LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Composition:

LOPERAMIDE HYDROCHLORIDE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Loperamide hydrochloride is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies. 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 WARNINGS ). - patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. - patients with abdominal pain in the absence of diarrhea. - patients with acute dysentery, which is characterized by blood in stools and high fever. - patients with acute ulcerative colitis. - patients with bacterial enterocolitis caused by invasive organisms including Salmonella , Shigella , and Campylobacter . - patients with pseudomembranous colitis (e.g., Clostridium difficile ) associ

Product summary:

Loperamide hydrochloride capsules USP, 2 mg are available as: A light brown opaque body and dark brown opaque capsule, imprinted "TEVA" on the cap and "0311" on the body NDC 68071-4075-6 Bottles of 6 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. Q 11/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
NUCARE PHARMCEUTICALS,INC.
----------
LOPERAMIDE HYDROCHLORIDE CAPSULES USP
RX ONLY
WARNING: TORSADES DE POINTES AND SUDDEN DEATH
CASES OF TORSADES DE POINTES, CARDIAC ARREST, AND DEATH HAVE BEEN
REPORTED WITH THE
USE OF A HIGHER THAN RECOMMENDED DOSAGES OF LOPERAMIDE HYDROCHLORIDE
(SEE
WARNINGS AND OVERDOSAGE).
LOPERAMIDE HYDROCHLORIDE IS CONTRAINDICATED IN PEDIATRIC PATIENTS LESS
THAN 2 YEARS OF
AGE (SEE CONTRAINDICATIONS).
AVOID LOPERAMIDE HYDROCHLORIDE DOSAGES HIGHER THAN RECOMMENDED IN
ADULTS AND
PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER DUE TO THE RISK OF SERIOUS
CARDIAC ADVERSE
REACTIONS (SEE DOSAGE AND ADMINISTRATION).
DESCRIPTION
Loperamide hydrochloride is a white to slightly yellow powder and is
freely soluble in methanol,
isopropyl alcohol, chloroform and slightly soluble in water.
Loperamide hydrochloride,
4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-
piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal
for oral use. Its structural formula
is:
C
H
ClN
O
•HCl M.W. 513.51
Loperamide hydrochloride is available in 2 mg capsules.
The inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide
black, iron oxide red, iron oxide
yellow, lactose monohydrate, pregelatinized corn starch, magnesium
stearate, shellac, and titanium
dioxide.
29
33
2
2
CLINICAL PHARMACOLOGY
Mechanism of Action
_In vitro _and animal studies show that loperamide hydrochloride acts
by slowing intestinal motility and by
affecting water and electrolyte movement through the bowel. Loperamide
binds to the opiate receptor in
the gut wall. Consequently, it inhibits the release of acetylcholine
and prostaglandins, thereby reducing
propulsive peristalsis, and increasing intestinal transit time.
Loperamide increases the tone of the anal
sphincter, thereby reducing incontinence and urgency.
Pharmacodynamics
Loperamide prolongs the transit time of the intestinal contents. It
reduces daily fecal volume, increases
the viscosity and bulk density, and dim