Loperamide Hydrochloride (Page 5 of 5)

Laboratory Testing

Standard drug screens for opioids do not include an assay for loperamide; such testing for opioids will yield negative results even in the presence of loperamide.

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.

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 mg 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:

Loperamide Hydrochloride Capsules, USP are available containing 2 mg of loperamide hydrochloride, USP.

The capsule is a hard-shell gelatin capsule with a light brown opaque cap and a light brown opaque body filled with white to off-white powder blend. The capsule is axially printed with MYLAN over 2100 in black ink on both the cap and the body. They are available as follows:

NDC 51079-690-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).

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

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12526
9/17

PRINCIPAL DISPLAY PANEL — 2 mg

NDC 51079-690-20

Loperamide
Hydrochloride
Capsules, USP
2 mg

100 Capsules (10 x 10)

Each capsule contains:
Loperamide
hydrochloride, USP . . . . 2 mg

Usual Dosage: See accompanying
prescribing information.

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

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-4574 R9

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Loperamide Hydrochloride 2 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-690(NDC:0378-2100)
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
FERROSOFERRIC OXIDE
SILICON DIOXIDE
GELATIN, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FERRIC OXIDE RED
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color brown (light brown opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;2100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-690-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-690-01)
1 NDC:51079-690-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-690-20)
2 NDC:51079-690-19 25 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-690-17)
2 NDC:51079-690-17 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-690-19)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072741 03/10/1997
Labeler — Mylan Institutional Inc. (039615992)

Revised: 11/2017 Mylan Institutional Inc.

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