LOPERAMIDE HYDROCHLORIDE capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

REMEDYREPACK INC.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Loperamide Hydrochloride Capsules (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 is also indicated for reducing the volume of discharge from ileostomies. Loperamide Hydrochloride Capsules is 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 difficle ) associated with the use of broad-spectrum antibiotics. 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 subjects and identified as "dope" by 11% and possibly dope mixed with some other kind of drug by another 22%. Loperamide abuse and misuse have been reported, especially at doses of 60 mg or greater. Loperamide can have greater CNS opioid effects at higher doses or with co-administration of drugs that increase systemic exposure and/or increase CNS penetration of loperamide (through inhibition of the CYP450 enzyme system or inhibition of P-glycoprotein). Loperamide is primarily being misused for relief from opioid withdrawal, and abused by a few users who obtain some (reportedly mild-moderate) level of euphoria. In animals, parenteral administration of loperamide hydrochloride can cause physical dependence, cross-tolerance to opioids, and all the other pharmacologic effects typical of mu- opioid agonists. Studies in morphine-dependent monkeys demonstrated that loperamide hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal.

Ringkasan produk:

Capsules - each capsule contains 2 mg of loperamide hydrochloride. The capsules have a light brown opaque cap and a light brown opaque body with an “^" over “605” imprinted radially on one segment. NDC: 70518-3413-00 NDC: 70518-3413-01 PACKAGING: 10 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx Only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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LOPERAMIDE HYDROCHLORIDE
BOXED WARNING
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 CAPSULES (SEE WARNINGS AND
OVERDOSAGE).
LOPERAMIDE HYDROCHLORIDE CAPSULES IS CONTRAINDICATED IN PEDIATRIC
PATIENTS LESS THAN 2 YEARS OF AGE (SEE CONTRAINDICATIONS).
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 Capsules USP (loperamide hydrochloride),
4-(p-chlorophenyl)-
4-hydroxy-N,N-dimethyl- _a,a- _diphenyl-1-piperidinebutyramide
monohydrochloride, is a
synthetic antidiarrheal for oral use.
Loperamide Hydrochloride Capsules USP is available in 2mg capsules.
The inactive ingredients are: Magnesium stearate, microcrystalline
cellulose, sodium
starch glycolate, lactose monohydrate, colloidal silicon dioxide. In
addition, the hard
gelatin capsule also contains gelatin, black iron oxide, red iron
oxide, titanium dioxide
and yellow iron oxide. The black printing ink contains black iron
oxide, propylene glycol,
shellac, and potassium hydroxide.
CLINICAL PHARMACOLOGY
Mechanism of Action
_In vitro _and animal studies show that Loperamide Hydrochloride
Capsules (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
vo