Betamethasone

Registered South African indications:

• Steroid responsive dermatoses

Contraindications

• Hypersensitivity to the active ingredients or any of its excipients
• Herpes simplex, vaccinia, varicella or tuberculosis of skin
• Rosacea
• Acne vulgaris
• Pruritis without inflammation
• Perianal and genital pruritis
• Perioral dermatitis
• Widespread plaque psoriasis
• Long term use in diabetic patients
• Untreated cutaneous infections
• Long term use in patients with tuberculosis

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Occlusive dressings
• Application to face and eyes
• Psoriasis
• Skin crease areas
• Chronic leg ulcers

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

Non-infective, steroid responsive dermatoses

• Topical (cre, oin, lot): 0.1%. Apply small quantity to affected area, 8-12hrly
• Topical (cre, oin): 0.05%. Apply small quantity to affected area, 12hrly

Steroid responsive dermatoses of the scalp 

• Topical (lot): 0.1%. Initial: Apply small quantity to affected area, 12hrly; Maintenance: Reduce frequency of application; May require occlusive dressing

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See link: General prescribing points for steroids

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For resistant plaques occlusive dressings can be applied overnight

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Re-evaluate after 2-4 weeks

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CAUTION: Flammable

Not recommended for use in children; Specialist initiation only

Pregnancy

• Caution
• There are limited data from the use of topical betamethasone valerate 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; however, administration of betamethasone valerate 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 topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Administration of betamethasone valerate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant. If used during lactation betamethasone valerate should not be applied to the breasts to avoid accidental ingestion by the infant

Renal Impairment

• Caution; no dose adjustment recommended
  Minimum quantity should be used for the shortest duration to achieve the desired clinical benefit

Hepatic Impairment

• Caution; no dose adjustment recommended
  Minimum quantity should be used for the shortest duration to achieve the desired clinical benefit

Elderly

• Caution; no dose adjustment recommended
  Minimum quantity should be used for the shortest duration to achieve the desired clinical benefit

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Benign intracranial hypertension

Cardiovascular Disorders

• Hypertension

Endocrine and Metabolic Disorders

• Hypothalamic-pituitary-adrenal axis suppression
• Cushingoid features
• Growth retardation in children
• Cushing's syndrome
• Delayed weight gain
• Osteoporosis
• Hyperglycaemia
• Glucosuria
• Decreased endogenous cortisol levels

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Skin thinning
• Dilation of superficial blood vessels
• Loss of elasticity
• Ecchymoses
• Purpura
• Trichorrhexis
• Pruritus
• Local skin burning
• Allergic contact dermatitis
• Erythema
• Rash
• Urticaria
• Pustular psoriasis
• Skin dryness
• Striae
• Pigmentation changes
• Hypertrichosis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Opportunistic infection

Sensory Disorders

• Raised intraocular pressure
• Corneal ulcers
• Visual impairment
• Cataract
• Glaucoma

CYP3A4 inhibitor

None routine

Cream 0.1% - EML (Primary)

Betamethasone is a glucocorticoid receptor agonist, which acts as an anti-inflammatory agent via multiple mechanisms to inhibit late phase allergic reactions. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes.

Cream (per 100g) 0.05g

• Betnovate (Sekpharma) originator

Cream (per g) 0.5mg

• Betnovate (Sekpharma) originator
• Diprosone  (MSD) originator

Cream (per g) 0.1g

• Adco-Betamethasone (Adcock)
• Betnesol cream (Pharmacare)
• Lenovate cream (Pharmacare)
• Persivate cream (Pharmacare)
• Repivate cream (Cipla)
• Topivate Cream (Pharma Q)
• Vari-Betamethasone (Barrs)

Cream (per 100g) 0.1g

• Betnovate (Sekpharma) originator

Ointment (per g) 0.5mg

• Diprosone (MSD) originator

Ointment (per g) 1mg

• Lenovate ointment (Pharmacare)
• Persivate ointment (Pharmacare)
• Vari-Betamethasone (LeBasi)

Ointment (per 100g) 0.1g

• Betnovate (Sekpharma) originator

Lotion (per 100g) 0.1g

• Betnovate Scalp (Sekpharma) originator

Also available in the following forms: Eye drop, nose drop, tablet, syrup and injection.

COMBINATION PREPARATIONS

Betamethasone dipropionate/ Calcipotriol

Ointment 0.5mg/5μg

• Dovobet (Adcock)

Betamethasone dipropionate/ Salicylic acid

Lotion (per g) 0.5mg/20mg

• Diprosalic Lotion (MSD) originator

Ointment (per g) 0.5mg/30mg

• Diprosalic (MSD) originator

Betamethasone dipropionate/ Clomitrazole 

Cream (per g) 0.5mg/10mg

• Lotriderm cream (MSD) originator

Betamethasone/ Gentamicin

Cream (per g) 0.5mg/1mg

• Diprogenta (MSD) originator

Ointment (per g) 0.5mg/1mg

• Diprogenta (MSD) originator