SUDAFED NOSE SPRAY Aqueous solution Ref.[6461] Active ingredients: Pseudoephedrine Xylometazoline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

Pharmacodynamic properties

Pharmacotherapeutic group: Nasal preparations, sympathomimetics, plain
ATC code: R01AA07

It acts directly on α-adrenoreceptors but does not act on β-receptors. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief. Onset of action is within minutes, the decongestant effect being prolonged and lasting for up to 10 hours.

Pharmacokinetic properties

Absorption, Distribution, Biotransformation and Elimination

Little information is available concerning the absorption, distribution, Biotransformation and elimination of xylometazoline in man. Absorption into the nasal mucosal tissues is rapid.

Pharmacokinetics in Renal/Hepatic Impairment

There have been no specific studies of this product or xylometazoline in hepatic or renal impairment.

Pharmacokinetics in the Elderly

There have been no specific clinical studies of this product or xylometazoline in the elderly.

Preclinical safety data

Mutagenicity

There is insufficient information available to determine whether xylometazoline has mutagenic potential.

Carcinogenicity

There is insufficient information available to determine whether xylometazoline has carcinogenic potential.

Teratogenicity

There is insufficient information available to determine whether xylometazoline has teratogenic potential.

Fertility

No studies have been conducted in animals to determine whether xylometazoline has the potential to impair fertility. There is no information on the effects of this product on fertility.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.