Clobetasol Propionate

Registered South African indications:

• Resistant inflammatory and pruritic manifestations of steroid responsive dermatoses
• Moderate to severe scalp psoriasis (sha)

Contraindications

• Hypersensitivity to the active ingredients or any of its excipients
• Untreated cutaneous or scalp infections
• Rosacea
• Acne vulgaris
• Pruritis without inflammation
• Perianal and genital pruritus
• Perioral dermatitis
• Children < 1 year
• Ulcerative skin or scalp lesions

Cautions

• Pregnancy
• Breastfeeding
• Occlusive dressings
• Application to face and eyelids
• Impaired skin barrier
• Psoriasis
• Infants and children < 12 years
• Chronic leg ulcers

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

Resistant inflammatory and pruritic manifestations of steroid responsive dermatosis e.g. psoriasis, recalcitrant dermatoses, lichen planus, discoid lupus erythematosus

• Topical (oin, cre): Initial: Apply small quantity to affected area, 12-24hrly; Maintenance: Reduce frequency of applications; Max: 50g/week; Max duration: 4 weeks

See link: General prescribing points for steroids

Overnight occlusive dressings may be used for more resistant lesions

Application to face should be limited to 5 days and not occluded

Scalp psoriasis - moderate to severe

• Topical (sha): Initial: Apply 7.5ml, dly, to dry scalp and lesions, leave for 15min prior to washing; Max duration: 4 weeks; Maintenance: Reduce frequency of applications to twice a week; Max: 50g/week

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

Resistant inflammatory and pruritic manifestations of steroid responsive dermatosis e.g. psoriasis, recalcitrant dermatoses, lichen planus, discoid lupus erythematosus

Younger than 1 year

• Contraindicated

Older than 1 year

• Topical (oin, cre): Initial: Apply small quantity to affected area, 12-24hrly; Maintenance: Reduce frequency of applications; Max duration: 5 days

See link: General prescribing points for steroids

Pregnancy

• Caution
• There are limited data from the use of clobetasol in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development.  The relevance of this finding to humans has not been established. Administration of clobetasol during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration

Breastfeeding

• Caution; not recommended
• The safe use of topical corticosteroids during lactation has not been established. It is not known whether the topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Administration of clobetasol during breastfeeding should only be considered if the expected benefit to the mother outweighs the risk to the infant. If used during breastfeeding clobetasol should not be applied to the breasts to avoid accidental ingestion by the infant

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

• Permitted - No warnings

Cardiovascular Disorders

• Hypertension

Endocrine and Metabolic Disorders

• Hypothalamic-pituitary-adrenal axis suppression
• Cushingoid features 
• Delayed weight gain
• Growth retardation in children
• Osteoporosis
• Hyperglycaemia
• Glucosuria
• Decreased endogenous cortisol levels
• Alopecia
• Trichorrhexis

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Local skin burning
• Skin atrophy
• Striae
• Telangiectasias
• Skin wrinkling
• Skin dryness
• Pigmentation changes
• Hypertrichosis
• Allergic contact dermatitis
• Dermatitis
• Pustular psoriasis
• Erythema
• Rash
• Urticaria
• Acne
• Subcutaneous atrophy
• Bruising 
• Purpura
• Rosacea-like dermatitis
• Perioral dermatitis
• Acneiform eruptions
• Miliaria
• Skin maceration
• Application site irritation or pain

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Worsening of local infections
• Opportunistic infections

Sensory Disorders

• Cataract
• Glaucoma 

CYP3A4 inhibitors

None routine

Clobetasol acts as an anti-inflammatory agent via multiple mechanisms to inhibit late phase allergic reactions. These include decreasing the density of mast cells; decreasing chemotaxis and activation of eosinophils; decreasing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibiting the metabolism of arachidonic acid.

Cream (per 100g) 0.05g

• Dermovate (Sekpharma) originator
• Dovate (Pharmacare)
• Xenovate (Pharmacare)

Ointment (per 100g) 0.05g

• Dermovate (Sekpharma) originator
• Dovate (Pharmacare)
• Xenovate (Pharmacare)

Scalp Application (per 100g) 0.05g

• Dermovate (Sekpharma) originator

Spray Solution (per g) 500ug

• Clobex Spray (Galdema) originator

Shampoo (per g) 0.5mg

• Clobex Shampoo (Galdema) originator