clobetasol (Rx)

Brand and Other Names:Cormax, Clobex, more...Clobex Spray, Cormax Ointment, Cormax Scalp Application, Impoyz, Olux, Olux-E
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream, topical

  • 0.025% (Impoyz)
  • 0.05% (Temovate)

foam, topical

  • 0.05% (Olux, Olux E)

gel, topical

  • 0.05%

lotion, topical

  • 0.05% (Clobex)

ointment, topical

  • 0.05% (Temovate)

shampoo, topical

  • 0.05% (Clobex)
  • 0.05% (Clodan)

solution, topical

  • 0.05%

spray, topical

  • 0.05% (Clobex Spray)
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Corticosteroid-responsive Dermatoses

Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Cream/foam: Apply thin layer to affected areas q12hr and rub in gently and completely; not to exceed 50 g/week

Lotion: Apply to affected skin areas BID and rub in gently and completely; not to exceed 50 g/week;

Scalp

  • Foam: Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g or 50 mL/week

Scalp Psoriasis

See also Administration

Indicated for moderate-to-severe forms of scalp psoriasis

Shampoo: Apply thin film to dry scalp qDay; leave in place for 15 min; add water, lather, and then rinse thoroughly; limit treatment to 4 consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis

Foam: Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g/week

Plaque Psoriasis

Mild-to-moderate

  • Foam: Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g/week

Moderate-to-severe

  • Indicated for moderate to severe plaque psoriasis
  • See also Administration
  • Emollient cream/lotion: Apply to affected area BID for up to 2 weeks (cream) or up to 4 weeks if needed (emollient cream, lotion) when application is <10% of body surface area; not to exceed 50 g/week or 50 mL/week; treatment with lotion >2 weeks should be limited to localized lesions (<10% body surface area), which have not improved sufficiently with therapy; not to exceed 50 g or 50 mL/week;
  • Cream 0.025%: Apply a thin layer to the affected skin areas BID for up to 2 consecutive weeks
  • Spray
    • Indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA)
    • Apply by spraying onto affected area q12hr; rub into skin; should not be used for more than 4 weeks; treatment with spray beyond 2 weeks should be limited to localized lesions which have not improved sufficiently

Dosing Considerations

Cream 0.025%

  • Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 gram/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis

Clobex Lotion, 0.05%

  • Should not be used with occlusive dressings
  • Limitations of use
    • Should not be used on the face, axillae, or groin and should not be used if there is atrophy at treatment site
    • Should not be used in the treatment of rosacea or perioral dermatitis

Shampoo

  • Limitations of use
    • Should not be used on the face, groin or axillae
    • Avoid any contact with the eyes and lips
    • In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo

Foam

  • Limitations of use
    • Avoid face, axillae, and groin
    • Avoid use if skin atrophy is present at treatment site

Dosage Forms & Strengths

cream, topical

  • 0.05% (Cormax, Embeline E)

foam, topical

  • 0.05% (Olux, Olux E)

lotion topical

  • 0.05% (Clobex)

shampoo, topical

  • 0.05% (Clobex)
  • 0.05% (Clodan)

spray, topical

  • 0.05% (Clobex)
more...

Corticosteroid-responsive Dermatoses

<12 years

  • Safety and efficacy not established

>12 years (cream/foam)

  • Apply thin layer to affected areas q12hr and rub in gently and completely; not to exceed 50 g/week

Corticosteroid-responsive Dermatoses of the Scalp

<12 years

  • Safety and efficacy not established

>12 years (foam)

  • Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g or 50 mL/week

Scalp Psoriasis

<12 years

  • Safety and efficacy not established

>12 years (shampoo)

  • Apply thin film to dry scalp qDay; leave in place for 15 min; add water, lather, and then rinse thoroughly

Mild to Moderate Plaque-type Psoriasis of Nonscalp Areas

<12 years

  • Safety and efficacy not established

>12 years (foam)

  • Apply to affected area in scalp q12hr for up to 2 weeks; not to exceed 50 g/week
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Adverse Effects

1-10%

Lotion

  • Skin atrophy (4.2%)
  • Telangiectasia (3.2%)
  • Discomfort skin (1.3%)
  • Dry skin (1%)

Frequency Not Defined

Skin atrophy

Striae

Burning

Cracking/fissuring of the skin

Erythema

Folliculitis

Irritation

Numbness

Pruritus

Stinging

Hypopigmentation (high potency topical steroids)

