dose of naloxone.