LOPERAMIDE HYDROCHLORIDE capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Mylan Institutional Inc.

INN:

LOPERAMIDE HYDROCHLORIDE

composition:

LOPERAMIDE HYDROCHLORIDE 2 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

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 51079-690-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12526 9/17

authorization_status:

Abbreviated New Drug Application

SPC

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
MYLAN INSTITUTIONAL INC.
----------
WARNING: TORSADES DE POINTES AND SUDDEN DEATH
1. ● 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
).
2. ● LOPERAMIDE HYDROCHLORIDE CAPSULES ARE CONTRAINDICATED IN
PEDIATRIC
PATIENTS LESS THAN 2 YEARS OF AGE (SEE CONTRAINDICATIONS ).
3. ● 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 and urgency.
PHARMACODYNAMICS
Loperamide prolongs the