Fluocinolone Acetonide

Registered South African indications:

• Inflammatory, pruritic and allergic disorders of the skin including eczema, dermatitis, intertrigo, prurigo, lichen planus, psoriasis and discoid lupus erythematosus (cre,oin)
• Inflammatory dermatoses on most parts of the body. Useful in treating seborrhoea, seborrhoeic dermatitis and psoriasis of the scalp, and other hairy regions of the body (gel)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Primary infections of the skin caused by bacteria, fungi or viruses
• Rosacea
• Acne
• Perioral dermatitis
• Nappy rash
• Anogenital pruritis
• Children <1 year of age

Cautions

• Hypersensitivity to cetostearyl alcohol or propylene glycol
• Pregnancy
• Breastfeeding
• Prolonged use
• Application to face
• Application near eyes
• Psoriasis
• Skin crease areas
• Infection associated with an inflammatory skin condition
• Conditions where barrier function of the skin is impaired

Forms avail. in SA and covered in this monograph: cre, oin, gel

Inflammatory, pruritic and allergic disorders of the skin including eczema, dermatitis, intertrigo, prurigo, lichen planus, psoriasis and discoid lupus erythematosus

• Topical (cre, oin): Apply small quantity sparingly to affected area(s), 2-3 times dly, massaged gently and thoroughly into the skin

When an occlusive dressing is required, the affected area is first thoroughly cleansed, the preparation is then applied and covered with suitable plastic dressing. In some cases the application of hot, moist compresses may be an advantage

The preparation with rare exceptions should not be applied to the face. If applied this should not be for prolonged periods

The creams are particularly suitable for very inflamed or weeping surfaces. The ointments are suitable for dry scaly lesions

Inflammatory dermatoses on most parts of the body. Useful in treating seborrhoea, seborrhoeic dermatitis and psoriasis of the scalp, and other hairy regions of the body

• Topical (gel): Apply small quantity sparingly to affected area(s), 2-3 times dly, massaged gently and thoroughly into the skin

- For scalp treatment

• Topical (gel): Apply small quantity and massage into the scalp using fingertips, in the morning and night

- For maintenance therapy

• Topical (gel): Repeat treatment once to twice weekly, and it may be advantageous to combine this with the weekly use of a suitable medicated preparation

Paed. forms avail. in SA and covered in this monograph: cre, oin, gel

Inflammatory, pruritic and allergic disorders of the skin including eczema, dermatitis, intertrigo, prurigo, lichen planus, psoriasis and discoid lupus erythematosus (cre,oin)
Inflammatory dermatoses on most parts of the body. Useful in treating seborrhoea, seborrhoeic dermatitis and psoriasis of the scalp, and other hairy regions of the body (gel)

• Younger than 1 year: Use is not advised
• Older than 1 year: See adult dosage

Treatment of children should not normally extend over 5 days

Occlusion should not be used on children

Pregnancy

• Caution
• 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

Breastfeeding

• Caution
• 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

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Benign intracranial hypertension

Endocrine and Metabolic Disorders

• Depressed hypothalamic-pituitary-adrenal axis
• Growth retardation
• Cushingoid state

Skin and Subcutaneous Tissue Disorders

• Atrophic skin changes
• Striae
• Skin thinning
• Loss of elasticity
• Dilatation of superficial blood vessels
• Telangiectasia
• Ecchymosis
• Dermatitis
• Perioral dermatitis
• Acne or worsening of acne
• Acne rosacea
• Mild depigmentation
• Hypertrichosis
• Irritation at the application site

Immune, Blood and Lymphatic System Disorders

• Local hypersensitivity reactions
• Opportunistic infections (if used on infected lesions without appropriate anti-infective therapy)

None known

None routine

Fluocinolone acetonide is a synthetic anti-inflammatory corticosteroid. Its mechanisms of action are related to vasoconstriction and suppression of membrane permeability, mitotic activity, the immune response and release of inflammatory mediators.

Cream (per g) 0.25mg

• Cortoderm (Pharmacare)
• Synalar (Glenmark) originator

Cream  (per 5g) 1.25mg

• Cortoderm (Pharmacare)

Ointment  (per g) 0.25mg

• Cortoderm (Pharmacare)
• Synalar (Glenmark) originator

Ointment  (per 5g) 1.25mg

• Cortoderm (Pharmacare)

Gel  (per g) 0.25mg

• Synalar (Glenmark) originator

COMBINATION PREPARATIONS

Cliquinol/ Fluocinolone acetonide

Cream (per g) 30mg/0.25mg

• Synalar C (Glenmark) originator

Ointment (per g) 30mg/0.25mg

• Synalar C (Glenmark) originator

Fluocinolone acetonide/ Neomycin

Cream (per g) 0.25mg/3500iu

• Synalar N (Glenmark) originator

Ointment (per g) 0.25mg/3500iu

• Synalar N (Glenmark) originator