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:

Bryant Ranch Prepack

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Composition:

LOPERAMIDE HYDROCHLORIDE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see WARNINGS ). - patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. - patients with abdominal pain in the absence of diarrhea. - patients with acute dysentery, which is characterized by blood in stools and high fever. - patients with acute ulcerative colitis. - patients with bacterial enterocolitis caused by invasive organisms including Salmonella , Shigella , and Campylobacter . - patients with pseudomembranous colitis (e.g., Clostridium difficile ) associa

Product summary:

NDC: 63629-1452-9: 5 Capsules in a BOTTLE NDC: 63629-1452-1: 15 Capsules in a BOTTLE NDC: 63629-1452-2: 30 Capsules in a BOTTLE NDC: 63629-1452-3: 20 Capsules in a BOTTLE NDC: 63629-1452-4: 12 Capsules in a BOTTLE NDC: 63629-1452-5: 60 Capsules in a BOTTLE NDC: 63629-1452-6: 24 Capsules in a BOTTLE NDC: 63629-1452-7: 14 Capsules in a BOTTLE NDC: 63629-1452-8: 9 Capsules in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
----------
LOPERAMIDE HYDROCHLORIDE CAPSULES USP
RX ONLY
WARNING: TORSADES DE POINTES AND SUDDEN DEATH
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).
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.
The inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide
black, iron oxide red,
29
33
2
2
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 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 the intestinal contents. It
reduces daily fecal
volume, increases the viscosity and bulk density, and diminishe