LOPERAMIDE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Composition:

LOPERAMIDE HYDROCHLORIDE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Loperamide hydrochloride capsules USP, 2 mg are available as: A light brown opaque body and dark brown opaque capsule, imprinted "TEVA" on the cap and "0311" on the body and packaged in: Bottles of 10  -  NDC # 16590-423-10 Bottles of 12  -  NDC # 16590-423-12 Bottles of 20  -  NDC # 16590-423-20 Bottles of 30  -  NDC # 16590-423-30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. M 3/2011 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOPERAMIDE HYDROCHLORIDE - LOPERAMIDE HYDROCHLORIDE CAPSULE
STAT RX USA LLC
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LOPERAMIDE HYDROCHLORIDE CAPSULES USP
0311
RX ONLY
DESCRIPTION
Loperamide hydrochloride is a white to slightly yellow powder and is
freely soluble in methanol,
isopropyl alcohol, chloroform and slightly soluble in water.
Loperamide hydrochloride,
4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-
piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal
for oral use. Its structural formula
is:
C
H ClN O •HCl M.W. 513.51
Loperamide hydrochloride is available in 2 mg capsules.
Each capsule, for oral administration, contains 2 mg loperamide
hydrochloride. Loperamide
hydrochloride capsules USP also contain the inactive ingredients:
dimethylpolysiloxane, gelatin, iron
oxide black, iron oxide red, iron oxide yellow, lactose monohydrate,
pregelatinized corn starch,
magnesium stearate, shellac, 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 hydrochloride 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 loperamide hydrochloride capsule. Plasma levels are highest
approximately five hours after
administration of