Xderm-S
Generic Name
Clobetasol Propionate + Salicylic Acid
Manufacturer
Arogo Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xderm s 005 3 ointment | ৳ 70.00 | N/A |
Description
Overview of the medicine
Xderm-S 0.05-3 Ointment is a combination topical corticosteroid and keratolytic used for the treatment of various inflammatory and hyperkeratotic skin conditions, such as psoriasis and resistant eczema.
Uses & Indications
Dosage
Adults
Apply a thin layer to the affected skin area once or twice daily. Treatment should not exceed 2 weeks. Do not use more than 50 grams of ointment per week.
Elderly
Use with caution due to increased skin fragility and potential for systemic absorption. Lower frequency or shorter duration may be required.
Renal_impairment
Use with caution due to potential for systemic absorption of salicylic acid and clobetasol, which are renally excreted. Monitor for salicylate toxicity if extensive use.
How to Take
For external use only. Apply a thin film to the affected skin and gently rub in. Wash hands thoroughly before and after application. Do not apply to the face, groin, axillae, or for diaper rash. Avoid contact with eyes and mucous membranes. Do not use with occlusive dressings unless specifically advised by a physician.
Mechanism of Action
Clobetasol Propionate is a potent corticosteroid that provides anti-inflammatory, antipruritic, and vasoconstrictive effects by inducing phospholipase A2 inhibitory proteins (lipocortins), thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Salicylic Acid acts as a keratolytic agent, causing shedding of the outer layer of skin, reducing scaling and hyperkeratosis, and enhancing the penetration of clobetasol.
Pharmacokinetics
Onset
Symptomatic relief typically observed within a few days of consistent application.
Excretion
Mainly excreted by the kidneys (clobetasol and its metabolites, salicylic acid and its metabolites/conjugates).
Half life
Clobetasol Propionate (systemic): Approximately 3.6 to 15 hours. Salicylic Acid (systemic): Approximately 2 to 3 hours, but can be longer with overdose.
Absorption
Systemic absorption of both Clobetasol Propionate and Salicylic Acid can occur, especially with prolonged use, application to large surface areas, occlusive dressings, or on damaged skin. Absorption of clobetasol is generally less than 5%, while salicylic acid absorption can be significant.
Metabolism
Both active ingredients are primarily metabolized in the liver. Clobetasol undergoes extensive metabolism, while salicylic acid is metabolized to various conjugates.
Side Effects
Contraindications
- Hypersensitivity to Clobetasol Propionate, Salicylic Acid, or any excipients
- Children under 12 years of age
- Rosacea, acne vulgaris, perioral dermatitis
- Perianal and genital pruritus
- Primary cutaneous viral infections (e.g., herpes simplex, varicella)
- Primary cutaneous fungal infections (e.g., candidiasis, tinea)
- Primary bacterial infections (e.g., impetigo)
- Ulcerated skin conditions, broken or severely inflamed skin
- Vaccination reactions
Drug Interactions
Systemic corticosteroids
May potentiate systemic effects and HPA axis suppression.
Other topical corticosteroids
Concurrent use may increase the risk of systemic side effects and local skin reactions.
Salicylic acid-containing products
Increased risk of salicylate toxicity if applied extensively or used with other salicylate products.
Diuretics (thiazides, loop diuretics)
Concurrent use with systemic corticosteroids may enhance potassium depletion.
Non-steroidal anti-inflammatory drugs (NSAIDs)
Risk of salicylate toxicity may be increased.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep away from direct sunlight.
Overdose
Acute overdose with topical application is unlikely. Chronic overuse or application to large areas may lead to systemic effects of corticosteroids (e.g., HPA axis suppression, Cushing's syndrome) and salicylate toxicity (e.g., tinnitus, dizziness, confusion). Treatment is symptomatic and supportive.
Pregnancy & Lactation
Use during pregnancy and lactation should only be considered if the potential benefit outweighs the potential risk to the fetus or infant. Avoid large areas, prolonged use, or application to the breasts during lactation. Consult a physician.
Side Effects
Contraindications
- Hypersensitivity to Clobetasol Propionate, Salicylic Acid, or any excipients
- Children under 12 years of age
- Rosacea, acne vulgaris, perioral dermatitis
- Perianal and genital pruritus
- Primary cutaneous viral infections (e.g., herpes simplex, varicella)
- Primary cutaneous fungal infections (e.g., candidiasis, tinea)
- Primary bacterial infections (e.g., impetigo)
- Ulcerated skin conditions, broken or severely inflamed skin
- Vaccination reactions
Drug Interactions
Systemic corticosteroids
May potentiate systemic effects and HPA axis suppression.
Other topical corticosteroids
Concurrent use may increase the risk of systemic side effects and local skin reactions.
Salicylic acid-containing products
Increased risk of salicylate toxicity if applied extensively or used with other salicylate products.
Diuretics (thiazides, loop diuretics)
Concurrent use with systemic corticosteroids may enhance potassium depletion.
Non-steroidal anti-inflammatory drugs (NSAIDs)
Risk of salicylate toxicity may be increased.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep away from direct sunlight.
Overdose
Acute overdose with topical application is unlikely. Chronic overuse or application to large areas may lead to systemic effects of corticosteroids (e.g., HPA axis suppression, Cushing's syndrome) and salicylate toxicity (e.g., tinnitus, dizziness, confusion). Treatment is symptomatic and supportive.
Pregnancy & Lactation
Use during pregnancy and lactation should only be considered if the potential benefit outweighs the potential risk to the fetus or infant. Avoid large areas, prolonged use, or application to the breasts during lactation. Consult a physician.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Off-patent
Clinical Trials
Clinical trial data regarding efficacy and safety are generally available for the individual active components and similar combination products. Specific trial data for 'Xderm-S' may be available upon request from the manufacturer.
Lab Monitoring
- For prolonged or extensive use, periodic assessment of HPA axis function (e.g., plasma cortisol levels, ACTH stimulation test) may be necessary.
- Monitor for signs of salicylate toxicity if extensively applied, especially in children or patients with renal impairment.
Doctor Notes
- Emphasize the potent nature of clobetasol and the importance of short-term use (max 2 weeks).
- Educate patients about proper application technique and potential local and systemic side effects.
- Advise against use on the face, intertriginous areas, and in children without specialist consultation.
Patient Guidelines
- Do not use this ointment for longer than prescribed by your doctor, usually not more than 2 weeks.
- Avoid applying to the face, groin, or armpits unless specifically instructed by a doctor.
- Do not cover the treated area with bandages or other occlusive dressings unless advised by your healthcare provider.
- Keep out of reach of children and pets.
Missed Dose Advice
If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one.
Driving Precautions
Xderm-S 0.05-3 Ointment is for topical use and is not expected to affect the ability to drive or operate machinery.
Lifestyle Advice
- Maintain good skin hygiene to prevent secondary infections.
- Avoid known irritants or allergens that may worsen your skin condition.
- Use moisturizers regularly to keep your skin hydrated, especially after bathing.
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