Skip to Content

XEMACORT 20 MG/G + 1 MG/G CREAM

Active substance(s): BETAMETHASONE VALERATE / FUSIDIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Xemacort 20 mg/g + 1 mg/g cream

2

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.

3

PHARMACEUTICAL FORM
Cream
White to off white, smooth, homogeneous cream.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Xemacort 20 mg/g + 1 mg/g cream is indicated for the treatment of
eczematous dermatoses including atopic eczema, infantile eczema (children of
1 year and over), discoid eczema, stasis eczema, contact eczema and
seborrhoeic eczema when secondary bacterial infection is confirmed or
suspected.
Consideration should be given to official guidance on the appropriate use of
antibacterial agents.

4.2

Posology and method of administration
Posology
A single treatment course should not normally exceed 2 weeks.
Method of administration
For cutaneous use
A small quantity should be applied to the affected area twice daily until a
satisfactory response is obtained. In the more resistant lesions the effect of
Xemacort 20 mg/g + 1 mg/g cream can be enhanced by occlusion with
polyethylene film. Overnight occlusion is usually adequate.

4.3

Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in
section 6.1.
Due to the content of corticosteroid, fusidic acid/betamethasone cream is
contraindicated in the following conditions:
Infants under one year of age with infected dermatitis.
Systemic fungal infections.
Primary skin infections caused by fungi, virus or bacteria, either untreated or
uncontrolled by appropriate treatment (see section 4.4).
Skin manifestations in relation to tuberculosis or syphilis, either untreated or
uncontrolled by appropriate therapy.
Acne vulgaris.
Perioral dermatitis and rosacea.

4.4

Special warnings and precautions for use
Long-term continuous topical therapy should be avoided, particularly in infants and
children.
Depending on the application site, possible systemic absorption of betamethasone
valerate should always be considered during treatment with fusidic
acid/betamethasone.
Due to the content of corticosteroid, fusidic acid/betamethasone should be used with
care near the eyes. Avoid getting fusidic acid/betamethasone into the eyes (see
section 4.8).
Glaucoma might result if the preparation enters the eye.

Raised intra-ocular pressure and glaucoma may also occur after topical use of steroids
near the eyes, particularly with prolonged use in patients predisposed to developing
glaucoma.
Reversible hypothalamic pituitary adrenal (HPA) axis suppression may occur
following systemic absorption of topical corticosteroids.
Fusidic acid/betamethasone should be used with care in children as paediatric patients
may demonstrate greater susceptibility to topical corticosteroids induced HPA axis
suppression and Cushing's syndrome than adult patients. Avoid large amounts,
occlusion and prolonged treatment (see section 4.8).
Adrenal suppression can occur even without occlusion. Cushing syndrome may occur
as a potential risk in line with adrenal suppression. Atrophic changes may occur on
the face and to a lesser degree in other parts of the body, after prolonged treatment
with potent topical steroids.
Bacterial resistance has been reported to occur with the use of fusidic acid applied
topically. As with all antibiotics, extended or recurrent application may increase the
risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and
betamethasone valerate to no more than 14 days at a time will minimise the risk of
developing resistance.
This also prevents the risk that the immunosuppressive action of corticosteroid might
mask any potential symptoms of infections due to antibiotic resistant bacteria.
Due to the content of corticosteroid having immunosuppressant effect, fusidic acid/
betamethasone may be associated with increased susceptibility to infection,
aggravation of existing infection, and activation of latent infection. It is advised to
switch to systemic treatment if infection cannot be controlled with topical treatment
(see section 4.3).
Steroid-antibiotic combinations should not be continued for more than 7 days in the
absence of any clinical improvement since in this situation occult extension of the
infection may occur due to the masking of the steroid. Similarly, steroids may also
mask hypersensitivity reactions.
Xemacort 20 mg/g + 1 mg/g cream contains cetostearyl alcohol which may cause
local skin reactions (e.g. contact dermatitis) and chlorocresol which may cause
allergic reactions.

4.5

Interaction with other medicinal products and other forms of interaction
None known

4.6

Fertility, pregnancy and lactation
Pregnancy
Fusidic acid:
No effects during pregnancy are anticipated, since systemic exposure to
fusidic acid is negligible. Studies in animals have not shown teratogenic
effects with fusidic acid. Limited studies in animals have shown negligible
systemic absorption of topical fusidic acid.
Betamethasone valerate:
There are no or limited amount of data from the use of topical betamethasone
valerate in pregnant women. Studies in animals have shown reproductive
toxicity/foetal abnormalities (see section 5.3).
Xemacort 20 mg/g + 1 mg/g cream should not be used during pregnancy
unless clearly necessary.
Breast-feeding
No effects on the breast-fed newborn/infant are anticipated since the systemic
exposure of the topically applied fusidic acid and betamethasone valerate to a
limited area of skin of the breast-feeding woman is negligible. Xemacort 20
mg/g + 1 mg/g cream can be used during breast-feeding but should not be
applied on the breasts to avoid accidental ingestion by the infant
Fertility
There are no clinical studies with fusidic acid/betamethasone regarding
fertility.

