Betamethasone/ Clotrimazole

Registered South African indications:

• Fungal infections of the skin with inflammation

Contraindications 

• Hypersensitivity to the active ingredient or to any of the excipients in this combination product
• Hypersensitivity to other corticosteroids or imidazoles
• Facial rosacea
• Acne vulgaris
• Perioral dermatitis
• Napkin eruptions
• Bacterial or viral infections

 Cautions 

• Pregnancy 
• Breastfeeding
• Elderly
• Prolonged use
• Children 
• Psoriasis 
• Damaged skin
• Large areas of the body 
• Flexures 
• Application to face and around eyes 
• Occlusive dressings

Forms avail. in SA and covered in this monograph: cre 

Fungal infections of the skin with inflammation

Betamethasone/ Clotrimazole
0.5/10 (mg/g) 

• Topical (cre): Apply to affected area, 12hrly

Use for shorter periods on facial skin

Should NOT be used with occlusive dressings

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

Fungal infections of the skin with inflammation

Betamethasone/ Clotrimazole
0.5/10 (mg/g) 

• Younger than 12 years: Not established for use
• Older than 12 years: See adult dosage

Course should be limited to 5 days in children

Should NOT be used with occlusive dressings

Pregnancy

• Caution
• There is inadequate evidence of safety in pregnancy. Clotrimazole has shown no teratogenic effect in animals but is foetotoxic at high oral doses
• Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus. Hence betamethasone/clotrimazole cream should only be used in pregnancy if the benefit justifies the potential risk to the foetus and such use should not be extensive i.e. in large amounts or for long periods

Breastfeeding

• Caution
• It is not known whether the components of betamethasone/clotrimazole cream are excreted in human milk and therefore caution should be exercised when treating breastfeeding mothers

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Paraesthesia 
• Increased intracranial pressure 
• Hypothalamic-pituitary-adrenal axis suppression 

Endocrine and Metabolic Disorders

• Cushing's syndrome 

Skin and Subcutaneous Tissue Disorders

• Burning
• Stinging
• Blistering 
• Urticaria 
• Peeling 
• Pruritis
• Maculopapular rash 
• Oedema 
• Erythema 
• Secondary infection 
• Irritation
• Dryness
• Folliculitis
• Hypertrichosis
• Acneiform eruptions
• Hyperpigmentation
• Hypopigmentation
• Perioral dermatitis
• Allergic contact dermatitis
• Maceration of the skin
• Secondary infection
• Skin atrophy
• Striae miliaria
• Ecchymoses
• Sensitisation

None known

None routine

Clotrimazole
Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity. It inhibits biosynthesis of the sterol ergostol, an important component of fungal cell membranes. Its action leads to increased membrane permeability and disruption of enzyme systems bound to the membrane. 

Betamethasone
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.

COMBINATION PREPARATIONS

Betamethasone/ Clotrimazole

Cream (per g) 0.5mg/10mg

• Lotriderm cream (Organon) originator