Aminocaproic acid

Generic Name: Aminocaproic acid

Brand Names: Amicar

Drug Type: Small Molecule

Chemical Formula: C_₆H_₁₃NO_₂

CAS Number: 60-32-2

Unique Ingredient Identifier: U6F3787206

Overview

An antifibrinolytic agent that acts by inhibiting plasminogen activators which have fibrinolytic properties.

Indication

For use in the treatment of excessive postoperative bleeding.

Associated Conditions

Hemorrhage

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation	2021/03/24	NCT04814433	Phase 4	Terminated	NYU Langone Health
Activated Factor Seven in Traumatic Retro Peritoneal Hematoma	2020/06/11	NCT04424563	N/A	Completed	King Abdul Aziz Specialist Hospital
Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.	2017/12/08	NCT03365999	Phase 2	Completed	Universidad Autonoma de Nuevo Leon
A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery	2016/01/15	NCT02656472	Phase 4	Completed	Wake Forest University Health Sciences
Randomized Clinical Trial With Aminocaproic Acid in the Prevention of Exodontic Bleeding in Anticoagulants Patients	2014/09/12	NCT02238288	Phase 4	UNKNOWN	Grupo de Estudos Multicentricos em Onco-Hematologia
Efficacy of Amicar for Children Having Craniofacial Surgery	2014/09/03	NCT02229968	Phase 2	Active, not recruiting	Children's National Research Institute
PRevention Of BLeeding in hEmatological Malignancies With Antifibrinolytic (Epsilon Aminocaproic Acid)	2014/02/28	NCT02074436	Phase 2	Terminated	Emory University
TXA vs. Amicar in Total Knee and Hip Arthroplasty	2014/01/09	NCT02030821	Phase 4	Completed	Duke University
Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty	2012/02/07	NCT01527968	Not Applicable	UNKNOWN	Heekin Orthopedic Research Institute
Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery	2010/11/25	NCT01248104	Not Applicable	Completed	Loma Linda University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Aminocaproic acid	Amneal Pharmaceuticals NY LLC	69238-1596	ORAL	0.25 g in 1 mL	11/1/2023
Aminocaproic acid	TruPharma LLC	52817-815	ORAL	0.25 g in 1 mL	11/17/2022
AMICAR	Carilion Materials Management	68151-3023	ORAL	500 mg in 1 1	6/11/2015
Aminocaproic acid	Amneal Pharmaceuticals NY LLC	60219-1637	ORAL	500 mg in 1 1	12/23/2019
AMICAR	Akorn Operating Company LLC	49411-051	ORAL	1000 mg in 1 1	6/28/2022
Aminocaproic Acid	Akorn Operating Company LLC	17478-769	ORAL	1000 mg in 1 1	7/6/2022
Aminocaproic acid	Novadoz Pharmaceuticals LLC	72205-049	ORAL	500 mg in 1 1	9/21/2023
AMINOCAPROIC ACID	Carnegie Pharmaceuticals, LLC	80005-128	ORAL	500 mg in 1 1	4/20/2023
Aminocaproic Acid	Seton Pharmaceuticals, LLC	13925-530	ORAL	500 mg in 1 1	9/11/2020
Aminocaproic acid	Amneal Pharmaceuticals NY LLC	69238-1637	ORAL	500 mg in 1 1	12/29/2023

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
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AMICAR INJECTION - LIQ IV 250MG/ML	wyeth canada	02169746	Liquid - Intravenous	250 MG / ML	2/4/1997
AMICAR SYR 250MG/ML	lederle cyanamid canada inc.	00127663	Syrup - Oral	250 MG / ML	12/31/1964
AMICAR - SYR 250MG/ML	wyeth-ayerst canada inc.	02171473	Syrup - Oral	250 MG / ML	10/15/1997
AMICAR TAB 500MG	lederle cyanamid canada inc.	00127671	Tablet - Oral	500 MG / TAB	12/31/1964
AMICAR - TAB, 500MG	wyeth canada	02169754	Tablet - Oral	500 MG	11/11/1996
AMICAR INJ 250MG/ML	lederle cyanamid canada inc.	00127655	Liquid - Intravenous	250 MG / ML	12/31/1964

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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