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Details for Generic Name: clonidine hydrochloride

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Clonidine hydrochloride is the generic ingredient in five branded drugs marketed by Exela Pharma Scs Llc, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Zydus Pharms Usa Inc, Mylan Institutional, Actavis Elizabeth, Anchen Pharms, Concordia Pharms Inc, Boehringer Ingelheim, Alembic Pharms Ltd, Am Therap, Carlsbad, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs, Interpharm, Mutual Pharm, Mylan, Par Pharm, Sandoz, Sun Pharm Inds Inc, Teva, Unichem, Vintage, Warner Chilcott, and Watson Labs, and is included in fifty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for clonidine hydrochloride. Four suppliers are listed for this compound.

Summary for Generic Name: clonidine hydrochloride

Drug Master File Entries: see list21
Suppliers / Packaging: see list9
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: clonidine hydrochloride

Clinical Trials for: clonidine hydrochloride

Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
Status: Recruiting Condition: Healthy

Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
Status: Completed Condition: Hypertension

Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
Status: Completed Condition: Healthy

Intrathecal Clonidine in Cesarean Section May Lead to Worse Blood Gas Results in the Newborns
Status: Completed Condition: Pregnancy

The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients
Status: Not yet recruiting Condition: Delirium

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
Status: Recruiting Condition: Labor Pain

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
Status: Completed Condition: Hyperemesis Gravidarum

Pharmacokinetics and Clinical Effects of Escalating Doses of Clonidine in ICU Patients
Status: Not yet recruiting Condition: Delirium; Critical Illness

Epidural Clonidine for Lumbosacral Radiculopathy
Status: Terminated Condition: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination
Status: Not yet recruiting Condition: Postoperative Pain

Clonidine Versus Adenosine to Treat Neuropathic Pain
Status: Completed Condition: Pain

Phase I Clinical Trial to Determine the Safety of Clonidine in Infants With HIE During Therapeutic Hypothermia.
Status: Recruiting Condition: Hypoxic Ischemic Encephalopathy (HIE)

The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
Status: Completed Condition: Fascicular Block; Motor Activity; Pain, Postoperative; Latency Period

Comparison of Keppra and Clonidine in the Treatment of Tics
Status: Completed Condition: Tic Disorders; Tourette Syndrome

Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia
Status: Recruiting Condition: Cannabis Dependence; Marijuana Dependence

Efficacy of Clonidine and Propranolol in Dentistry (AAA)
Status: Recruiting Condition: Anxiety

Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
Status: Terminated Condition: Neonatal Abstinence Syndrome

Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor
Status: Withdrawn Condition: Labor Pain

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
Status: Recruiting Condition: Hot Flashes; Breast Cancer

A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Status: Completed Condition: Fecal Incontinence

Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
Status: Not yet recruiting Condition: Encephalopathy, Hypoxic-Ischemic

A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
Status: Recruiting Condition: Upper Extremity Fracture

Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine
Status: Completed Condition: Analgesia; Pain; Systemic Inflammatory Stress Response

Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
Status: Recruiting Condition: Pain

Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers
Status: Completed Condition: Acute Pain; Respiration; Sedation

Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)
Status: Completed Condition: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders

Use of Transdermal Clonidine in Trauma Patients
Status: Completed Condition: Delirium

Clonidine Versus Midazolam for Premedication
Status: Completed Condition: Anxiety; Pain

Does Perineural Clonidine Prolong Duration of a Nerve Block?
Status: Completed Condition: Healthy

Effect of a Bolus of Clonidine Systemically Administered on the Excitability of the Spinal Motoneurons of the Lower Extremity
Status: Recruiting Condition: Intraoperative Neurophysiological Monitoring; Pain Management

Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia
Status: Withdrawn Condition: Full Term Pregnant Patients; Undergoing Lower Segment Caesarian Section

PVB With vs. Without Clonidine for Ventral Hernia Repair
Status: Recruiting Condition: Ventral Hernia Repair

PeriOperative ISchemic Evaluation-2 Trial
Status: Completed Condition: Cardiovascular Disease

Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
Status: Recruiting Condition: Psychomotor Agitation

The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Status: Completed Condition: Hernia, Inguinal; Hydrocele

Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain
Status: Completed Condition: Pain

Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure
Status: Completed Condition: Preeclampsia

A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy
Status: Terminated Condition: Hypertension

Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
Status: Not yet recruiting Condition: Pilonidal Sinus

PeriOperative ISchemic Evaluation-2 Pilot
Status: Completed Condition: Cardiovascular Disease

Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
Status: Recruiting Condition: Spinal Anesthesia; Neonates

Clonidine and Morphine in Caudal Anesthesia
Status: Completed Condition: Postoperative Pain

Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery
Status: Withdrawn Condition: Shoulder Arthroscopy; Knee Arthroscopy

Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine
Status: Recruiting Condition: Post-operative Pain

Systematic Clonidine for Epidural Analgesia in Labour
Status: Completed Condition: Labour

Assessment of the Effect of Clonidine for Cataract Surgery
Status: Recruiting Condition: Pain; Arrythmia

Safety and Efficacy Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
Status: Completed Condition: Painful Diabetic Neuropathy; Diabetic Neuropathy; Neuropathy

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
Status: Completed Condition: Neonatal Abstinence Syndrome

A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy
Status: Enrolling by invitation Condition: Painful Diabetic Neuropathy; Diabetes

