Salison
Generic Name
Betamethasone Dipropionate + Salicylic Acid Ointment
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| salison 005 3 ointment | ৳ 70.00 | N/A |
Description
Overview of the medicine
Salison 0.05%-3% Ointment is a combination medication containing a potent corticosteroid (Betamethasone Dipropionate) and a keratolytic agent (Salicylic Acid). It is used to treat inflammatory skin conditions like psoriasis and eczema where excessive keratinization or scaling is prominent.
Uses & Indications
Dosage
Adults
Apply a thin film of ointment to the affected skin area once or twice daily, or as directed by the physician. Do not exceed two weeks of continuous treatment without medical advice.
Elderly
No specific dosage adjustment is required for elderly patients, but caution should be exercised due to increased skin fragility and potential for systemic absorption.
Renal_impairment
No specific dosage adjustment is typically needed for renal impairment, as systemic absorption from topical use is minimal. However, caution is advised with extensive or prolonged use.
How to Take
For external use only. Apply a thin layer to the clean, dry affected skin and gently rub it in. Wash hands thoroughly before and after application. Avoid contact with eyes, mouth, and other mucous membranes. Do not use occlusive dressings unless specifically advised by a doctor.
Mechanism of Action
Betamethasone Dipropionate, a potent corticosteroid, acts by inducing phospholipase A2 inhibitory proteins, thus preventing the release of arachidonic acid and subsequently inhibiting the formation of inflammatory mediators. Salicylic Acid acts as a keratolytic agent, softening and loosening scaly skin, which aids in the penetration of Betamethasone.
Pharmacokinetics
Onset
Symptomatic relief typically begins within a few days of regular application.
Excretion
Metabolites of both Betamethasone and Salicylic acid are primarily excreted by the kidneys.
Half life
Not well-defined for topical application; systemic absorption leads to hepatic metabolism and renal excretion.
Absorption
Systemic absorption of Betamethasone Dipropionate is generally low but can increase with prolonged use, application to large surface areas, occlusive dressings, or damaged skin. Salicylic acid can be absorbed systemically, especially from large areas or damaged skin.
Metabolism
Systemically absorbed Betamethasone is primarily metabolized in the liver. Salicylic acid is also metabolized in the liver to various conjugated metabolites.
Side Effects
Contraindications
- Hypersensitivity to Betamethasone Dipropionate, Salicylic Acid, or any other component of the ointment.
- Viral skin infections (e.g., herpes simplex, varicella).
- Fungal skin infections.
- Tuberculosis of the skin.
- Acne vulgaris, Rosacea, Perioral dermatitis.
- Vaccination reactions.
Drug Interactions
Systemic Salicylates
Topical salicylic acid can enhance the absorption of other topical corticosteroids. Systemic absorption of salicylic acid may occur, potentially leading to additive effects with oral salicylates. Caution is advised.
Other Topical Preparations
Avoid co-administration of other strong keratolytic agents or abrasive cleansers on the same area, as this may increase irritation or absorption.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Excessive or prolonged use of topical corticosteroids can lead to systemic effects such as HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. Excessive absorption of salicylic acid may lead to salicylism, characterized by dizziness, tinnitus, headaches, and confusion. Treatment is symptomatic and supportive. Discontinue use and consult a physician.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids should not be used extensively or for prolonged periods during pregnancy. Salicylic acid can be absorbed systemically; high doses during pregnancy have been associated with adverse fetal outcomes. Exercise caution when administering to a nursing woman. Consult a doctor before use.
Side Effects
Contraindications
- Hypersensitivity to Betamethasone Dipropionate, Salicylic Acid, or any other component of the ointment.
- Viral skin infections (e.g., herpes simplex, varicella).
- Fungal skin infections.
- Tuberculosis of the skin.
- Acne vulgaris, Rosacea, Perioral dermatitis.
- Vaccination reactions.
Drug Interactions
Systemic Salicylates
Topical salicylic acid can enhance the absorption of other topical corticosteroids. Systemic absorption of salicylic acid may occur, potentially leading to additive effects with oral salicylates. Caution is advised.
Other Topical Preparations
Avoid co-administration of other strong keratolytic agents or abrasive cleansers on the same area, as this may increase irritation or absorption.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Excessive or prolonged use of topical corticosteroids can lead to systemic effects such as HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. Excessive absorption of salicylic acid may lead to salicylism, characterized by dizziness, tinnitus, headaches, and confusion. Treatment is symptomatic and supportive. Discontinue use and consult a physician.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids should not be used extensively or for prolonged periods during pregnancy. Salicylic acid can be absorbed systemically; high doses during pregnancy have been associated with adverse fetal outcomes. Exercise caution when administering to a nursing woman. Consult a doctor before use.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from the manufacturing date when stored under recommended conditions.
Availability
Pharmacies, drugstores
Approval Status
Approved by regulatory authorities (e.g., DGDA)
Patent Status
Generic available, off-patent
Clinical Trials
The efficacy and safety of Betamethasone Dipropionate and Salicylic Acid combination ointments have been established through numerous clinical trials for steroid-responsive dermatoses with hyperkeratosis over decades. Studies confirm their effectiveness in reducing inflammation, scaling, and itching in conditions like psoriasis and chronic eczema.
Lab Monitoring
- For extensive or prolonged use, especially in children, monitoring of HPA axis suppression (e.g., plasma cortisol levels, ACTH stimulation test) may be considered.
- Not routinely required for short-term topical application.
Doctor Notes
- Educate patients on the proper application technique and duration of use to minimize adverse effects.
- Advise against using on the face, groin, or axillae due to increased risk of local side effects.
- Monitor for signs of HPA axis suppression in patients using the ointment extensively or for prolonged periods, especially children.
- Consider tapering off the treatment gradually to avoid rebound flares, especially in chronic conditions like psoriasis.
Patient Guidelines
- Use exactly as prescribed by your doctor.
- Do not use for longer than the prescribed duration (typically not more than 2 weeks continuously).
- Avoid applying to the face, groin, underarms, or diaper area unless specifically instructed by your doctor.
- Do not cover the treated area with bandages or other occlusive dressings unless directed.
- Wash your hands before and after applying the ointment.
- Report any signs of systemic side effects or skin irritation to your doctor.
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
Salison ointment is for topical use and is not expected to affect the ability to drive or operate machinery.
Lifestyle Advice
- Keep the affected skin area clean and dry.
- Avoid harsh soaps, detergents, or other irritants that may worsen the skin condition.
- Wear loose-fitting clothing to prevent friction on the treated areas.
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