Prochlorperazine

Overview

Prochlorperazine, also known as compazine, is a piperazine phenothiazine and first-generation antipsychotic drug that is used for the treatment of severe nausea and vomiting, as well as short-term management of psychotic disorders such as generalized non-psychotic anxiety and schizophrenia. It mainly works by depressing the chemoreceptor trigger zone and blocking D2 dopamine receptors in the brain. It was shown to also block histaminergic, cholinergic and noradrenergic receptors. Prochlorperazine was first developed in the 1950s and was first approved by the FDA in 1956. Although newer antiemetic agents such as 5-HT3 antagonists are more heavily promoted, prochlorperazine is still widely used in nausea and vomiting.

Indication

主要用于精神障碍，亦用于治疗严重的恶心、呕吐。

Associated Conditions

Acute Migraine
Schizophrenia
Tension Headache
Non-psychotic generalized anxiety
Severe Nausea and vomiting

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness	2024/06/10	NCT06450899	Phase 2	Recruiting	University of Colorado, Denver
Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness	2024/03/15	NCT06310642	Phase 4	Completed	CHRISTUS Health
Intravenous Fluids in Pediatric Migraine	2023/12/26	NCT06182098	Not Applicable	Recruiting	Dayton Children's Hospital
Intranasal Ketorolac Trial	2023/10/16	NCT06083571	Phase 2	Recruiting	Washington University School of Medicine
Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines	2023/08/01	NCT05967442	Phase 3	Completed	Wake Forest University Health Sciences
Melphalan on Disease Burden Measured by Next Generation Sequencing Before AHCT (Autologous Hematopoietic Cell Transplant) for Multiple Myeloma	2021/08/19	NCT05013437	Early Phase 1	Withdrawn	Koen van Besien
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients	2020/08/07	NCT04503668	Phase 3	Terminated	University of Michigan Rogel Cancer Center
Paracervical Injection for Headache in the Emergency Department	2019/10/01	NCT04109885	Phase 2	Terminated	Christian Fromm, MD
SPG Block for Acute Pediatric Migraine	2019/06/12	NCT03984045	Phase 3	UNKNOWN	Newark Beth Israel Medical Center
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy	2018/02/15	NCT03435003	Phase 4	Completed	Stony Brook University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PROCHLORPERAZINE MALEATE	Rebel Distributors Corp	21695-571	ORAL	5 mg in 1 1	6/11/2010
PROCHLORPERAZINE MALEATE	Blenheim Pharmacal, Inc.	10544-511	ORAL	5 mg in 1 1	2/25/2015
Prochlorperazine Maleate	ANI Pharmaceuticals, Inc.	70954-688	ORAL	5 mg in 1 1	1/9/2024
Prochlorperazine Edisylate	FOSUN PHARMA USA INC	72266-204	INTRAVENOUS, INTRAMUSCULAR	5 mg in 1 mL	5/4/2023
PROCHLORPERAZINE MALEATE	Liberty Pharmaceuticals, Inc.	0440-8190	ORAL	5 mg in 1 1	9/11/2013
PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	72162-2262	ORAL	10 mg in 1 1	2/18/2019
Compro	PD-Rx Pharmaceuticals, Inc.	55289-119	RECTAL	25 mg in 1 1	3/11/2024
PROCHLORPERAZINE	PharmPak, Inc.	54348-114	ORAL	10 mg in 1 1	10/8/2022
Prochlorperazine Edisylate	Cardinal Health 107, LLC	55154-4183	INTRAMUSCULAR, INTRAVENOUS	5 mg in 1 mL	12/21/2018
Prochlorperazine Edisylate	Hikma Pharmaceuticals USA Inc.	0641-6225	INTRAMUSCULAR, INTRAVENOUS	5 mg in 1 mL	4/3/2023

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
STEMETIL INJECTION 12.5 mg/ml	AVENTIS PHARMA, DAGENHAM, Sanofi S.r.L.	SIN01382P	INJECTION	12.5 mg/ml	5/19/1988
PROCHLOR TABLETS 5 mg	BEACONS PHARMACEUTICALS PTE. LTD.	SIN02049P	TABLET	5 mg	6/23/1988
PROPERAZINE TABLET 5 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN03002P	TABLET	5 mg	5/31/1989

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PROCHLORPERAZINE MALEATE TABLETS 5MG	N/A	PRUDENTLINK LIMITED	N/A	N/A	8/2/2018

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
APOHEALTH NAUSEA RELIEF prochlorperazine maleate 5mg tablet blister pack	186540	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/13/2011
NOUMED PROCHLORPERAZINE prochlorperazine maleate 5mg tablet blister pack	183035	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	5/10/2011
PROCALM prochlorperazine maleate 5 mg tablet blister pack	158415	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/19/2010
NPS-PROCHLORPERAZINE prochlorperazine maleate 5mg tablet blister pack	183036	Ipca Pharma (Australia) Pty Ltd	Medicine	A	5/10/2011
NAUSRELIEF prochlorperazine maleate 5mg tablets blister pack	186710	Generic Health Pty Ltd	Medicine	A	7/19/2011
PHARMACY HEALTH PROCHLORPERAZINE prochlorperazine maleate 5mg tablet blister pack	186709	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	7/19/2011
IPCA-PROCHLORPERAZINE prochlorperazine maleate 5 mg tablet blister pack	158414	Ipca Pharma (Australia) Pty Ltd	Medicine	A	4/19/2010
PRICELINE PHARMACY PROCHLORPERAZINE prochlorperazine maleate 5mg tablet blister pack	186541	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	7/13/2011
APO-PROCHLORPERAZINE prochlorperazine maleate 5 mg tablet blister pack	158416	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/19/2010
CHEMMART PHARMACY PROCHLORPERAZINE prochlorperazine maleate 5 mg tablet blister pack	276715	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/17/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PMS-PROCHLORPERAZINE SUPPOSITOIRES 10MG	Pharmascience Inc	00753688	Suppository - Rectal	10 MG / SUP	12/31/1989
STEMETIL	sanofi-aventis canada inc	01927795	Suppository - Rectal	10 MG	12/31/1958
ODAN-PROCHLORPERAZINE	odan laboratories ltd	00789720	Suppository - Rectal	10 MG	12/31/1989

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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