NASOBEC Nasal spray, suspension Ref.[49651] Active ingredients: Beclometasone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: decongestants and other nasal preparations for topical use, corticosteroids
ATC code: R01AD01

Following topical administration beclomethasone 17, 21-dipropionate (BDP) produces potent anti-inflammatory and vasoconstrictor effects.

BDP is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolysed via esterase enzymes to the active metabolite beclometasone-17 monopropionate (B-17-MP), which has high topical anti-inflammatory activity.

Beclomethasone dipropionate offers a preventative background treatment for hayfever when taken prior to allergen challenge. After which with regular use, BDP can continue to prevent allergy symptoms from re-appearing by reducing the sensitivity of nasal membranes.

5.2. Pharmacokinetic properties

Synthetic glucocorticoid which demonstrates potent properties within the nasal tract without significant systemic activity at recommended doses.

The pharmacokinetics of beclometasone dipropionate have not been extensively studied. The currently available chemical methods are not of sufficient sensitivity to measure therapeutically relevant plasma concentrations, particularly those occurring following inhalation.

General characteristics of the active substance

Absorption

Beclometasone dipropionate is readily absorbed from the gastro-intestinal tract. It is also well absorbed from sites of local application. When administered by topical application, as in the case of Aqueous Nasal Spray, sufficient beclometasone dipropionate may be absorbed to give systemic effects.

Distribution

The drug is rapidly distributed to all body tissues. It crosses the placenta and may be excreted in small amounts in breast milk.

Elimination

After metabolism in the liver and kidney, the drug is excreted in the urine.

Characteristics in patients

As above.

5.3. Preclinical safety data

None.

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