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Clobetasol: Pediatric drug information

Clobetasol: Pediatric drug information
(For additional information see "Clobetasol: Drug information" and see "Clobetasol: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Clobetasol Propionate E;
  • Clobetavix;
  • Clobex;
  • Clobex Spray;
  • Clodan;
  • Impeklo [DSC];
  • Impoyz;
  • Olux [DSC];
  • Olux-E [DSC];
  • Tasoprol [DSC];
  • Temovate [DSC];
  • Tovet
Brand Names: Canada
  • APO-Clobetasol;
  • Clobex;
  • Clobex Spray;
  • Dermovate;
  • MYLAN-Clobetasol;
  • ODAN Clobetasol;
  • REDDY-Clobetasol;
  • Sandoz Clobetasol;
  • TARO-Clobetasol;
  • TARO-Clobetasol Topical;
  • TEVA-Clobetasol
Therapeutic Category
  • Adrenal Corticosteroid;
  • Anti-inflammatory Agent;
  • Corticosteroid, Topical;
  • Glucocorticoid
Dosing: Pediatric

Note: Dosage should be based on severity of disease and patient response; use the smallest amount for the shortest period of time to avoid HPA axis suppression; discontinue therapy when control is achieved; reassess diagnosis if no improvement is seen within 2 weeks. Due to the high incidence of adrenal suppression noted in clinical studies, clobetasol lotion, shampoo, and spray are not recommended for use in patients <18 years of age.

Dermatoses

Dermatoses (steroid-responsive):

Cream 0.05%, emollient cream, gel, ointment: Children ≥12 years and Adolescents: Topical: Apply sparingly to affected area twice daily for up to 2 weeks; maximum weekly dose: 50 g/week.

Emollient foam: Children ≥12 years and Adolescents: Topical: Apply a thin layer to affected area twice daily in the morning and evening for up to 2 weeks; maximum weekly dose: 50 g/week or 21 capfuls/week.

Lotion: Adolescents ≥18 years: Topical: Apply twice daily for up to 2 weeks; maximum weekly dose: 50 g/week or 50 mL/week.

Solution: Children ≥12 years and Adolescents: Topical: Apply sparingly to affected area of scalp twice daily for up to 2 weeks; maximum weekly dose: 50 mL/week.

Plaque-type psoriasis of nonscalp areas, mild to moderate

Plaque-type psoriasis of nonscalp areas, mild to moderate: Children ≥12 years and Adolescents: Foam: Topical: Apply thin layer to affected area twice daily for up to 2 weeks; maximum weekly dose: 50 g/week or 21 capfuls/week.

Plaque-type psoriasis, moderate to severe

Plaque-type psoriasis, moderate to severe:

Cream 0.025%: Adolescents ≥18 years: Topical: Apply thin layer twice daily for up to 2 weeks; maximum weekly dose: 50 g/week.

Emollient cream: Adolescents ≥16 years: Topical: Apply sparingly twice daily for up to 2 weeks; if response is not adequate, may be used for up to 2 more weeks if application is <10% of BSA; use with caution; maximum weekly dose: 50 g/week.

Lotion: Adolescents ≥18 years: Topical: Apply twice daily for up to 2 weeks; may extend treatment for an additional 2 weeks for localized lesions <10% of BSA; maximum weekly dose: 50 g/week or 50 mL/week.

Spray: Adolescents ≥18 years: Apply by spraying directly onto affected area twice daily and gently rub into skin for up to 4 weeks; treatment beyond 2 weeks should be limited to localized lesions which have not improved sufficiently. Maximum weekly dose: 50 g/week or 59 mL/week. Do not use more than 26 sprays per application or 52 sprays per day.

Scalp psoriasis, moderate to severe

Scalp psoriasis, moderate to severe:

Foam: Children ≥12 years and Adolescents: Topical: Apply thin layer twice daily for up to 2 weeks; maximum weekly dose: 50 g/week or 21 capfuls/week.

Shampoo: Adolescents ≥18 years: Topical: Apply thin film to affected area of dry scalp once daily for up to 4 weeks; maximum weekly dose: 50 g/week or 50 mL/week.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Adult

(For additional information see "Clobetasol: Drug information")

Note: Discontinue when control achieved; if improvement not seen within 2 weeks, reassessment of diagnosis may be necessary.

