Dyvon Plus

It is indicated for the topical treatment of plaque type psoriasis of the scalp & body.

Non-steroid

Betamethasone Dipropionate is a potent topically-active corticosteroid producing prompt, marked and prolonged anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive properties, without curing the underlying condition. These effects can be enhanced under occlusive conditions due to increased penetration of stratum corneum (by approximately a factor of 10). Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1, 25(OH)2D3 receptor. Calcipotriol is as potent as 1,25(OH)2D3, the naturally occurring active form of vitamin D, in regulating cell proliferation and cell differentiation, but much less active than 1,25(OH)2D3 in its effect on calcium metabolism. Calcipotriol induces differentiation and suppresses proliferation (without any evidence of a cytotoxic effect) of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis. The therapeutic goal envisaged with Calcipotriol is thus a normalization of epidermal growth.

Apply required quantity of Ointment & spray of Topical Suspension once daily to the affected areas & 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 Ointment & Topical Suspension is not for oral, ophthalmic or intravaginal use.

Betamethasone & Calcipotriol containing preparation is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It is also contraindicated in patients with known disorders of calcium metabolism. Patients with severe renal insufficiency or severe hepatic disorders are also contraindicated. Hypercalcemia & hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize. Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome & unmask latent diabetes. Rate of adrenal suppression increased with treatment duration. Systemic absorption may require evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. Local adverse reactions may include atrophy, striae, irritation, acne form eruptions, hypopigmentation, & allergic contact dermatitis & may be more likely with occlusive use or more potent corticosteroids. Use is not recommended on face, axillae, groin or where atrophy is present. Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.

The most common adverse reactions are folliculitis & burning sensation of skin.

There are no adequate & well-controlled studies in pregnant women. Ointment & Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Systemically administered corticosteroids appear in human milk & could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriol & Betamethasone Ointment or Suspension is administered to a nursing woman.

Store in a cool (below 25ºC) & dry place & protect from light. Do not refrigerate. Keep out of the reach of children.

Ointment: Each gm ointment contains Betamethasone 0.5 mg as Betamethasone Dipropionate BP and Calcipotriol BP 0.05 mg. Topical Suspension: Each gm topical suspension contains Betamethasone 0.5 mg as Betamethasone Dipropionate BP and Calcipotriol 0.05 mg as Calcipotriol Monohydrate BP.