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Details for Generic Name: loperamide hydrochloride

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Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by Mcneil Cons, Mcneil Ped, Banner Pharmacaps, Mylan, Roxane, Sandoz, Teva, Janssen Pharms, Alpharma Us Pharms, Duramed Pharms Barr, Hi Tech Pharma, Perrigo, Watson Labs, Wockhardt, Perrigo R And D, Mcneil, Able, Contract Pharmacal, LNK, Ohm Labs, and Ranbaxy, and is included in thirty-one NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for loperamide hydrochloride. Twenty-two suppliers are listed for this compound.

Summary for Generic Name: loperamide hydrochloride

Tradenames:6
Patents:3
Applicants:21
NDAs:31
Drug Master File Entries: see list10
Suppliers: see list22
Therapeutic Class:Gastrointestinal Agents

Clinical Trials for: loperamide hydrochloride

Efficacy of Loperamide in Treating Patients for C. Difficile Colitis and Diarrheal Disease of Unknown Cause Associated With Antibiotic Therapy
Status: Recruiting Condition: Antibiotic Associated Diarrhea; Clostridium Difficile

Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Status: Recruiting Condition: Fecal Incontinence

Loperamide Grapefruit Juice Interaction PK Trial
Status: Completed Condition: Drug Interaction

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Status: Recruiting Condition: Rectal Cancer; Ulcerative Colitis; Short Bowel Syndrome

Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Status: Not yet recruiting Condition: Dehydration, Diverting Ileostomy, Loperamide

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.
Status: Completed Condition: Intestinal Obstruction

A Comparison of Three Medications to Treat Diarrhea in Adults.
Status: Completed Condition: Diarrhea

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects
Status: Completed Condition: Intestinal Obstruction

Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea
Status: Completed Condition: Travelers' Diarrhea

Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions
Status: Completed Condition: Healthy

Imodium Syrup Versus Imodium Tablets for Faecal Incontinence
Status: Withdrawn Condition: Fecal Incontinence

Azithromycin, With or Without Loperamide, to Treat Travelers' Diarrhea
Status: Completed Condition: Diarrhea

Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer
Status: Completed Condition: Colorectal Cancer; Diarrhea

Efavirenz and Ritonavir on Human Brian P-Glycoprotein
Status: Active, not recruiting Condition: Drug Effects

Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
Status: Recruiting Condition: Relapsing Remitting Multiple Sclerosis

Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea
Status: Completed Condition: Diarrhea

The Pharmacodynamic/Pharmacokinetic Interaction of Tipranavir and Ritonavir With Loperamide in Healthy Volunteers
Status: Completed Condition: Healthy

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
Status: Completed Condition: Fecal Incontinence

Acupuncture for Patients With Diarrhea-predominant IBS: a Randomized Controlled Trial
Status: Completed Condition: Diarrhea-predominant Irritable Bowel Syndrome; Functional Diarrhea

The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit
Status: Recruiting Condition: Concentration-Time Profiles in Stomach & Intestine.

Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea
Status: Recruiting Condition: Acute Watery Diarrhea; Dysentery/Febrile Diarrhea

A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Status: Terminated Condition: Diarrhea

Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
Status: Completed Condition: Chemotherapeutic Agent Toxicity; Colorectal Cancer; Diarrhea

Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet
Status: Completed Condition: Healthy

Prospective Randomized Open Label Study of the Treatment of Therapy-Associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -
Status: Not yet recruiting Condition: Diarrhea; Enteritis; Cancer

A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals
Status: Not yet recruiting Condition: Short Bowel Syndrome; Short Gut Syndrome; SBS; Short Bowel; Short Gut

Educational-Medical-Behavioral Treatment of Fecal Incontinence
Status: Enrolling by invitation Condition: Fecal Incontinence

Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Status: Terminated Condition: Diarrhoea, Clostridium Difficile

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
Status: Completed Condition: Fecal Incontinence

ADAM-Afatinib Diarrhea Assessment and Management
Status: Recruiting Condition: Carcinoma, Non-Small-Cell Lung

