Halobetasol Propionate 0.01%

Introduction: Halobetasol Propionate 0.01% is a super-high potency topical corticosteroid used for plaque psoriasis and corticosteroid-responsive skin conditions.

How it works: Corticosteroids play a role in cellular signaling, immune function, inflammation and protein regulation. Tazarotene is a retinoid prodrug which is converted to its active form, tazarotenic acid, which binds to retinoic acid receptors and may modify gene expression.

Important Information: Apply a thin layer once daily to affected areas. Contraindicated in pregnancy. Do not exceed 50 grams per week.

• Plaque psoriasis - in adults
• Corticosteroid-responsive dermatoses

Other Topical corticosteroids

Super-high potency topical corticosteroid

Corticosteroids play a role in cellular signaling, immune function, inflammation and protein regulation. Tazarotene is a retinoid prodrug which is converted to its active form, tazarotenic acid, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ and RARγ, but shows relative selectivity for RARβ and RARγ and may modify gene expression.

Halobetasol Propionate inhibits production of inflammatory mediators and Tazarotene modifies gene expression to regulate skin cell growth.

Adult Dose:

• Apply a thin layer to affected areas once daily
• Rub in gently
• Do not exceed approximately 50 g per week
• Can be used for up to 8 weeks

Children (under 18 years):

• Safety and effectiveness not evaluated

* Use as directed by the registered physician

For external use only. Apply a thin layer to affected areas and rub in gently. Skin should be dry before application after bathing. Do not use on face, groin or axillae.

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and follow your regular schedule.

Common Side Effects:

• Redness
• Itching
• Swelling
• Burning
• Stinging
• Folliculitis
• Atrophy
• Peeling
• Rash

Rare: Skin ulcer, increased eye pressure, increased sensitivity to sun, skin discoloration

Precautions:

• Contraindicated in pregnancy - Tazarotene is a teratogenic substance
• In females of reproductive potential, obtain negative pregnancy test within 2 weeks prior to initiating treatment
• HPA axis suppression may occur - caution with prolonged use or large areas
• Avoid exposure to sunlight and sunlamps
• Do not use on eczematous skin

Contraindications:

• Pregnancy

Drug Interactions:

• Contraindicated with patients taking corticosteroids by mouth or injection
• Do not use with other products containing corticosteroids

Food Interactions: No data available.

Use in Pregnancy: Contraindicated in pregnancy. Tazarotene is a teratogenic substance.

Use in Lactation: No data on presence of Tazarotene and Halobetasol Propionate in human milk. Use with caution.

Pediatric Use: Safety and effectiveness in patients under 18 years have not been evaluated.

Geriatric Use: Use as per doctor's advice for elderly patients.

Renal & Hepatic Impairment: Minimal systemic absorption due to topical use - no known restrictions.

Overdose: Excessive prolonged use may suppress HPA axis - reduce or stop use. Appropriate symptomatic treatment should be given.

Storage: Store below 30°C, protected from light. Keep out of reach of children.

Halobetasol Propionate 0.01% Lotion