LOTRIDERM Cream Ref.[50612] Active ingredients: Betamethasone Clotrimazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

5.1. Pharmacodynamic properties

Lotriderm Cream contains the dipropionate ester of betamethasone, a glucocorticoid exhibiting the general properties of corticosteroids, and clotrimazole which is an imidazole antifungal agent.

Topical corticosteroids are effective in the treatment of a range of dermatoses because of their anti-inflammatory anti-pruritic and vasoconstrictive actions.

Clotrimazole is a broad-spectrum antifungal agent with activity against Trichomones, Staphylococci and Bacteroides.

5.2. Pharmacokinetic properties

Lotriderm is intended for treatment of skin conditions and is applied topically. Thus there are minimal pharmacokinetic aspects related to bioavailability at the site of action.

Clotrimazole penetrates the epidermis after topical administration but there is little, if any, systemic absorption.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, integrity of skin and use of occlusion.

Systemically absorbed topical corticosteroids are bound to plasma proteins metabolised in the liver and excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SmPC.

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