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:

RedPharm Drug, Inc.

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Composition:

LOPERAMIDE HYDROCHLORIDE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Loperamide hydrochloride capsules are 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 is also indicated for reducing the volume of discharge from iloestomies. 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 ps

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 and packaged in bottles of 100 (NDC 0093-0311-01) and 500 (NDC 0093-0311-05). 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. P 10/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
REDPHARM DRUG, INC.
----------
BOXED WARNING
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:
[Structural formula for loperaminde hydrochloride]
C29H33ClN2O2•HCl M.W. 513.51
Loperamide hydrochloride is available in 2 mg capsules.
Each capsule, for oral administration, contains 2 mg loperamide
hydrochloride.
Loperamide hydrochloride capsules USP also contain 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.
CLINICAL PHARMACOLOGY
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 peristalsis, and
increasing intestinal
transit time. Loperamide increases the tone of the anal sphincter,
thereby reducing
incontinence and urgency.
In man, loperamide hydrochloride prolongs the tra