LOPERAMIDE HYDROCHLORIDE capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

RedPharm Drug, Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 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. • patien

製品概要:

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 2100in black ink on both the cap and the body. They are available as follows: NDC 0378-2100-01 bottles of 100 capsules NDC 0378-2100-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 10/2016 LOP:R13

認証ステータス:

Abbreviated New Drug Application

製品の特徴

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
REDPHARM DRUG, INC.
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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 dosage of loperamide hydrochloride capsules
(see WARNINGS and
OVERDOSAGE ).
● Loperamide hydrochloride capsules are contraindicated in pediatric
patients less than 2 years of
age (see CONTRAINDICATIONS ).
● Avoid loperamide hydrochloride capsules 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, 4-(p-chlorophenyl)-4-hydroxy-N,
N-dimethyl-α,α-diphenyl-1-
piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal
for oral use.
[Loperamide Hydrochloride Structural Formula]
Loperamide hydrochloride is available in 2 mg capsules.
Loperamide hydrochloride capsules, USP contain the following inactive
ingredients: black iron oxide,
colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium
stearate, microcrystalline cellulose,
red iron oxide, sodium lauryl sulfate, sodium starch glycolate,
titanium dioxide, and yellow iron oxide.
In addition, the black imprinting ink also contains black iron oxide,
D&C Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
Lake, propylene glycol, and shellac glaze.
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 pr