LOPERAMIDE HYDROCHLORIDE capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Physicians Total Care, Inc.

INN (Nama Internasional):

LOPERAMIDE HYDROCHLORIDE

Komposisi:

LOPERAMIDE HYDROCHLORIDE 2 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea 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 patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. Loperamide hydrochloride is contraindicated in patients with abdominal pain in the absence of diarrhea. Loperamide hydrochloride is not recommended in infants below 24 months of age. Loperamide hydrochloride should not be used as the primary therapy: - in patients with acute dysentery, which is characterized by blood in stools and high fever, - in patients with acute ulcerative colitis, - in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter, - in patients with pseudomembranous colitis associated with the u

Ringkasan produk:

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: Store at 20° to 25°C (68° to 77°F). [See USP for 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 REVISED JULY 2006 LOP:R11 Distributed and Repackaged by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

LOPERAMIDE HYDROCHLORIDE - LOPERAMIDE HYDROCHLORIDE CAPSULE
PHYSICIANS TOTAL CARE, INC.
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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: colloidal silicon
dioxide, gelatin, iron oxides, lactose (hydrous), magnesium stearate,
microcrystalline cellulose, sodium
starch glycolate and titanium dioxide.
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 prolongs the transit time of the
intestinal contents. It reduces the daily
fecal volume, increases the viscosity and bulk density, and diminishes
the loss of fluid and electrolytes.
Tolerance to the antidiarrheal effect has not been observed. Clinical
studies have indicated that the
apparent elimination half-life of loperamide in man is 10.8 hours with
a range of 9.1 to 14.4 hours.
Plasma levels of unchanged drug remain below 2 nanograms per mL after
the intake of a 2 mg capsule of
loperamide hydrochloride. Plasma levels are highest approximately 5
hours after administration of the
capsule and 2.5 hours after the liquid. The peak plasma levels of
loperamide were similar for both
formulations. Elimination of loperamide mainly occurs by oxidative
N-demethylation. Cytochrome P450
(CYP450) isozymes, CYP2C8 and CYP3A4, are thought to play an important
role in loperamide N-
demethylation process since quercetin (CYP2C8 inhibitor) and
ket