Skip to content
ClinCalc Pro
Menu
Potent topical corticosteroid Pregnancy: UK SPC section 4.6 - Pregnancy: there is inadequate evidence of safety in human pregnancy. Topical administration of steroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects on the human foetus. Lactation: topical steroids should not be applied to the breasts prior to nursing. When steroid treatment is considered necessary during breast feeding, both the amount applied and the length of treatment should be minimised.

Fluocinolone acetonide

Brand names: Synalar

Fluocinolone acetonide is a potent topical corticosteroid used for inflammatory skin conditions such as eczema and psoriasis, available in formulations including a scalp application.

Adult dose

Dose: Inflammatory, pruritic and allergic disorders of the skin (eczema and dermatitis, prurigo, psoriasis excluding widespread plaque psoriasis, lichen planus, discoid lupus erythematosus): a small quantity of the cream applied lightly to the affected area two or three times a day and massaged gently and thoroughly into the skin (adults including the elderly)
Route: Topical (cream applied to the skin) - not for the eyes
Frequency: Two or three times a day
SOURCE SCOPE: UK SPC for SYNALAR (Fluocinolone Acetonide 0.025%) Cream 100g (eMC product 100199). The Synalar ointment, gel and diluted (1 in 4) presentations are not covered by this SPC. INDICATIONS (section 4.1, verbatim): 'Synalar contains an effective topical steroid and is suitable for treating a wide variety of inflammatory, pruritic and allergic disorders of the skin. Synalar is particularly suitable for topical application in: Eczema and dermatitis; atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis. Prurigo Psoriasis (Excluding widespread plaque psoriasis) Lichen Planus, Discoid Lupus Erythematosus.' POSOLOGY (section 4.2, verbatim): 'A small quantity of the Synalar preparation is applied lightly to the affected area two or three times a day, and massaged gently and thoroughly into the skin. When an occlusive dressing is required, the affected area should first be thoroughly cleansed. Synalar is then applied and covered with a suitable dressing. Occlusion should not be used for children or for the face. In some cases, the application of hot, moist compresses may be an advantage. The cream is particularly suitable for moist or weeping surfaces and for flexures of the body.' NO MAXIMUM QUANTITY, weekly total or fingertip-unit figure is printed. The only stated limit is one of DURATION (section 4.4): 'It is recommended that treatment on the face and for children should not normally be extended beyond five days, and occlusion in such cases should not be used.' The label states the product is a strong steroid (section 4.4: 'The label will state strong steroid'). Avoid the eyes. Only use where there is an associated infection if adequate anti-infective cover is given. CHILDREN: see paedDose; not advised under one year of age.

Paediatric dose

Dose: Children above one year: as for adults - a small quantity of the cream applied lightly to the affected area two or three times a day; on the face and in children treatment should not normally extend beyond five days, and occlusion should not be used. Not advised under one year of age
Route: Topical (cream applied to the skin) - not for the eyes
Frequency: Two or three times a day
NOT WEIGHT-BASED - dosePerKg is null; a quantity per application is not printed. SPC section 4.2 heading, verbatim: 'Adults (including the elderly) and children above one'; 'Occlusion should not be used for children or for the face.' Section 4.3: 'Synalar preparations are not advised in the treatment of children under one year of age.' Section 4.4: 'It is recommended that treatment on the face and for children should not normally be extended beyond five days, and occlusion in such cases should not be used.' '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.'

Dose adjustments

Renal

No renal dose adjustment is stated in the UK SPC sections retrieved (section 4.2 gives none).

Hepatic

No hepatic dose adjustment is stated in the UK SPC sections retrieved (section 4.2 gives none).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Primary infections of the skin caused by bacteria, fungi or viruses
  • Rosacea, acne, perioral dermatitis, anogenital pruritus and napkin eruptions
  • Patients hypersensitive to any of the ingredients
  • Not advised in the treatment of children under one year of age

Side effects

  • Frequency not known (SPC section 4.8) - Immune system: local hypersensitivity reactions
  • Endocrine: adrenal suppression. Eye: vision blurred
  • Skin: dermatitis, perioral dermatitis, acne or worsening of acne, acne rosacea
  • Extensive treatment, particularly involving occlusive dressings or where skin folds are involved, can result in local atrophic changes such as striae, skin thinning and telangiectasia; mild depigmentation (which may be reversible), hypertrichosis and irreversible striae
  • 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: irritation at the site of application
  • Infections: use of topical steroids on infected lesions without appropriate anti-infective therapy can result in the spread of opportunist infections

Interactions

  • None known (SPC section 4.5)

Monitoring

  • Careful patient supervision is important; discontinue treatment if unfavourable reactions are seen
  • Local atrophic skin changes and dilatation of the superficial blood vessels with long-term continuous use, particularly under occlusive dressings or in skin folds
  • Features of hypercorticalism and underlying adrenal suppression where use is prolonged or areas are extensive, even without occlusion - especially in infants and children
  • Topical steroid withdrawal: if the condition recurs within days to weeks after successful treatment a withdrawal reaction should be suspected; reapply only with caution and seek specialist advice or consider other options (more likely on delicate sites such as the face and flexures)
  • Psoriasis: risk of rebound relapse following development of tolerance, and of generalised pustular psoriasis
  • Blurred vision or other visual disturbance: consider referral to an ophthalmologist (possible cataract, glaucoma or central serous chorioretinopathy)
  • Excipients: cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis); propylene glycol may cause skin irritation

Clinical monograph

How it works

It activates intracellular glucocorticoid receptors, producing anti-inflammatory, immunosuppressive and vasoconstrictive effects within the skin.

Prescribing in practice

  • As a potent steroid, prolonged use or application to the face, flexures or under occlusion increases the risk of skin atrophy and systemic absorption; use the lowest effective potency for the shortest duration.
  • Lower-strength formulations are preferred for delicate sites such as the face and skin folds.
  • Do not apply to untreated bacterial, fungal or viral skin infection.

Monitoring

No routine laboratory monitoring is required; review for clinical response and local corticosteroid adverse effects.

Counselling the patient

  • Apply thinly to affected areas only and avoid the face and skin folds unless directed.
  • Stop and seek advice if the skin shows signs of infection.
  • Continue regular emollients between steroid applications.

Evidence & guidelines

Topical corticosteroids of appropriate potency are recommended in NICE eczema and psoriasis guidance, tailored to severity and site.

Reference: NICE CG57; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.