LOPERAMIDE HYDROCHLORIDE capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Cardinal Health 107, LLC

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Loperamide hydrochloride is 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: Loperamide is not a controlled substance. Loperamide is a mu-opioid agonist. A human abuse potential study of loperamide hydrochloride at single doses up to 60 mg (3.75 times the recommended maximum adult dosage of 16 mg per day) was compared, in a double-blind cross-over design using nine subjects who had been active opiate users, to a threshold dose of codeine sulfate at 120 mg (96 mg base) or placebo. This resulted in one subject (11%) feeling a drug on placebo and identifying it as "dope" (heroin) and liking it slightly. Codeine was felt by 56% of subjects and identified as "dope" by 44%. Loperamide was felt by 44% of subjec

Termék összefoglaló:

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. Available: Overbagged with 10 Capsules per bag, NDC 55154-4699-0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: American Health Packaging Columbus, OH 43217 Distributed by: Cardinal Health Dublin, OH 43017 L55213720322 8422901/0717

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
CARDINAL HEALTH 107, LLC
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LOPERAMIDE HYDROCHLORIDE CAPSULES USP
8422901/0717
RX ONLY
WARNING: TORSADES DE POINTES AND SUDDEN DEATH
•
•
•
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.
CASES OF TORSADES DE POINTES, CARDIAC ARREST, AND DEATH HAVE BEEN
REPORTED WITH THE USE OF A HIGHER THAN RECOMMENDED DOSAGES OF
LOPERAMIDE HYDROCHLORIDE (SEE WARNINGS AND OVERDOSAGE).
LOPERAMIDE HYDROCHLORIDE IS CONTRAINDICATED IN PEDIATRIC PATIENTS
LESS THAN 2 YEARS OF AGE (SEE CONTRAINDICATIONS).
AVOID LOPERAMIDE HYDROCHLORIDE 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).
29
33
2
2
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
Mechanism of Action
_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.
Pharmacodynamics
Loperamide prolongs the transit time of the intestinal contents. It
reduces daily fecal
volume, increases the viscosity and bulk dens