Clobesol SA 0.05%+3% Ointment 30g Tube

✔️ Dosage & Administration

Adults

Apply a thin layer of the ointment to the affected areas twice daily and gently rub it in until absorbed.

For some patients, adequate control may be maintained with less frequent application. Treatment with this high-potency corticosteroid should be discontinued once adequate control has been achieved.

If there is no improvement within 2 weeks, the diagnosis should be reassessed by a healthcare professional.

• Do not use with occlusive dressings unless specifically instructed by a doctor.
• Treatment should generally not continue beyond 2 consecutive weeks without medical supervision.
• Do not exceed 50 g per week, because excessive use may increase systemic corticosteroid absorption and suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Children

Use in children below 12 years of age is not recommended unless specifically prescribed by a healthcare professional.

✔️ Interaction

No significant drug interactions have been reported with topical clobetasol propionate when used as directed.

Salicylic acid has no known significant interactions when used appropriately. However, topical salicylic acid may increase the absorption of other medicines applied to the same area. Therefore, avoid applying other topical medicines to the same skin area unless advised by a healthcare professional.

✔️ Safety Information:

• Use clobetasol propionate cautiously on skin close to the eyes.
• Prolonged application over large areas may result in significant systemic absorption and adrenal suppression.
• Children are particularly susceptible to systemic corticosteroid effects because of their relatively larger skin surface area compared with body weight.
• Potent topical corticosteroids should be used cautiously in psoriasis because prolonged or inappropriate use may cause rebound relapse, tolerance, pustular psoriasis, or local and systemic toxicity.
• Patients being treated for psoriasis should be monitored carefully.
• If an inflammatory skin lesion becomes infected, appropriate antimicrobial treatment should be considered.
• If infection spreads, corticosteroid treatment may need to be stopped and appropriate systemic antimicrobial therapy initiated.
• Avoid unnecessary use of occlusive dressings, as warm and moist conditions may encourage bacterial growth.
• Clean the affected skin appropriately before applying a fresh dressing when a dressing is medically indicated.
• Avoid contact with broken or severely inflamed skin unless specifically advised by a healthcare professional.
• Salicylate toxicity may occur if salicylic acid is applied to extensive areas, particularly in neonates or very young children.
• Do not use this preparation for longer than prescribed.

✔️ Side Effects

• Skin thinning (local atrophy), particularly with prolonged use
• Burning, irritation, or dryness
• Hypersensitivity reactions
• Worsening or rebound of psoriasis after discontinuation
• Rare development of pustular psoriasis
• Systemic corticosteroid effects following excessive absorption

Salicylic acid may occasionally cause:

• Skin irritation
• Dryness
• Sensitivity reactions

✔️ This preparation should not be used in patients with:

• Hypersensitivity to clobetasol propionate, salicylic acid, or any component of the formulation
• Primary infected bacterial or fungal skin lesions when appropriate anti-infective treatment is not being provided
• Primary cutaneous viral infections, including herpes simplex, vaccinia, and varicella
• Tuberculous skin lesions
• Certain corticosteroid-responsive dermatoses in very young children
• Known salicylate hypersensitivity

Clobetasol-containing preparations should not be used for dermatoses in children under 1 year of age, including dermatitis and diaper eruptions.

✔️ Pregnancy & Lactation

Pregnancy

Animal studies with topical corticosteroids have shown the potential for fetal developmental abnormalities. The relevance of these findings to humans has not been fully established.

This combination should be used during pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus. Avoid extensive application, large quantities, or prolonged treatment during pregnancy unless specifically directed by a doctor.

Lactation

The safety of topical clobetasol propionate during breastfeeding has not been fully established. Use should therefore be considered only when clinically necessary and under medical supervision.

Although no specific contraindication has been established for topical salicylic acid during pregnancy or lactation, its safety has not been fully established. Use with caution and avoid extensive application.

✔️ Storage:

• Store in a cool and dry place.
• Protect from direct light.
• Keep the container tightly closed when not in use.
• Keep out of the reach of children.
• Do not use after the expiry date.