Version May 2024
Dermatitis: Topical: Apply sparingly to affected area twice daily; after ~7 days assess need for continued therapy. When used OTC do not exceed 15 g/week.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no specific dosage adjustments provided in the manufacturer's labeling. Apply the least amount and for the shortest duration necessary to achieve desired clinical effect.
There are no specific dosage adjustments provided in the manufacturer's labeling. Apply the least amount and for the shortest duration necessary to achieve desired clinical effect.
Refer to adult dosing. Apply the least amount and for the shortest duration necessary to achieve desired clinical effect.
Dermatitis: Children ≥12 years and Adolescents: Topical: Refer to adult dosing.
There are no specific dosage adjustments provided in the manufacturer’s labeling. Apply the least amount and for the shortest duration necessary to achieve desired clinical effect.
There are no specific dosage adjustments provided in the manufacturer’s labeling. Apply the least amount and for the shortest duration necessary to achieve desired clinical effect.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Dermatologic: Burning sensation of skin, erythema of skin, skin irritation
Local: Local hypersensitivity reaction
Postmarketing:
Cardiovascular: Hypertension
Dermatologic: Hypertrichosis, pruritus, skin rash, urticaria
Endocrine & metabolic: Cushingoid appearance, decreased cortisol, growth retardation (slow growth and delayed weight in children), HPA-axis suppression, hyperglycemia, obesity, weight gain
Genitourinary: Glycosuria
Hypersensitivity: Hypersensitivity reaction
Infection: Opportunistic infection
Neuromuscular & skeletal: Osteoporosis
Ophthalmic: Cataract, glaucoma
Hypersensitivity to clobetasone or any component of the formulation; as monotherapy in the treatment of fungal (eg, candidiasis, tinea), bacterial (eg, impetigo), primary cutaneous viral (eg, herpes simplex, vaccinia, varicella), syphilitic, or tuberculous skin infections; acne vulgaris; rosacea; psoriasis; pruritus without inflammation.
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Contact dermatitis: Allergic contact dermatitis can occur and is usually diagnosed by failure to heal rather than clinical exacerbation; discontinue use if irritation occurs and treat appropriately.
• Hypersensitivity: Hypersensitivity reactions may rarely occur; discontinue use if signs/symptoms of hypersensitivity occur and treat as indicated.
• Immunosuppression: Prolonged use may result in fungal or bacterial superinfection; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.
• Ocular effects: Topical corticosteroids, including clobetasone, may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular changes. Avoid contact with eyes.
• Skin reactions: Discontinue if skin irritation or contact dermatitis occurs; do not use in patients with decreased skin circulation.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome (rare), hyperglycemia, or glycosuria (Böckle 2014; Dhar 2014; Hengge 2006). Absorption is increased by the use of occlusive dressings, application to denuded skin, application to large surface areas, or prolonged use.
Special populations:
• Older adult: Because of the risk of adverse effects associated with systemic absorption, topical corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration.
• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids (Halverstam 2007; Hosking 1978). Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients (Kristmundsdottir 1987).
Other warnings/precautions:
• Appropriate use: For external use on intact skin only; avoid contact with eyes. Do not apply to the face, scalp, genitals, groin, axilla, or between toes without medical supervision. Do not cover treated area with occlusive dressings. If symptoms fail to improve within a few days to a week, discontinue use and reassess. Not indicated as monotherapy for bacterial, fungal, viral, syphilitic, or tuberculous skin infections; may be used as adjunctive therapy for skin infections with inflammatory component.
Not available in the US
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as butyrtate:
Spectro EczemaCare Medicated Cream: (30 g)
Topical: For external use only; not for ophthalmic, oral, or intravaginal use. Wash hands prior to and after administration. Apply sparingly to affected area with fingertip as directed in product labeling. Do not cover treated area or apply to open skin. Do not apply to the face, scalp, genitals, groin, axilla, or between toes without medical supervision. Avoid contact with eyes.
Topical: For external use only. Wash hands prior to and after administration. Apply sparingly to affected area with fingertip as directed in product labeling. Not for ophthalmic, oral, or intravaginal use; do not use on open skin; do not apply to face, underarms, or groin area unless directed by physician; avoid contact with eyes; do not occlude affected area.
Note: Not approved in the US
Dermatitis: Management of localized eczema and dermatitis including atopic eczema and irritant and allergic contact dermatitis.
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Itraconazole: May increase the serum concentration of Clobetasone. Risk X: Avoid combination
Nirmatrelvir and Ritonavir: May increase the serum concentration of Clobetasone. Risk C: Monitor therapy
Ritonavir: May increase the serum concentration of Clobetasone. Risk X: Avoid combination
Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).
Systemic bioavailability of topical corticosteroids is variable (eg, integrity of skin, use of occlusion) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).
When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).
It is not known if sufficient quantities of clobetasone are absorbed following topical administration to produce detectable amounts in breast milk.
Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding, then clean nipples prior to the next feeding (Vestergaard 2019).
HPA axis suppression and adrenal insufficiency
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Clobetasone has intermediate range potency.
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