LOPERAMIDE HYDROCHLORIDE- 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:

PD-Rx Pharmaceuticals, Inc.

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 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 diff

Product summary:

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: bottles of 8, 10, 12, 15 and 20 capsules. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, INC.
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WARNING: TORSADES DE POINTES AND SUDDEN DEATH
1. ● CASES OF TORSADES DE POINTES, CARDIAC ARREST, AND DEATH HAVE
BEEN REPORTED WITH THE
USE OF A HIGHER THAN RECOMMENDED DOSAGE OF LOPERAMIDE HYDROCHLORIDE
CAPSULES (SEE
WARNINGS AND OVERDOSAGE).
2. ● LOPERAMIDE HYDROCHLORIDE CAPSULES ARE CONTRAINDICATED IN
PEDIATRIC PATIENTS LESS THAN
2 YEARS OF AGE (SEE CONTRAINDICATIONS).
3. ● AVOID LOPERAMIDE HYDROCHLORIDE CAPSULES 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, 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: black iron oxide,
colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium
stearate, microcrystalline cellulose,
red iron oxide, sodium lauryl sulfate, sodium starch glycolate,
titanium dioxide, and yellow iron oxide.
In addition, the black imprinting ink also contains black iron oxide,
D&C Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
Lake, propylene glycol, and shellac glaze.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
_In vitro _and animal studies show that loperamide hydrochloride
capsules act 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