Clonidine

Overview

Clonidine is an imidazole derivate that acts as an agonist of alpha-2 adrenoceptors. This activity is useful for the treatment of hypertension, severe pain, and ADHD. Clonidine was granted FDA approval on 3 September 1974.

Indication

Clonidine tablets and transdermal systems are indicated for the treatment of hypertension alone or in combination with other medications. A clonidine injection is indicated for use with opiates in the treatment of severe cancer pain where opiates alone are insufficient. An extended release tablet of clonidine is indicated for the treatment of ADHD either alone or in combination with other medications. Clonidine is also used for the diagnosis of pheochromocytoma, treatment of nicotine dependance, and opiate withdrawal.

Associated Conditions

Attention Deficit Hyperactivity Disorder (ADHD)
Defiant Disorder, Oppositional
Gilles de la Tourette's Syndrome
Hot Flashes
Human Growth Hormone Deficiency
Hypertension
Opioid Withdrawal (Disorder)
Pheochromocytoma
Postherpetic Neuralgia
Sialorrhea caused by clozapine
Diabetic diarrhea
Methadone withdrawal
Severe Cancer pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Regional Anesthesia EMG Study	2024/02/29	NCT06287151	Not Applicable	Recruiting	Nationwide Children's Hospital
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats	2023/09/22	NCT06049797	N/A	Active, not recruiting	Astellas Pharma Global Development, Inc.
Clonidine Versus Granisetron for Shivering Prevension	2023/09/11	NCT06031090	Phase 2	Recruiting	Zagazig University
Efficacy of Intrathecal Clonidine Versus Neostigmine as Adjuvants to Bupivacaine on Postoperative Maternal and Fetal Outcomes After Elective Cesarean Section	2023/07/13	NCT05943613	Phase 1	Not yet recruiting	Assiut University
Clonidine With Morphine in Patient Controlled Analgesia Pump in Vaso-Occlusive Crisis in Sickle Cell Disease Patient	2023/05/08	NCT05848531	Phase 4	Recruiting	Centre Hospitalier Universitaire Saint Pierre
Clonidine for Infra-orbital Nerve Block During Pediatric Cleft Lip Revision Surgeries	2023/03/29	NCT05790044	Not Applicable	Not yet recruiting	Assiut University
Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet	2022/11/14	NCT05614648	Phase 3	Terminated	Sollis Therapeutics, Inc.
Consciousness, Psilocybin, and Well-Being	2022/10/24	NCT05592379	Phase 1	Completed	University of Wisconsin, Madison
Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal	2022/10/12	NCT05575219	Phase 4	Completed	The University of Texas Health Science Center, Houston
Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis	2022/09/29	NCT05560230	Phase 4	Completed	University of Aarhus

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Clonidine Hydrochloride	Solco Healthcare LLC	43547-565	ORAL	0.100 mg in 1 1	5/25/2023
clonidine hydrochloride	Alembic Pharmaceuticals Inc.	62332-054	ORAL	0.1 mg in 1 1	9/30/2021
Clonidine Hydrochloride	Method Pharmaceuticals, LLC	58657-648	ORAL	0.2 mg in 1 1	12/11/2023
clonidine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	29300-468	ORAL	0.1 mg in 1 1	12/30/2020
CLONIDINE HYDROCHLORIDE	DirectRX	61919-718	ORAL	0.1 mg in 1 1	5/12/2023
clonidine hydrochloride	NuCare Pharmaceuticals,Inc.	68071-4041	ORAL	0.1 mg in 1 1	1/20/2022
clonidine hydrochloride	Preferred Pharmaceuticals Inc.	68788-8080	ORAL	0.2 mg in 1 1	4/28/2023
Clonidine Hydrochloride	Bryant Ranch Prepack	63629-2316	ORAL	0.2 mg in 1 1	1/13/2022
clonidine hydrochloride	Alembic Pharmaceuticals Limited	46708-307	ORAL	0.2 mg in 1 1	1/27/2023
clonidine hydrochloride	A-S Medication Solutions	50090-7009	ORAL	0.1 mg in 1 1	12/30/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Clonidine Hydrochloride Pills	西南药业股份有限公司	国药准字H50021972	化学药品	滴丸剂	8/27/2020
Clonidine Hydrochloride Injection	西南药业股份有限公司	国药准字H50021454	化学药品	注射剂	9/7/2020
Clonidine Hydrochloride Injection	天方药业有限公司	国药准字H41020374	化学药品	注射剂	9/4/2020
Clonidine Hydrochloride Injection	华润双鹤药业股份有限公司	国药准字H11020772	化学药品	注射剂(小容量注射剂)	7/23/2021
Clonidine Hydrochloride Sustained-Release Tablets	力品药业（厦门）股份有限公司	国药准字H20223470	化学药品	片剂	6/30/2022
Clonidine Adhesive Patch	哈尔滨瀚钧现代制药有限公司	国药准字H23023542	化学药品	贴剂	3/22/2024
Clonidine Hydrochloride Tablets	丹东医创药业有限责任公司	国药准字H21022378	化学药品	片剂	8/18/2020
Clonidine Hydrochloride Tablets	天方药业有限公司	国药准字H41020434	化学药品	片剂	4/7/2024
Clonidine Hydrochloride Tablets	华润双鹤药业股份有限公司	国药准字H11020771	化学药品	片剂	11/2/2020
Clonidine Hydrochloride Tablets	陕西西岳制药有限公司	国药准字H20064755	化学药品	片剂	1/7/2022

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CATAPRES 150 Clonidine hydrochloride 150 microgram tablet blister pack	78376	Clinect Pty Ltd	Medicine	A	5/25/2001
CLONIDINE Lupin clonidine hydrochloride 100 micrograms tablet bottle	265778	Southern Cross Pharma Pty Ltd	Medicine	A	11/24/2016
CATAPRES clonidine hydrochloride 150 microgram/1mL injection ampoule	17919	Clinect Pty Ltd	Medicine	A	9/26/1991
CLONIDINE HCI INJECTION MEDSURGE clonidine hydrochloride 150 microgram/1 mL solution for injection ampoule	306824	Medsurge Pharma Pty Ltd	Medicine	A	9/26/2018
CATAPRES 100 clonidine hydrochloride 100 microgram tablet blister pack	17921	Clinect Pty Ltd	Medicine	A	9/26/1991
MZ Clonidine HCl Injection clonidine hydrochloride 150 microgram/1 mL solution for injection ampoule	233725	Medsurge Pharma Pty Ltd	Medicine	A	11/24/2015
APO-CLONIDINE clonidine hydrochloride 100 micrograms tablet bottle	265776	Southern Cross Pharma Pty Ltd	Medicine	A	11/24/2016
CLONIDINE SCP clonidine hydrochloride 100 micrograms tablet bottle	265777	Southern Cross Pharma Pty Ltd	Medicine	A	11/24/2016

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