LOPERAMIDE HYDROCHLORIDE capsule

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (Isem Internazzjonali):

LOPERAMIDE HYDROCHLORIDE

Kompożizzjoni:

LOPERAMIDE HYDROCHLORIDE 2 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 . - patients with pseudomembranous colitis (e.g., Clostridium difficl

Sommarju tal-prodott:

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 0615-8087-39 blistercards of 30 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. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2022 VPL:LOP:R1

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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LOPERAMIDE HYDROCHLORIDE CAPSULES, USP 2 MG
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 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:
MECHANISM OF ACTION:
_In vitro _and animal studies show that loperamide hydrochloride
capsules act 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 a