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:

DIRECT RX

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 cap, imprinted "TEVA" on the cap and "0311" on the body and packaged in bottles of 100 and 500. 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
DIRECT RX
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​LOPERAMIDE HYDROCHLORIDE​
DESCRIPTION SECTION
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:
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 SECTION
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 the capsule and 2.5 hours after the liqui