Clobetasol

Impoyz

0.025% creamVerenigde StatenIn de handelToegelaten op 28 nov 2017

Inhoud in het Engels

Openen in het registerVraag Osler ernaar

Indicaties

IMPOYZ Cream 0.025% is indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. IMPOYZ Cream is a corticosteroid indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older ( 1 )

Contra-indicaties

None. None ( 4 )

Waarschuwingen en voorzorgen

Clobetasol propionate has been shown to suppress the HPA axis at the dose tested. ( 5.1 ) Cushing’s syndrome, hyperglycemia, and glucosuria can also result from systemic absorption of topical corticosteroids. ( 5.1 ) Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis develops. ( 5.1 ) Children may be more susceptible to systemic toxicity from use of topical corticosteroids.

( 5.1 , 8.4 ) Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings, prolonged use, or use of higher potency corticosteroids, including clobetasol propionate. These reactions include; irritation, dryness, acneiform eruptions, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. ( 5.1 , 6.2 )

5.1Effects on the Endocrine System

IMPOYZ Cream can cause reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential of systemic absorption, use of topical corticosteroids, including IMPOYZ Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Waarschuwingen en voorzorgen

5.1Effects on the Endocrine System

Zwangerschap en borstvoeding

8.1Pregnancy Risk Summary

There are no available data on IMPOYZ Cream in pregnant women to inform a drug-associated risk for adverse development outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroids during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible (see Data ).

In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparisons of animal exposure with human exposure are provided due to minimal systemic exposure noted after topical administration of IMPOYZ Cream [see Clinical Pharmacology (12.3) ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk or birth defect loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality.

However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49-40.11)]. In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group.

The majority of exposed subjects treated large areas of the body [a mean quantity of 60 g/month (range, 12-170g)] over long periods of time. Animal Data In an embryofetal development study in mice, subcutaneous administration of clobetasol propionate resulted in fetotoxicity at the highest dose tested ( 1mg/kg) and malformations at the lowest dose tested (0.03 mg/kg). Malformations seen included cleft palate and skeletal abnormalities.

In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.

Impoyz

Indicaties

Contra-indicaties

Waarschuwingen en voorzorgen

5.1Effects on the Endocrine System

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Impoyz

Indicaties

Contra-indicaties

Waarschuwingen en voorzorgen

5.1Effects on the Endocrine System

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5.2Local Adverse Reactions with Topical Corticosteroids

5.3Concomitant Skin Infections Use

5.4Allergic Contact Dermatitis

Zwangerschap en borstvoeding

8.1Pregnancy Risk Summary

Bijwerkingen

6.1Clinical Trials Experience

6.2Postmarketing Experience

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