Bullous pemphigoid

Bullous pemphigoid (off-label use) (monotherapy or combination therapy):

Mild to moderate disease: Topical: Cream (0.05%): Apply 10 to 30 g/day in 1 to 2 divided doses either on lesions only (localized bullous pemphigoid) or over entire body (normal and blistered skin), sparing the face (non-localized bullous pemphigoid). If disease control is not achieved in 1 to 3 weeks, may increase to 40 g/day in 2 divided doses (Ref).

Severe or extensive disease: Topical: Cream (0.05%): Apply 30 to 40 g/day in 2 divided doses over entire body (normal and blistered skin), sparing the face and anogenital areas (Ref).

Duration of therapy: Once control of disease activity is achieved, continue same dosage for 15 days, then taper over 4 to 12 months. If relapse (≥3 new lesions/month) occurs during dose reduction period, increase to previous dose (Ref).

Relapse (≥3 new lesions/month) following treatment withdrawal: Topical: Cream (0.05%): Apply 10 to 40 g/day in divided doses based on extent of relapse (Ref).

Oral mucosal inflammation

Oral mucosal inflammation (off-label use): Topical: Cream: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week); discontinue application when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Plaque-type psoriasis of nonscalp areas, mild to moderate

Plaque-type psoriasis of nonscalp areas, mild to moderate: Topical: Foam: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week).

Plaque-type psoriasis, moderate to severe

Plaque-type psoriasis, moderate to severe: Topical:

Cream (0.025%), emollient cream, lotion (0.05%): Apply twice daily for up to 2 weeks (cream) or up to 4 weeks if needed (emollient cream, lotion) when application is <10% of body surface area (maximum dose: 20 actuations/day for ≤7 days [lotion metered-dose pump], 50 g/week or 50 mL/week). Treatment with lotion beyond 2 weeks should be limited to localized lesions (<10% body surface area) that have not improved sufficiently.

Spray: Apply by spraying directly onto affected area twice daily and gently rub into skin. Limit treatment to 4 consecutive weeks; treatment beyond 2 weeks should be limited to localized lesions that have not improved sufficiently. Maximum total dose: 50 g/week or 59 mL/week. Do not use more than 26 sprays per application or 52 sprays per day.

Scalp psoriasis, moderate to severe

Scalp psoriasis, moderate to severe: Topical:

Foam: Apply twice daily for up to 2 weeks (maximum dose: 50 g/week).

Shampoo: Apply thin film to dry scalp once daily (maximum dose: 50 g/week or 50 mL/week); leave in place for 15 minutes, then add water, lather, and rinse thoroughly. Limit treatment to 4 consecutive weeks.

Steroid-responsive dermatoses

Steroid-responsive dermatoses: Topical: Cream (0.05%), emollient cream, emollient foam, foam, gel, lotion, ointment, solution: Apply twice daily for up to 2 weeks (maximum dose: 20 actuations/day for ≤7 days [lotion metered-dose pump], 50 g/week or 50 mL/week).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency may depend upon formulation used, length of application, surface area covered, and the use of occlusive dressings.

>10%: Endocrine & metabolic: HPA-axis suppression (13% to 56%)

1% to 10%:

Dermatologic: Eczema (pruritus hiemalis: 2%), erythema (<2%), folliculitis (<2%), hypopigmentation (1% to 2%), pruritus (<2%), skin atrophy (≤4%), skin fissure (<2%), stinging of skin (<2%), telangiectasia (≤3%), xeroderma (≤2%)

Local: Application site reaction (2% to 4%), local irritation (<2%)

Nervous system: Headache (≤2%), localized burning (≤10%), local discomfort (1%), numbness of fingers (<2%)

Respiratory: Nasopharyngitis (5%), streptococcal pharyngitis (1%), upper respiratory tract infection (8%)

<1%:

Dermatologic: Alopecia, dermatitis, scalp pustules, skin rash, skin tenderness (scalp)

Nervous system: Scalp tightness, tingling of skin (scalp)

Ophthalmic: Eye irritation

Frequency not defined:

Dermatologic: Local acneiform eruptions, urticaria

Local: Application site edema

Postmarketing:

Dermatologic: Atrophic striae, contact dermatitis, desquamation, exacerbation of psoriasis, excoriation of skin, exfoliation of skin, hypertrichosis, indurated plaques of the skin, lichenoid eruption, miliaria, papule of skin, perioral dermatitis, skin pain

Endocrine & metabolic: Cushing's syndrome

Infection: Secondary infection

Local: Application site induration

Neuromuscular & skeletal: Pathological fracture due to osteoporosis (Gönül 2015)

Ophthalmic: Cataract, glaucoma, increased intraocular pressure, retinopathy

Contraindications

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to clobetasol, other corticosteroids, or any component of the formulation; primary infections of the scalp (scalp solution only); treatment of rosacea, acne vulgaris, perioral dermatitis, or perianal and genital pruritus; viral (eg, herpes or varicella) lesions of the skin, bacterial or fungal skin infections, parasitic infections, skin manifestations relating to tuberculosis or syphilis, eruptions following vaccinations; ulcerous wounds; application to eyes or eyelids; children <2 years of age (shampoo, spray); children <1 year of age (cream, ointment, scalp application). Note: Product labels may vary (refer also to product labels).

