Clobex

Plain Topical Corticosteroids
Topical Scalp Anti-inflammatories, with Corticosteroids

 
Best results are obtained when topical corticosteroids of adequate strength are used for specified lengths of time. Patients who fail to respond to clobetasol treatment after 1 to 4 weeks should be re-evaluated.
Discontinue once control of the treated condition has been achieved. Intermittent application may need to be continued to maintain remission or control of the condition in some cases. Some authorities recommend cyclic applications (i.e., 2 weeks of clobetasol treatment followed by 1 week of lubrication only) for chronic conditions like psoriasis. The lowest effective maintenance application should be used. Other options include changing to a less potent topical corticosteroid for maintenance and control of inflammation and symptoms.

For topical dermatologic use only. Not for ophthalmic, oral, or intravaginal use. Generally not recommended for use on the face or intertriginous areas.
Restrict application to the active lesions or affected areas and try to avoid normal surrounding skin.
Do not use clobetasol propionate preparations with occlusive dressings. Instruct patients not to bandage, cover, or wrap area in any way that may be occlusive.

Cream, emollient cream, gel, or ointment:
Wash hands before and after application. Use gloves if required by universal precautions. Apply sparingly in a thin film and rub gently into affected area.
The amount of cream or ointment needed to cover a certain area can be calculated. A 1 g application of cream covers 100 cm2 of skin. The entire skin surface of the average size adult will be covered by 30 g of topical steroid cream.

Scalp solution:
Wash hands before and after application. Use gloves if required by universal precautions. Apply sparingly in a thin film to the affected areas of the scalp; rub in gently and completely.
Topical foam:
Olux foam
Prior to first application, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.
Invert the can and push the button to dispense a small amount of foam into the cap of the can, or directly on the affected skin area, taking care to avoid contact with the eyes. The amount should be no more than 1 and a half capfuls (approximately the size of a golf ball). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam. If the can seems warm or the foam seems runny, run the can under cold water.
Using your fingertips, gently massage a thin layer of foam into affected areas until the foam disappears. If applying to the scalp, move the hair away from the affected area so that the foam can be applied directly to the affected areas. Repeat until the affected areas are treated.
Wash hands after application. Patients should wash their hands after application unless the foam is being used to treat the hands.
Throw away any of the unused medicine that was dispensed out of the can.
This product is flammable; avoid heat, flame, or smoking during and immediately following application of the foam.
Tovet foam
Prior to first application, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.
Shake well prior to each use.
Invert the can and press the nozzle.
Press down on the actuator to dispense a small amount of the foam into the palm of the hand.
Apply a thin layer to the affected area and rub in gently until foam disappears. Use gloves if required by universal precautions.
Wash hands after application. Patients should wash their hands after application unless the foam is being used to treat the hands.
Throw away any of the unused medicine that was dispensed out of the can.
This product is flammable; avoid heat, flame, or smoking during and immediately following application of the foam.
Topical spray:
Wash hands before and after treatment. Spray directly onto the affected skin areas; rub in gently but completely.
Topical shampoo:
Wash hands before and after treatment. Do not wet hair prior to use. Apply directly to the affected area of the scalp. Rub in gently; leave on the scalp for 15 minutes. Instruct patients not to cover their head while the shampoo is on the scalp. After 15 minutes, add water, lather and rinse completely.

Dental topical preparation for application to oral vesiculoerosive disease:
NOTE: Clobetasol is not approved by the FDA for dental administration.
An extemporaneous preparation of clobetasol for buccal or oral mucous membrane application can be compounded by combining clobetasol propionate ointment in a 1:1 ratio with a plasticized hydrocarbon gel (Orabase-plain). No stability data are currently available.

skin atrophy / Delayed / 0-2.0
papilledema / Delayed / Incidence not known
increased intracranial pressure / Early / Incidence not known
retinopathy / Delayed / Incidence not known
visual impairment / Early / Incidence not known
ocular hypertension / Delayed / Incidence not known

erythema / Early / 1.0-10.0
withdrawal / Early / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
growth inhibition / Delayed / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
glycosuria / Early / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
Cushing's syndrome / Delayed / Incidence not known
hypertension / Early / Incidence not known
cataracts / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
skin ulcer / Delayed / Incidence not known
tolerance / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known

maculopapular rash / Early / 1.0-10.0
pruritus / Rapid / 1.0-10.0
skin irritation / Early / 2.0-10.0
xerosis / Delayed / 1.0-10.0
striae / Delayed / 0-2.0
acneiform rash / Delayed / 0-2.0
infection / Delayed / 0-2.0
skin hypopigmentation / Delayed / 0-2.0
folliculitis / Delayed / 0-2.0
miliaria / Delayed / 0-2.0
hypertrichosis / Delayed / 0-2.0
telangiectasia / Delayed / 0-2.0
vesicular rash / Delayed / 0.3-0.3
ocular irritation / Rapid / 0.3-0.3
alopecia / Delayed / 0.3-0.3
headache / Early / 0.3-0.3

