Loperamide Hydrochloride Capsules is 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, OVERDOSAGE).
(1 capsule = 2 mg)
Patients should receive appropriate fluid and electrolyte replacement as needed.
Adults and Pediatric Patients 13 Years and Older: The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. The maximum daily dose is 16mg (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 6-12, 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 to 20 kg): 1 mg three times daily (3 mg total daily dosage) Six to eight years (20 to 30 kg): 2 mg twice daily. (4 mg total daily dosage)
Eight to twelve years (greater than 30kg): 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. The total daily dosage should not exceed recommended dosages for the first day.
‘The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of Loperamide Hydrochloride Capsules 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 average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules per day). The maximum daily dosage is 16 mg (eight capsules per day). 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 Hydrochloride Capsules administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.
No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dose adjustment is required for the elderly.
In general, elderly patients may be more susceptible to drug-associated effects of the QT interval. Avoid Loperamide Hydrochloride Capsules in elderly patients taking drugs that can result in prolongation of the QT interval (for example, Class IA or III antiarrhythmics) or in patients with risk factors for Torsades de Pointes (see WARNINGS).
No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment (see PRECAUTIONS).
The pharmacokinetics of loperamide have not been studied in patients with hepatic impairment.
Use Loperamide Hydrochloride Capsules with caution in such patients because the systemic exposure may be increased due to reduced metabolism (see PRECAUTIONS).
Capsules — each capsule contains 2 mg of loperamide hydrochloride. The capsules have a light brown opaque cap and a light brown opaque body with an “^” over “605” imprinted radially on one segment.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Revised October 2021
Edenbridge Pharmaceuticals, LLC
Parsippany, NJ 07054
Printed in USA
|LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride capsule|
|Labeler — Edenbridge Pharmaceuticals LLC. (948715060)|
Revised: 10/2021 Edenbridge Pharmaceuticals LLC.
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