Warnings/Precautions

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 may occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Local effects: Local effects may occur, including folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria, skin atrophy, and telangiectasia; local adverse effects may be irreversible.

• Ocular effects: Topical corticosteroids, including clobetasol, may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular changes. Avoid contact with eyes.

• Skin infections: Concomitant skin infections may be present or develop during therapy; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Special populations:

• Pediatric: Use in children <12 years of age is not recommended. 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. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients. Clobex and Impeklo lotion, Clobex shampoo, Clobex spray, and Clodan shampoo are not recommended for use in patients ≤17 years of age.

Dosage form specific issues:

• Emollient cream: Contains imidurea which releases traces of formaldehyde as a breakdown product; formaldehyde may cause allergic sensitization or irritation upon skin contact.

• Foam/Spray: The foam and spray are flammable. Avoid fire, flame, or smoking during and immediately following application.

Other warnings/precautions:

• Appropriate use: Do not use if there is atrophy at the treatment site. Do not use with occlusive dressing. Do not use on the face, axillae, or groin or for the treatment of acne vulgaris, rosacea, or perioral dermatitis.

Warnings: Additional Pediatric Considerations

The extent of percutaneous absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Infants and small children may be more susceptible to HPA axis suppression, intracranial hypertension, Cushing syndrome, or other systemic toxicities due to larger skin surface area to body mass ratio. Due to the high incidence of adrenal suppression noted in clinical studies, clobetasol lotion, shampoo, and spray are not recommended for use in patients <18 years of age. In a study of patients with moderate to severe atopic dermatitis (involving ≥20% BSA) receiving Clobex 0.05% lotion twice daily for 2 weeks, 9 of the14 pediatric patients (12 to 17 years of age) included developed adrenal suppression, compared to 2 of the 10 pediatric patients receiving the cream. In a study of patients receiving Clobex 0.05% shampoo, 5 of 12 pediatric patients (12 to 17 years of age) developed HPA axis suppression.

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as propionate:

Clobetasol Propionate E: 0.05% (15 g, 30 g, 60 g) [contains cetostearyl alcohol, propylene glycol]

Clobetasol Propionate E: 0.05% (15 g, 30 g, 60 g) [contains propylene glycol]

Impoyz: 0.025% (100 g) [contains cetostearyl alcohol, methylparaben, propylparaben]

Temovate: 0.05% (30 g [DSC], 60 g [DSC]) [contains cetostearyl alcohol, chlorocresol (chloro-m-cresol), propylene glycol]

Generic: 0.05% (15 g, 30 g, 45 g, 60 g)

Foam, External, as propionate:

Olux: 0.05% (50 g [DSC], 100 g [DSC]) [cfc free; contains alcohol, usp, cetyl alcohol, propylene glycol]

Olux-E: 0.05% (50 g [DSC], 100 g [DSC]) [cfc free; contains cetyl alcohol, propylene glycol]

Tovet: 0.05% (100 g) [contains cetyl alcohol, propylene glycol]

Generic: 0.05% (50 g, 100 g)

Gel, External, as propionate:

Generic: 0.05% (15 g, 30 g, 60 g)

Kit, External, as propionate:

Clobetavix: 0.05% [contains propylene glycol]

Clodan: 0.05% [DSC] [contains alcohol, usp, cetyl alcohol, edetate (edta) disodium, propylene glycol]

Tasoprol: 0.05% [DSC] [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben]

Tovet: 0.05% [DSC] [contains cetyl alcohol, edetate (edta) disodium, methylparaben, propylene glycol, trolamine (triethanolamine)]

Liquid, External, as propionate:

Clobex Spray: 0.05% (59 mL, 125 mL) [contains alcohol, usp]

Generic: 0.05% (59 mL, 125 mL)

Lotion, External, as propionate:

Clobex: 0.05% (59 mL, 118 mL)

