LOPERAMIDE HYDROCHLORIDE capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Unit Dose Services

INN (Nama Antarabangsa):

LOPERAMIDE HYDROCHLORIDE

Komposisi:

LOPERAMIDE HYDROCHLORIDE 2 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
UNIT DOSE SERVICES
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WARNING: TORSADES DE POINTES AND SUDDEN DEATH
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,
● 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).
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 t