Betamethasone + Calcipotriol

Allopathic
Indications
  • Approved Indications:
    • Topical treatment of stable plaque psoriasis (mild to moderate severity) on the body and scalp.
    • Management of psoriatic plaques to reduce scaling, redness, and thickness.
  • Clinically Accepted Off-Label Uses:
    • Treatment of other inflammatory dermatoses responsive to corticosteroids and vitamin D analogues, under specialist guidance.
    • Use as adjunct therapy in psoriasis with extensive involvement or resistant lesions.
Dosage & Administration
  • Formulation and Route:
    • Topical ointment, cream, or gel applied to affected skin areas.
  • Adults:
    • Apply a thin layer once or twice daily (usually twice daily) to affected areas.
    • Treatment duration typically up to 4 weeks; may extend with physician approval.
  • Pediatrics:
    • Use with caution; safety and efficacy in children under 12 years not well established.
    • Apply under medical supervision; minimize duration.
  • Elderly:
    • No specific dose adjustments; use cautiously due to increased skin sensitivity.
  • Special Populations:
    • Avoid use on large body surface areas to reduce risk of systemic absorption.
  • Administration Notes:
    • Avoid contact with eyes and mucous membranes.
    • Do not use occlusive dressings unless prescribed.
    • Wash hands after application unless treating the hands.
Mechanism of Action (MOA)

Betamethasone is a potent corticosteroid that exerts anti-inflammatory, immunosuppressive, and antiproliferative effects by binding to glucocorticoid receptors, modulating gene transcription to suppress pro-inflammatory cytokines and immune cell activation. Calcipotriol, a synthetic vitamin D3 analogue, regulates keratinocyte proliferation and differentiation by binding to vitamin D receptors, normalizing epidermal cell growth and reducing psoriatic plaque formation. The combination offers synergistic effects, balancing inflammation suppression with normalization of skin cell turnover.

Pharmacokinetics
  • Absorption: Both agents are minimally absorbed systemically when applied topically on intact skin; increased absorption possible with extensive application or occlusion.
  • Distribution: Localized primarily to the epidermis and dermis; minimal systemic distribution.
  • Metabolism: Betamethasone metabolized hepatically after systemic absorption; calcipotriol metabolized to less active metabolites.
  • Elimination: Metabolites excreted mainly via urine and feces.
  • Half-Life: Systemic half-life not clinically significant due to minimal absorption.
  • Onset: Clinical improvement usually observed within 1–2 weeks of consistent use.
Pregnancy Category & Lactation
  • Pregnancy: Category C – Use only if potential benefits justify the potential risk to the fetus. Topical use with limited systemic absorption; however, avoid large area application.
  • Lactation: Unknown if excreted in breast milk; caution advised. Use only on small areas and avoid breast contact during treatment.
Therapeutic Class
  • Combination topical corticosteroid and vitamin D3 analogue.
  • Betamethasone: potent glucocorticoid.
  • Calcipotriol: vitamin D3 receptor agonist.
Contraindications
  • Known hypersensitivity to betamethasone, calcipotriol, or formulation excipients.
  • Patients with disorders of calcium metabolism (e.g., hypercalcemia, vitamin D toxicity).
  • Presence of untreated bacterial, viral, or fungal skin infections at application sites.
  • Use on face, groin, or axillae unless specifically prescribed.
Warnings & Precautions
  • Avoid prolonged or extensive use to prevent systemic corticosteroid effects and hypercalcemia.
  • Monitor for skin atrophy, telangiectasia, or steroid-induced dermatitis with prolonged use.
  • Use cautiously in patients with impaired calcium metabolism or renal insufficiency.
  • Discontinue if signs of skin irritation or allergic reactions occur.
  • Not recommended for use in children under 12 years unless supervised.
Side Effects
  • Common:
    • Local skin irritation, burning, itching, erythema
    • Dryness or peeling of skin
    • Mild hypercalcemia symptoms with excessive use of calcipotriol
  • Less Common:
    • Skin atrophy, telangiectasia from corticosteroid
    • Allergic contact dermatitis
    • Folliculitis
  • Rare / Serious:
    • Systemic corticosteroid effects (rare with topical use)
    • Hypercalcemia and related symptoms (headache, nausea) with overuse
    • Secondary skin infections due to immunosuppression
Drug Interactions
  • Concomitant use with other topical corticosteroids or vitamin D analogues increases risk of adverse effects.
  • Avoid simultaneous use with UV light therapy or tanning beds unless directed by a physician, due to increased risk of photosensitivity.
  • No significant systemic drug interactions expected due to minimal absorption.
Recent Updates or Guidelines
  • Clinical guidelines recommend combination therapy for enhanced efficacy and reduced corticosteroid dose compared to monotherapy.
  • Emphasis on limiting duration of use to reduce side effects.
  • New formulations focus on improving tolerability and adherence in plaque psoriasis.
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F).
  • Protect from moisture and direct sunlight.
  • Keep container tightly closed.
  • Keep out of reach of children.