Bromhexine

Overview

Bromhexine is mucolytic agent used for a variety of respiratory conditions associated with increased mucus secretion. It is derived from the Adhatoda vasica plant and aids in the clearance of excess mucus, improving breathing and reducing cough. It was introduced into the market in 1963, and is widely available as an over-the-counter drug in many countries. Recently, bromhexine and its metabolite ambroxol have garnered interest for the potential prevention and treatment of COVID-19 due to their interactions with cell receptors in the lungs.

Indication

Bromohexine is used alone or with other ingredients such as diphenhydramine, dextromethorphan, and guaifenesin to reduce mucus viscosity and clear mucus in conditions associated with mucus hypersecretion, including the common cold, influenza, respiratory tract infections, or other conditions.

Associated Conditions

Bronchiectasis
Common Cold
Cough
Cough caused by Common Cold
Nasal Congestion
Whooping Cough

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study on the Pharmacokinetics of Bromine Hexane Hydrochloride Tablets in Healthy Adults	2020/12/17	NCT04672707	Phase 1	Completed	Second Affiliated Hospital of Wenzhou Medical University
BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization	2020/06/09	NCT04424134	Phase 3	UNKNOWN	Lomonosov Moscow State University Medical Research and Educational Center
Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease	2020/05/28	NCT04405999	Phase 4	Completed	Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia	2020/04/21	NCT04355026	Phase 4	UNKNOWN	General and Teaching Hospital Celje
Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals	2020/04/09	NCT04340349	Early Phase 1	UNKNOWN	Instituto Nacional de Rehabilitacion
Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)	2020/02/18	NCT04273763	Not Applicable	UNKNOWN	Second Affiliated Hospital of Wenzhou Medical University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
VASICAN TABLET 8 mg	PT. ACTAVIS INDONESIA	SIN02528P	TABLET	8 mg	4/18/1989
BROMXINE TABLET 8 mg	ATLANTIC LABORATORIES CORPN LTD	SIN09127P	TABLET	8 mg	1/13/1997
VASICAN SYRUP 4 MG/5ML	PT.ACTAVIS INDONESIA	SIN02864P	SYRUP	4 mg/5 ml	5/22/1989
BROMHEXINE TABLET 8 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN02479P	TABLET	8 mg	3/6/1989
AXCEL BROMHEXINE TABLET 8 mg	KOTRA PHARMA (M) SDN BHD	SIN10906P	TABLET	8 mg	4/30/1999
MUCOLIX ELIXIR 4 mg/5 ml	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN02846P	ELIXIR	4 mg/5 ml	5/22/1989
BISLAN TABLET 8 mg	Y S P INDUSTRIES (M) SDN BHD	SIN10582P	TABLET	8 mg	12/22/1998
BROMHEXINE ELIXIR 4 mg/5 ml	SUNWARD PHARMACEUTICAL PRIVATE LIMITED, SUNWARD PHARMACEUTICAL SDN BHD	SIN02468P	ELIXIR	4 mg/5 ml	2/27/1989
HOSOLVON TABLET 8 mg	HOVID BHD, HOVID Bhd.	SIN05034P	TABLET	8.00mg	8/30/1990
DURO-TUSS CHESTY COUGH LIQUID	Ensign Laboratories Pty Ltd	SIN10014P	SOLUTION	12 mg/15 ml	9/21/1998

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
NEODINE TAB	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	1/11/2002
FAST FLU TAB	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	10/18/2002
X-COLD CAP	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	6/30/2000
SPEEDY COLD AND COUGH CAP	N/A	NEOCHEM PHARMACEUTICAL LABORATORIES LIMITED	N/A	N/A	9/11/2006
SURE-RELIEF COLD AND COUGH CAP	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	6/30/2000
ANTI-COLD TAB	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	9/30/2002
COFENZA CAP	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	6/30/2000
Q-COLD TAB	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	9/30/2002
BISOPIN TAB 8MG	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	1/6/1992
N2012 CAP	N/A	karen laboratories o/b karen pharmaceutical co ltd	N/A	N/A	2/8/2010

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PHARMACY HEALTH CHESTY MUCUS COUGH RELIEF bromhexine hydrochloride 1.6mg/mL oral liquid bottle	297830	Soul Pattinson Manufacturing Pty Ltd	Medicine	A	12/20/2017
DURO-TUSS CHESTY COUGH TABLETS FORTE tablet blister pack	210274	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	5/30/2013
BISOLVON CHESTY KIDS STRAWBERRY FLAVOUR bromhexine hydrochloride 0.8mg/mL oral liquid bottle	182576	Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare	Medicine	A	4/28/2011
MAXICLEAR CHESTY COUGH bromhexine hydrochloride 8 mg tablet blister pack	366254	AFT Pharmaceuticals Pty Ltd	Medicine	A	5/17/2021
XYOTUSS Chesty Cough lozenges Berry flavour blister pack	379630	Mapaex Consumer Healthcare (Australia) Pty Ltd	Medicine	A	11/30/2021
PRICELINE PHARMACY CHESTY MUCUS COUGH RELIEF bromhexine hydrochloride 1.6mg/mL oral liquid bottle	297831	Soul Pattinson Manufacturing Pty Ltd	Medicine	A	12/20/2017
XYOTUSS Chesty Cough Lozenges Lemon Flavour blister pack	379631	Mapaex Consumer Healthcare (Australia) Pty Ltd	Medicine	A	11/30/2021
PHARMACY ACTION DOUBLE ACTION CHESTY COUGH RELIEF oral liquid bottle	198704	Generic Health Pty Ltd	Medicine	A	6/25/2012
GUARDIAN MUCUS RELIEF FORTE bromhexine hydrochloride 8 mg tablet blister pack	471330	AdiraMedica Pty Ltd	Medicine	A	12/2/2024
TERRYWHITE CHEMMART CHESTY COUGH RELIEF DUAL ACTION oral liquid bottle	304301	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	6/14/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
AMOXICILINA/BROMHEXINA ARDINE 500 mg/8 mg CÁPSULAS DURAS	Laboratorio Reig Jofre, S.A.	53003	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Not 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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