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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 Life Sciences, 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-one suppliers are listed for this compound.

Summary for Generic Name: loperamide hydrochloride

Drug Master File Entries: see list10
Suppliers: see list21
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Clinical Trials for: loperamide hydrochloride

Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Status: Completed Condition: Diarrhea

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

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

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

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

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

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

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

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

Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.
Status: Not yet recruiting Condition: Cancer

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.

Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study
Status: Not yet recruiting Condition: High Output Stoma

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

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

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

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: Withdrawn Condition: Short Bowel Syndrome; Short Gut Syndrome; SBS; Short Bowel; Short Gut

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

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

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

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

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

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

A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
Status: Withdrawn Condition: Short Bowel Syndrome; Short Gut Syndrome; SBS; Short Gut

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

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

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

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

Pectin Start Early Enteral Nutritional Support in Critically Ill Patients
Status: Completed Condition: Nutrition Disorders; Critical Illness

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Observational Study of Perioperative Chemotherapy in Gastric Cancer
Status: Active, not recruiting Condition: Gastric Cancer

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

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

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

Methylnaltrexone Use for Opioid-induced Postoperative Constipation
Status: Recruiting Condition: Constipation

Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)
Status: Recruiting Condition: Constipation-predominant IBS (IBS-C)

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

REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy
Status: Recruiting Condition: Estrogen Receptor Positive Breast Cancer; Breast Cancer

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

Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care Patients
Status: Completed Condition: Constipation; Palliative Care

Bowel Function After Minimally Invasive Urogynecologic Surgery
Status: Completed Condition: Bowel Function

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

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

Pectin, Aging and Intestinal Barrier Function
Status: Not yet recruiting Condition: Healthy Young Adults; Healthy Elderly

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

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

PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
Status: Completed Condition: Healthy

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

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

Comparison of Psyllium and Microcrystalline Cellulose on Glycemic Measures in Subjects With Impaired Fasting Glucose
Status: Completed Condition: Impaired Fasting Glucose

Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia
Status: Completed Condition: Hypercholesterolemia

Sequential Therapy Versus Quadriple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection
Status: Recruiting Condition: H Pylori Treatment

Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
Status: Completed Condition: Diarrhea

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mcneil Cons
loperamide hydrochloride; simethicone
TABLET;ORAL021140-001Nov 30, 2000OTCYes6,103,260<disabled>Y<disabled>
loperamide hydrochloride
TABLET;ORAL075232-001Jan 6, 2000OTCNo<disabled><disabled>
Duramed Pharms Barr
loperamide hydrochloride
SOLUTION;ORAL074991-001Dec 29, 1997DISCNNo<disabled><disabled>
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 1996OTCYes5,679,376<disabled>Y<disabled>
Mcneil Ped
loperamide hydrochloride
CAPSULE;ORAL017690-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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