Betamethasone/ Salicylic Acid

Registered South African indications:

• Hyperkeratotic dermatoses
• Dry dermatoses

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Rosacea
• Acne
• Perioral dermatitis
• Perianal and genital pruritus
• Tuberculous skin lesions
• Viral skin lesions (e.g. herpes simplex, vacinia, varicella)
• Napkin eruptions, fungal or bacterial skin infections (without coadministration with anti-infective therapy)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Children
• Long-term continuous therapy
• Use over large areas of damaged skin or in flextures
• Psoriasis
• Contact with eyes and mucous membranes
• Application to face
• Concomitant use of occlusive dressings
• Skin irritation or sensitisation
• Smoking or going near naked flames due to fire hazard

Forms avail. in SA and covered in this monograph: lot, oin

Hyperkeratotic and dry dermatoses responsive to corticosteroid therapy - sub-acute and chronic
Psoriasis

Betamethasone/ Salicylic acid
0.5/30 (mg/g)

• Topical (lot, oin): Apply to affected area, 12hrly; Treatment duration: 2 weeks

Paed. forms avail. in SA and covered in this monograph: lot, oin

Hyperkeratotic and dry dermatoses responsive to corticosteroid therapy - sub-acute and chronic
Psoriasis

Betamethasone/ Salicylic acid
0.5/30 (mg/g)

• Topical (lot, oin): Apply to affected area, 12hrly; Max duration: 5 days

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• Caution; not recommended
• 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 foetus
• Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients

Breastfeeding

• Caution; not recommended 
• It is unknown 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

Renal Impairment

• Caution; no information available 

Hepatic Impairment

• Caution; no information available 

Elderly

• Caution; no information available 

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Intracranial hypertension

Endocrine and Metabolic Disorders

• Hypothalamic pituitary adrenal axis suppression
• Cushing's syndrome
• Linear growth retardation
• Delayed weight gain

Skin and Subcutaneous Tissue Disorders

• Skin atrophy
• Striae
• Superficial vascular dilation
• Dermatitis
• Burning
• Itching
• Irritation
• Dryness
• Folliculitis
• Hypertrichosis
• Acneiform eruptions
• Hypopigmentation
• Perioral dermatitis
• Allergic contact dermatitis
• Maceration of the skin
• Secondary infection
• Miliaria

Sensory Disorders

• Blurred vision

No information available

None routine

Paediatric patients

• Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituary-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

Diprosalic preparations contain the dipropionate ester of betamethasone which is a glucocorticoid exhibiting the general properties of corticosteroids, and salicylic acid which has keratolytic properties. Salicylic acid is applied topically in the treatment of hyperkeratotic and scaling conditions where its keratolytic action facilitates penetration of the corticosteroid. In pharmacological doses, corticosteroids are used primarily for their anti-inflammatory and/or immune suppressive effects. Topical corticosteroids such as betamethasone dipropionate are effective in the treatment of a range of dermatoses because of their anti-inflammatory, anti-pruritic and vasoconstrictive actions. However, while the physiologic, pharmacologic and clinical effects of the corticosteroids are well known, the exact mechanisms of their action in each disease are uncertain.

COMBINATION PREPARATIONS

Betamethasone/ Salicylic acid

Ointment (per g) 0.5mg/30mg

• Diprosalic (MSD) originator

Lotion (per g) 0.5mg/30mg

• Diprosalic (MSD) originator