Beprosalic

Beprosalic

betamethasone + salicylic acid

Manufacturer:

Taisho

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Contents
Betamethasone dipropionate, salicylic acid.
Description
Lotion: A colourless and slightly viscous solution contains 0.064% w/v Betamethasone dipropionate and 2.0% w/v Salicylic Acid with Methyl Paraben 0.1% w/v as preservative.
Ointment: Beprosalic Ointment contains Betamethasone diproprionate 0.064% w/w, (equivalent to 0.05% w/w of betamethasone), and 3% w/w Salicylic acid in a paraben free ointment base of white soft paraffin and liquid paraffin.
Action
Lotion: Betamethasone dipropionate is a topically active fluorinated corticosteroid which has anti-inflammatory, anti-pruritic and vasoconstrictive actions. Salicylic Acid has keratolytic properties, as well as bacteriostatic and fungicidal actions.
Pharmacology: Topical corticosteroids have anti-inflammatory, anti-pruritic and vasoconstrictive actions. When administered topically, particularly under occlusive dressing or when the skin is broken, sufficient corticosteroid may be absorbed to give systemic effects. Corticosteroids are extensively bound to plasma proteins. Only unbound corticosteroids has pharmacological effects or is metabolised. They are metabolised mainly in the liver, also in the kidney and are excreted in the urine. Salicylic Acid has keratolytic properties. It produces slow and painless destruction of the epithelium. When administered topically to large areas of the body, it may cause symptoms of acute systemic salicylate poisoning.
Ointment: Pharmacodynamics: Betamethasone dipropionate is a topically active fluorinated corticosteroid which has anti-inflammatory, anti-pruritic and vasoconstrictive actions. Salicylic acid has keratolytic properties, as well as bacteriostatic and fungicidal actions.
Pharmacokinetics: When applied topically, particularly to large areas, when the skin is broken, or under occlussive dressings, corticosteroids may be absorbed in sufficient amounts to cause systemic effects. Most corticosteroids in the circulation are extensively bound to plasma proteins. They are metabolized mainly in the liver but also on other tissues, and are excreted in the urine. Salicylic acid is readily absorbed through the skin and symptoms of acute systemic salicylate poisoning have been reported after excessive use.
Indications/Uses
For the relief of the inflammatory manifestations of hyperkeratotic and dry corticosteroid-responsive dermatoses which include psoriasis, chronic atopic dermatitis, neurodermatitis, and seborrhoeic dermatitis.
Dosage/Direction for Use
Lotion: Apply a few drops to the affected area two times daily.
Maintenance: Apply less often.
Oinment: Wash and dry affected area. Apply sparingly to the affected area and rub in twice daily, morning and evening or as directed.
If symptoms persist please consult the doctor or pharmacist.
Overdosage
Symptoms: Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency. Excessive prolonged use of topical preparations containing Salicylic acid may cause symptoms of salicylism.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In case of chronic corticosteroid toxicity, slow withdrawal of steroids is advised. Treatment of salicylism is symptomatic. Measures should be taken to rid the body of salicylate. Administer oral sodium bicarbonate to alkalinize and force diuresis.
Contraindications
Hypersensitivity to Betamethasone dipropionate, other corticosteroids, Salicylic acid, or other salicylates, or any component in the base. Topical corticosteroids are contraindicated in most viral infections of the skin and also tuberculosis and acne rosacea.
Special Precautions
Discontinue use if irritation, sensitivity, excessive dryness or other reactions develop. In the presence of infection, appropriate treatment should be given. Corticosteroids applied topically can be absorbed in sufficient amount to produce systemic effects like adrenal suppression, manifestations of Cushing's syndrome, hyperglycaemia and glucosuria in some patients, particularly in infants and children. Salicylic Acids in preparation applied to the skin can also be absorbed in sufficient amounts to produce salicylism. Therefore suitable precautions must be taken with Beprosalic during prolonged treatment, when treating extensive body surfaces areas, when using the occlusive technique and when treating children (because of a larger skin surface area to bodyweight ratio). Suitable precautions must be taken when treating stasis dermatitis and other skin diseases with impaired circulation. Discontinue use if irritation, sensitivity or other reactions develop and institute appropriate treatment. Not suitable for ophthalmic use. Do not use in or around the eyes.
Use In Pregnancy & Lactation
Safety of its use during pregnancy and lactation has not been established. Thus it should be used only if the potential benefit justifies the potential risk to the foetus or nursing infant.
Adverse Reactions
Reported local adverse reactions associated with corticosteroids are burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, maceration of the skin, secondary infection, skin atrophy, striae and miliria. Salicylic acid preparations may cause dermatitis.
Drug Interactions
Not known.
Caution For Usage
Ointment: This preparation is for the treatment of the current condition only.
Do not allow use by other person and dispose of unused material when the treatment is complete.
Storage
Keep container well closed. Protect from strong light. Store below 30°C. For external use only.
Shelf-life: 3 years.
ATC Classification
D07BC01 - betamethasone and antiseptics ; Belongs to the class of potent (group III) corticosteroids, in combination with antiseptics. Used in the treatment of dermatological diseases.
Presentation/Packing
Lotion 30 mL. Oint 15 g, 450 g.
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