Clobetavix, Clobevate, Clobex, Clodan, Cormax, Embeline, Embeline E, Impeklo, Impoyz, Olux, Olux-E, Tasoprol, Temovate, Temovate E, Temovate Scalp, Tovet

Rx

Topical, synthetic fluorinated corticosteroid
Used for moderate-severe corticosteroid-responsive dermatoses, including psoriasis
One of the most potent topical corticosteroids; recommended for short-term / cyclic treatment

Apply a thin layer topically to the affected skin area(s) 2 times daily. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis.  

Apply a thin layer topically to the affected skin area(s) 2 times daily. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis.  

Apply a thin layer topically to the affected skin area(s) 2 times daily. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis.

Apply a thin layer topically to the affected scalp area(s) 2 times daily. Max: 50 mL/week. If no improvement within 2 weeks, reassess diagnosis.

Apply a thin layer topically to the affected scalp area(s) 2 times daily. Max: 50 mL/week. If no improvement within 2 weeks, reassess diagnosis.

Apply a thin layer topically to the affected skin area(s) 2 times daily until symptoms resolve. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis. Proactive, intermittent application of topical corticosteroids 1 to 2 times weekly to areas that commonly flare is recommended to help prevent relapses.

Apply a thin layer topically to the affected skin area(s) 2 times daily until symptoms resolve. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis. Proactive, intermittent application of topical corticosteroids 1 to 2 times weekly to areas that commonly flare is recommended to help prevent relapses.

Apply a thin layer topically to the affected skin area(s) 2 times daily until symptoms resolve. Max: 50 g/week. If no improvement within 2 weeks, reassess diagnosis. Proactive, intermittent application of topical corticosteroids 1 to 2 times weekly to areas that commonly flare is recommended to help prevent relapses.

Apply a thin layer topically to the affected scalp area(s) 2 times daily until symptoms resolve. Max: 50 mL/week. If no improvement within 2 weeks, reassess diagnosis. Proactive, intermittent application of topical corticosteroids 1 to 2 times weekly to areas that commonly flare is recommended to help prevent relapses.

Apply a thin layer topically to the affected scalp area(s) 2 times daily until symptoms resolve. Max: 50 mL/week. If no improvement within 2 weeks, reassess diagnosis. Proactive, intermittent application of topical corticosteroids 1 to 2 times weekly to areas that commonly flare is recommended to help prevent relapses.

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Treatment beyond 2 consecutive weeks is not recommended. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Treatment beyond 2 consecutive weeks is not recommended. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Treatment beyond 4 consecutive weeks is not recommended. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Treatment beyond 4 consecutive weeks is not recommended. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Spray directly onto the affected skin area(s) twice daily. Max: 50 g/week. Limit treatment beyond 2 weeks to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Apply a thin layer topically to the affected skin area(s) twice daily. Max: 50 g/week. Limit treatment beyond 2 weeks to localized lesions (less than 10% of body surface area) of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Apply topically to the psoriatic scalp area(s) twice daily. Max: 50 g/week. Limit treatment to 2 consecutive weeks. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Apply topically to the psoriatic scalp area(s) twice daily. Max: 50 g/week. Limit treatment to 2 consecutive weeks. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Apply topically to the psoriatic scalp area(s) once daily. Leave in place for 15 minutes, then lather and rinse. Max: 50 g/week. Limit treatment to 4 consecutive weeks. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Apply a thin layer to the affected vulvar, labial, and perineal areas twice daily, once in the morning and once at night. Treatment must be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used. In a retrospective, uncontrolled analysis of 36 women with biopsy-proven lichen sclerosis, the initial clobetasol treatment course provided remission of symptoms in 77% of patients, and 47% noted an improvement in tissue appearance at one year of follow-up. The authors noted that intermittent clobetasol applications may be needed to maintain results.

Apply a thin layer to affected vulvar areas for 3 months- use once daily for the first month, then on alternate days for the second month, and then twice weekly for the third month. This regimen has been studied and is strongly recommended by the British Association of Dermatologists.[63760] [63761] Another regimen that has been shown to be effective is clobetasol applied once daily for 3 months; if symptoms resolved in less than 3 months, the ointment was applied twice weekly for the remainder of the treatment period.[63755]

Limited reports have used topical clobetasol propionate cream as an alternative to intralesional corticosteroid injections. Treatment was prescribed with 0.05% clobetasol propionate cream applied to the area twice daily for 2 weeks, followed by a 1-week intermission. The cycle was repeated as needed. The 3 cases responded within 4 months to the topical treatment. Children were closely monitored for adrenal suppression. Clobetasol application was reserved for instances in which the risks of the disease (e.g., permanent visual loss) to the infant or the young child outweighed the potential risks of clobetasol treatment. Because the involution of the hemangioma occurs at a slower rate than would intralesional injection, topical clobetasol would not be appropriate in instances of acute, severe visual axis occlusion.

