clobetasol (Rx)

Brand and Other Names:Cormax, Clobex, more...Clobex Spray, Cormax Ointment, Cormax Scalp Application, Impoyz, Olux, Olux-E, Clobex Shampoo, Clodan Kit, Clodan Shampoo
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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 Shampoo, Clodan Shampoo, Clodan Kit)

solution, topical

  • 0.05%

spray, topical

  • 0.05% (Clobex Spray)

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 Shampoo, Clodan Shampoo, Clodan Kit)

spray, topical

  • 0.05% (Clobex)

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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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Olux topical
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0.05 % foam
Olux topical
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0.05 % foam
Olux topical
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0.05 % foam
Impoyz topical
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0.025 % cream
Clodan topical
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0.05 % shampoo
Clobex topical
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0.05 % liquid
Clobex topical
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0.05 % shampoo
Clobex topical
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0.05 % liquid
Clobex topical
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0.05 % lotion
Clobex topical
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clobetasol topical
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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clobetasol for the scalp
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Temovate topical
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0.05 % cream
Temovate topical
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0.05 % ointment

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Patient Handout

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Patient Education
clobetasol topical

CLOBETASOL SPRAY - TOPICAL

(kloh-BAY-tuh-sol)

COMMON BRAND NAME(S): Clobex

USES: Clobetasol is used by adults to treat moderate to severe plaque psoriasis. Clobetasol reduces the swelling, itching and redness that can occur with this condition. This medication is a very strong (super-high-potency) corticosteroid.This medication is not recommended for use in children younger than 18 years of age due to an increased risk of side effects. Ask the doctor or pharmacist for details.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using clobetasol spray and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Use this medication on the skin only. Do not use it on the face, groin or underarms unless directed to do so by your doctor.Wash and dry your hands before applying. Clean and dry the affected area. Apply a thin film of the medication to the affected area and gently rub in, usually 2 times daily or as directed by your doctor. Do not bandage, wrap or cover the area unless directed to do so by your doctor.After applying the medication, wash your hands unless you are using this medication to treat the hands. If applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting the medication in your nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water.Use this medication exactly as prescribed. Do not increase your dose, use it more frequently, or use it for longer than 2 weeks in a row. Do not apply more than one 50-gram bottle in a given week unless directed by your doctor. Doing so could increase your risk of side effects.Inform your doctor if your condition persists or worsens after 2 weeks.

SIDE EFFECTS: Burning, stinging, itching, irritation, dryness, and redness may occur when this medication is first applied to the skin. These effects should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: stretch marks (striae), skin thinning/discoloration, unusual hair growth, acne, hair bumps (folliculitis).Skin infections can become worse when using this medication. Notify your doctor if redness, swelling or irritation does not improve.Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using clobetasol, tell your doctor or pharmacist if you are allergic to it; or to any other steroids (e.g., hydrocortisone, dexamethasone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, other skin conditions (e.g., rosacea, perioral dermatitis), immune system problems.Do not use if there is an infection or sore in the area to be treated.Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: oral corticosteroids (e.g., prednisone), drugs that suppress the immune system (e.g., cyclosporine).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.Inform all your doctors that you use or have used this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from heat and open flame. Do not puncture the bottle. Do not freeze, refrigerate or store above 86 degrees F (30 degrees C). Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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:

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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.