Impeklo: 0.05% (68 g [DSC]) [contains propylene glycol]

Generic: 0.05% (59 mL, 118 mL)

Ointment, External, as propionate:

Temovate: 0.05% (15 g [DSC], 30 g [DSC]) [contains propylene glycol]

Generic: 0.05% (15 g, 30 g, 45 g, 60 g)

Shampoo, External, as propionate:

Clobex: 0.05% (118 mL) [contains alcohol, usp]

Clodan: 0.05% (118 mL) [contains alcohol, usp]

Generic: 0.05% (118 mL)

Solution, External, as propionate:

Generic: 0.05% (25 mL, 50 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Clobetasol Prop Emollient Base External)

0.05% (per gram): $4.54

Cream (Clobetasol Propionate External)

0.05% (per gram): $7.65 - $9.24

Cream (Impoyz External)

0.025% (per gram): $16.20

Foam (Clobetasol Propionate Emulsion External)

0.05% (per gram): $7.02

Foam (Clobetasol Propionate External)

0.05% (per gram): $1.18 - $7.02

Foam (Tovet External)

0.05% (per gram): $8.34

Gel (Clobetasol Propionate External)

0.05% (per gram): $2.76 - $9.26

Liquid (Clobetasol Propionate External)

0.05% (per mL): $6.69

Liquid (Clobex Spray External)

0.05% (per mL): $9.45

Lotion (Clobetasol Propionate External)

0.05% (per mL): $0.92 - $4.90

Lotion (Clobex External)

0.05% (per mL): $10.68

Ointment (Clobetasol Propionate External)

0.05% (per gram): $8.27 - $8.66

Shampoo (Clobetasol Propionate External)

0.05% (per mL): $0.76 - $3.46

Shampoo (Clobex External)

0.05% (per mL): $8.95

Shampoo (Clodan External)

0.05% (per mL): $6.93

Solution (Clobetasol Propionate External)

0.05% (per mL): $0.29 - $4.13

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External, as propionate:

Dermovate: 0.05% (15 g, 50 g)

Generic: 0.05% (15 g, 30 g, 50 g, 450 g, 454 g)

Liquid, External, as propionate:

Clobex Spray: 0.05% (59 mL, 125 mL) [contains alcohol, usp]

Generic: 0.05% (59 mL)

Ointment, External, as propionate:

Dermovate: 0.05% (15 g, 50 g)

Generic: 0.05% (15 g, 50 g, 450 g, 454 g)

Shampoo, External, as propionate:

Clobex: 0.05% (15 mL, 118 mL) [contains alcohol, usp]

Generic: 0.05% (120 mL)

Solution, External, as propionate:

Dermovate: 0.05% (20 mL, 60 mL)

Generic: 0.05% (20 mL, 59 mL, 60 mL, 90 mL)

Additional Information

Considered to be a super high potency topical corticosteroid; clobetasol is a prednisolone analog with a high level of glucocorticoid activity and slight degree of mineralocorticoid activity.

Administration: Pediatric

Topical: Apply the smallest amount that will cover affected area. For topical use only; avoid contact with eyes and mucous membranes. Do not apply to face, groin, axillae, diaper area, or intertriginous areas; avoid contact with eyes. Do not use if there is atrophy at the treatment site. Minimize contact to nonaffected areas of the body; wash hands after applying. Occlusive dressings not recommended; do not occlude affected area unless directed by a physician. Not for oral, ophthalmic, or intravaginal use.

Cream, emollient cream, gel, lotion, ointment, solution: Rub in gently and completely.

Emollient foam: Shake can before use. Turn can upside down and spray a small amount of foam into the cap, other cool surface, or to affected area. Massage foam into affected area.

Foam: Turn can upside down and spray a small amount (maximum: 11/2 capful or about the size of a golf ball) of foam into the cap, other cool surface, or to affected area. If the can is warm or foam is runny, place can under cold, running water. If fingers are warm, rinse with cool water and dry prior to handling (foam will melt on contact with warm skin). Massage foam into affected area.

Shampoo: Use on dry scalp; do not wet hair prior to use. Do not use a shower cap or bathing cap while shampoo is on the scalp. Leave in place for 15 minutes, then wet hair, lather, and rinse hair and scalp completely. Although no additional shampoo is necessary to cleanse the hair, a nonmedicated shampoo may be used after application if desired. Avoid contact with eyes and lips.

