Betamethasone 0.06% | Calcipotriene 0.006% | Diphenhydramine 1%

Route: Topical application to affected skin areas (e.g., psoriatic plaques, eczematous lesions) as directed by the prescriber.

• Apply a thin layer to the affected area once or twice daily; gently rub in completely.
• Avoid application to face, axillae, or groin unless specifically directed, as these areas absorb corticosteroids more readily.
• Do not use under occlusive dressings without prescriber guidance, as occlusion significantly increases corticosteroid and calcipotriene absorption.
• Wash hands after application unless treating the hands.

Dosing frequency and duration are prescriber-determined. General clinical considerations:

• Typically applied once to twice daily to affected areas.
• For psoriasis, guidelines recommend high-potency corticosteroids for up to 4 weeks; reassess for need to continue, taper, or step down potency.
• Calcipotriene has a maximum recommended weekly application (typically limited by the manufacturer to ≤100 g/week for standard formulations) to prevent hypercalcemia; prescriber determines allowable quantity.

• Betamethasone: Glucocorticoid receptor agonist; induces lipocortin synthesis (inhibiting phospholipase A2 and arachidonic acid cascade), suppresses NF-κB-driven pro-inflammatory cytokines (TNF-α, IL-1, IL-6), and exerts anti-mitotic effects reducing keratinocyte hyperproliferation characteristic of psoriasis.
• Calcipotriene: Binds vitamin D receptor (VDR) in keratinocytes and T cells; modulates gene expression to inhibit keratinocyte proliferation, promote epidermal differentiation, and reduce Th1/Th17 immune cell activity in psoriatic lesions.
• Diphenhydramine: Competitive antagonist at H₁ histamine receptors in cutaneous tissues; reduces histamine-mediated pruritus. Also possesses mild sodium channel-blocking local anesthetic properties that contribute to topical itch relief.

This triple-combination cream is targeted at inflammatory dermatoses characterized by hyperproliferation and pruritus, most commonly psoriasis with itch as a prominent symptom. Betamethasone and calcipotriene together have additive antiproliferative and anti-inflammatory efficacy (the FDA-approved combination Taclonex® validates this pairing's clinical utility). Diphenhydramine addresses the antipruritic dimension.

Prescriber monitoring:

• Monitor serum calcium periodically with extended use over large areas, as calcipotriene can cause hypercalcemia via vitamin D receptor activity.
• Assess for signs of HPA axis suppression with prolonged high-potency betamethasone use.
• Topical diphenhydramine carries sensitization risk; monitor for allergic contact dermatitis, which can mimic the underlying condition.

Contraindications:

• Known hypersensitivity to any component
• Hypercalcemia or disorders of calcium metabolism (calcipotriene)
• Skin infections (bacterial, fungal, viral) at the application site

Warnings & Precautions:

• Hypercalcemia: Large-area or prolonged use of calcipotriene can disrupt calcium homeostasis; monitor serum calcium and avoid use exceeding prescriber-specified quantity limits.
• HPA axis suppression: Betamethasone at 0.06% is a potent steroid; prolonged large-area use may suppress adrenal function, particularly in children.
• Topical diphenhydramine sensitization: Diphenhydramine applied topically is a known sensitizer and can cause allergic contact dermatitis; avoid on large areas or broken skin.
• Avoid face, eyes, and mucosal surfaces.

Drug Interactions:

• CYP3A4 inhibitors may increase systemic betamethasone exposure.
• Concurrent systemic calcium or vitamin D supplementation may increase hypercalcemia risk with calcipotriene.

Common Side Effects: Application site burning, stinging, erythema (betamethasone, calcipotriene); skin atrophy and telangiectasias with extended corticosteroid use; transient hypercalcemia (calcipotriene at high doses); topical diphenhydramine contact sensitization.

Store at controlled room temperature (20–25°C / 68–77°F). Protect from light and heat. Do not refrigerate or freeze. Keep tightly capped. Note that calcipotriene is sensitive to light; avoid prolonged light exposure. Use before the beyond-use date assigned by Genesis Compounding. Keep out of reach of children.

Why are a steroid and a vitamin D analog combined in this cream?

Betamethasone (steroid) and calcipotriene (vitamin D analog) target psoriatic inflammation and keratinocyte hyperproliferation through complementary, non-overlapping mechanisms. Their combination produces additive antiproliferative and anti-inflammatory effects while also reducing the irritation that calcipotriene alone can cause—an approach validated by FDA-approved combination products for psoriasis.

What does the diphenhydramine do in this formula?

Diphenhydramine is an antihistamine included primarily for its antipruritic (itch-relieving) activity. It blocks H₁ histamine receptors in the skin and has mild local anesthetic properties, helping to address the itch component that often accompanies psoriasis or eczema.

How much of this cream can I use per week?

Your prescriber will specify the maximum weekly quantity. Calcipotriene use must be quantity-limited to avoid systemic hypercalcemia, and the potent corticosteroid must be used for the shortest effective duration. Follow your prescriber's instructions precisely.

Is this an FDA-approved product?

This compounded preparation is not FDA-approved as a finished drug product. It is prepared by Genesis Compounding as a 503A prescription compounding product for a specific patient. The individual active ingredients are established pharmaceuticals used in dermatology.

How should I store this cream?

Store at room temperature away from heat and light. Do not freeze. Use before the beyond-use date on the label. Calcipotriene is light-sensitive, so store away from direct sunlight.