Halonate

 0.05% Cream
Healthcare Pharmaceuticals Ltd.

20 gm tube: ৳ 130.00

Indications
  • Approved Indications:
    • Treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, including:
      • Psoriasis vulgaris (moderate to severe, localized plaques)
      • Atopic dermatitis (eczema)
      • Contact dermatitis
      • Seborrheic dermatitis
      • Lichen planus
      • Discoid lupus erythematosus
      • Other corticosteroid-responsive dermatoses requiring potent topical steroids
  • Clinically Accepted Off-Label Uses:
    • Management of hypertrophic scars and keloids (topical application)
    • Adjunctive therapy in alopecia areata
    • Relief of inflammation and itching in insect bites and minor burns

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Dosage & Administration
  • Adults and Adolescents (≥12 years):
    • Apply a thin layer of halobetasol propionate topical cream, ointment, or foam once or twice daily to the affected area.
    • Maximum recommended duration: 2 consecutive weeks.
    • Total body surface area treated should not exceed 50 grams per week.
    • Discontinue therapy once control of symptoms is achieved to minimize adverse effects.
  • Pediatrics (<12 years):
    • Use with caution; only under strict medical supervision.
    • Duration and frequency should be minimized due to increased risk of systemic absorption and side effects.
  • Elderly:
    • Use standard dosing but monitor carefully for skin thinning and systemic effects.
  • Special Populations:
    • No specific dose adjustments required in renal or hepatic impairment due to minimal systemic absorption.
  • Administration Instructions:
    • Clean and dry affected skin before application.
    • Avoid contact with eyes, mouth, and mucous membranes.
    • Avoid occlusive dressings unless specifically directed by a healthcare professional.
    • Wash hands thoroughly after application unless treating the hands.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Mechanism of Action (MOA)

Halobetasol propionate is a highly potent synthetic corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It binds with high affinity to intracellular glucocorticoid receptors, leading to modulation of gene transcription. This results in suppression of pro-inflammatory cytokines, inhibition of leukocyte infiltration, and decreased production of mediators such as prostaglandins and leukotrienes. These effects reduce inflammation, itching, and edema in the skin, providing symptomatic relief in inflammatory dermatoses.

Pharmacokinetics
  • Absorption: Minimal systemic absorption through intact skin; absorption can increase with broken skin, occlusion, or prolonged use.
  • Distribution: Primarily localized to epidermis and dermis with limited systemic distribution.
  • Metabolism: Metabolized in the skin and liver via reduction and conjugation to inactive metabolites.
  • Elimination: Excreted primarily in urine as metabolites.
  • Onset of Action: Clinical improvement often seen within days of starting treatment.
  • Half-life: Not well characterized due to minimal systemic exposure.
Pregnancy Category & Lactation
  • Pregnancy: Classified as FDA Pregnancy Category C. Animal studies have shown potential risk at high systemic doses. Topical use in humans should only be considered if benefits outweigh risks.
  • Lactation: Unknown if halobetasol propionate is excreted in human milk. Minimal systemic absorption suggests low risk; however, caution is advised, and application on the breast should be avoided during breastfeeding.
  • Data: Limited human safety data; use with caution.
Therapeutic Class
  • Primary Therapeutic Class: Topical Corticosteroid
  • Subclass: Super-high potency (Class I) corticosteroid
Contraindications
  • Known hypersensitivity to halobetasol propionate or any excipients in the formulation
  • Untreated bacterial, viral, fungal, or parasitic skin infections
  • Rosacea, perioral dermatitis, or acne vulgaris
  • Skin ulcerations or wounds where corticosteroid use is contraindicated
Warnings & Precautions
  • Limit duration of use to avoid skin atrophy, telangiectasia, striae, and other corticosteroid-induced dermal changes.
  • Avoid use on thin-skinned areas (face, genitals, intertriginous regions) unless specifically directed.
  • Risk of hypothalamic-pituitary-adrenal (HPA) axis suppression with extensive use or occlusion.
  • Monitor for secondary infections as corticosteroids can mask symptoms.
  • Use cautiously in pediatric and elderly populations.
  • Discontinue if hypersensitivity or local skin irritation occurs.
  • Avoid occlusive dressings unless prescribed.
Side Effects
  • Common:
    • Burning, itching, irritation, or dryness at application site
    • Folliculitis
    • Skin peeling or redness
  • Less Common/Rare:
    • Skin atrophy (thinning)
    • Telangiectasia
    • Striae (stretch marks)
    • Hypopigmentation or hyperpigmentation
    • Hypertrichosis (excess hair growth)
    • Allergic contact dermatitis or sensitization reactions
    • Secondary skin infections due to immune suppression
  • Systemic Effects (rare):
    • HPA axis suppression, particularly with prolonged or extensive use
    • Cushingoid features
Drug Interactions
  • Due to minimal systemic absorption, significant drug interactions are rare.
  • Avoid concurrent use with other topical agents that may irritate skin or increase systemic absorption.
  • Use caution if combined with systemic immunosuppressants or corticosteroids due to potential additive effects.
  • No known significant interactions with food or alcohol.
Recent Updates or Guidelines
  • Clinical guidelines emphasize restricting treatment duration to 2 weeks to reduce risk of adverse effects.
  • Recommendations advise against use on large body surface areas or under occlusion without medical supervision.
  • Recent dermatology guidelines promote cautious use in vulnerable populations such as children and elderly.
  • Monitoring for systemic corticosteroid effects has been reinforced in updated safety warnings.
Storage Conditions
  • Store at controlled room temperature between 20°C and 25°C (68°F to 77°F).
  • Protect from light, heat, and moisture.
  • Keep container tightly closed.
  • Do not freeze.
  • Avoid contamination by not touching applicator tip to skin.
  • No refrigeration or reconstitution needed.