Novel Topical Therapies for the Treatment of Genital Pain
Status: Active, not recruiting Condition: Female Genital Diseases

CASAD for Severe Diarrhea in the Emergency Department
Status: Terminated Condition: Cancer; Diarrhea

(11C)dLop as a Marker of P-Glycoprotein Function in Patients With Gliomas
Status: Terminated Condition: Low Grade Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Oligoastrocytoma

The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
Status: Recruiting Condition: Diarrhea; Medullary Thyroid Cancer

DHB Supplement Interaction Study
Status: Recruiting Condition: Healthy Volunteers

Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults
Status: Completed Condition: Antidiarrheals

A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
Status: Not yet recruiting Condition: Short Bowel Syndrome; Short Gut Syndrome; SBS; Short Gut

Impact of Training on Diarrhoea Management
Status: Completed Condition: Acute Childhood Diarrhea

Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products
Status: Completed Condition: Diarrhea

Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care (STOP-Trial)
Status: Not yet recruiting Condition: Hypertension

Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth
Status: Recruiting Condition: Cardiac Arrest

Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico
Status: Completed Condition: Diarrhea

Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
Status: Terminated Condition: Adult Brain Tumors

Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer
Status: Not yet recruiting Condition: Cancer

Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)
Status: Not yet recruiting Condition: Ebola Virus Disease

A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients
Status: Completed Condition: Cryptosporidiosis; HIV Infections

Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs
Status: Completed Condition: Cryptosporidiosis; HIV Infections

Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Status: Completed Condition: Diarrhea; HIV Infections

A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence
Status: Terminated Condition: Faecal Incontinence

Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy
Status: Withdrawn Condition: Diarrhea; Unspecified Adult Solid Tumor, Protocol Specific

For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy
Status: Terminated Condition: Neoplasm Metastasis; Colorectal Neoplasms

Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
Status: Recruiting Condition: Gastrointestinal Neoplasms

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy
Status: Active, not recruiting Condition: Diarrhea; Gastrointestinal Complications; Unspecified Adult Solid Tumor, Protocol Specific

Safety and Efficacy of AST-120 in the Treatment of Pouchitis
Status: Completed Condition: Pouchitis

A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules
Status: Completed Condition: HIV Infection

Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis
Status: Terminated Condition: Pouchitis

Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.
Status: Not yet recruiting Condition: Acute Gastroenteritis

Alvocidib, Oxaliplatin, Fluorouracil, and Leucovorin Calcium in Treating Patients With Advanced Solid Tumors
Status: Completed Condition: Unspecified Adult Solid Tumor, Protocol Specific

A Phase II Neo-adjuvant Study Assessing TCH (Docetaxel, Carboplatin and Trastuzumab) and TCHL (Docetaxel, Carboplatin, Trastuzumab and Lapatinib) in HER-2 Positive Breast Cancer Patients.
Status: Active, not recruiting Condition: Breast Cancer

Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation
Status: Completed Condition: Cancer; Diarrhea; Abdominal Pain; Quality of Life

Triple Target Treatment (3T) Which Combines Stimulation With Amplitude Modulated Middle Frequency (AM-MF), Electromyography (EMG)-Triggered Stimulation and EMG-Biofeedback Compared With EMG-Biofeedback in Anal Incontinence
Status: Completed Condition: Fecal Incontinence

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea
Status: Completed Condition: Metastatic Colorectal Cancer

Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.
Status: Completed Condition: Diarrhea; Malaria

A Study of Xiang-Sha-Liu-Jun-Zi-Tang in Patients With Irritable Bowel Syndrome
Status: Recruiting Condition: Irritable Bowel Syndrome

Economics of Diarrhoea in Intensive Care Unit
Status: Completed Condition: Critical Illness

Diarrhea Predominant Irritable Bowel Syndrome in Females
Status: Completed Condition: Irritable Bowel Syndrome

PS-341 and Radiation to Treat Advanced Cancer of the Head and Neck
Status: Completed Condition: Squamous Cell Carcinoma

Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer
Status: Withdrawn Condition: Neoplasms, Breast

Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.
Status: Not yet recruiting Condition: Irritable Bowel Syndrome

The Effect of Physiotherapy for the Treatment of Fecal Incontinence.
Status: Recruiting Condition: Fecal Incontinence

Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation
Status: Completed Condition: Constipation

ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer
Status: Recruiting Condition: Primary Malignant Neoplasm of Ascending Colon

Observational Study of Perioperative Chemotherapy in Gastric Cancer
Status: Recruiting Condition: Gastric Cancer

Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
Status: Completed Condition: Lymphoma

Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures
Status: Recruiting Condition: Other Acute Pain; Pain Experienced During Cystoscopy

Galectin-3 Blockade in Patients With High Blood Pressure
Status: Recruiting Condition: Hypertension

Properties of Dietary Fibre and Energy Intake
Status: Completed Condition: Healthy Male Subjects

Treatment of Neonatal Abstinence Syndrome
Status: Completed Condition: Neonatal Abstinence Syndrome

Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
Status: Completed Condition: Cure Rate of Helicobacter Pylori Infection

CANHelp Working Group Treatment Trials
Status: Enrolling by invitation Condition: Helicobacter Pylori Infection

MRI and Microbiota Analysis in Constipation
Status: Recruiting Condition: Constipation

Ispaghula and Colonic Water Content
Status: Active, not recruiting Condition: Healthy

A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation
Status: Completed Condition: Constipation

Influence of Carob and Probiotics on Acute Diarrhea in Children
Status: Not yet recruiting Condition: Diarrhea

Fiber Longer Term Study on Energy Intake
Status: Completed Condition: Healthy

Effect of Calcium Polycarbophil on Type II Diabetes Mellitus Control: a Randomized Double-blind Study
Status: Completed Condition: Diabetes Mellitus Type II

PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy
Status: Not yet recruiting Condition: Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain

Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis
Status: Recruiting Condition: Breakthrough Pain; Mucositis; Radiotherapy; Chemotherapy; Head and Neck Cancer

Effects of Perioperative Belladonna and Opium Suppositories on Postoperative Pain and Morphine Consumption on Patients After Robotic Assisted Laparoscopic Radical Prostatectomy
Status: Completed Condition: Pain Management

Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
Status: Completed Condition: Irritable Bowel Syndrome

Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects
Status: Terminated Condition: Non-Insulin-dependent Diabetes Mellitus

Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules
Status: Completed Condition: Healthy Male Volunteers

Trial to Evaluate the Effect of Plantago Ovata Husk in the Remission of Metabolic Syndrome in Children and Adolescents
Status: Terminated Condition: Metabolic Syndrome

Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET
Status: Completed Condition: Lymphoma

Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA
Status: Recruiting Condition: Prostatic Neoplasms

Alternative Options to Minimize Niacin-Induced Flushing
Status: Completed Condition: Hypercholesterolemia; Flushing

Psyllium Fiber Versus Placebo in Early Treatment After STARR for Obstructed Defecation: a Double-blind RCT
Status: Completed Condition: Constipation; Incontinence

Efficacy of Racecadotril in Acute Watery Diarrhea in Children
Status: Completed Condition: Acute Diarrhea; Acute Gastroenteritis

Study of Psyllium 6.8 g Versus Placebo on Satiety in Healthy Volunteers
Status: Completed Condition: Hunger

Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health
Status: Active, not recruiting Condition: Constipation

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
CAPSULE;ORAL072741Sep 18, 1991RXNo<disabled><disabled>
Perrigo
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
SOLUTION;ORAL073243Jan 21, 1992OTCNo<disabled><disabled>
Teva
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
SOLUTION;ORAL073478Jun 23, 1995DISCNNo<disabled><disabled>
Hi Tech Pharma
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
SOLUTION;ORAL074352Nov 17, 1995OTCNo<disabled><disabled>
Perrigo
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL076029Aug 30, 2002OTCNo<disabled><disabled>
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