País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)
Contract Pharmacy Services-PA
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: - 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
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 NDC 67046-454-07 blisterpacks of 7 NDC 67046-454-14 blisterpacks of 14 NDC 67046-454-15 blisterpacks of 15 NDC 67046-454-20 blisterpacks of 20 NDC 67046-454-21 blisterpacks of 21 NDC 67046-454-28 blisterpacks of 28 NDC 67046-454-30 blisterpacks of 30 NDC 67046-454-60 blisterpacks of 60 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: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA
Abbreviated New Drug Application
LOPERAMIDE HYDROCHLORIDE- LOPERAMIDE HYDROCHLORIDE CAPSULE CONTRACT PHARMACY SERVICES-PA ---------- LOPERAMIDE HYDROCHLORIDE CAPSULES USP 454 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, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide. 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 density, Llegiu el document complet