Felodipine

Overview

Felodipine is a long-acting 1,4-dihydropyridine calcium channel blocker (CCB)b. It acts primarily on vascular smooth muscle cells by stabilizing voltage-gated L-type calcium channels in their inactive conformation. By inhibiting the influx of calcium in smooth muscle cells, felodipine prevents calcium-dependent myocyte contraction and vasoconstriction. Felodipine is the most potent CCB in use and is unique in that it exhibits fluorescent activity. In addition to binding to L-type calcium channels, felodipine binds to a number of calcium-binding proteins, exhibits competitive antagonism of the mineralcorticoid receptor, inhibits the activity of calmodulin-dependent cyclic nucleotide phosphodiesterase, and blocks calcium influx through voltage-gated T-type calcium channels. Felodipine is used to treat mild to moderate essential hypertension.

Indication

For the treatment of mild to moderate essential hypertension.

Associated Conditions

Hypertension

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Felodipine Controlled Release Tablets and Felodipine Sustained Release Tablets in Healthy Subjects Under Fasting State Comparative Pharmacokinetic Study	2022/11/14	NCT05614037	Phase 1	Active, not recruiting	Overseas Pharmaceuticals, Ltd.
Copenhagen Acute Renal Complications After Transplantations Study Group	2016/04/20	NCT02744872	Phase 4	Completed	Rigshospitalet, Denmark
The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release in Chinese Patients.	2015/01/13	NCT02336607	Not Applicable	Completed	AstraZeneca
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions	2014/12/30	NCT02327247	Not Applicable	Completed	Ranbaxy Laboratories Limited
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions	2014/12/08	NCT02311530	Not Applicable	Completed	Ranbaxy Laboratories Limited
Coffee Interaction With the Antihypertensive Drug Felodipine	2014/09/05	NCT02232269	Phase 1	Completed	Lawson Health Research Institute
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fed Condition	2012/06/28	NCT01630902	Phase 1	Completed	Torrent Pharmaceuticals Limited
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fasting Condition	2012/06/28	NCT01630655	Phase 1	Completed	Torrent Pharmaceuticals Limited
Compare the Effects of Lercanidipine Hydrochloride Tablet (Zanidip®) and Felodipine Sustained-Release Tablet for Hypertension	2012/01/27	NCT01520285	Phase 4	Completed	Lee's Pharmaceutical Limited
Combined Antihypertensive Therapy and Sexual Dysfunction	2010/11/11	NCT01238705	Phase 4	UNKNOWN	LanZhou University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
FELODIPINE	Wockhardt USA LLC.	64679-411	ORAL	2.5 mg in 1 1	11/26/2019
Felodipine	Westminster Pharmaceuticals, LLC	69367-264	ORAL	2.5 mg in 1 1	4/4/2023
FELODIPINE	Wockhardt USA LLC.	64679-412	ORAL	5 mg in 1 1	11/26/2019
Felodipine	Rising Pharma Holdings, Inc.	57237-110	ORAL	10 mg in 1 1	2/17/2024
Felodipine	Bryant Ranch Prepack	63629-2017	ORAL	2.5 mg in 1 1	5/21/2021
Felodipine	Glenmark Pharmaceuticals Inc., USA	68462-233	ORAL	2.5 mg in 1 1	12/11/2018
Felodipine	Glenmark Pharmaceuticals Inc., USA	68462-234	ORAL	5 mg in 1 1	12/11/2018
Felodipine	A-S Medication Solutions	50090-2421	ORAL	10 mg in 1 1	12/11/2018
Felodipine	Westminster Pharmaceuticals, LLC	69367-265	ORAL	5 mg in 1 1	4/4/2023
Felodipine	Physicians Total Care, Inc.	54868-0823	ORAL	2.5 mg in 1 1	8/31/2010

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
PLENDIL TABLET 5 mg	ASTRAZENECA AB, ASTRAZENECA PTY LTD, AstraZeneca Pharmaceutical Co. Ltd	SIN08781P	TABLET, EXTENDED RELEASE	5 mg	7/3/1996
PLENDIL TABLET 10 mg	ASTRAZENECA AB, ASTRAZENECA PTY LTD, AstraZeneca Pharmaceutical Co. Ltd	SIN08768P	TABLET, EXTENDED RELEASE	10 mg	7/3/1996
PLENDIL TABLET 2.5 mg	ASTRAZENECA AB, ASTRAZENECA PTY LTD, AstraZeneca Pharmaceutical Co. Ltd	SIN07738P	TABLET, EXTENDED RELEASE	2.5 mg	6/15/1994

