This preparation is indicated for:

• Short-term treatment of resistant or difficult-to-manage eczema
• Neurodermatoses
• Psoriasis (excluding widespread plaque psoriasis), especially when secondary bacterial or fungal infection is present, suspected, or likely to occur
• Other inflammatory skin conditions that do not respond adequately to less potent corticosteroids

Each gram of cream contains:

• Clobetasol Propionate BP 0.5 mg
• Neomycin Sulphate BP 5 mg
• Nystatin BP 100,000 IU

Each gram of ointment contains:

• Clobetasol Propionate BP 0.5 mg
• Neomycin Sulphate BP 5 mg
• Nystatin BP 100,000 IU

Clobetasol Propionate is a highly potent topical corticosteroid used for severe inflammatory skin disorders such as eczema and psoriasis that are not responsive to weaker steroids. Neomycin Sulphate is an aminoglycoside antibiotic effective against a variety of bacterial infections. Nystatin is an antifungal agent that destroys fungi and yeasts by disrupting their cell membranes. Topical corticosteroids like clobetasol act mainly through anti-inflammatory effects, including vasoconstriction and reduction of collagen synthesis. Neomycin binds to bacterial ribosomal subunits and inhibits protein synthesis. It may also cause misreading of mRNA, leading to production of abnormal proteins. Nystatin binds to sterols in fungal cell membranes, increasing permeability and causing leakage of intracellular contents.

Adults: Apply sparingly to the affected area once or twice daily until improvement occurs. In very resistant lesion, especially where there is hyperkeratosis, the anti-inflammatory effect of this preparation can be enhanced (if necessary) by occluding the treatment area with polythene. Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient's condition being reviewed.

Elderly: This preparation is suitable for use in elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of Neomycin Sulphate may occur.

Children: This preparation is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus this cream/ointment is not recommended for use in neonates and infants (younger than 2 years).

Neomycin Sulphate may enhance and prolong the respiratory depressant effects of neuromuscular blocking agents if significant systemic absorption occurs. However, when used as directed, systemic absorption is minimal and clinically significant interactions are unlikely. No serious interactions have been reported with Clobetasol Propionate or Nystatin.

This medicine should not be used in patients with rosacea, acne vulgaris, perioral dermatitis, primary viral skin infections (e.g., herpes simplex, chickenpox), or known hypersensitivity to any of the components.

• Prolonged use over large areas may lead to systemic absorption and features of hypercortisolism
• Long-term or intensive use of potent corticosteroids may cause local skin thinning, stretch marks, and dilation of superficial blood vessels, especially under occlusion or in skin folds
• Pigmentation changes and excessive hair growth (hypertrichosis) have been reported

There is limited data on the use of topical neomycin during pregnancy and lactation. Neomycin may cross the placenta and pose a theoretical risk of fetal toxicity. Therefore, this preparation is not recommended during pregnancy and breastfeeding unless clearly necessary. The safety of clobetasol in lactating mothers has not been established.

Long-term continuous use should be avoided, particularly in infants and children, due to the risk of adrenal suppression. When applied to the eyelids, care must be taken to prevent entry into the eyes, as it may lead to glaucoma. If accidental contact occurs, rinse thoroughly with water.

Acute overdose is unlikely. However, with prolonged or excessive use, signs of hypercortisolism may develop. In such cases, the topical steroid should be discontinued gradually.

Clobetasol / Clobetasone & Combined Preparations

Store below 25°C. Do not freeze. Keep out of reach of children.