Enhanced permeation5



  • At half the strength of other clobetasol products, Impoyz and its formulation showed lower systemic exposure compared to Temovate® (clobetasol propionate cream) Cream, 0.05%.2

  • In a Murine model, Transcutol® improved clobetsol propionate solubility and its skin retention in comparison to propylene glycol commonly used in older formulations.3

  • The most common side effect of Impoyz Cream includes discoloration of the treated site. This is not the only possible side effect of Impoyz Cream.1

  • Impoyz Cream can cause reversible hypothalamic-pituitary-arenal (HPA) axis suppression with the potential for glucocosticosteroid insufficiency.2


References:
1. Impoyz [package insert] Primus Pharmaceuticals, Inc. 2021.
2. Draelos Z, et al. A Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing with Clobetasol Propionate Cream (Impoyz® ), 0.025% versus Clobetasol Propionate (Temovate®) Cream, 0.05% in Subjects with Moderate to Severe Plaque Psoriasis. Skin. 2018. 2:(6)410-420.
3. Trivedi K et al. Development of Novel Microemulsion Based Topical Formulation of Clobetasol Propionate and Salicylic Acid for The Treatment of Psoriasis. Int. Res. J. Pharm. 2018;9 (5).
4. Ghadially R, et al. Stratum Corneum Structure and Function Correlates with Phenotype in Psoriasis. Invest Dermatol. 1996; 107:558-564.
5. W. Osborne, David. Skin Penetration and Permeation Properties of Transcutol®--Neat or Diluted Mixtures. AAPS PharmSciTech. November 2018.

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PRACTITIONERS
IMPOYZ® (clobetasol propionate) Cream, 0.025%, for topical use

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
IMPOYZ Cream is a corticosteroid indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Effects on the Endocrine System: IMPOYZ Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during or after withdrawal of treatment. Potential systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. Systemic effects of topical corticosteroids may also manifest as Cushing's syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses. Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios.

Local Adverse Reactions: Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings, prolonged use, or use of high potency corticosteroids, including clobetasol propionate. These reactions may include: atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria.

Concomitant Skin Infections: Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of IMPOYZ Cream until the infection has been adequately treated.

Allergic Contact Dermatitis: Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.

DOSAGE AND ADMINISTRATION
  • Apply a thin layer of IMPOYZ Cream to the affected skin area twice daily and rub in gently and completely. Wash hands after each application. Use IMPOYZ Cream for up to 2 consecutive weeks of treatment.
  • Discontinue IMPOYZ Cream when control is achieved.
  • The total dosage should not exceed 50 g per week.
  • Do not use if atrophy is present at the treatment site.
  • Do not bandage, cover, or wrap the treated skin area unless directed by a physician.
  • Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.
  • IMPOYZ Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
ADVERSE REACTIONS
The most common adverse reaction (incidence ≥ 1%) is application site discoloration.

To report SUSPECTED ADVERSE REACTIONS, contact Primus Pharmaceuticals, Inc. at 1-480-483-1410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
IMPOYZ® (clobetasol propionate) Cream, 0.025%, for topical use

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
IMPOYZ Cream is a corticosteroid indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Effects on the Endocrine System: IMPOYZ Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during or after withdrawal of treatment. Potential systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. Systemic effects of topical corticosteroids may also manifest as Cushing's syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses. Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios.

Local Adverse Reactions: Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings, prolonged use, or use of high potency corticosteroids, including clobetasol propionate. These reactions may include: atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria.

Concomitant Skin Infections: Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of IMPOYZ Cream until the infection has been adequately treated.

Allergic Contact Dermatitis: Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.

DOSAGE AND ADMINISTRATION ADVERSE REACTIONS
The most common adverse reaction (incidence ≥ 1%) is application site discoloration.

To report SUSPECTED ADVERSE REACTIONS, contact Primus Pharmaceuticals, Inc. at 1-480-483-1410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References:
1. Impoyz [package insert] Primus Pharmaceuticals, Inc. 2021.
2. Draelos Z, et al. A Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing with Clobetasol Propionate Cream (Impoyz® ), 0.025% versus Clobetasol Propionate (Temovate®) Cream, 0.05% in Subjects with Moderate to Severe Plaque Psoriasis. Skin. 2018. 2:(6)410-420.
3. Trivedi K et al. Development of Novel Microemulsion Based Topical Formulation of Clobetasol Propionate and Salicylic Acid for The Treatment of Psoriasis. Int. Res. J. Pharm. 2018;9 (5).
4. Ghadially R, et al. Stratum Corneum Structure and Function Correlates with Phenotype in Psoriasis. Invest Dermatol. 1996; 107:558-564.