Spray: Spray directly onto affected area of skin. Gently and completely rub into skin after spraying. Do not use more than 26 sprays per application or 52 sprays per day; refer to product labeling for detailed instructions for use.

Administration: Adult

Topical: Apply the smallest amount that will cover affected area. For topical use only; avoid contact with eyes and mucous membranes. Do not apply to face, scalp, axilla, groin, or intertriginous areas. Do not use if there is atrophy at the treatment site. Do not cover, bandage, or wrap the treated area unless instructed. Minimize contact to nonaffected areas of the body. Wash hands after use.

Cream, emollient cream, gel, lotion, ointment, solution: Rub in gently and completely.

Emollient foam: Shake can before use. Turn can upside down and spray a small amount (approximately a capful) of foam into the cap. Massage foam into affected area until foam absorbed.

Foam: Turn can upside down and spray a small amount (golf-ball size) of foam into the cap or another cool surface. If the can is warm or foam is runny, place can under cold, running water. If fingers are warm, rinse with cool water and dry prior to handling (foam will melt on contact with warm skin). Massage foam into affected area.

Shampoo: Limit treatment to 4 consecutive weeks. Use on dry hair; do not wet hair prior to use. Do not use a shower cap or bathing cap while shampoo is on the scalp. Leave in place for 15 minutes, then wet hair, lather and rinse hair and scalp completely. Although no additional shampoo is necessary to cleanse the hair, a nonmedicated shampoo may be used after application if desired.

Spray: Spray directly onto affected area of skin. Gently and completely rub into skin after spraying.

Storage/Stability

Cream, emollient cream, lotion, ointment: Store between 15°C to 30°C (59°F to 86°F); do not refrigerate or freeze.

Emollient foam, foam: Store between 20ºC and 25ºC (68ºF and 77ºF); do not expose to temperatures >49°C (120°F). Avoid fire, flame, or smoking during and immediately following application.

Gel: Store between 2°C and 30°C (36°F and 86°F).

Shampoo: Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)

Solution: Store at controlled room temperature; recommendations may vary; refer to manufacturer’s labeling. Do not use near an open flame.

Spray: Store at room temperature; do not expose to temperatures >30°C (86°F). Do not freeze or refrigerate. Spray is flammable; do not use near open flame.

Use

Short-term relief of inflammation and pruritus associated with corticosteroid-responsive dermatoses (Cream 0.05%, emollient cream, emollient foam, gel, and ointment: FDA approved in ages ≥12 and adults; Lotion: FDA approved in ages ≥18 years and adults); short-term relief of inflammation and pruritus associated with moderate to severe corticosteroid-responsive dermatoses of the scalp (Solution: FDA approved in ages ≥12 years and adults); short-term treatment of mild to moderate plaque psoriasis of nonscalp regions (Foam: FDA approved in ages ≥12 years and adults); short-term treatment of moderate to severe plaque-type psoriasis (Emollient cream: FDA approved in ages ≥16 years and adults; Cream 0.025%, lotion, spray: FDA approved in ages ≥18 years and adults); short-term treatment of moderate to severe forms of scalp psoriasis (Foam: FDA approved in ages ≥12 years and adults; Shampoo: FDA approved in ages ≥18 years and adults).

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

International issues:

Clobex [US, Canada, and multiple international markets] may be confused with Codex brand name for Saccharomyces boulardii [Italy]

Cloderm: Brand name for clobetasol [China, India, Malaysia, Singapore, Thailand], but also brand name for alclometasone [Indonesia]; clocortolone [US, Canada]; clotrimazole [Germany]

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).

Pregnancy Considerations

Information related to the use of clobetasol in pregnancy is limited (Westermann 2012).

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).

Monitoring Parameters

Assess HPA axis suppression in patients using potent topical steroids applied to a large surface area or to areas under occlusion (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test).

Mechanism of Action

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. Clobetasol has very high range potency.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Percutaneous absorption is variable and dependent upon many factors including vehicle used, integrity of epidermis, dose, and use of occlusive dressings (not recommended); absorption is increased by occlusive dressings or with decreased integrity of skin (eg, inflammation or skin disease); gel has greater absorption than cream