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
FEDISYN E.R.F.C. TAB 5MG	N/A	SYNMOSA BIOPHARMA (HONG KONG) COMPANY LIMITED	N/A	N/A	7/10/2009
FELODIP 2.5 EXTENDED-RELEASE TABLETS 2.5MG	N/A	i & c (hong kong) limited	N/A	N/A	10/18/2021
FELODIPIN STADA RETARD TAB 5MG	N/A	STADA PHARMACEUTICALS (ASIA) LIMITED	N/A	N/A	3/28/2002
CZSY-FELO S.R. SUSTAINED-RELEASE TABLET 5MG	N/A	REGAL MEDICAL HEALTHCARE LIMITED	N/A	N/A	9/4/2015

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TRIASYN 5.0/5.0 tablet blister pack	67183	Sanofi-Aventis Australia Pty Ltd	Medicine	A	12/18/1998
FELODUR ER felodipine 10mg extended release tablet blister pack	60982	Clinect Pty Ltd	Medicine	A	11/10/1997
FELODIPINE-DWRN 10 felodipine 10mg modified release tablets blister pack	424190	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/28/2023
PLENDIL ER felodipine 5mg extended release tablet blister pack	51775	Clinect Pty Ltd	Medicine	A	7/6/1995
FELODIL XR 2.5 felodipine 2.5 mg modified release tablet blister pack	431930	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/1/2025
FELODIPINE AZN ER felodipine 5 mg extended release tablet blister pack	409176	AstraZeneca Pty Ltd	Medicine	A	7/27/2023
FELODUR ER felodipine 5mg extended release tablet blister pack	60981	Clinect Pty Ltd	Medicine	A	11/10/1997
PLENDIL ER felodipine 2.5mg extended release tablet blister pack	51774	Clinect Pty Ltd	Medicine	A	7/6/1995
PLENDIL ER felodipine 10mg extended release tablet blister pack	51776	Clinect Pty Ltd	Medicine	A	7/6/1995
FELODIPINE AZN ER felodipine 2.5mg extended release tablet blister pack	409175	AstraZeneca Pty Ltd	Medicine	A	7/27/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ALTACE PLUS FELODIPINE 5MG + 5MG	sanofi-aventis canada inc	02240306	Tablet - Oral	5 MG	6/27/2006
ALTACE PLUS FELODIPINE 2.5MG + 2.5MG	sanofi-aventis canada inc	02240307	Tablet - Oral	2.5 MG	6/27/2006
SANDOZ FELODIPINE	Sandoz Canada, Inc.	02280264	Tablet (Extended-Release) - Oral	5 MG	8/15/2006
PLENDIL	glenwood gmbh pharmazeutische erzeugnisse	00851787	Tablet (Extended-Release) - Oral	10 MG	12/31/1992
RENEDIL SRT 5MG	hoechst canada inc.	00864013	Tablet (Extended-Release) - Oral	5 MG / TAB	12/31/1992
RENEDIL SRT 2.5MG	hoechst roussel canada inc.	02069539	Tablet (Extended-Release) - Oral	2.5 MG / SRT	12/31/1994
RENEDIL SRT 2.5MG	hoechst canada inc.	02057786	Tablet (Extended-Release) - Oral	2.5 MG / SRT	12/31/1994
RENEDIL SRT 10MG	hoechst roussel canada inc.	01989596	Tablet (Extended-Release) - Oral	10 MG / TAB	12/31/1994
SANDOZ FELODIPINE	Sandoz Canada, Inc.	02280272	Tablet (Extended-Release) - Oral	10 MG	8/15/2006
PLENDIL	glenwood gmbh pharmazeutische erzeugnisse	00851779	Tablet (Extended-Release) - Oral	5 MG	12/31/1992

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LOGIMAX 5 MG/50 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA	Recordati Industria Chimica E Farmaceutica S.P.A.	60612	COMPRIMIDO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica	Commercialized
FELODIPINO SANDOZ 5 mg COMPRIMIDOS DE LIBERACIÓN PROLONGADA	Sandoz Farmaceutica S.A.	64832	COMPRIMIDO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
PLENDIL 5 mg COMPRIMIDOS DE LIBERACION PROLONGADA	Glenwood Gmbh Pharmazeutische Erzeugnisse	59269	COMPRIMIDO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized
TRIAPIN 5 mg/5 mg COMPRIMIDOS DE LIBERACION PROLONGADA	Sanofi Aventis S.A.	62760	COMPRIMIDO DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica	Commercialized

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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