Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1     Pharmacodynamic properties
Pharmacotherapeutic group: 14.1.1. medicines used in otorhinolaryngological disorders. Topical products, ATC Code: R01A A07
Mechanism of action

Xylometazoline hydrochloride is a sympathomimetic agent that acts on -adrenergic receptors in the nasal mucosa. When administered in the nose, it exerts a constricting effect on nasal blood vessels, decongesting the nasal mucosa and surrounding regions of the pharynx. It also reduces the symptoms associated with mucus hypersecretion and facilitates the drainage of the secretions that obstruct the passage. This effect enables the decongestion of the nasal passages, allowing patients to breathe more easily through the nose.

Pharmacodynamic effects
The effect of Otrivin Menthol starts within 2 minutes after administration and lasts for up to 10 hours.

Otrivin Menthol is well tolerated, even by patients with sensitive mucosa. It does not impair the function of the ciliated epithelium.

In addition to the active substance xylometazoline, Otrivin Menthol contains refreshing aromatic menthol and eucalyptol vapors.

Clinical Trials
Allergic Rhinitis
Thirty-six subjects with persistent allergic rhinitis were evaluated to compare their response to 0.1% xylometazoline hydrochloride nasal spray vs mometasone furoate 100 mcg nasal spray.
Xylometazoline hydrochloride was superior to mometasone in terms of peak nasal inspiratory flow, forced inspiratory volume and nasal obstruction score (p<0.05).

Pharmacokinetic Properties

5.2     Pharmacokinetic properties
In humans, after the local application of the drug to the nose, plasma concentrations of xylometazoline are very low, close to the limit of detection.

Absorption
Local administration leads to minimal systemic absorption. However, systemic absorption of intranasal xylometazoline occurs and can lead to systemic sympathomimetic adverse effects when the recommended dose is exceeded (see warnings and precautions).

Distribution
There are no data from human studies.

Biotransformation
There are no data from human studies.
Elimination
There are no data from human studies.