Metabolism: Hepatic

Excretion: Urine and feces

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Clobate | Clobex | Cloderm | Delor | Dermovate | Gamavate | Promax;
  • (AR) Argentina: Cantril | Clob x | Clobefar | Clobeplus | Clobesol | Clobex | Dermadex | Dermexane | Klomadex | La ribatra | Perfracort | Proavenal c | Ribatra | Salac | Salvicutan;
  • (AT) Austria: Clarelux | Clobex | Dermovate;
  • (AU) Australia: Clobex;
  • (BD) Bangladesh: Aclobet | Clobederm | Clobenate | Clobesol | Clovate | Cobesol | Dermacort | Dermasol | Dermasol s | Dermasone | Dermatas | Dermex | Dermovate | Dersole | Eclo | Exovate n | Medodermone | Nyclobate | Protasol | Steclo | Temovate | Topiclo | Topisol | Xderm | Xenocort | Xenovate;
  • (BE) Belgium: Clarelux | Dermovate;
  • (BG) Bulgaria: Clobederm | Dermovate;
  • (BR) Brazil: Clob x | Clobesol | Clobirex | Cortalen c | Dermacare | Propionato de clobetasol | Propiosol | Psorex | Psorin | Psorizol | Therapsor | Topirex;
  • (CH) Switzerland: Clarelux | Clobex | Dermovate;
  • (CI) Côte d'Ivoire: Clomed;
  • (CL) Chile: Alticort | Balsan | Clob x | Clobaderm | Clobetasol | Cortopic | Dermovate | Koniderm | Lobevat | Xinder;
  • (CN) China: Clobetasol | Clobetasol propion | Dermovate | En fu shuang | Eurobetsol | Si fu shuang;
  • (CO) Colombia: Betazol | Clabsol | Clob x | Clobecare | Clobent | Clobeskin | Clobetasol | Clobetasol la sante | Clobetasol mk | Clobetasol propionato | Clobetazol mk | Clobetex | Clobetrin | Clobex | Clobezan | Dermovate | Derprosol | Difazin | Lobevat | Tazolin | Tridirtex | Trimicort;
  • (CZ) Czech Republic: Clarelux | Clobex | Dermovate;
  • (DE) Germany: Butavate | Clarelux | Clobegalen | Clobetasol Acis | Clobex | Dermovate | Dermoxin | Dermoxinale | Karison;
  • (DK) Denmark: Dermovat;
  • (DO) Dominican Republic: Biocortone | Clobetasol | Clobetavic | Clobexpro | Cloderma | Dermovate | Lobevat | Panacutal | Suclobe;
  • (EC) Ecuador: Clob x | Clobetasol la sante | Clobetasol mk | Cortopic | Dermovate | Lobevat | Powercort | Salvicutan;
  • (EE) Estonia: Dermovate;
  • (EG) Egypt: Clerovate | Clobitat | Clobutra | Clovacort | Cortistazen | Dermasol | Dermopharm | Dermovate | Jedcovate;
  • (ES) Spain: Clarelux | Clobex | Clobisdin | Decloban;
  • (ET) Ethiopia: Clobetasol | Clobetasol propionate shampoo | Cloderm | Delor | Dermovate | Medodermone | Timovate | Ysp dermosol;
  • (FI) Finland: Clarelux | Dermovat;
  • (FR) France: Clarelux | Clobetasol substipharm | Clobex | Dermoval;
  • (GB) United Kingdom: Clobaderm | Clobetasol | Dermovate | Etrivex;
  • (GR) Greece: Butavate | Clarelux | Clobetan | Clobex | Rubocort | Yugofin;
  • (HK) Hong Kong: Axcel Clobetasol | Clobasol | Clobex | Cloderm | Cp-Clobetasol | Dermasone | Dermaway | Dermo | Dermosol | Dermovate | Dermowel | Dhabesol | Dovate | Eurobetsol | Medodermone | Megavate | Neovate | Prosol | Qualiderm | Sensoderm | Uni-Dermo | Uniderm | Univate | Vida Clobetasol;
  • (HU) Hungary: Clobex | Closanasol | Dermoforte | Dermovate;
  • (ID) Indonesia: Bersol | Clobesan | Clobetasol | Cloderm | Closol | Dermovate | Elopro | Forderm | Hercum | Ikaderm | Kloderma | Klonat | Lamodex | Lotasbat | Psoriderm | Tempovate;
  • (IE) Ireland: Clarelux | Dermovate | Etrivex;
  • (IL) Israel: Dermovate;
