Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)
Preferred Pharmaceuticals, Inc.
LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE 2 mg
ORAL
PRESCRIPTION DRUG
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
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 and packaged in bottles of; Bottle of 15 - 68788-9079-1 Bottle of 30 - 68788-9079-3 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. Q 11/2016 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE PREFERRED PHARMACEUTICALS, INC. ---------- LOPERAMIDE HYDROCHLORIDE CAPSULES USP 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. 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. 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 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 Przeczytaj cały dokument