Betamethasone Dipropionate + Salicylic Acid

Approved Indications:
This combination is used for topical treatment of corticosteroid-responsive dermatoses where hyperkeratosis, scaling, or thickened skin is present, including:

• Psoriasis (especially plaque-type and chronic stable forms)
• Chronic eczema or lichenified atopic dermatitis
• Seborrheic dermatitis
• Lichen simplex chronicus
• Ichthyosis and hyperkeratotic skin conditions with inflammatory components
• Contact dermatitis with excessive scaling

Off-Label or Clinically Accepted Uses:

• Palmoplantar psoriasis with thick scales
• Scalp psoriasis (when applied as a lotion or solution)
• Chronic prurigo nodularis associated with lichenification
• Keloid scars (adjunct in topical management)

Dosage Forms:

• Cream, ointment, lotion, and scalp solution (varies by brand)
• Common strengths: Betamethasone Dipropionate 0.05% + Salicylic Acid 3%

Adults and Adolescents (≥12 years):

• Apply a thin film once or twice daily to affected area(s), depending on severity
• Maximum Duration:
• Psoriasis: up to 2 weeks (or until resolution, whichever is earlier)
• Chronic dermatoses: intermittent use may be advised for maintenance
• Scalp Use: Apply sparingly to dry scalp at night and wash off in the morning

Pediatrics (<12 years):

• Not routinely recommended unless under close medical supervision
• Use with extreme caution due to risk of systemic absorption of both components
• Limit application to small areas and short durations

Elderly:

• Use with caution; monitor for skin atrophy
• Dosage same as adults unless contraindicated due to frail skin

Renal/Hepatic Impairment:

• No formal dose adjustments needed
• Use with caution in renal impairment due to possible systemic absorption of salicylic acid in large areas or broken skin

Administration Notes:

• Avoid application to face, groin, or axillae unless instructed
• Do not use under occlusive dressings unless prescribed
• Avoid use on broken or infected skin

This fixed-dose combination exerts a synergistic effect via its two components:
Betamethasone Dipropionate, a potent synthetic corticosteroid, binds to intracellular glucocorticoid receptors, modifying gene expression to suppress pro-inflammatory cytokines and inhibit inflammatory cell migration. It reduces erythema, swelling, pruritus, and other signs of inflammation.
Salicylic Acid, a keratolytic agent, solubilizes intercellular cement in the stratum corneum by breaking down keratin, promoting desquamation and increasing drug penetration. It facilitates deeper corticosteroid delivery and reduces scaling and hyperkeratosis.

Absorption:

• Betamethasone Dipropionate: Minimal systemic absorption on intact skin; increases with large area use, occlusion, or broken skin
• Salicylic Acid: Absorbed through skin, especially in children or with prolonged use on damaged skin

Bioavailability:

• Topical application results in localized effects; bioavailability variable depending on skin condition and application method

Distribution:

• Primarily remains localized in the dermis and epidermis; salicylate may enter systemic circulation in small amounts

Metabolism:

• Betamethasone: Hepatically metabolized via CYP3A4 into inactive metabolites
• Salicylic Acid: Metabolized in liver to salicyluric acid and salicyl phenolic glucuronide

Excretion:

• Renal (urine) for both components as inactive metabolites
• Elimination half-life:
• Betamethasone: ~10 hours (systemic);
• Salicylic acid: 2–4 hours when absorbed

Onset of Action:

• Symptom relief often within 24–48 hours of application

Pregnancy:

• FDA Category C
• Use only if clearly indicated; avoid large-area or prolonged use due to potential systemic corticosteroid effects and salicylate absorption
• Animal studies show risk at high doses; no controlled studies in pregnant women

Lactation:

• Unknown if topical use results in excretion into breast milk
• Avoid applying near the breast or to large skin areas
• Use caution, especially in neonates or premature infants

• Primary Class: Topical Corticosteroid + Keratolytic Agent
• Subclass:
• Betamethasone Dipropionate: Super-potent (Class I) topical glucocorticoid
• Salicylic Acid: Keratolytic, exfoliant, mild antiseptic

• Hypersensitivity to betamethasone, salicylic acid, or any formulation component
• Viral, fungal, or bacterial skin infections (unless treated concurrently)
• Acne vulgaris, rosacea, or perioral dermatitis
• Children under 2 years of age
• Ulcerated or severely damaged skin
• Application on mucous membranes or near the eyes

• High-Risk Groups:
• Children, elderly, pregnant women, and patients with impaired skin barrier
• Serious Potential Risks:
• HPA axis suppression
• Salicylate toxicity (especially in children or renal impairment)
• Skin atrophy, striae, telangiectasia
• Clinical Monitoring:
• Long-term users: Periodic adrenal function assessment (ACTH stimulation test)
• Assess for signs of systemic corticosteroid toxicity
• Early Signs of Adverse Events:
• Local irritation, skin thinning, allergic rash, systemic malaise
• Salicylate poisoning signs: nausea, dizziness, tinnitus (rare)

Common (Dermatologic):

• Burning, itching, redness
• Irritation, dryness, folliculitis

Less Common:

• Skin thinning, striae, telangiectasia
• Hypopigmentation
• Secondary infection at application site

Rare/Serious:

• Systemic corticosteroid effects (Cushingoid features, adrenal suppression)
• Salicylate toxicity (rare, with excessive use or absorption)
• Allergic contact dermatitis

Onset & Severity:

• Local side effects typically occur within days
• Serious effects may emerge with prolonged or high-dose use

Major Interactions:

• CYP3A4 inhibitors (e.g., ritonavir, itraconazole): may enhance systemic betamethasone exposure
• Systemic NSAIDs or aspirin: May increase salicylate levels or additive GI toxicity risk if significant absorption occurs
• Topical irritants or sensitizers: May worsen local reactions

Enzyme Systems Involved:

• Betamethasone: CYP3A4
• Salicylic Acid: Hepatic conjugation (glucuronidation); not CYP-mediated

• Emphasis on intermittent use of potent steroid-salicylic acid combinations to reduce risk of HPA suppression
• Preferred as short-term therapy in patients with thick plaques of psoriasis
• Newer formulations under evaluation for optimized skin delivery with reduced adverse effects

• Temperature: Store below 25°C (77°F); do not freeze
• Humidity: Store in a dry place; avoid excessive moisture
• Light Protection: Keep away from direct sunlight
• Container: Keep tightly closed after each use
• Handling Precautions:
• Do not use past expiry
• Shake lotion formulations before use
• Keep out of reach of children