MedPath

Quinidine

Generic Name
Quinidine
Brand Names
Nuedexta
Drug Type
Small Molecule
Chemical Formula
C20H24N2O2
CAS Number
56-54-2
Unique Ingredient Identifier
ITX08688JL

Overview

Quinidine is a D-isomer of quinine present in the bark of the Cinchona tree and similar plant species. This alkaloid was first described in 1848 and has a long history as an antiarrhythmic medication. Quinidine is considered the first antiarrhythmic drug (class Ia) and is moderately efficacious in the acute conversion of atrial fibrillation to normal sinus rhythm. It prolongs cellular action potential by blocking sodium and potassium currents. A phenomenon known as “quinidine syncope” was first described in the 1950s, characterized by syncopal attacks and ventricular fibrillation in patients treated with this drug. Due to its side effects and increased risk of mortality, the use of quinidine was reduced over the next few decades. However, it continues to be used in the treatment of Brugada syndrome, short QT syndrome and idiopathic ventricular fibrillation.

Indication

Quinidine is indicated for the management and prophylactic therapy of atrial fibrillation/flutter, as well as the suppression of recurrent documented ventricular arrhythmias. It is also used in the treatment of Brugada syndrome, short QT syndrome and idiopathic ventricular fibrillation..

Associated Conditions

  • Atrial Fibrillation or Flutter
  • Malaria caused by Plasmodium falciparum
  • Pseudobulbar Affect (PBA)
  • Ventricular Arrhythmia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/19
Phase 1
Completed
2025/05/16
Phase 1
Completed
2025/02/26
Phase 1
Completed
2024/11/26
Phase 1
Completed
2024/07/10
Phase 1
Completed
2022/10/26
Phase 1
Completed
2022/10/25
Phase 2
ENROLLING_BY_INVITATION
2022/07/06
Phase 1
Completed
2021/03/05
Phase 1
Completed
2018/11/28
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Eon Labs, Inc.
0185-1047
ORAL
300 mg in 1 1
9/13/2019
Sun Pharmaceutical Industries, Inc.
53489-141
ORAL
324 mg in 1 1
2/1/2018
Carilion Materials Management
68151-2701
ORAL
324 mg in 1 1
2/13/2015
Otsuka America Pharmaceutical, Inc
59148-053
ORAL
10 mg in 1 1
12/31/2022
Eon Labs, Inc.
0185-4346
ORAL
200 mg in 1 1
9/13/2019
Eywa Pharma Inc
71930-016
ORAL
324 mg in 1 1
12/29/2021
Carilion Materials Management
68151-1991
ORAL
200 mg in 1 1
10/4/2012
EPIC PHARMA, LLC
42806-513
ORAL
200 mg in 1 1
12/15/2021
Richmond Pharmaceuticals, Inc.
54738-901
ORAL
324 mg in 1 1
3/6/2019
EPIC PHARMA, LLC
42806-512
ORAL
300 mg in 1 1
12/15/2021

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
QUINIDINE SULFATE TAB 200MG
stanley pharmaceuticals, a division of vita health products inc.
00179256
Tablet - Oral
195 MG
12/31/1957
QUINIDINE 200 TAB
PRO DOC LIMITEE
00563692
Tablet - Oral
200 MG
12/31/1982
QUINIDINE SULFATE INJECTION 190MG/ML
hospira healthcare ulc
00497525
Solution - Intramuscular
190 MG / ML
12/31/1981
APO QUINIDINE TAB 200MG
00441740
Tablet - Oral
200 MG
12/31/1979
QUINIDINE GLUCONATE FOR INJ 80MG/ML USP
eli lilly canada inc
00128740
Liquid - Intravenous ,  Intramuscular
80 MG / ML
12/31/1991
QUINATE TAB 325MG
rougier pharma division of ratiopharm inc
00311731
Tablet - Oral
325 MG
12/31/1979
QUINIDINE SULFATE 200MG
rougier pharma division of ratiopharm inc
00026883
Tablet - Oral
200 MG
12/31/1970
QUINIDEX EXTENTABS SRT 300MG
ayerst laboratories
01913883
Tablet (Extended-Release) - Oral
300 MG
12/31/1991
QUINIDINE SULFATE TAB 200MG
glaxo wellcome inc.
00004782
Tablet - Oral
200 MG
12/31/1938
APO-QUIN-G TAB 325MG
00595934
Tablet - Oral
325 MG
12/31/1985

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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