XEMACORT Cream Ref.[49961] Active ingredients: Betamethasone Fusidic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters, Bar, Hertfordshire EN6, 1TL, United Kingdom

Product name and form

Xemacort 20 mg/g + 1 mg/g cream.

Pharmaceutical Form

Cream.

White to off white, smooth, homogeneous cream.

Qualitative and quantitative composition

1 g cream contains 20 mg fusidic acid and 1 mg betamethasone corresponding to 1,214 mg betamethasone valerate.

Excipients with known effect: Contains cetostearyl alcohol 72 mg/g and chlorocresol 1 mg/g.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Betamethasone

Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. Betamethasone has anti-inflammatory, antipruritic, and vasoconstrictive properties.

Fusidic acid

Fusidic acid belongs to a unique group of antibiotics, the fusidanes, which act to inhibit bacterial protein synthesis by blocking the lengthening of factor G. Fusidic acid is active against staphylococcus epidermidis and methicillin resistant staphylococci.

List of Excipients

Macrogol cetostearyl ether
Cetostearyl alcohol
Chlorocresol
Liquid paraffin
Sodium dihydrogen phosphate dihydrate
White soft paraffin
All-rac-α-tocopherol
Purified water
Sodium hydroxide

Pack sizes and marketing

Aluminium tubes with a white conical polyethylene cap of 5 gram, 15 gram, 30 gram, and 60 grams.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters, Bar, Hertfordshire EN6, 1TL, United Kingdom

Marketing authorization dates and numbers

PL 04569/1625

Date of first authorisation: 23 March 2015
Date of latest renewal: 24 March 2020

Drugs

Drug Countries
XEMACORT United Kingdom

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