This combination topical ointment is indicated for the treatment of plaque-type psoriasis vulgaris that is suitable for topical therapy. The topical suspension form is indicated for the treatment of plaque psoriasis affecting the scalp and other areas of the body.

Betamethasone Dipropionate is a potent topical corticosteroid with strong anti-inflammatory, antipruritic, vasoconstrictive, and immunosuppressive effects. It provides rapid and sustained symptom relief but does not address the underlying cause of the disease. Its effects may be enhanced under occlusion due to increased skin penetration.

Calcipotriol is a non-steroidal antipsoriatic agent derived from vitamin D. It acts by binding to vitamin D receptors and regulating keratinocyte proliferation and differentiation. It promotes normal skin cell development while inhibiting excessive growth seen in psoriasis, with minimal impact on calcium metabolism compared to natural vitamin D. The combined action helps normalize epidermal growth and improve psoriatic lesions.

Topical Ointment: This Ointment is indicated for topical use only. The phototoxic effects have not been studied in psoriasis patients. All psoriasis-affected areas treated with this Ointment should be, where possible, protected from direct sunlight and UV-light with items of clothing.

Adults: This ointment should be applied topically to the affected area once daily. The maximum daily dose should not exceed 15 gm. The maximum recommended weekly dose of ointment is 100 gm/week. The treated area should not be more than 30% of the body surface. The use of this ointment should be intermittent for up to one year under close medical supervision. Treatment should be limited to four week periods with Calcipotriol used alone for one month between periods of use of this ointment as needed.

Children: This ointment is not recommended for use in children and adolescents below the age of 18 years.

Topical Suspension: Apply required quantity of spray of Topical Suspension once daily to the affected areas and gently rub in using the tips of the fingers. Treatment may be continued for up to 8 weeks. Treatment may be discontinued earlier, if symptoms are cleared. The maximum weekly dose should not exceed 100 gm. Shake before use. This Topical Suspension is not for oral, ophthalmic or intravaginal use.

Concomitant use with other corticosteroids may increase the risk of additive adverse effects.

This combination is contraindicated in patients with known hypersensitivity to betamethasone, calcipotriol, or any component of the formulation. It is also contraindicated in patients with disorders of calcium metabolism, severe renal impairment, or severe hepatic disease.

The most commonly reported adverse effects include folliculitis and a burning sensation at the application site.

There are no adequate and well-controlled studies in pregnant women. This medication should be used during pregnancy only if the expected benefit outweighs the potential risk to the fetus. Systemically administered corticosteroids are known to pass into breast milk and may affect infant growth or adrenal function. It is not known whether topical use results in significant systemic absorption. Therefore, caution is advised when used in breastfeeding women.

Hypercalcemia and hypercalciuria may occur; discontinue treatment until calcium levels normalize if these develop. Topical corticosteroids may cause reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing’s syndrome, and may unmask latent diabetes. The risk increases with prolonged use, use over large areas, or occlusive therapy. Local adverse effects may include skin atrophy, striae, irritation, acne-like eruptions, hypopigmentation, and allergic contact dermatitis. These are more likely with potent steroids or occlusive use. Avoid use on the face, axilla, groin, or areas with existing skin atrophy. Children are more susceptible to systemic toxicity from topical corticosteroids.

Betamethasone & combined preparations.

Store below 25°C in a cool and dry place, protected from light. Do not refrigerate. Keep out of reach of children.