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Drug overview for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride):
Generic name: CLOBETASOL PROPIONATE/LEVOCETIRIZINE DIHYDROCHLORIDE
Drug class: Topical Antihistamines
Therapeutic class: Dermatological
Clobetasol propionate is a synthetic fluorinated corticosteroid.
Clobetasol propionate shares the actions of other topical corticosteroids and is used for the short-term relief of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, including plaque psoriasis and dermatoses of the scalp (e.g., scalp psoriasis).
Generic name: CLOBETASOL PROPIONATE/LEVOCETIRIZINE DIHYDROCHLORIDE
Drug class: Topical Antihistamines
Therapeutic class: Dermatological
Clobetasol propionate is a synthetic fluorinated corticosteroid.
Clobetasol propionate shares the actions of other topical corticosteroids and is used for the short-term relief of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, including plaque psoriasis and dermatoses of the scalp (e.g., scalp psoriasis).
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The following indications for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride):
Topical clobetasol propionate cream, ointment, gel, lotion, and foam are applied sparingly in thin films and are rubbed gently into the affected area twice daily, preferably in the morning and evening. Clobetasol propionate solution is applied to affected areas of the scalp twice daily, in the morning and evening. Clobetasol propionate shampoo is applied in a thin film to affected areas of the dry (not wet) scalp once daily; the shampoo should be left in place for 15 minutes before lathering and rinsing.
Because certain areas of the body may be more susceptible to atrophic changes than others following treatment with corticosteroids, clobetasol propionate cream, ointment, gel, lotion, foam, and shampoo should not be applied to the face or intertriginous areas (e.g., axilla, groin). Although there are no restrictions regarding use of clobetasol propionate solution on the face, axilla, or groin, the manufacturer states that patients receiving the solution should be observed frequently if these areas are to be treated.
When clobetasol propionate foam is applied, the canister containing the drug should be inverted and a small amount (up to a maximum of a golf-ball-sized dollop or 11/2 capfuls) of the preparation placed into the cap of the canister, onto a saucer, or other cool surface, or directly on the lesion, taking care to avoid contact with the eyes. The foam should not be dispensed directly to the hands (unless the hands are the affected area), since the foam will begin to melt immediately upon contact with warm skin. If the canister seems warm to the touch or the foam seems runny, the canister should be placed under cold running tap water.
When applying clobetasol propionate foam to a hairy area, hair should be moved away from the affected area to allow application of the drug onto each affected area. The drug should be massaged gently with clean, dry fingertips into the affected area until the foam disappears; repeat until the entire affected area has been treated. Clobetasol propionate foam is flammable; therefore, exposure to flames or smoking should be avoided during and immediately after application.
When clobetasol propionate shampoo is applied to the dry scalp, hair should be moved away from the affected area to allow application of the drug directly onto each affected area. The bottle should be positioned over the affected area and gently squeezed so that a small amount of shampoo is released directly onto the affected area, avoiding any contact with the face, eyes, or lips; if accidental contact occurs, the area should be rinsed thoroughly with water. After application onto the scalp, the drug should be spread so that the entire affected area is covered with a thin uniform film.
The drug should then be massaged gently into the affected area; the procedure should be repeated to treat additional affected areas. When all affected areas have been treated, the hands should be washed, and the shampoo should be left in place for 15 minutes. After 15 minutes, water should be added and the shampoo should be lathered, and then all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck, shoulders) should be rinsed thoroughly.
Although no additional shampoo is necessary to cleanse the hair, a nonmedicated shampoo may be used if desired.
Some patients may respond initially to once-daily or intermittent therapy (e.g., twice daily 3 days per week). Clobetasol therapy should be discontinued and a less potent topical corticosteroid preparation substituted as soon as clinically feasible, but dosage should not exceed 50 g of clobetasol propionate 0.05% cream, foam, or ointment or 50 mL (50 g) of clobetasol propionate 0.05%
lotion, solution, or shampoo per week. Use of clobetasol propionate cream, foam, gel, lotion, ointment, or solution generally should not exceed 14 days. Although clobetasol propionate 0.05%
emollient cream or lotion (applied to no more than 10% of body surface area) may be used for up to 4 consecutive weeks in the management of plaque psoriasis, the manufacturers state that additional benefits of extended treatment (i.e., beyond 2 weeks) should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA)-axis suppression. The manufacturer states that use of clobetasol propionate 0.05% shampoo should be limited to 4 consecutive weeks.
If complete resolution is not achieved following 4 weeks of therapy, a less potent topical corticosteroid may be substituted for clobetasol propionate shampoo. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.
Many clinicians indicate that more prolonged clobetasol therapy rarely may be necessary in patients with resistant conditions, but careful monitoring is essential. The risk of adverse systemic corticosteroid effects (e.g., HPA-axis suppression, Cushing's syndrome, hyperglycemia) associated with use of this potent corticosteroid must be carefully considered. Intermittent maintenance therapy, such as administration of the drug once- or twice-weekly for up to 6 months, has resulted in prolonged periods of remission from corticosteroid-responsive dermatoses in some patients.
Clobetasol propionate cream, foam, gel, lotion, ointment, solution, or shampoo should not be used with occlusive dressings and patients should be warned that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive.
Because certain areas of the body may be more susceptible to atrophic changes than others following treatment with corticosteroids, clobetasol propionate cream, ointment, gel, lotion, foam, and shampoo should not be applied to the face or intertriginous areas (e.g., axilla, groin). Although there are no restrictions regarding use of clobetasol propionate solution on the face, axilla, or groin, the manufacturer states that patients receiving the solution should be observed frequently if these areas are to be treated.