Intracranial hypertension reported in children with use of topical formulation

Adrenal suppression, Cushing syndrome, hyperglycemia

Acneform lesions

Secondary infection

Pigmentation changes

HPA suppression (with higher potency used >2 weeks); doses as low as 2 g/day can produce HPA suppression

Postmarketing Reports

The following adverse reactions have been identified during post-approval use of clobetasol propionate: striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria

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Warnings

Contraindications

Viral, fungal, or tubercular skin lesions

Hypersensitivity

Ophthalmic use

Cautions

Chronic topical corticosteroid therapy may interfere with growth and development in children

May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, especially in younger children or patients receiving high doses for prolonged periods

Use lower potency in children; may absorb proportionally larger amounts after topical application and may cause systemic effects; treatment of children <12 years not recommended; prolonged use may affect growth velocity (routinely monitor growth in pediatric patient); Clobex lotion, Clobex spray, Clobex shampoo, Clodan shampoo not recommended for use in patients <17 years

Allergic contact dermatitis reported with use; diagnosed by failure to heal rather than clinical exacerbation

Kaposi sarcoma reported with prolonged corticosteroid treatment; consider discontinuing therapy if it occurs

Percutaneous absorption of corticosteroids may cause manifestations of Cushing syndrome

Topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract; glaucoma and cataracts reported in postmarketing; avoid contact with eyes; advise patients to report any visual symptoms

Foam dosage form is flammable; avoid fire, flame, or smoking during and immediately following application

Local effects, including perioral dermatitis, acneiform eruptions, folliculitis, hypopigmentation, skin atrophy, miliaria, secondary infection, and telangiectasia may occur; effects may be reversible

Concomitant skin infections may be present or develop during therapy; discontinue if dermatological infection persists after antimicrobial therapy

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Pregnancy & Lactation

Pregnancy

Safety data on clobetasol in pregnant woman is not available

Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy

Advise pregnant women of the potential risk to a fetus and to use clobetasol on the smallest area of skin and for the shortest duration possible

In animal reproduction studies, increased malformations (eg, cleft palate and skeletal abnormalities), were observed after SC administration of clobetasol to pregnant mice and rabbits

Lactation

No information is available regarding the presence of clobetasol in breast milk or its effects on the breastfed infant or on milk production

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects

Unknown whether topical administration of clobetasol could result in sufficient systemic absorption to produce detectable quantities in human milk

To minimize potential exposure to the breastfed infant via breast milk, use clobetasol on the smallest area of skin and for the shortest duration possible while breastfeeding

Advise breastfeeding women to avoid applying clobetasol directly to the nipple and areola to prevent direct infant exposure

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; and reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation

Pharmacokinetics

Absorption: Percutaneously

Metabolism: Hepatic

Excretion: Urine and feces

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Administration

Topical Administration

For topical use only; not for oral, ophthalmic, or intravaginal use

Cream or gel

  • Apply onto affected skin area
  • Do not use if atrophy is present at treatment site
  • Do not bandage, cover, or wrap treated skin area unless directed by a physician
  • Avoid use on face, scalp, axilla, groin, or other intertriginous areas
  • Wash hands after each application

Foam

  • Apply a thin layer to affected area(s) morning and evening
  • For proper dispensing of foam, shake the can, hold it upside down, and press actuator
  • Dispense a small amount of foam (about a capful) and gently massage the foam into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed
  • Avoid contact with the eyes

Shampoo

  • Apply onto dry (not wet) scalp qDay in a thin film to affected areas only
  • Leave in place for 15 minutes before lathering and rinsing
  • Rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (eg, hands, face, neck and shoulders)
  • Avoid contact with eyes and lips Minimize contact to nonaffected areas of the body
  • Although no additional shampoo is necessary to cleanse your hair, you may use a nonmedicated shampoo if desired
  • Do not cover your head with a shower or bathing cap while shampoo is on the scalp

Spray

  • Spray to affected area(s); rub in gently and completely
  • Avoid contact with the eyes
  • Avoid use on face, scalp, axilla, groin, or other intertriginous areas
  • Wash hands after each application

Storage

Cream

  • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
  • Do not freeze

Foam or spray

  • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
  • Flammable
  • Avoid fire, flame, or smoking during and immediately following application
  • Contents under pressure; do not puncture or incinerate
  • Do not expose to heat or store at temperatures above 120°F (49°C)
  • Keep out of reach of children

Lotion

  • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
  • Do not freeze

Shampoo

  • Store at room temperature between 20-25˚C (68-77˚F)
  • Keep bottle tightly closed
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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.