Xylometazoline

Overview

Xylometazoline is an imidazoline derivative with sympathomimetic and nasal decongestant activity. Xylometazoline works by binding to alpha (α)-adrenergic receptors to cause vasoconstriction of nasal blood vessels. Xylometazoline is available in over-the-counter (OTC) nasal sprays or drops to temporarily relieve nasal congestion due to cold, hay fever or other respiratory allergies. In some countries, it is available as combination products with ipratropium, domiphen, or dexpanthenol.

Indication

Xylometazoline is indicated for the temporary relief of nasal congestion due to cold, hay fever or other respiratory allergies.

Associated Conditions

Allergic Rhinitis (AR)
Nasal Congestion
Seasonal Allergic Rhinitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Cocaine, Lidocaine/Xylometazoline and Saline for Nasal Analgesia	2024/06/05	NCT06443255	Phase 3	Recruiting	Rigshospitalet, Denmark
LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media	2023/04/07	NCT05804123	Not Applicable	Completed	Anabio R&D
Xylometazoline and Cocaine for Nasal Vasoconstriction	2022/04/19	NCT05334017	Phase 4	Completed	Rigshospitalet, Denmark
Nasal Breathing and Physical Capacity	2021/01/15	NCT04712799	Phase 4	Recruiting	Sorlandet Hospital HF
Non-interventional Study With Ectoin Containing and/or Decongesting Nasal Spray in Patients With Rhinosinusitis	2018/10/03	NCT03693976	N/A	Completed	Bitop AG
Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis	2018/03/29	NCT03480100	N/A	Completed	Bitop AG
Xylometazoline During Nasal Flexible Bronchoscopy	2018/02/07	NCT03424889	Not Applicable	Completed	All India Institute of Medical Sciences, New Delhi
The Role of the Nose in Snoring and Sleep Apnea	2017/03/07	NCT03072173	Not Applicable	UNKNOWN	Lovisenberg Diakonale Hospital
4"S" - Seasonal Symptoms Suppression Study	2015/09/23	NCT02557269	Phase 4	UNKNOWN	Association Asthma, Bulgaria
Nasal Prep for Nasendoscopy in Children	2011/05/10	NCT01351298	Phase 4	Completed	Children's & Women's Health Centre of British Columbia

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
SNUP STADA® SPRAY 0.1%	Ursapharm Arzneimittel GmbH	SIN15198P	SPRAY	0.100g	3/23/2017
OTRIVIN NASAL SPRAY 0.1%	GSK Consumer Healthcare SARL	SIN11624P	SPRAY	1 mg/ml	8/14/2001
OTRIVIN NASAL DROPS 0.05%	GSK Consumer Health SARL	SIN11622P	SOLUTION	0.5 mg/ml	8/14/2001

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
XUZULEX NASAL SPRAY(OSCO) 0.1%	N/A	WILSON TRADING COMPANY LIMITED	N/A	N/A	5/3/2010
OTRIVIN MENTHOL NASAL SPRAY 0.1%	N/A	Haleon Hong Kong Limited	N/A	N/A	12/24/2010
OTRIVIN NASAL SPRAY 0.1%	N/A	Haleon Hong Kong Limited	N/A	N/A	8/5/1978
OTRIVIN NASAL DROPS 0.1%	N/A	Haleon Hong Kong Limited	N/A	N/A	8/4/1978
OTRIVIN METERED DOSE NASAL SPRAY 0.05%	N/A	Haleon Hong Kong Limited	N/A	N/A	5/29/2011
OTRIVIN PAED NASAL DROPS 0.05%	N/A	Haleon Hong Kong Limited	N/A	N/A	8/4/1978

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OTRIVIN JUNIOR NASAL SPRAY xylometazoline hydrochloride 0.5mg/mL pump actuated metered dose aerosol	142227	Haleon Australia Pty Ltd	Medicine	A	7/17/2007
Maxiclear Nasal Spray	370171	AFT Pharmaceuticals Pty Ltd	Medicine	A	6/24/2021
OTRIVIN MENTHOL xylometazoline hydrochloride 1 mg/mL nasal spray pump actuated metered dose aerosol	99690	Haleon Australia Pty Ltd	Medicine	A	2/11/2004
TERRYWHITE CHEMMART XYLOCLEAR NASAL SPRAY xylometazoline hydrochloride 138 micrograms/actuation pump actuated metered dose nasal spray bottle	398940	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	11/7/2022
CODRAL NASAL SPRAY + MOISTURISER xylometazoline hydrochloride 1 mg/mL pump manual actuated bottle	464753	Johnson & Johnson Pacific Pty Ltd	Medicine	A	10/17/2024
NEOVIN JUNIOR NASAL SPRAY xylometazoline hydrochloride 0.5 mg/mL pump actuated metered dose aerosol bottle	430866	Neo Health (OTC) Pty Ltd	Medicine	A	12/14/2023
NEOVIN ADULT NASAL DROPS xylometazoline hydrochloride 1 mg/mL bottle	430867	Neo Health (OTC) Pty Ltd	Medicine	A	12/14/2023
NEOVIN ADULT NASAL SPRAY xylometazoline hydrochloride 1 mg/mL pump actuated metered dose aerosol bottle	430863	Neo Health (OTC) Pty Ltd	Medicine	A	12/14/2023
NEOVIN JUNIOR NASAL DROPS xylometazoline hydrochloride 0.5 mg/mL bottle	430913	Neo Health (OTC) Pty Ltd	Medicine	A	12/15/2023
SUDAFED XYLOMETAZOLINE xylometazoline hydrochloride 1mg/mL pump actuated metered dose nasal spray	302800	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/9/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OTRIVIN ALLERGY AND COLD DECONGESTANT NASAL SPRAY	glaxosmithkline consumer healthcare ulc	02238867	Spray - Nasal	0.05 %	8/9/1999
COLD AND ALLERGY DECONGESTANT NASAL SPRAY	teva canada limited	02351927	Spray - Nasal	0.1 % / W/V	10/1/2011
VAPORISATEUR NASAL DECONGESTIONNANT	Laboratoires Confab Inc	00788503	Solution - Nasal	0.1 %	12/31/1991
OTRIVIN WITH M-D PUMP	novartis consumer health canada inc.	00741043	Spray - Nasal	.1 %	12/31/1987
NASAL DECONGESTANT SPRAY WITH MOISTURIZERS	Laboratoires Confab Inc	02241736	Spray - Nasal	0.1 % / W/V	11/11/2000
OTRIVIN PEDIATRIC DECONGESTANT NOSE DROPS	novartis consumer health canada inc.	00623458	Drops - Nasal	.05 %	12/31/1960
NASAL DECONGESTANT SPRAY WITH MOISTURIZERS	crls	02452863	Spray - Nasal	0.1 % / W/V	2/27/2017
DECONGESTANT NASAL SPRAY	Jamp Pharma Corporation	02250845	Spray - Nasal	0.1 %	1/31/2005
DECONGESTANT NASAL SPRAY 0.1% USP	ksl pharmaceuticals	00881155	Spray - Nasal	.1 %	12/31/1992
OTRIVIN MEDICATED COLD & ALLERGY RELIEF	haleon canada ulc	00653330	Spray - Nasal	0.1 % / W/V	12/31/1961

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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