Mometasone Furoate 0.1% W/W Cream
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate 0.1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 1 mg of mometasone furoate (0.1 % w/w mometasone furoate).
Excipients:
80 mg propylene glycol monopalmitostearate per gram cream 70 mg stearyl alcohol per gram cream
Traces, up to a maximum of 0.015mg Butylated hydroxytoluene (E321) per gram cream
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
White to off-white, smooth cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Mometasone Furoate 0.1% w/w Cream is indicated for the symptomatic treatment of inflammatory skin conditions which respond to external treatment with glucocorticoids such as atopic dermatitis and psoriasis (excluding widespread plaque psoriasis).
4.2 Posology and method of administration
Adults (including elderly patients), adolescents and children aged 6 years and
over:
A thin film of Mometasone Furoate 0.1% w/w Cream should be applied to the affected skin area once daily. One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand.
Use of a weaker corticosteroid is often advisable when there is a clinical improvement.
Mometasone Furoate 0.1% w/w Cream should not be used for long periods (over 3 weeks) or on large areas (over 20% of body surface area). In children a maximum of 10% of body surface area should be treated.
Use of topical corticosteroids in children aged 6 years and over, or on the face should be limited to the least amount compatible with an effective therapeutic regimen, and duration of treatment should be no more than 5 days.
Children below 6 years
Mometasone Furoate 0.1% w/w Cream is not recommended for use in children below 6 years of age due to insufficient data on safety (see section 4.8).
4.3 Contraindications
Hypersensitivity to the active substance mometasone furoate or to any of the excipients.
Mometasone Furoate 0.1% w/w Cream is contraindicated in facial rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo), viral (e.g. herpes simplex, herpes zoster and chickenpox) and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions.
4.4 Special warnings and precautions for use
Mometasone Furoate 0.1% w/w Cream should not be used on the eyelids. Caution should be observed in patients who are hypersensitive to any other corticosteroid.
If irritation or sensitisation develop with the use of Mometasone Furoate 0.1% w/w Cream, treatment should be withdrawn and appropriate therapy instituted.
Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.
Local and systemic toxicity is common especially following long continued use on large areas of damaged or broken skin, in flexures and with polythene occlusion. Caution should be exercised when large areas of the body are treated and long term continuous therapy should be avoided in all patients irrespective of age.
Mometasone Furoate 0.1% w/w Cream should not be applied to broken skin.
Topical steroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of centralised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.
As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop which takes the form of a dermatitis with intense redness, stinging and burning. This can be prevented by slow reduction of the treatment, for instance continue treatment on an intermittent basis before discontinuing treatment.
Hyperglycaemia and glucosuria can occur in some patients after topical application due to systemic absorption.
Glucocorticoids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing.
Mometasone Furoate 0.1% w/w Cream contains propylene glycol, which may cause skin irritation.
Mometasone Furoate 0.1% w/w Cream contains stearyl alcohol and also butylated hydroxytoluene, which may cause skin irritations/reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed
4.6 Fertility, Pregnancy and lactation
Pregnancy
Corticosteroids cross the placenta. There is very limited data on the use of topical mometasone during pregnancy. After systemic use of high dose corticosteroids, effects on the fetus/neonate have been described (intra-uterine growth retardation, adrenocortical suppression, cleft palate).
Animal studies have shown reproduction toxicity and teratogenity (see section 5.3). The potential risk for humans is unknown.
Although systemic exposure is limited, Mometasone Furoate 0.1% w/w Cream should only be used during pregnancy when clearly necessary.
Pregnant women should not use the product on large skin areas for long periods.
Lactation
It is not known whether mometasone is excreted into breast milk. However, topical application of mometasone on limited skin areas is not likely to result in any risk for breastfed children. The product should not be applied on the breasts directly before breastfeeding.
