Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)
allphamed Pharbil Arzneimittel GmbH
ORAL
PRESCRIPTION DRUG
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
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 42799-605-03 (30 CAPSULES) NDC 42799-605-01 (100 CAPSULES) NDC 42799-605-02 (500 CAPSULES) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Revised October 2021 Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336 Rx Only Printed in USA
Abbreviated New Drug Application
LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE ALLPHAMED PHARBIL ARZNEIMITTEL GMBH ---------- 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 redu Lestu allt skjalið