Drugs List

Therapeutic Indications

Uses

Dermatitis
Eczema
Lichen planus
Lupus erythematosus - discoid
Otitis externa - eczematous
Prurigo
Psoriasis excluding widespread plaque psoriasis

Contraindications

Children under 1 year
Nappy rash
Acne vulgaris
Anogenital pruritus
Hypersensitivity to lanolin
Perioral dermatitis
Rosacea
Skin infection

Precautions and Warnings

Breastfeeding
Pregnancy

Appropriate antibiotic therapy required in presence or if risk of infection
Careful supervision of patients with psoriasis required
Some formulations contain hydroxybenzoate
Some formulations contain lanolin
Avoid accumulation of product in skin folds or in angles of the nose
Avoid application to extensive areas
Avoid contact with eyes
Avoid occlusion in children or on face
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Cleanse skin thoroughly before applying occlusive dressings
Occlusive dressings can increase the likelihood of systemic absorption
Adrenal suppression may occur even without occlusion
Prolonged use may cause atrophic skin changes
Risk of generalised pustular psoriasis with use of topical corticosteroids
Discontinue if hypersensitivity reactions occur
Avoid long-term use particularly in infants and children
Limit use in children to 5 days
Limit use on face to 5 days
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to take care when applying to the face
Fire hazard: Keep away from naked flames and potential sources of ignition

Adrenal suppression is a hazard of corticosteroids and treatment regimens which augment systemic absorption are all likely to precipitate the condition. Patients applying fluocinolone acetonide preparations to a large surface area, to flexural sites, or to areas under occlusion should thus be evaluated periodically for evidence of adrenal suppression. Particular caution is also warranted in patients on long term continuous therapy as they are additionally at risk of often irreversible atrophic skin changes.

Treatment with corticosteroids is further associated with a number of side effects which may seriously complicate the condition of patients suffering from 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.

Pregnancy and Lactation

Pregnancy

Use fluocinolone acetonide with caution in pregnancy.

UK licensed product information warns that the use of topical fluocinolone acetonide during pregnancy is possibly associated with a very small risk of side effects to mother and foetus. The warning stems from the results of animal studies in which topical corticosteroids were associated with side effects such as interference with brain growth, cleft palate and intra-uterine growth retardation.

However, Lee (2000) note that human experience with systemic corticosteroids has not shown any evidence of congenital anomalies or foetal toxicity. The authors thus conclude that treatment with topical fluocinolone is compatible with pregnancy. Schaefer (2007) concur provided the treatment time of topical corticosteroids is brief and the area covered is not extensive.

Occlusion should probably be avoided, along with any other treatment regimen liable to augment systemic absorption. Whenever possible, lower potency preparations should be preferred.

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 to 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 fluocinolone acetonide with caution in breastfeeding.

UK licensed product information recommends that topical fluocinolone acetonide should only be used during breastfeeding if it is clearly necessary. Furthermore, practitioners should prescribe low doses and keep the duration of treatment as short as possible.

Lee (2000), Hale (2014) and the reference database, Lactmed, on the other hand, consider topical fluocinolone acetonide 0.025% to be compatible with breastfeeding.

LactMed offers the following recommendations for practitioners who still wish to prescribe topical fluocinolone acetonide for use on the nipple:
Prescribers should advise their patients to wipe the cream off thoroughly prior to nursing if applied to breast or nipple area.
A water-miscible preparation is preferred to avoid the possibility of the infant ingesting any paraffin residues when licking on the nipple.

Corticosteroids may be excreted into breast milk, however milk levels of topically applied drugs are expected to be minimal.

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

Acne (at application site)
Adrenal suppression
Allergic contact dermatitis
Exacerbation of infection
Hypertrichosis
Irritation (localised)
Mild depigmentation and vellus hair
Perioral dermatitis
Pustular psoriasis
Sensitisation
Striae (irreversible)
Superficial vascular dilation
Telangiectasia
Thinning of skin

Presentation

Topical formulation of fluocinolone acetonide

Drugs List

Therapeutic Indications

Uses

Dermatitis
Eczema
Lichen planus
Lupus erythematosus - discoid
Otitis externa - eczematous
Prurigo
Psoriasis excluding widespread plaque psoriasis

Dosage

Patients should be switched to weaker preparations of fluocinolone acetonide as their condition improves.

Occlusion techniques must not be used in children or on the face, but they may be used on other parts of the body. Occlusion should only be performed on thoroughly cleansed skin. In some circumstances, the application of hot, moist compresses may be beneficial.

The cream is particularly suitable for moist surfaces and for flexural areas while the ointment is more appropriate for dry, scaly lesions.