Great Auricular Nerve Block for Tympanomastoid Surgery: Will the Addition of Clonidine Enhance the Duration of Analgesia?
Status: Completed Condition: Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma

Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
Status: Completed Condition: Is an Only Child

Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Transdermal Clonidine in Chronic Hemodialysis Patients
Status: Recruiting Condition: Renal Dialysis

Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children
Status: Completed Condition: Respiration, Artificial; Critical Illness; Conscious Sedation; Deep Sedation

The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass
Status: Completed Condition: Glycemia During Coronary Artery Bypass Graft; Sedation During Pre-anesthetic Medication

Clonidine in Femoral Nerve Block Surgery in Children
Status: Withdrawn Condition: Other Reconstructive Surgery

EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)
Status: Active, not recruiting Condition: Heart Disease

Intra-articular Morphine and Clonidine Injections for Pain Management in Hip Arthroscopy
Status: Not yet recruiting Condition: Femoracetabular Impingement; Pain, Postoperative

Using Clonidine to Improve Leg Weakness in People With Heart Failure
Status: Completed Condition: Heart Failure

Labor Analgesia With Ropivacaine and Clonidine
Status: Completed Condition: Labor Pain

The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Status: Terminated Condition: Pain; Anxiety

Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients
Status: Completed Condition: Opioid-Related Disorders

Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section
Status: Completed Condition: Post Operative Pain

Pilot Study: Intraoperative Clonidine and Postoperative Behaviour
Status: Completed Condition: Negative Behaviour Change

Clonidine for Neonatal Abstinence Syndrome Study
Status: Terminated Condition: Neonatal Abstinence Syndrome

Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
Status: Completed Condition: Attention Deficit Disorder With Hyperactivity

Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery
Status: Completed Condition: Anesthesia

Epidural Clonidine Versus Corticosteroid for Low Back Pain
Status: Terminated Condition: Back Pain

Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients
Status: Not yet recruiting Condition: Sedation in Intensive Care

Clonidine for Neurocognitive Sequelae
Status: Withdrawn Condition: Treatment-Related Cancer

The Oslo Study of Clonidine in Elderly Patients With Delirium
Status: Recruiting Condition: Delirium

The Value of Adding Either Meperdine or Fentanyl to Clonidine-bupivacaine
Status: Completed Condition: Amputation Stumps

Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
Status: Completed Condition: Oral Mucositis

Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Epidural Clonidine for Postoperative Hyperalgesia
Status: Withdrawn Condition: Postoperative Hyperalgesia

Transversus Abdominis Plane (TAP) Block for Cesarean Section
Status: Terminated Condition: Hyperalgesia, Secondary

Pediatric Tonsillectomy Pain Reduction Study
Status: Completed Condition: Postoperative Pain

Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial
Status: Completed Condition: Normal Pregnancy

Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Status: Terminated Condition: Ventricular Tachycardia

To Compare lidocaine2%/Clonidine in Combination, With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade
Status: Completed Condition: Bimalleolar Fractures of the Ankle.; Sciatic Nerve Block.; Saphenous Nerve Block.; Post Operative Analgesia Duration.

Clonidine - Ropivacaine in Peribulbar Anesthesia
Status: Completed Condition: Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia

Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study
Status: Not yet recruiting Condition: Mechanical Ventilation Complication

CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
Status: Completed Condition: ADHD

Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Status: Completed Condition: Attention Deficit Disorder With Hyperactivity

Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation
Status: Completed Condition: Pediatric Spinal Anesthesia

Pilot Study for the NorCAPITAL Trial
Status: Completed Condition: Chronic Fatigue Syndrome

Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?
Status: Completed Condition: Schizophrenia

Use of Clonidine to Prevent Withdrawal Following Prolonged Dexmedetomidine Infusions
Status: Enrolling by invitation Condition: Sedation

Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2
Status: Enrolling by invitation Condition: Diabetes Mellitus; Local Anesthesia

Effect of Clonidine on Responses to Imagery Scripts
Status: Completed Condition: Cocaine Abuse; Heroin Abuse

Diabetic Neuropathy Topical Treatment
Status: Not yet recruiting Condition: Diabetic Neuropathy; Pain

NAS Treatment - Opiate Versus Non-Opiate
Status: Active, not recruiting Condition: Neonatal Abstinence Syndrome

The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients
Status: Completed Condition: Ascitic Cirrhosis; Hyperactivation of Sympathetic Nervous System

Medications Development for Drug Abuse Disorders
Status: Recruiting Condition: Opioid Related Disorders; Opioid Dependence; Opioid Addiction

Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy
Status: Completed Condition: Pain; Postoperative

Atopic Dermatitis Itch
Status: Recruiting Condition: Cutaneous Nerves CNS Itch

Effects of Intravenous Clonidine on Ocular Blood Flow and Intraocular Pressure
Status: Completed Condition: Physiology

The Relationships Between the Noradrenergic, Opioid and Pain System
Status: Not yet recruiting Condition: Experimental Pain Perception

A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
Status: Completed Condition: Sialorrhoea

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
clonidine hydrochloride
TABLET;ORAL078895-001Aug 26, 2009RXNo<disabled><disabled>
Alembic Pharms Ltd
clonidine hydrochloride
TABLET;ORAL091368-003Dec 6, 2011RXNo<disabled><disabled>
clonidine hydrochloride
TABLET;ORAL070317-001Jun 9, 1987RXNo<disabled><disabled>
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Preferred citation:

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

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