OTRIVIN ADULT Menthol Nasal spray, solution Ref.[50845] Active ingredients: Xylometazoline

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: decongestants for topical use, sympathomimetics, plain.
ATC Code: R01AA07

Mechanism of action and pharmacodynamic effects

Otrivine Adult Menthol Nasal Spray is a sympathomimetic agent with marked alpha-adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. It also reduces associated symptoms of mucus hypersecretion and facilitates drainage of blocked secretions. This enables patients suffering from colds to breathe more easily through the nose.

The effect of Otrivine Adult Menthol Nasal Spray begins within a few minutes and lasts for up to 10 hours.

Otrivine is generally well tolerated and does not impair the function of ciliated epithelium.

Otrivine Adult Menthol Nasal Spray also contains cooling aromatic vapours of menthol and eucalyptol.

5.2. Pharmacokinetic properties

Plasma concentrations of xylometazoline in man after local nasal application of the product are very low and close to the limit of detection.

Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.

5.3. Preclinical safety data

Xylometazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylometazoline was given subcutaneously in mice and rats.

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