Mometasone Furoate

Registered South African indications:

• Relief of the inflammatory manifestations of psoriasis and corticosteroid-responsive dermatoses

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Viral infections such as herpes simplex, vaccinia and varicella
• Untreated fungal infections (cre)

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Ophthalmic use

• Mometasone furoate is not for ophthalmic use, including the eyelids, because of the very rare risk of glaucoma simplex or subcapsular cataract
• Use with caution near eyes

Irritation or sensitisation

• If irritation or sensitisation develop with the use of mometasone furoate, treatment should be discontinued, and appropriate therapy instituted

Systemic absorption

• Systemic absorption of topical corticosteroids, such as mometasone, can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycaemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid such as mometasone to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression
• Risk increases when using large quantities, applying to wide body areas or damaged skin, and when using occlusive dressings
• 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

Discontinuation of treatment

• As with all potent topical glucocorticoids, such as mometasone, 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

Duration of use

• Safety of use for more than three weeks has not been established and mometasone furoate should therefore be used for short courses only
• Long term continuous or inappropriate use of topical steroids such as mometasone can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated
• Mometasone furoate should not be applied to any skin crease areas and especially not in the nappy area of infants. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected
• Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered

Skin changes

• Glucocorticoids such as mometasone can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing

Use in psoriasis

• Treatment of psoriasis may provoke the pustular form of the disease
• Topical steroids such as mometasone 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

Secondary infection

• Institute suitable concomitant antimicrobial therapy if a secondary microbial skin infection is present. If a favourable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled

Visual disturbance

• If symptoms like blurred vision occur, refer to an ophthalmologist for evaluation of cataracts, glaucoma, or central serous chorioretinopathy (CSCR)

Fire hazard

• Instruct patients not to smoke or go near naked flames - risk of severe burns
• Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it

Effects on ability to drive and use machines

• Mometasone furoate has no or negligible influence on the ability to drive or operate machinery

Forms avail. in South Africa and covered in this monograph: cre, lot, oin

South African registered indications and dosages

Relief of the inflammatory manifestations of psoriasis and corticosteroid-responsive dermatoses

• Topical (cre, oin): Apply a thin film to completely cover the affected area, once dly; Max duration: 3 weeks

- Scalp lesions

• Topical (lot): Apply a few drops to the affected skin area and massage gently and thoroughly into the skin, once dly; Max duration: 3 weeks

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Treatment should be discontinued when the dermatologic disorder is controlled. According to clinical response, duration of therapy may vary from a few days to a longer period of time. However, treatment should not be continued for more than 3 weeks without patient re-evaluation

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See link: General prescribing points for steroids

Paed. forms avail. in South Africa and covered in this monograph: cre, lot, oin

South African registered indications and dosages

Relief of the inflammatory manifestations of psoriasis and corticosteroid-responsive dermatoses

Younger than 2 years

•  Not recommended

Older than 2 years

•  Topical (cre, oin): See adult dosage; Max duration: 3 weeks

- Scalp lesions

Younger than 2 years

•  Not recommended

Older than 2 years

•  Topical (lot): See adult dosage; Max duration: 3 weeks

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Treatment should be discontinued when the dermatologic disorder is controlled. According to clinical response, duration of therapy may vary from a few days to a longer period of time. However, treatment should not be continued for more than 3 weeks without patient re-evaluation

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Paediatric 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 in paediatric patients below 2 years of age have not been established, its use in this age group is not recommended. 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

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Mometasone furoate cream should not be applied to any skin crease areas and especially not in the nappy area of infants

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See link: General prescribing points for steroids

Pregnancy

South African recommendations

• Caution; not recommended
• Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, mometasone furoate should not be used during pregnancy

Breastfeeding

South African recommendations

• Caution; not recommended
• Mometasone Furoate is not recommended for breastfeeding mothers

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

Infections and Infestations

Frequency unknown

• Infection
• Furuncle

Endocrine Disorders

Less frequent

• Benign intracranial hypertension
• Cushingoid state
• Depression of the hypothalamic-pituitary-adrenal axis
• Consequent suppression of the adrenal gland
• Growth retardation

Nervous System Disorders

Less frequent

• Burning sensation

Frequency unkown 

• Paraesthesia

Eye Disorders

Frequency unknown

• Blurred vision

Skin and Subcutaneous Tissue Disorders

Less frequent

• Allergic contact dermatitis
• Burning
• Dryness
• Folliculitis
• Irritation
• Itching
• Secondary infection
• Skin atrophy
• Acneiform eruptions
• Perioral dermatitis
• Hypertrichosis
• Hypopigmentation
• Miliaria
• Maceration
• Skin thinning
• Loss of elasticity
• Dilation of superficial blood vessels
• Telangiectasia
• Ecchymosis
• Pruritus

Frequency unknown

• Withdrawal reactions
  - Redness of the skin which may extend to areas beyond the initial affected area
• Burning or stinging sensation
• Itch
• Skin peeling
• Oozing pustules

General Disorders and Administration Site Conditions

Frequency unknown 

• Application site pain
• Application site reactions

No information available

None routine

Mometasone is a medium-potency synthetic topical steroid that has anti-inflammatory, antipruritic and vasoconstrictive actions.

Cream (per g) 1mg

• Aspen Mometasone (Pharmacare)
• Elocon (Organon) originator
• Momate (Activo)
• Mometagen 0,1% (Mylan)

Ointment (per g) 1mg

• Elocon (Organon) originator
• Momate (Activo)

Lotion (per g) 1mg

• Elocon (Organon) originator

Also available in the following forms: Nasal spray and inhaler.

COMBINATION PREPARATIONS

Mometasone/ Salicylic acid

Ointment (per g) 1mg/50mg

• Elosalic (Schering-Plough) originator