LOPERAMIDE HYDROCHLORIDE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Edenbridge Pharmaceuticals LLC.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Loperamide Hydrochloride Capsules (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 is also indicated for reducing the volume of discharge from ileostomies. 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 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

產品總結:

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

授权状态:

Abbreviated New Drug Application

产品特点

LOPERAMIDE HYDROCHLORIDE - LOPERAMIDE HYDROCHLORIDE CAPSULE
EDENBRIDGE PHARMACEUTICALS LLC.
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LOPERAMIDE HYDROCHLORIDE
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 CAPSULES (SEE WARNINGS AND
OVERDOSAGE).
LOPERAMIDE HYDROCHLORIDE CAPSULES IS 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 Capsules USP (loperamide hydrochloride),
4-(p-chlorophenyl)-
4-hydroxy-N,N-dimethyl-_a,a- _diphenyl-1-piperidinebutyramide
monohydrochloride, is a
synthetic antidiarrheal for oral use.
Loperamide Hydrochloride Capsules USP is available in 2mg capsules.
The inactive ingredients are: Magnesium stearate, microcrystalline
cellulose, sodium
starch glycolate, lactose monohydrate, colloidal silicon dioxide. In
addition, the hard
gelatin capsule also contains gelatin, black iron oxide, red iron
oxide, titanium dioxide
and yellow iron oxide. The black printing ink contains black iron
oxide, propylene glycol,
shellac, and potassium hydroxide.
CLINICAL PHARMACOLOGY
Mechanism of Action
_In vitro _and animal studies show that Loperamide Hydrochloride
Capsules (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