Prescription Drug Information: Loperamide Hydrochloride (Page 3 of 3)

DOSAGE & ADMINISTRATION

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.

Acute Diarrhea

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.

Chronic Diarrhea

Adults

‘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.

Elderly

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).

Renal Impairment

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).

Hepatic Impairment

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).

HOW SUPPLIED

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.

NDC 42799-605-03

(30 CAPSULES)

NDC 42799-605-01

(100 CAPSULES)

NDC 42799-605-02

(500 CAPSULES)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Revised October 2021

Edenbridge Pharmaceuticals, LLC

Parsippany, NJ 07054

877-381-3336

Rx Only

Printed in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ct
(click image for full-size original)
100 ct
(click image for full-size original)
500 ct
(click image for full-size original)
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42799-605
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
POTASSIUM HYDROXIDE
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 605
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42799-605-03 30 CAPSULE in 1 BOTTLE None
2 NDC:42799-605-01 100 CAPSULE in 1 BOTTLE None
3 NDC:42799-605-02 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215001 09/25/2020
Labeler — Edenbridge Pharmaceuticals LLC. (948715060)

Revised: 10/2021 Edenbridge Pharmaceuticals LLC.

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