When clobetasol propionate foam is applied, the canister containing the drug should be inverted and a small amount (up to a maximum of a golf-ball-sized dollop or 11/2 capfuls) of the preparation placed into the cap of the canister, onto a saucer, or other cool surface, or directly on the lesion, taking care to avoid contact with the eyes. The foam should not be dispensed directly to the hands (unless the hands are the affected area), since the foam will begin to melt immediately upon contact with warm skin. If the canister seems warm to the touch or the foam seems runny, the canister should be placed under cold running tap water.
When applying clobetasol propionate foam to a hairy area, hair should be moved away from the affected area to allow application of the drug onto each affected area. The drug should be massaged gently with clean, dry fingertips into the affected area until the foam disappears; repeat until the entire affected area has been treated. Clobetasol propionate foam is flammable; therefore, exposure to flames or smoking should be avoided during and immediately after application.
When clobetasol propionate shampoo is applied to the dry scalp, hair should be moved away from the affected area to allow application of the drug directly onto each affected area. The bottle should be positioned over the affected area and gently squeezed so that a small amount of shampoo is released directly onto the affected area, avoiding any contact with the face, eyes, or lips; if accidental contact occurs, the area should be rinsed thoroughly with water. After application onto the scalp, the drug should be spread so that the entire affected area is covered with a thin uniform film.
The drug should then be massaged gently into the affected area; the procedure should be repeated to treat additional affected areas. When all affected areas have been treated, the hands should be washed, and the shampoo should be left in place for 15 minutes. After 15 minutes, water should be added and the shampoo should be lathered, and then all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck, shoulders) should be rinsed thoroughly.
Although no additional shampoo is necessary to cleanse the hair, a nonmedicated shampoo may be used if desired.
Some patients may respond initially to once-daily or intermittent therapy (e.g., twice daily 3 days per week). Clobetasol therapy should be discontinued and a less potent topical corticosteroid preparation substituted as soon as clinically feasible, but dosage should not exceed 50 g of clobetasol propionate 0.05% cream, foam, or ointment or 50 mL (50 g) of clobetasol propionate 0.05%
lotion, solution, or shampoo per week. Use of clobetasol propionate cream, foam, gel, lotion, ointment, or solution generally should not exceed 14 days. Although clobetasol propionate 0.05%
emollient cream or lotion (applied to no more than 10% of body surface area) may be used for up to 4 consecutive weeks in the management of plaque psoriasis, the manufacturers state that additional benefits of extended treatment (i.e., beyond 2 weeks) should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA)-axis suppression. The manufacturer states that use of clobetasol propionate 0.05% shampoo should be limited to 4 consecutive weeks.
If complete resolution is not achieved following 4 weeks of therapy, a less potent topical corticosteroid may be substituted for clobetasol propionate shampoo. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.
Many clinicians indicate that more prolonged clobetasol therapy rarely may be necessary in patients with resistant conditions, but careful monitoring is essential. The risk of adverse systemic corticosteroid effects (e.g., HPA-axis suppression, Cushing's syndrome, hyperglycemia) associated with use of this potent corticosteroid must be carefully considered. Intermittent maintenance therapy, such as administration of the drug once- or twice-weekly for up to 6 months, has resulted in prolonged periods of remission from corticosteroid-responsive dermatoses in some patients.
Clobetasol propionate cream, foam, gel, lotion, ointment, solution, or shampoo should not be used with occlusive dressings and patients should be warned that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 0 severe contraindications.
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Adrenocortical insufficiency |
| Diabetes mellitus |
The following adverse reaction information is available for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 15 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Folliculitis Purpura Skin and skin structure infection Skin atrophy |
| Rare/Very Rare |
|---|
|
Adrenocortical insufficiency Bullous dermatitis Cataracts Central serous chorioretinopathy Glaucoma Hypothalamic-pituitary insufficiency Ocular hypertension Skin hypopigmentation Skin striae Skin ulcer Urticaria |
There are 24 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Erythema Stinging of skin |
Acute pain at drug application site Blurred vision Headache disorder Paresthesia Pruritus of skin Skin rash Telangiectasia Treatment site sequelae |
| Rare/Very Rare |
|---|
|
Acneiform eruption Alopecia Blistering skin Contact dermatitis Dry skin Dyschromia Glycosuria Hirsutism Hypercortisolism Hyperesthesia Hyperglycemia Miliaria Perioral dermatitis Skin irritation |
The following precautions are available for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
The teratogenic potential of topical clobetasol propionate is not known; however, the drug appears to undergo percutaneous absorption, and reproduction studies in mice and rabbits using subcutaneous dosages of the drug as low as 30 mcg/kg (approximately 0.04 times the human topical dose) or 3 mcg/kg (approximately 0.02 times the human topical dose), respectively, have revealed evidence of substantial harm to the fetus (e.g., cleft palate, cranioschisis, skeletal abnormalities). Teratogenic effects of clobetasol were observed at subcutaneous dosages about one-fourth to one-twelfth those of betamethasone in these animals. In addition, although the teratogenic potential of topical clobetasol has not been studied, other potent corticosteroids have been shown to be teratogenic in animals following topical application.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ILEXOR (clobetasol propionate/levocetirizine dihydrochloride)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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