Drugs List

Therapeutic Indications

Uses

Treatment of inflammatory and pruritic manifestations of:
Psoriasis (excluding widespread plaque psoriasis)
Atopic dermatitis

Precautions and Warnings

Pregnancy (see Pregnancy section)
Breastfeeding (see Lactation section)

Children and infants are particularly susceptible to adrenal suppression. Treatment of children should not exceed 5 days and occlusion should not be used. Caution is required in children under 2 years of age. The safety and efficacy of mometasone has not been established in these patients.

Long-term, continuous use of topical corticosteroids should be avoided in all patients. Such use greatly increases the risk of local and systemic toxicity, particularly in flexural sites or when the preparation has been applied on large areas of damaged skin or when occlusion has been used. Adrenal suppression and atrophic skin changes are more likely to occur following long-term continuous therapy.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, topical use of mometasone should be discontinued until the infection is adequately controlled.

Systemic absorption of topical corticosteroids 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 to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

Treatment with corticosteroids is associated with a number of side effects which may seriously complicate the condition of patients suffering with psoriasis. Patients may experience rebound relapse if tolerance develops; generalised pustular psoriasis and/or systemic toxicity may also arise as a consequence of a damaged skin barrier. Prescribers are therefore advised to carefully supervise the treatment of patients with psoriasis.

Avoid sudden discontinuation. 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.

For use on the face, advise patients to apply a very thin film and avoid contact with the eyes. Occlusion should neither be employed on children nor the face.

Contains propylene glycol, may cause skin irritation.

Discontinue if irritation or sensitisation occur.

Pregnancy and Lactation

Pregnancy

Topical mometasone should only be used during pregnancy after careful consideration.

At the time of printing, there are only limited data describing the topical use of mometasone in human pregnancy. The risk of side effects to the human foetus is unknown.

Animal studies of topical corticosteroids have revealed side effects such as cleft palate and intra-uterine growth retardation.

However, Lee (2000) note that the extensive human experience with systemic corticosteroids has not shown any evidence of congenital anomalies. Schaefer (2007), concludes that the use of potent topical corticosteroids such as mometasone furoate is acceptable during pregnancy if the preparation is applied to small areas and at the recommended dose. Lee (2000) recommends that treatment regimens should follow a pulse-dose pattern consisting of up to 7 days of steroid treatment followed by 2-3 days of abatement.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Mometasone should only be given to breastfeeding women after careful consideration.

Corticosteroids may be excreted into breast milk. Hale (2010) suggests it would be unlikely for mometasone to be excreted into human milk in clinically relevant levels. Lee (2000) considers the use of topical corticosteroids during lactation is unlikely to cause any problems.

If mometasone preparations are used on the breast, they should be washed off before breastfeeding and re-applied later. It may also be prudent to employ water-miscible preparations to ensure easy washing-off and avoid the possibility that the infant ingests any paraffin residues when licking.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Skin atrophy
Striae
Perioral dermatitis
Acne-like eruptions
Hypertrichosis
Adrenal suppression
Folliculitis
Burning sensation (local)
Pruritus
Irritation (localised)
Maceration (prolonged use)
Miliaria
Exacerbation of infection
Telangiectasia
Pustular psoriasis
Dry skin
Paraesthesia
Pain at application site
Application site reaction
Dermatitis
Hypopigmentation
Cushing's syndrome
Suppression of growth in children and adolescents

Presentation

Cream containing 0.1% of mometasone furoate
Ointment containing 0.1% of mometasone furoate

Drugs List

Therapeutic Indications

Uses

Treatment of inflammatory and pruritic manifestations of:
Psoriasis (excluding widespread plaque psoriasis)
Atopic dermatitis

Dosage

Adults

Elderly

Children

Precautions and Warnings

Pregnancy (see Pregnancy section)
Breastfeeding (see Lactation section)

Children and infants are particularly susceptible to adrenal suppression. Treatment of children should not exceed 5 days and occlusion should not be used. Caution is required in children under 2 years of age. The safety and efficacy of mometasone has not been established in these patients.

Long-term, continuous use of topical corticosteroids should be avoided in all patients. Such use greatly increases the risk of local and systemic toxicity, particularly in flexural sites or when the preparation has been applied on large areas of damaged skin or when occlusion has been used. Adrenal suppression and atrophic skin changes are more likely to occur following long-term continuous therapy.

Should an infection develop, use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly, topical use of mometasone should be discontinued until the infection is adequately controlled.

Systemic absorption of topical corticosteroids 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 to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

Treatment with corticosteroids is associated with a number of side effects which may seriously complicate the condition of patients suffering with psoriasis. Patients may experience rebound relapse if tolerance develops; generalised pustular psoriasis and/or systemic toxicity may also arise as a consequence of a damaged skin barrier. Prescribers are therefore advised to carefully supervise the treatment of patients with psoriasis.

Avoid sudden discontinuation. 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.

For use on the face, advise patients to apply a very thin film and avoid contact with the eyes. Occlusion should neither be employed on children nor the face.

Contains propylene glycol, may cause skin irritation.

Discontinue if irritation or sensitisation occur.

Pregnancy and Lactation

Pregnancy

Topical mometasone should only be used during pregnancy after careful consideration.

At the time of printing, there are only limited data describing the topical use of mometasone in human pregnancy. The risk of side effects to the human foetus is unknown.

Animal studies of topical corticosteroids have revealed side effects such as cleft palate and intra-uterine growth retardation.

However, Lee (2000) note that the extensive human experience with systemic corticosteroids has not shown any evidence of congenital anomalies. Schaefer (2007), concludes that the use of potent topical corticosteroids such as mometasone furoate is acceptable during pregnancy if the preparation is applied to small areas and at the recommended dose. Lee (2000) recommends that treatment regimens should follow a pulse-dose pattern consisting of up to 7 days of steroid treatment followed by 2-3 days of abatement.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Mometasone should only be given to breastfeeding women after careful consideration.

Corticosteroids may be excreted into breast milk. Hale (2010) suggests it would be unlikely for mometasone to be excreted into human milk in clinically relevant levels. Lee (2000) considers the use of topical corticosteroids during lactation is unlikely to cause any problems.

If mometasone preparations are used on the breast, they should be washed off before breastfeeding and re-applied later. It may also be prudent to employ water-miscible preparations to ensure easy washing-off and avoid the possibility that the infant ingests any paraffin residues when licking.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patients who use topical mometasone on the face to apply it very thinly and avoid contact with the eyes.

Advise patient to avoid sudden discontinuation of therapy. Treatment can be intermittent before discontinuing.

Advise breastfeeding women to wash any preparation off prior to breastfeeding.

Side Effects

Skin atrophy
Striae
Perioral dermatitis
Acne-like eruptions
Hypertrichosis
Adrenal suppression
Folliculitis
Burning sensation (local)
Pruritus
Irritation (localised)
Maceration (prolonged use)
Miliaria
Exacerbation of infection
Telangiectasia
Pustular psoriasis
Dry skin
Paraesthesia
Pain at application site
Application site reaction
Dermatitis
Hypopigmentation
Cushing's syndrome
Suppression of growth in children and adolescents

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Storage requirements vary according to brand.

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

BNF for Children (2012-2013) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Mometasone cream and ointment. Auden McKenzie (Pharma Division). Revised June 2012.
Summary of Product Characteristics: Elocon cream and ointment. Merck Sharp and Dohme Ltd. Revised March 2012.

Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Abingdon.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Mometasone, topical. Last revised: April 3, 2012
Last accessed: October 22, 2012