Mometasone Furoate 0.1% W/W Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate 0.1% w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains 1 mg of mometasone furoate (0.1% w/w mometasone furoate).
Excipients: 20 mg propylene glycol monopalmitostearate per gram of ointment
(2.0% w/w)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Opaque ointment.
4.1 Therapeutic indications
Mometasone Furoate 0.1% w/w Ointment is indicated for the treatment of inflammatory and pruritic manifestations of psoriasis (excluding widespread plaque psoriasis) and atopic dermatitis.
This medicinal product is indicated in adults and children above 6 years of age.
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 Ointment should be applied to the affected areas of skin 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 Ointment 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 6years: Mometasone Furoate 0.1% Ointment 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
Mometasone Furoate 0.1% w/w Ointment is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster, chickenpox, verrucae vulgares, condylomata acuminate and molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections, varicella, tuberculosis, syphilis or post-vaccine reactions. Mometasone Furoate 0.1% Ointment should not be used on wounds or on skin which is ulcerated. Mometasone Furoate 0.1% w/w Ointment should not be used in patients who are sensitive to mometasone furoate or to other corticosteroids or to any of the ingredients in this medicine.
4.4 Special warnings and special precautions for use
If irritation or sensitisation develop with the use of Mometasone Furoate 0.1% w/w Ointment, 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.
Systemic absorption of topical corticosteriods can produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in
infants and children.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. As the safety and efficacy of Mometasone Furoate in paediatric patients below 6 years of age have not been established, its use in this age group is not recommended.
Local and systemic toxicity is common especially following long continued use on large areas of damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face, occlusion should not be used. If used on the face, courses should be limited to 5 days and occlusion should not be used. Long term continuous therapy should be avoided in all patients irrespective of age.
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.
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 Ointment contains propylene glycol which may cause skin irritation.
Mometasone Furoate 0.1% w/w Ointment topical preparations are not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, Pregnancy and lactation
During pregnancy and lactation treatment with Mometasone Furoate should be performed only on the physician’s order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There are no adequate and well-controlled studies with Mometasone Furoate in pregnant women and therefore the risk of such effects to the human fetus is unknown. However as with all topically applied
glucocorticoids, the possibility that fetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a very small risk of such effects in the human fetus. Like other topically applied glucocorticoids, Mometasone Furoate should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the fetus.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Mometasone Furoate 0.1% w/w Ointment should be administered to nursing mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breast feeding should be discontinued.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
|
Table 1: Treatment-related adverse reactions reported with Mometasone Furoate by body system and frequency Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10 000,); not known (cannot be estimated from available data) | |
|
Infections and infestations Not known |
Infection, furuncle |
|
Very rare |
Folliculitis |
|
Nervous system disorders Not known |
Paraesthesia, |
|
Very rare |
Burning sensation |
|
Skin and subcutaneous tissue disorders Not known |
Dermatitis contact, skin hypopigmentation, hypertrichosis, skin striae, dermatitis acneiform, skin atrophy |
|
Very rare |
Pruritus |
|
General disorders and administration site conditions Not known |
Application site pain, application site reactions |
Local adverse reactions reported infrequently with topical dermatalogic corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis, maceration of the skin, miliaria and telangiectasiae.
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 area to body weight ratio.
Chronic corticosteroids therapy may interfere with the growth and development of children.
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 <National reporting system>.
4.9 Overdose
Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.
The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Mometasone furoate exhibits marked anti-inflammatory activity and marked antipsoriatic activity in standard animal predictive models.
In the croton oil assay in mice, mometasone was equipotent to betamethasone valerate after single application and about 8 times as potent after five applications.
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
Pharmacokinetic studies have indicated that systemic absorption following topical application of mometasone furoate ointment 0.1% is minimal, approximately 0.4% of the applied dose in man, the majority of which is excreted within 72 hours following application. Characterisation of metabolites was not feasible owing to the small amounts present in plasma and excreta.
5.3 Preclinical safety data
There are no findings of relevance other than those mentioned elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hexylene glycol White beeswax
Propylene glycol monopalmitostearate Dilute phosphoric acid White soft paraffin Purified water
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed
with other medicinal products.
6.3 Shelf life
2 years.
In-use shelf life: 3 months
6.4 Special precautions for storage
Store below 30 °C.
Nature and contents of container
6.5.
Collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a polypropylene cap.
Pack sizes: 30g, 60g or 100g.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Auden Mckenzie (Pharma Division) Ltd
McKenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 17507/0112
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/06/2012
10 DATE OF REVISION OF THE TEXT
26/06/2015