  • (IN) India: Adivate | Agiclob | Belsonate | Betanate | Betsalic | C Vate | Cataderm | Cesol | Clobaderm | Clobenate | Clobetagen | Clobetamil | Clobetex | Clobetol | Clobiderm | Clobital | Cloderm | Clofoam | Clomed | Clomic | Clonate | Clonext | Clonova | Clop | Clop-e | Clored | Clorega | Closalve | Clovate | Cloviva | Clozema | Cortaz | Cortent | Corticlob | Cortimax | Cosvate | Cutivate | Dermolin | Dermotyl | Ecziclo | Epivate | Exderm | Exel | Impoyz | Keralyte | Klosoft | Lobate | Lozivate | Niosol | Nuvate | Obet | Ocovate | Olclobee | Oleb | Olprovate | Plosat | Powercort | Psoricort C | Psorobet | Saclo | Soltop | Somaderm | Sonaderm | Steriderm | Supravate | Tenovate | Tezcort | Topical | Topifort | Topinate | Topsor | Tufderm | Tuffclo | Zenclobate | Zincort;
  • (IQ) Iraq: As dermodeem | Dermodad | Dermodeen d | Dermoden mdi | Dermodin | Dermoheal | Dermoyat;
  • (IT) Italy: Civic | Clobecare | Clobesol | Clobetasolo isdin | Clobetasolo pfa | Etrivex | Movate;
  • (JO) Jordan: Clobederm | Clobevate | Cloderm | Delor | Dermovate | Klobederm | Medodermone;
  • (JP) Japan: Betaleston | Comclo | Delspart | Dermovate | Dertopica | Entyfluson taiyo | Entyfluson towa | Glydil | Mahady | Myalone | Siodelbate | Solvega;
  • (KE) Kenya: Clobederm | Clobeta | Clobit | Cloprone | Closol | Cosvate | Cutisol | Daclobet | Dermasol | Dermovate | Niosol | Powercort;
  • (KR) Korea, Republic of: Berdant | Betabate | Clerben | Clobate | Clobeta | Clobex | Crosol | Demaron | Derbisol | Dermocort | Dermovate | Domo horn | Domohoron | J clobel | K tasol | Kosol | Kovate | Prosol | Prot | Staven | Userin;
  • (KW) Kuwait: Clobesol | Clobex | Dermovate | Gamavate | Promax;
  • (LB) Lebanon: Decloban | Dermasone | Dermovate;
  • (LT) Lithuania: Clobederm | Closanasol | Dermovate | Topinate;
  • (LU) Luxembourg: Clarelux | Clobex | Dermovate;
  • (LV) Latvia: Clobederm | Closanasol | Dermovate | Dermoxin;
  • (MA) Morocco: Clarelux | Clobex | Dermoval;
  • (MX) Mexico: Clobesol | Clobetasol | Clobexpro | Dermatovate | Lobevat | Pilisar | Pirovate | Salac | Topifort | Tsuyoi;
  • (MY) Malaysia: Axcel Clobetasol | Betaclob | Betasol | Clobet | Clobetasol | Clobex | Cloderm | Clonate | Clop | Clovate | Dermapro | Dermosol | Dermovate | Dhabesol | Glevate | Lobesol | Quace Eczema | Uniderm | Univate;
  • (NG) Nigeria: Betasol | Betasol plus | Cenovate | Clobendan | Dermovate | Haloderm | Neutrotone | Sinovate | Vineal;
  • (NL) Netherlands: Clarelux | Clobetasol-17-propionaat Fisher | Clobetasolpropionaat Teva | Clobex | Dermovate | Eczoria;
  • (NO) Norway: Clobex | Dermovat | Dermovate | Karison;
  • (NZ) New Zealand: Clobetasol | Dermol | Dermovate;
  • (PE) Peru: Albaler | Alidzol | Alizar | Betazol | Clob x | Clobecort | Clobenate | Clobesol | Clobetasol | Clobetasol 0.05% | Clobezan | Dermovate | Lipcobel | Lobevat | Medivate | Powercort | Topicalm | Xoricrem;
  • (PH) Philippines: Cleovate | Clobederm | Clobenate | Clobetasol | Clobex | Clobila | Clobimed | Clobison | Cloderm | Clonate | Closderm | Clovate | Dermacare | Dermosol | Dermovate | Glevate | Probelin | Ritemed clobetasol propionate;
  • (PK) Pakistan: Anrozim | Beltapro | Biovate | Clobecort | Clobederm | Clobet | Clobeta | Clobetol | Clobetrex | Clobevate | Clobicare | Clodrm | Clonate | Covate | Derbitol | Dermasol | Dermit | Dermovate | Duclob | Emovate | Globeta | Kortizone | Maxivate | Norzy | Obet | Primovate;
