UTABON PEDIATRIC Nasal drops, solution Ref.[51151] Active ingredients: Oxymetazoline

Source: Medicines Authority (MT)  Publisher: J Uriach and CIA S.A., Av. Camí Reial 51-57, 08184 Palau-Solitá i Plegamans, (Barcelona), Spain

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Sympathomimetics for nasal administration
ATC Code: R01AA05

Oxymetazoline is an imidazole derivative, similar in structure to adrenergic drugs, with specific action on the α1 adrenergic receptors that causes local vasoconstriction and, therefore, reduces nasal congestion.

5.2. Pharmacokinetic properties

When oxymetazoline is administered topically on the nasal mucosa, the onset of action is very fast (5 to 10 minutes) and lasts several hours (8 to 12 hours).

Available literature states up to 50% reduction in nasal blood flow after topical administration of doses between 10 and 120 µg of oxymetazoline. This reduction has been shown to be significant 5 minutes after administration by this route.

Oxymetazoline can be absorbed systemically through the nasal mucosa and the gastrointestinal tract, causing systemic side effects, particularly when excessive doses are given. Children and the elderly are more liable to absorb this drug.

The elimination half-life is approximately 5 to 8 hours.

In the first 72 hours, 30% of the absorbed drug is excreted unchanged through the urine and approximately 10% through the faeces.

5.3. Preclinical safety data

Given its extensive clinical use, safety problems are not expected when this medicinal product is used at the recommended doses.

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