†Indicates off-label use

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Deferasirox: (Moderate) Because gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including corticosteroids.
Metyrapone: (Major) Medications which affect pituitary or adrenocortical function, including all corticosteroid therapy, should be discontinued prior to and during testing with metyrapone. Patients taking inadvertent doses of corticosteroids on the test day may exhibit abnormally high basal plasma cortisol levels and a decreased response to the test. Although systemic absorption of topical corticosteroids is minimal, temporary discontinuation of these products should be considered if possible to reduce the potential for interference with the test results.

Clobetasol/Clobetasol Propionate/Clobetavix/Cormax/Embeline/Embeline E/Impoyz/Tasoprol/Temovate/Temovate E Topical Cream: 0.025%, 0.05%
Clobetasol/Clobetasol Propionate/Clobevate/Embeline/Temovate Topical Gel: 0.05%
Clobetasol/Clobetasol Propionate/Clobex Topical Spray: 0.05%
Clobetasol/Clobetasol Propionate/Clobex/Clodan Topical Shampoo: 0.05%
Clobetasol/Clobetasol Propionate/Clobex/Impeklo Topical Lotion: 0.05%
Clobetasol/Clobetasol Propionate/Cormax/Embeline/Temovate/Temovate E Topical Ointment: 0.05%
Clobetasol/Clobetasol Propionate/Cormax/Embeline/Temovate/Temovate Scalp Topical Sol: 0.05%
Clobetasol/Clobetasol Propionate/Olux/Olux-E/Tovet Topical Foam: 0.05%

50 mL/week scalp or topical solutions and shampoo; 59 mL/week spray solution; 50 g/week other topicals.

50 mL/week scalp or topical solutions and shampoo; 59 mL/week spray solution; 50 g/week other topicals.

>= 16 years: Safety and efficacy of lotion, shampoo, and spray solution have not been established; 50 g/week of other formulations.
13 to < 16 years: Safety and efficacy of emollient cream, lotion, shampoo, and spray solution have not been established; 50 g/week of other formulations.

>= 12 years: Safety and efficacy of emollient cream, lotion, shampoo, and spray solution have not been established; 50 g/week of other formulations.
< 12 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Topical corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2 , an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.

Clobetasol is administered topically to the skin as a cream, gel, ointment, or topical solution.
 
Because clobetasol is fluorinated and also contains a substituted 17-hydroxyl group, it is not metabolized in the skin. Repeated application results in a cumulative depot effect in the skin, which may lead to a prolonged duration of action and increased systemic absorption. Due to the fact that circulating levels are below the level of detection, the use of pharmacodynamic endpoints for assessing the systemic exposure of topical clobetasol is necessary. Once in the systemic circulation, clobetasol is metabolized in the liver, but systemic metabolism has not been fully quantified. Excretion of clobetasol propionate and its metabolites occurs via the urine and bile.

The extent of percutaneous absorption of the topical corticosteroids is dependent on many factors, including the pharmaceutical vehicle and the integrity of the epidermis. Absorption after topical application of clobetasol is increased in areas that have skin damage, inflammation, or occlusion, or in areas where the stratum corneum is thin such as the eyelids, genitalia, axillae, and face. The use of occlusive dressings with the application of clobetasol enhances penetration into the skin, and may increase the chance of systemic absorption. Ointments have a hydrating effect, are lipophilic, and enhance the penetration of clobetasol into the skin. Clobetasol gels, foams, and solutions also have enhanced topical penetration versus cream preparations. Once absorbed, maximal vasoconstrictive effects of clobetasol occur within 1.5 hours of application. Anti-inflammatory effects are usually not seen for hours after clobetasol application, since the mechanism of action requires alterations in synthesis of proteins.

Clobetasol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids, including clobetasol, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. There are no adequate and well-controlled studies of teratogenic effects from topical application of clobetasol in pregnant women. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in animal studies. Clobetasol has greater potency, and thus greater teratogenic potential, than other topical corticosteroids. After subcutaneous clobetasol propionate administration to pregnant mice and rabbits, increased malformations, such as cleft palate and skeletal abnormalities, were observed.

It is not known whether topical administration of clobetasol could result in sufficient systemic absorption to produce detectable quantities in breast milk to cause issues during breast-feeding; the manufacturers recommend to use with caution. However, most dermatologists stress that topical corticosteroids can be safely used during lactation. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.