  • (PL) Poland: Clarelux | Clobederm | Clobetaxon | Clobex | Dermklobal | Dermovate | Novate;
  • (PR) Puerto Rico: Clobetasol | Clobetasol e | Clobetasol Proprionate | Clobetavix | Clobevate | Clobex | Clodan | Cormax | Embeline | Embeline e | Impoyz | Isovate | Olux | Temovate | Temovate e | Tovet;
  • (PT) Portugal: Clarelux | Clobetasol cantabria | Clobetasol ratiopharm | Dermovate | Dermovate capilar | Etrivex;
  • (PY) Paraguay: Clobetasol propionato mintlab | Clobetazol pasteur | Cloxial | Dermatrin | Dermexane | Dermovate | Hexoderm forte | Imecort | Perfracort | Salac;
  • (QA) Qatar: Clobederm | Clobex | Cloderm | Clovate | Cortimax | Delor | Dermamed | Dermovate | Dermovate Scalp Application | Gamavate;
  • (RO) Romania: Clobetasol | Clobetasol mk | Clobetazol atb | Cloderm | Dermione | Dermovate;
  • (RU) Russian Federation: Clovate | Cloveit | Dermovate | Dermoveit | Etrivex | Powercort | Powercourt;
  • (SA) Saudi Arabia: Clobate | Clobederm | Cloderm | Cortimax | Decloban | Delor | Dermal | Dermamed | Dermovate | Etrivex | Gamavate | Promax;
  • (SE) Sweden: Clobetasol teva | Clobex | Dermovat | Dermovate | Klobetasol APL;
  • (SG) Singapore: Clobex | Cloderm | Clonovate | Dermosol | Dermovate | Dhabesol | Lobesol | Medodermone | Uniderm | Univate;
  • (SK) Slovakia: Clarelux | Clobex | Dermovate;
  • (TH) Thailand: Betasol | Bifon | Bovate | Chinovate | Clinoderm | Clobasone | Clobet | Clobetasol | Clobetate | Clobevate | Clobex | Cloderm | Clodermis | Clomabet pip | Clonovate | Clorbet | Clotasol | Clovate | Cobesol | Cotaso | Delacor | Dergemate | Dermaman | Dermasil | Dermazone | Dermonar | Dermovate | Hofvate | Kaltazone | Klobecort | Medodermone | P-vate | Pharmavate | Pharmovet | Pronate | Psoclosol | Ptocort | Selma | Starmovate | Stivate | Tacosol | Uniderm;
  • (TN) Tunisia: Clobex | Dermocort | Dermoval | Psoriacort;
  • (TR) Turkey: Clobesol | Clovate | Dermovate | Klobate | Psobetazol | Psoderm | Psovate;
  • (TW) Taiwan: Basol | Beclosol | Befurine | Belolin | Belosol | Besol | Bestasol | Betasol | C.p.p. | Cleosol | Clobenofe | Clobesol | Clobesone | Clobeta | Clobetasol | Clobex | Clolux | Clomold | Closil | Closol | Clotasol | Clotasone | Cpicon | Debesol | Defulin | Dermocure | Dermofute | Dermolex | Dermosol | Dermovate | Euclobe | Fu shuang "ching chang" | Fucon | Fulet | Genuvate | Jinfsone | Kec. Jen | Kfulin | Kotason | Mannin | Medodermone | Miping | Multigive | Pevigen | Pirigen | S.Z | Shu le fu | Solbeta | Vimax | Yihfu;
  • (UA) Ukraine: Carizon | Clobederm | Clobeskin | Clovate | Dermovate | Derylife | Povercort;
  • (UG) Uganda: Dermovate | Glevate | Lemonvate | Movate | Tasol;
  • (UY) Uruguay: Betazol | Clob x | Clobesol | Clobesol LA | Clobex | Dermovate | Efacort | Lobevat | Salac | Ultracort;
  • (VE) Venezuela, Bolivarian Republic of: Betactiv | Betasol | Clobetasol | Dermadex | Dermazol | Dermovate | Glevate | Lobevat | Zoryzol;
  • (VN) Viet Nam: Amfacort | Apisolvat | Betaclo | Clonbate | Knevate | Neutasol | Philclobate | Vataxon;
  • (ZA) South Africa: Betasol | Clobex | Dermovate | Dovate | Powercort | Xenovate;
  • (ZM) Zambia: Betasol | Bg sol | Clobit | Cloderm | Enderm | Powercort;
  • (ZW) Zimbabwe: Glevate
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Topic 12609 Version 601.0

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