4.7

Effects on ability to drive and use machines
Xemacort 20 mg/g + 1 mg/g cream has no or negligible influence on the ability to
drive or to use machines.

4.8

Undesirable effects

The estimation of the frequency of undesirable effects is based on a pooled
analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reaction during treatment is pruritis
Undesirable effects are listed by MedDRA SOC and the individual undesirable
effects are listed starting with the most frequently reported. Within each
frequency grouping, adverse reactions are presented in the order of decreasing
seriousness.
Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000
Immune system disorders
Uncommon:
(≥1/1,000 and <1/100)

Hypersensitivity

Skin and subcutaneous tissue disorders
Uncommon:
Dermatitis contact
(≥1/1,000 and <1/100)
Eczema (condition aggravated)
Skin burning sensation
Pruritus
Dry skin
Rare:
Erythema
(≥1/10,000 and <1/1,000)
Urticaria
Rash (including rash erythematous and
rash generalised)
General disorders and administration site conditions

Uncommon:

(≥1/1,000 and <1/100)

Rare:
(≥1/10,000 and <1/1,000)

Application site pain
Application site irritation
Application site swelling
Application site vesicles

Systemic undesirable class effects of corticosteroids like betamethasone
valerate include adrenal suppression especially during prolonged topical
administration (see section 4.4).
Raised intraocular pressure, glaucoma and cataract may also occur after
topical use of corticosteroids near the eyes, particularly with prolonged use
and in patients predisposed to developing glaucoma and cataract (see section
4.4).
Dermatological undesirable class effects of potent corticosteroids include:
Atrophy, dermatitis (including dermatitis contact and dermatitis acneiform),
perioral dermatitis, skin striae, telangiectasia, rosacea, erythema,
hypertrichosis, hyperhidrosis and depigmentation. Ecchymosis may also occur
with prolonged use of topical corticosteroids.

Class effects for corticosteroids have been uncommonly reported for fusidic
acid/betamethasone cream described in the frequency table above.
Paediatric population
The observed safety profile is similar in children and adults (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
For topically applied fusidic acid, no information concerning potential
symptoms and signs due to overdose administration is available. Cushing's
syndrome and adrenocortical insufficiency may develop following topical
application of corticosteroids in large amounts and for more than 3 weeks.
Systemic consequences of an overdose of the active substances after accidental
oral intake are unlikely to occur. The amount of fusidic acid in one tube of
Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream does not exceed the oral
daily dose of systemic treatment. A single oral overdose of corticosteroids is
rarely a clinical problem.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, potent, combinations with
antibiotic.
ATC code: D07C-C01.
Xemacort 20 mg/g + 1 mg/g cream combines the well-known antiinflammatory and antipruritic effects of betamethasone with the potent topical
antibacterial action of fusidic acid. Betamethasone is a topical steroid rapidly
effective in those inflammatory dermatoses which normally respond to this
form of therapy. More refractory conditions can often be treated successfully.
When applied topically, fusidic acid is effective against Staphyloccus aureus,
Streptococci, Corynebacteria, Neisseria and certain Clostridia and
Bacteroides. Concentrations of 0.03 to 0.12 microgram per ml inhibit nearly
all strains of S. aureus. The antibacterial activity of fusidic acid is not
diminished in the presence of betamethasone.

5.2

Pharmacokinetic properties
There are no data which define the pharmacokinetics of fusidic
acid/betamethasone cream, following topical administration in man.
However, in vitro studies show that fusidic acid can penetrate intact human
skin. The degree of penetration depends on factors such as the duration of
exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted
mainly in the bile with little excreted in the urine.
Betamethasone is absorbed following topical administration. The degree of
absorption is dependent on various factors including skin condition and site of
application. Betamethasone is metabolised largely in the liver but also to a
limited extent in the kidneys, and the inactive metabolites are excreted with
the urine.

5.3

Preclinical safety data
Studies of corticosteroids in animals have shown reproductive toxicity (e.g.
cleft palate, skeletal malformations, low birth weight).

6

PHARMACEUTICAL PARTICULARS

6.1

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

6.2

Incompatibilities
Not applicable

6.3

Shelf life
Unopened container: 30 months.
After first opening: 6 months.

6.4

Special precautions for storage
Do not store above 30ºC.

6.5

Nature and contents of container
Aluminium tubes with a white conical plastic cap of 5 gram, 15 gram, 30
gram, and 60 grams.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.

7

MARKETING AUTHORISATION HOLDER
Generics [UK] Limited t/a Mylan

Station Close,
Potters Bar,
Hertfordshire EN6 1TL,
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 04569/1625

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/03/2015

10

DATE OF REVISION OF THE TEXT
01/10/2016

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide