Diprosalic

Diprosalic

betamethasone + salicylic acid

Manufacturer:

Merck Sharp & Dohme

Distributor:

A. Menarini
Full Prescribing Info
Contents
Betamethasone dipropionate, salicylic acid.
Description
Each gram contains: Betamethasone Dipropionate 640 mcg (equivalent to Betamethasone 500 mcg) and Salicylic Acid 30 mg.
Diprosalic ointment contains betamethasone dipropionate, a synthetic fluorinated corticosteroid and salicylic acid, a keratolytic and antifungal.
Drug Substance: Betamethasone Dipropionate, betamethasone 17α, 21-dipropionate, a synthetic fluorinated corticosteroid, has anti-inflammatory, anti-pruritic and vasoconstrictive properties. The empirical formula is C28H37FO7 and Molecular Weight is 504.6.
Salicylic acid, 2-Hydroxybenzoic acid, has keratolytic and antifungal properties. The empirical formula is C7H6O3 and Molecular Weight is 138.1.
Action
Pharmacology: Betamethasone dipropionate, a synthetic fluorinated corticosteroid, has anti-inflammatory, antipruritic and vasoconstrictive actions. Topical salicylic acid has keratolytic properties as well as bacteriostatic and fungicidal actions.
Indications/Uses
Betamethasone dipropionate, salicylic acid (Diprosalic) Ointment is indicated for the relief of the inflammatory manifestations of hyperkeratotic and dry corticosteroid-responsive dermatoses such as psoriasis, chronic atopic dermatitis, neurodermatitis (lichen simplex chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), dyshidrosis (pompholyx), seborrheic dermatitis of the scalp, ichthyosis vulgaris and other ichthyotic conditions.
Dosage/Direction for Use
A thin film of Betamethasone dipropionate, salicylic acid (Diprosalic) Ointment should be applied to cover completely the affected area, twice daily, in the morning and at night.
For some patients, adequate maintenance therapy may be achieved with less frequent application.
Overdosage
Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing's disease.
Excessive or prolonged use of topical preparations containing salicylic acid may cause symptoms of salicylism.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
Treatment of salicylism is symptomatic. Measures should be taken to rid the body rapidly of salicylate. Administer oral sodium bicarbonate to alkalinize the urine and force diuresis.
Contraindications
Betamethasone dipropionate, salicylic acid (Diprosalic) Ointment is contraindicated in those patients with a history of sensitivity reactions to any of its components.
Special Precautions
If irritation or sensitization develops with the use of Betamethasone dipropionate, salicylic acid (Diprosalic) Ointment, treatment should be discontinued.
In the presence of an infection, appropriate therapy is indicated.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids or salicylic acid will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
If excessive dryness or increased skin irritation develops, discontinue use of this preparation.
Betamethasone dipropionate, salicylic acid (Diprosalic) Ointment and Lotion is not for ophthalmic use. Avoid contact with eyes and mucous membranes.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Use in Children: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema.
Drug Abuse and Dependence: None Known.
Any Other Relevant Safety Information: None.
Use in Pregnancy & Lactation: Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use In Pregnancy & Lactation
Use in Pregnancy And In Nursing Women: Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Adverse reactions that have been reported with the use of topical corticosteroids include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
The following may occur more frequently with the use of occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Drug Interactions
Drug Interactions: None known.
Interference with Laboratory Tests: None identified.
Storage
Store below 30°C.
MIMS Class
Topical Anti-Infectives with Corticosteroids
ATC Classification
D07XC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids in other combinations. Used in the treatment of dermatological diseases.
Presentation/Packing
Oint 5 g, 10 g.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in