Drugs List

Therapeutic Indications

Uses

Eczema - atopic and discoid eczema
Dermatitis - neuro-dermatitis, seborrhoeic and contact dermatitis
Prurigo
Psoriasis (excluding widespread plaque psoriasis)
Lichen planus
Discoid lupus erythematosus

Administration

For topical administration.

Cream - may be used for wet or dry lesions
Ointment - particularly suitable for dry scaly lesions

Contraindications

Children under 1 year old
Rosacea
Acne
Perioral dermatitis
Tuberculous, syphilitic, fungal and viral skin infections
Napkin eruption
Anogenital pruritus

Precautions and Warnings

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

Long term continuous use of topical steroids can produce atrophic skin changes and dilation of the superficial blood vessels, particularly when occlusive dressings are used, or where skin folds are involved.

Prolonged use of topical steroids or treatment of extensive areas, even without occlusion, can result in sufficient absorption of the steroid to produce the features of hypercorticalism and underlying adrenal suppression, especially in infants and children.

Treatment on the face should not extend beyond 5 days, and in such cases, occlusion should not be used.

Where there is bacterial infection associated with an inflammatory skin condition, fluocinonide cream or ointment should only be administered if adequate antibacterial cover is also given. The use of topical steroids on infected lesions, without the addition of appropriate anti-infective therapy can result in the spread of opportunistic infections.

When using topical steroids to treat psoriasis, there are risks of rebound relapse following the development of tolerance, and of generalised pustular psoriasis. Impairment of the barrier function of the skin may lead to local and systemic toxicity. Careful patient supervision is required.

Care should be taken to avoid contact with the eyes.

Pregnancy and Lactation

Pregnancy

Caution should be used when treating pregnant women.

There is inadequate evidence of safety in human pregnancy. It is not known if if fluocinonide can cross the human placenta however its molecular weight is low enough to suggest it could.

Topical administration of steroids to pregnant animals can cause abnormalities to foetal development and intrauterine growth retardation.
There may be a small risk of such effects on the human foetus.

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

Use with caution.

No human data on the use of fluocinonide during breastfeeding is available at the time of writing.

Topical steroids should not be applied to the breasts whilst nursing. If topical treatment is considered necessary on other parts of the body, the amount applied and the length of treatment should be minimised. Briggs suggests if long term therapy is required consideration should be given to a less potent corticosteroid.

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

Hypersensitivity reactions
Irritation at application site
Local atrophic changes
Striae (irreversible)
Thinning of skin
Telangiectasia
Adrenal suppression
Contact dermatitis
Perioral dermatitis
Acne
Skin depigmentation
Hypertrichosis

Presentation

Topical formulations of fluocinonide.

Drugs List

Therapeutic Indications

Uses

Eczema - atopic and discoid eczema
Dermatitis - neuro-dermatitis, seborrhoeic and contact dermatitis
Prurigo
Psoriasis (excluding widespread plaque psoriasis)
Lichen planus
Discoid lupus erythematosus

Dosage

Adults

Children

Administration

For topical administration.

Cream - may be used for wet or dry lesions
Ointment - particularly suitable for dry scaly lesions

Contraindications

Children under 1 year old
Rosacea
Acne
Perioral dermatitis
Tuberculous, syphilitic, fungal and viral skin infections
Napkin eruption
Anogenital pruritus

Precautions and Warnings

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

Long term continuous use of topical steroids can produce atrophic skin changes and dilation of the superficial blood vessels, particularly when occlusive dressings are used, or where skin folds are involved.

Prolonged use of topical steroids or treatment of extensive areas, even without occlusion, can result in sufficient absorption of the steroid to produce the features of hypercorticalism and underlying adrenal suppression, especially in infants and children.

Treatment on the face should not extend beyond 5 days, and in such cases, occlusion should not be used.

Where there is bacterial infection associated with an inflammatory skin condition, fluocinonide cream or ointment should only be administered if adequate antibacterial cover is also given. The use of topical steroids on infected lesions, without the addition of appropriate anti-infective therapy can result in the spread of opportunistic infections.

When using topical steroids to treat psoriasis, there are risks of rebound relapse following the development of tolerance, and of generalised pustular psoriasis. Impairment of the barrier function of the skin may lead to local and systemic toxicity. Careful patient supervision is required.

Care should be taken to avoid contact with the eyes.

Pregnancy and Lactation

Pregnancy

Caution should be used when treating pregnant women.

There is inadequate evidence of safety in human pregnancy. It is not known if if fluocinonide can cross the human placenta however its molecular weight is low enough to suggest it could.

Topical administration of steroids to pregnant animals can cause abnormalities to foetal development and intrauterine growth retardation.
There may be a small risk of such effects on the human foetus.

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

Use with caution.

No human data on the use of fluocinonide during breastfeeding is available at the time of writing.

Topical steroids should not be applied to the breasts whilst nursing. If topical treatment is considered necessary on other parts of the body, the amount applied and the length of treatment should be minimised. Briggs suggests if long term therapy is required consideration should be given to a less potent corticosteroid.

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

Effects on Ability to Drive and Operate Machinery

No precautions are necessary.

Side Effects

Hypersensitivity reactions
Irritation at application site
Local atrophic changes
Striae (irreversible)
Thinning of skin
Telangiectasia
Adrenal suppression
Contact dermatitis
Perioral dermatitis
Acne
Skin depigmentation
Hypertrichosis

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

Ointment:
Store below 25 degrees C

Cream:
Store below 30 degrees C

Further Information

Last Full Review Date: December 2011

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Metosyn Ointment. Derma UK. Revised July 2015.

Summary of Product Characteristics: Metosyn FAPG Cream. Derma UK. Revised July 2015.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 August 2017