Drugs List

Therapeutic Indications

Uses

Treatment of dermatological conditions affecting the scalp and other hairy regions of the body:
Seborrhoea
Seborrhoeic dermatitis
Psoriasis (Excluding widespread plaque psoriasis)

Note that the gel may also be used satisfactorily on less hairy parts of the body.

Contraindications

Children under 1 year
Perioral dermatitis
Rosacea
Acne
Napkin eruption
Skin infections
Anogenital pruritus

Precautions and Warnings

Use with caution in the following situations:

Infants and children: They are at particular risk of adrenal suppression because of a large skin surface area to body mass ratio. Limit treatment to 5 days.
Elderly: Treatment may exacerbate age-related skin atrophy.
Use on the face: The face is particularly susceptible to atrophic changes. Treatment on the face should not exceed 5 days.
Pregnancy (see Pregnancy section).
Lactation (see Lactation section).

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.

Occlusion should neither be employed on children nor on the face. Patients using the preparation on the face should be advised to apply the product very thinly and to avoid contact with the eyes.

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; centralised 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.

Note that patients who develop a skin infection may only continue treatment with fluocinolone acetonide if adequate anti-infective cover is also given.

Discontinue if hypersensitivity reactions occur.

The preparation contains hydroxybenzoates.

Pregnancy and Lactation

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 and co-workers (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 and co-workers (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 (see Precautions and Warnings section). 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 14-17 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 at https://www.toxbase.org/

Licensed in pregnancy? - Manufacturer neither recommends nor contraindicates use, citing inadequate evidence of safety.

Recommended for use in pregnancy? - Yes, provided treatment time is brief and area covered is not extensive.

Known human teratogen? - No.

Animal data - Effects on brain growth, cleft palate, retardation of intra-uterine growth.

Crosses placenta? - Not known.

Lactation

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

Lee and co-workers (2000), Hale and co-workers (2006) and the reference database, LactMed (2007), on the other hand, consider topical fluocinolone acetonide 0.025% to be compatible with breastfeeding, although Hale and co-workers advise caution if the agent is used on the nipple.

LactMed (2007) 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.
- A water-miscible cream 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

Considered suitable or recommended by manufacturer? - Yes, if amount applied and duration of treatment are minimised.

UK Drugs in Lactation Advisory Service Classification - Compatible. Women who use the preparation on the breast should wash and dry her breasts before feeding.

Drugs excreted in breast milk? - Likely. However, topical application on relatively small areas and at recommended doses, should yield milk levels close to undetectable.

Drug substance licensed in infants? - Licensed for use above 1 year of age.

Side Effects

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

Drugs List

Therapeutic Indications

Uses

Treatment of dermatological conditions affecting the scalp and other hairy regions of the body:
Seborrhoea
Seborrhoeic dermatitis
Psoriasis (Excluding widespread plaque psoriasis)

Note that the gel may also be used satisfactorily on less hairy parts of the body.

Dosage

Adults

Elderly

Children

Additional Dosage Information

Contraindications

Children under 1 year
Perioral dermatitis
Rosacea
Acne
Napkin eruption
Skin infections
Anogenital pruritus

Precautions and Warnings

Use with caution in the following situations:

Infants and children: They are at particular risk of adrenal suppression because of a large skin surface area to body mass ratio. Limit treatment to 5 days.
Elderly: Treatment may exacerbate age-related skin atrophy.
Use on the face: The face is particularly susceptible to atrophic changes. Treatment on the face should not exceed 5 days.
Pregnancy (see Pregnancy section).
Lactation (see Lactation section).

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.

Occlusion should neither be employed on children nor on the face. Patients using the preparation on the face should be advised to apply the product very thinly and to avoid contact with the eyes.

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; centralised 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.

Note that patients who develop a skin infection may only continue treatment with fluocinolone acetonide if adequate anti-infective cover is also given.

Discontinue if hypersensitivity reactions occur.

The preparation contains hydroxybenzoates.

Pregnancy and Lactation

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 and co-workers (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 and co-workers (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 (see Precautions and Warnings section). 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 14-17 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 at https://www.toxbase.org/

Licensed in pregnancy? - Manufacturer neither recommends nor contraindicates use, citing inadequate evidence of safety.

Recommended for use in pregnancy? - Yes, provided treatment time is brief and area covered is not extensive.

Known human teratogen? - No.

Animal data - Effects on brain growth, cleft palate, retardation of intra-uterine growth.

Crosses placenta? - Not known.

Lactation

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

Lee and co-workers (2000), Hale and co-workers (2006) and the reference database, LactMed (2007), on the other hand, consider topical fluocinolone acetonide 0.025% to be compatible with breastfeeding, although Hale and co-workers advise caution if the agent is used on the nipple.

LactMed (2007) 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.
- A water-miscible cream 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

Considered suitable or recommended by manufacturer? - Yes, if amount applied and duration of treatment are minimised.

UK Drugs in Lactation Advisory Service Classification - Compatible. Women who use the preparation on the breast should wash and dry her breasts before feeding.

Drugs excreted in breast milk? - Likely. However, topical application on relatively small areas and at recommended doses, should yield milk levels close to undetectable.

Drug substance licensed in infants? - Licensed for use above 1 year of age.

Counselling

Breastfeeding women who apply the preparation on their breasts: The preparation should be washed off thoroughly prior to breastfeeding and may be reapplied later.

Patients using the product on the face should be advised to apply it thinly and to avoid application to the eyes.

Side Effects

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

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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Reference Sources

BNF for Children (2007) Pharmaceutical Press, London.

British National Formulary, 55th edition (2008) 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.

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: 27th December 2007
Last accessed: 20th June 2008

Information page on corticosteroids. Available from UK Drugs in Lactation Advisory Service. Trent and West Midland Regional Medicines Information.
https://www.ukmicentral.nhs.uk/drugpreg/corticosteroids.asp
Last accessed on 20th June 2008

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

Medications and Mother's Milk, 12th edition (2006) Hale, T.W. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Synalar gel. GP Pharma Ltd. Revised September 2005.