Aristobet

Approved Indications (Topical Use):

• Inflammatory Skin Conditions:
• Atopic dermatitis
• Contact dermatitis (irritant and allergic)
• Seborrheic dermatitis
• Nummular eczema
• Lichen simplex chronicus
• Discoid lupus erythematosus
• Neurodermatitis
• Psoriasis:
• Plaque-type psoriasis (excluding widespread plaque or pustular psoriasis)
• Other Dermatoses Responsive to Corticosteroids:
• Pruritus ani
• Pruritus vulvae
• Otitis externa
• Intertrigo
• Reactions to insect bites or stings

Clinically Accepted Off-label Uses:

• Lichen planus (localized)
• Granuloma annulare
• Localized alopecia areata
• Vitiligo (early or localized, adjunctive use)
• Chronic hand eczema (moderate to severe)
• Radiation dermatitis (mild-to-moderate cases)

Route: Topical application (cream, ointment, lotion, scalp application)

Adults:

• Apply a thin film to the affected area once or twice daily.
• Frequency may be reduced to once daily as condition improves.
• Maximum weekly amount should not exceed 50 grams.

Children (>1 year):

• Use once daily with minimal quantity.
• Limit use to 5–7 consecutive days, especially on the face or in folds.
• Prolonged use should be avoided due to increased absorption risk.

Infants (<1 year):

• Not routinely recommended unless under strict medical supervision.

Special Populations:

• Elderly: Use with caution; thinner skin may lead to enhanced absorption.
• Hepatic/Renal Impairment: No dose adjustment is typically required for topical use, but systemic exposure should be minimized.

Administration Notes:

• Do not apply to open wounds, broken skin, or mucosal surfaces.
• Avoid occlusive dressings unless directed by a healthcare provider.
• Do not use near eyes, mouth, or genital mucosa unless advised.

Betamethasone valerate is a potent synthetic glucocorticoid that works by binding to intracellular glucocorticoid receptors, which translocate to the cell nucleus and modify gene expression. It enhances the production of anti-inflammatory proteins (e.g., lipocortin) and inhibits the synthesis of pro-inflammatory mediators such as prostaglandins, cytokines, and interleukins. The result is a marked reduction in inflammation, vasodilation, capillary permeability, and immune cell infiltration in the skin, leading to symptomatic relief of erythema, edema, itching, and scaling.

• Absorption: Absorbed minimally through intact skin; higher absorption with damaged skin, prolonged use, or under occlusion.
• Distribution: Once absorbed, widely distributed and highly protein-bound in plasma.
• Metabolism: Primarily metabolized in the liver through hydrolysis of the ester bond and subsequent hepatic metabolism.
• Excretion: Excreted mainly via the urine as inactive metabolites.
• Onset of Action: Typically within a few hours after application.
• Elimination Half-life: Systemically, approximately 5–6 hours if absorbed.
• Bioavailability: Topical bioavailability varies by site of application (e.g., higher on face or genitalia than on palms or soles).

• Pregnancy:
• Classified as FDA Pregnancy Category C.
• Use only when the potential benefit justifies the potential risk to the fetus.
• High-dose, long-term application should be avoided during pregnancy, particularly under occlusion or on large areas.
• Lactation:
• Generally considered safe during breastfeeding due to low systemic absorption.
• Avoid application on or near the breast/nipple to prevent accidental oral ingestion by the infant.
• Use caution with high-potency corticosteroids; prefer low-to-medium potency options for extended use.

• Primary Class: Topical Corticosteroid
• Potency Level: Medium- to High-potency (varies slightly by formulation and concentration)
• Pharmacological Class: Synthetic fluorinated glucocorticoid

• Hypersensitivity to betamethasone or any component of the formulation
• Untreated bacterial, fungal, or viral skin infections
• Acne vulgaris
• Perioral dermatitis
• Rosacea
• Skin ulceration or open wounds
• Children under 1 year of age, particularly in diaper areas
• Application near the eyes

• Prolonged use may cause skin thinning, striae, purpura, and telangiectasia.
• Avoid prolonged use on face, intertriginous areas, or under occlusion.
• May cause systemic corticosteroid effects, especially in pediatric patients or with extensive application.
• Risk of adrenal suppression, Cushing’s syndrome, and growth retardation in children.
• Secondary infections can be masked; use antifungal/antibacterial agents concurrently when indicated.
• Rebound flare may occur upon abrupt discontinuation after long-term use.
• Avoid ocular exposure; risk of glaucoma and posterior subcapsular cataract.

Common Local Effects:

• Burning or stinging sensation
• Dryness or irritation at application site
• Itching (pruritus)
• Erythema

Less Common:

• Skin thinning (atrophy)
• Stretch marks (striae)
• Folliculitis
• Contact dermatitis
• Acneiform eruptions
• Hypertrichosis

Serious and Rare (Systemic):

• Adrenal suppression
• Cushingoid features
• Hyperglycemia
• Growth retardation in children (with long-term use)

Timing & Severity Notes:

• Local effects usually appear within the first week of use.
• Systemic effects are rare but dose- and duration-dependent.

• Topical corticosteroids have minimal systemic interaction potential.
• Potential interactions (if systemic absorption occurs):
• Ritonavir, itraconazole, and other CYP3A4 inhibitors: May increase systemic steroid levels.
• Other corticosteroids or immunosuppressants: Additive effects.
• No major food or alcohol interactions noted for topical use.
• Avoid concurrent use with other topical irritants unless advised by a physician.

• Recent dermatology guidelines emphasize limiting high-potency corticosteroid use to <4 weeks continuously, especially in sensitive areas.
• The American Academy of Dermatology (AAD) recommends a step-down approach or intermittent weekend therapy for chronic dermatoses.
• EMA has re-emphasized the importance of minimal effective dose to prevent long-term side effects in both adults and children.
• No new FDA warnings as of the latest update, but pediatric monitoring remains a key advisory focus.

• Store below 25°C (77°F).
• Keep container tightly closed.
• Protect from light, moisture, and heat.
• Do not freeze.
• For lotions or scalp applications, shake well before use.
• Keep out of reach of children.