Clobetasone Butyrate 0.05% Topical

Clobetasone Butyrate 0.05% Topical is a corticosteroid used for the treatment of inflammatory skin disorders such as eczema, dermatitis, atopic eczema, photodermatitis, otitis externa, primary irritant & allergic dermatitis (napkin rash), prurigo nodularis, seborrhoeic dermatitis, and insect bite reactions. It reduces inflammation by stabilizing leukocyte lysosomal membranes and decreasing inflammatory cell activity.

• Inflammatory skin disorders
• Eczema
• Dermatitis
• Atopic eczema
• Photodermatitis
• Otitis externa
• Primary irritant & allergic dermatitis (napkin rash)
• Prurigo nodularis
• Seborrhoeic dermatitis
• Insect bite reactions

Clobetasone butyrate is classed as a moderately potent topical corticosteroid. Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; and reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.

Clobetasone butyrate stabilizes leukocyte lysosomal membranes, inhibits migration of inflammatory cells, and decreases capillary permeability to reduce inflammation.

Adult Dose (Topical): Use as 0.05% cream or ointment to be applied thinly once or twice daily on affected areas. Should not be used every day for more than 4 weeks at a time.

Wash hands and dry them. Squeeze out the correct amount of cream onto index finger. Half a fingertip will cover a patch of skin the same size as the palm of hand. Gently rub the cream into the skin area that you are treating. Wash hands again (unless it is your hands you are treating).

If you miss a dose of Clobetasone Butyrate 0.05% Topical, apply it as soon as you remember. However, if it is almost time for your next application, skip the missed dose. Do not double the dose.

Common Side Effects:

• Local atrophic changes (skin thinning)
• Pigmentation changes
• Hypertrichosis (excessive hair growth)
• Increased liability to infection
• Infections may be masked
• Acute adrenal insufficiency
• Growth retardation in children
• Cushingoid symptoms
• Amenorrhoea
• Hyperhidrosis (excessive sweating)

• May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings.
• Use with caution in peptic ulcer, osteoporosis, psychoses or severe psychoneuroses.
• Not to be used indiscriminately for pruritus.
• Caution in CHF or hypertension, diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia.
• Caution in active or doubtfully quiescent tuberculosis.
• Not for local treatment of eye disorders.
• Avoid prolonged use on the face.
• Caution during pregnancy and lactation.

• Pregnancy (in high doses)
• Presence of acute infections
• Treatment of rosacea
• Leg ulcers
• Acne vulgaris
• Widespread plaque psoriasis
• Children under 1 year

No significant drug interactions are known.

No food interactions have been found or established.

Safety data on clobetasone in pregnant women is not available. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. Pregnancy Category C.

No information is available regarding the presence of clobetasone in breast milk or its effects on the breastfed infant or on milk production. Systemically administered corticosteroids appear in human milk and could suppress growth. Use on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid applying directly to the nipple and areola.

Contraindicated in children under 1 year of age.

Use with caution in elderly patients.

For topical use, no dose adjustment is required in renal or hepatic impairment. However, caution is required in chronic renal failure.

Acute overdosage is very unlikely to occur. In the case of chronic overdosage or misuse, features of hypercortisolism may appear; topical steroids should be discontinued gradually.

Store in a cool and dry place, away from light and out of reach of children.

Clobetasone Butyrate 0.05%