Adults

Elderly

Children

Contraindications

Children under 1 year
Nappy rash
Acne vulgaris
Anogenital pruritus
Hypersensitivity to lanolin
Perioral dermatitis
Rosacea
Skin infection

Precautions and Warnings

Breastfeeding
Pregnancy

Appropriate antibiotic therapy required in presence or if risk of infection
Careful supervision of patients with psoriasis required
Some formulations contain hydroxybenzoate
Some formulations contain lanolin
Avoid accumulation of product in skin folds or in angles of the nose
Avoid application to extensive areas
Avoid contact with eyes
Avoid occlusion in children or on face
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Cleanse skin thoroughly before applying occlusive dressings
Occlusive dressings can increase the likelihood of systemic absorption
Adrenal suppression may occur even without occlusion
Prolonged use may cause atrophic skin changes
Risk of generalised pustular psoriasis with use of topical corticosteroids
Discontinue if hypersensitivity reactions occur
Avoid long-term use particularly in infants and children
Limit use in children to 5 days
Limit use on face to 5 days
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to take care when applying to the face
Fire hazard: Keep away from naked flames and potential sources of ignition

Adrenal suppression is a hazard of corticosteroids and treatment regimens which augment systemic absorption are all likely to precipitate the condition. Patients applying fluocinolone acetonide preparations to a large surface area, to flexural sites, or to areas under occlusion should thus be evaluated periodically for evidence of adrenal suppression. Particular caution is also warranted in patients on long term continuous therapy as they are additionally at risk of often irreversible atrophic skin changes.

Treatment with corticosteroids is further associated with a number of side effects which may seriously complicate the condition of patients suffering from 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.

Pregnancy and Lactation

Pregnancy

Use fluocinolone acetonide with caution in pregnancy.

UK licensed product information warns that the use of topical fluocinolone acetonide during pregnancy is possibly associated with a very small risk of side effects to mother and foetus. The warning stems from the results of animal studies in which topical corticosteroids were associated with side effects such as interference with brain growth, cleft palate and intra-uterine growth retardation.

However, Lee (2000) note that human experience with systemic corticosteroids has not shown any evidence of congenital anomalies or foetal toxicity. The authors thus conclude that treatment with topical fluocinolone is compatible with pregnancy. Schaefer (2007) concur provided the treatment time of topical corticosteroids is brief and the area covered is not extensive.

Occlusion should probably be avoided, along with any other treatment regimen liable to augment systemic absorption. Whenever possible, lower potency preparations should be preferred.

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 to 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 fluocinolone acetonide with caution in breastfeeding.

UK licensed product information recommends that topical fluocinolone acetonide should only be used during breastfeeding if it is clearly necessary. Furthermore, practitioners should prescribe low doses and keep the duration of treatment as short as possible.

Lee (2000), Hale (2014) and the reference database, Lactmed, on the other hand, consider topical fluocinolone acetonide 0.025% to be compatible with breastfeeding.

LactMed offers the following recommendations for practitioners who still wish to prescribe topical fluocinolone acetonide for use on the nipple:
Prescribers should advise their patients to wipe the cream off thoroughly prior to nursing if applied to breast or nipple area.
A water-miscible preparation is preferred to avoid the possibility of the infant ingesting any paraffin residues when licking on the nipple.

Corticosteroids may be excreted into breast milk, however milk levels of topically applied drugs are expected to be minimal.

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

Acne (at application site)
Adrenal suppression
Allergic contact dermatitis
Exacerbation of infection
Hypertrichosis
Irritation (localised)
Mild depigmentation and vellus hair
Perioral dermatitis
Pustular psoriasis
Sensitisation
Striae (irreversible)
Superficial vascular dilation
Telangiectasia
Thinning of skin

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 ).

Further Information

Last Full Review Date: February 2015

Reference Sources

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

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.

Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 4 February 2015.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Synalar cream. GP Pharma Ltd. Revised September 2014.

Summary of Product Characteristics: Synalar cream 1 in 4 dilution. GP Pharma Ltd. Revised September 2014.

Summary of Product Characteristics: Synalar ointment 0.025% w/w. GP Pharma Ltd. Revised September 2014.

Summary of Product Characteristics: Synalar ointment 1 in 4 dilution. GP Pharma Ltd. Revised September 2014.

Summary of Product Characteristics: Synalar cream 1 in 10 dilution. GP Pharma Ltd. Revised September 2014.

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

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 07 June 2017

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
Fluocinolone Last revised: 1 August 2014
Last accessed: 4 February 2015