Corticosteroid

Derma-Smoothe/FS

Approved 3 Feb 1988TopicalOil

The FDA lists this product in 2 strengths and forms.

Indications

Derma-Smoothe/FS ® Scalp Oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults. ( 1 ) DERMA-SMOOTHE/FS ® Scalp Oil is indicated for the treatment of psoriasis of the scalp in adults.

Contraindications

None. None. ( 4 )

Warnings and precautions

Endocrine System Adverse Reactions: o Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 ) o Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. Potent corticosteroids use on large areas, prolonged use or occlusive use, altered skin barrier, liver failure, and young age may increase systemic absorption.

Modify use should HPA axis suppression develop. ( 5.1 ) Local Adverse Reactions: Local adverse reactions may include atrophy, striae irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis, and may be more likely with occlusive use or more potent corticosteroids. ( 5.2 , 6.1 ) Ophthalmic Adverse Reactions: May increase the risks of glaucoma and posterior subcapsular cataract. Avoid contact of DERMA-SMOOTHE/FS Scalp Oil with eyes.

Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. ( 5.3 )

5.1Endocrine System Adverse Reactions

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing's syndrome, hyperglycemia, and glucosuria can result from systemic absorption of topical corticosteroids. HPA axis suppression and Cushing's syndrome have been reported in patients receiving topical corticosteroids. Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Warnings and precautions

Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. ( 5.3 )

5.1Endocrine System Adverse Reactions

Adverse reactions

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

Endocrine System Adverse Reactions [see Warnings and Precautions (5.1) ]
Local Adverse Reactions [see Warnings and Precautions (5.2) ]
Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions in pediatric subjects treated for atopic dermatitis (≥5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Hill Dermaceuticals, Inc. at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

Because clinical trials are conducted under widely varying condition, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. An open-label safety study was conducted in 29 pediatric subjects 3 months to 2 years old to assess the HPA axis by ACTH stimulation testing following use of the formulation of DERMA-SMOOTHE/FS Scalp Oil twice daily for 4 weeks.

DERMA-SMOOTHE/FS Scalp Oil is not approved for use in pediatric patients for the treatment of psoriasis of the scalp. The most common adverse reactions were reported in the study: Table 1: Adverse Reactions in ≥2% Pediatric Subjects 3 Months to 2 Years of Age Treated with the Formulation of DERMA-SMOOTHE/FS Scalp Oil, N=30 Includes one subject who withdrew at Week 2 Adverse Reaction n (%) Cough 6 (20) Rhinorrhea 4 (13) Pyrexia 3 (10) Nasopharyngitis 2 (7) Hypopigmentation 2 (7) Abscess 1 (3) Atopic Dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Molluscum 1 (3) Rash 1 (3) Diarrhea 1 (3) Otitis Media 1 (3) URI 1 (3) Vomiting 1 (3)

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Endocrine Disorders: HPA axis suppression and Cushing’s syndrome Eye Disorders: glaucoma and cataracts Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema

Derma-Smoothe/FS

Indications

Contraindications

Warnings and precautions

5.1Endocrine System Adverse Reactions

Two medicines in one question?

Derma-Smoothe/FS

Indications

Contraindications

Warnings and precautions

5.1Endocrine System Adverse Reactions

Two medicines in one question?

5.2Local Adverse Reactions

5.3Ophthalmic Adverse Reactions Use

5.4Allergic Contact Dermatitis Use

5.5Concomitant Skin Infections Use

5.6Use in Peanut-Sensitive Individuals

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance

Guidelines