Betamethasone 0.08% | Calcipotriene 0.006% | Niacinamide 3%

Route: Topical application to affected skin areas as prescribed.

• Apply a thin layer to involved areas once to twice daily as directed.
• At the higher betamethasone concentration (0.08%), limit application area strictly to the prescribed zone.
• Avoid occlusive dressings unless specifically instructed; the increased corticosteroid concentration heightens the systemic absorption risk under occlusion.
• Avoid applying to face, intertriginous areas, or broken skin unless the prescriber has specifically directed such use.

Dosing is prescriber-determined; the 0.08% betamethasone concentration should be treated with the same precautions as superpotent/high-potency corticosteroids:

• Use the minimum effective amount for the shortest effective duration.
• Continuous application beyond 2–4 weeks requires prescriber reassessment.
• Calcipotriene weekly quantity limits apply; prescriber will define the maximum amount per week to avoid hypercalcemia.

• Betamethasone (0.08%): At this elevated concentration, binds glucocorticoid receptors with high affinity; nuclear translocation induces lipocortin synthesis, suppresses phospholipase A2, inhibits NF-κB, reduces synthesis of prostaglandins and leukotrienes, and exerts anti-mitotic effects on psoriatic keratinocytes with correspondingly greater systemic absorption risk.
• Calcipotriene: VDR agonist that normalizes keratinocyte proliferation/differentiation balance and modulates the IL-17/Th17 inflammatory axis central to psoriatic pathogenesis.
• Niacinamide: Suppresses cytokine-mediated epidermal inflammation, supports ceramide synthesis to improve barrier function, and provides a tolerability-enhancing effect in this higher-potency corticosteroid preparation.

The 0.08% betamethasone concentration reflects a prescriber-individualized decision for patients requiring greater corticosteroid potency, such as thick plaques or corticosteroid-refractory areas. All pharmacological and monitoring considerations applicable to high-potency betamethasone preparations apply with heightened vigilance at this concentration.

Prescriber monitoring:

• HPA axis evaluation (morning cortisol, ACTH stimulation if clinically indicated) in patients using large quantities or applying to large surface areas.
• Periodic serum calcium monitoring with calcipotriene use.
• Skin atrophy assessment: striae, telangiectasias, epidermal thinning.

Contraindications:

• Hypersensitivity to betamethasone, calcipotriene, niacinamide, or any formulation excipients
• Hypercalcemia, vitamin D toxicity
• Active cutaneous infection at treatment site

Warnings & Precautions:

• Enhanced systemic absorption risk: At 0.08%, betamethasone systemic exposure may be greater than standard commercial formulations; restrict to indicated areas and duration.
• HPA axis suppression and Cushing syndrome: Risk increases with concentration, surface area, and duration of use.
• Hypercalcemia: Calcipotriene systemic vitamin D activity must be monitored with large-area use.
• Pediatric patients have proportionally greater skin surface area relative to body weight; use with extreme caution in children.

Drug Interactions:

• CYP3A4 inhibitors increase systemic betamethasone concentrations.
• Vitamin D and calcium supplements may potentiate calcipotriene-associated hypercalcemia.

Common Side Effects: Local skin atrophy, striae, telangiectasias, perioral dermatitis, folliculitis (betamethasone); burning, stinging, irritation (calcipotriene); niacinamide is generally well-tolerated topically.

Store at controlled room temperature (20–25°C / 68–77°F). Protect from light and excessive heat. Do not freeze. Keep container sealed between uses. Use before the beyond-use date labeled by Genesis Compounding.

Why is the betamethasone concentration 0.08% in this formulation?

The prescriber selected 0.08% based on the patient's individual therapeutic needs—for example, a thickened or refractory plaque that has not responded adequately to lower-concentration betamethasone preparations. Compounding allows precise concentration customization for patient-specific requirements.

Does higher concentration mean more side effects?

Generally, yes. Higher corticosteroid concentrations increase the risk of local effects (skin atrophy, striae) and systemic effects (HPA axis suppression) when applied over large areas or for extended periods. This formulation should be used for the prescribed area and duration only.

What monitoring is recommended during treatment?

Your prescriber may check your serum calcium (due to calcipotriene) and assess your skin for atrophy, thinning, or other signs of corticosteroid effects during follow-up appointments. Report any unusual bruising, skin fragility, or stretch marks.

Is this product FDA-approved?

This is a 503A compounded preparation prepared by Genesis Compounding based on a prescriber's order for a specific patient. It is not an FDA-approved product, but the active ingredients are established dermatologic agents.

Can this be used under a bandage or wrap?

Occlusive dressings significantly increase corticosteroid and calcipotriene absorption. Do not use under occlusion unless your prescriber has specifically instructed it and is aware of the increased absorption risk at 0.08% betamethasone.