4.7 Effects on ability to drive and use machines
Mometasone Furoate 0.1% w/w Cream has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse reactions are listed in Table 1 according to MedDRA system organ class and in decreasing frequency defined as follows:
Very common (> 1/10)
Common (> 1/100 to < 1/10)
Uncommon (> 1/1,000 to < 1/100)
Rare (> 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (frequency cannot be estimated from the available data)
Adverse reactions that have been reported in connection with external corticosteroid treatment include:
Table 1: Treatment-related adverse reactions reported by body system and frequency
|
Skin and subcutaneous tissue disorders | |
|
Common: |
Mild to moderate burning sensations at the application site, tingling/stinging, pruritis, bacterial infections, |
|
paraesthesia,furunculosis and local skin atrophy. | |
|
Uncommon: |
Striae, irritation, hypertrichosis, hypopigmentation, perioral dermatitis, maceration of the skin, allergic contact dermatitis, papulous roseacea like dermatitis (facial skin), acneiform reactions, capillary brittleness (ecchymoses), miliaria, dryness, |
|
Infections and parasitic infestations |
sensitisation (mometasone), folliculitis. |
|
Uncommon | |
|
Vascular disorders |
Secondary infection. |
|
Very rare |
Telangiectasis |
An increased risk of systemic effects and local adverse events exists with frequent dosing, treatment of large areas or in the long term and also the treatment of intertriginous areas or with occlusive dressings. Hypopigmentation or hyperpigmentation has been reported in isolated cases (rare) in connection with other steroids and may therefore occur with Mometasone Furoate 0.1% w/w Cream.
Side effects which have been reported with systemic glucocorticoids -including adrenal suppression - may also occur with topically applied glucocorticoids.
Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface to body weight ratio. Chronic corticosteroids therapy may interfere with the growth and development of children.
Intracranial hypertension has been reported in paediatric patients receiving topical corticosteroids. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilloedema.
4.9 Overdose
Excessive long-term use of external corticosteroids may suppress HPA axis function and give rise to secondary adrenocortical insufficiency. If suppression of the HPA axis has been reported, it should be endeavoured, with the usual
caution being exercised in these situations, to reduce the frequency of applications or to try to withdraw the drug.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticoids, potent (group III)
ATC code: D07AC13
Mometasone Furoate 0.1% w/w Cream is a potent glucocorticoid, group III. The active substance, mometasone furoate, is a synthetic, non-fluorinated glucocorticoid with a furoate ester in position 17.
Like other corticosteroids for external use, mometasone furoate exhibits marked anti-inflammatory activity and marked anti-psoriatic activity in standard animal predictive models.
In the croton oil assay in mice, mometasone (ED50 = 0.2 pg/ear) was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications (ED50 = 0.002 pg/ear/day versus 0.014 pg/ear/day).
In guinea pigs, mometasone was approximately twice as potent as betamethasone valerate in reducing m.ovalis-induced epidermal acanthosis (i.e. anti-psoriatic activity) after 14 applications.
5.2 Pharmacokinetic properties
Results from percutaneous absorption studies have indicated that systemic absorption following topical application of mometasone furoate cream 0.1 % is minimal. The results show that about 0.7 % of the active ingredient is absorbed by the intact skin in 8 hours (without using an occlusive dressing).
Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.
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 the SPC.
6.1 List of excipients
Hexylene Glycol Water, purified Beeswax white
Propylene Glycol Monopalmitostearate Promulgen G (Stearyl alcohol and Ceteareth - 20)
Titanium Dioxide (E171)
Aluminium Starch octenylsuccinate Phosphoric acid concentrated (for pH adjustment)
Paraffin, white soft
Butylated hydroxytoluene (E321) - as an antioxidant in paraffin, white soft.
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years
After first opening: 12 weeks
6.4 Special precautions for storage
Store below 250C
Do not refrigerate or freeze
6.5 Nature and contents of container
15g, 20g, 30g latex lacquered aluminium tubes with high density polyethylene screw cap in a cardboard carton. Each carton contains one tube.
Not all packs sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7. MARKETING AUTHORISATION HOLDER
Glenmark Pharmaceuticals Europe Limited Laxmi House, 2 B Draycott Avenue, Kenton,
Middlesex, HA3 0BU,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 25258/0118
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/04/2011
10 DATE OF REVISION OF THE TEXT
10/10/2014