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General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.
Topical corticosteroids are known to potentially induce: post treatment rebound, relapses upon discontinuation of treatment; development of tolerance (tachyphylaxis); development of local toxicity such as skin atrophy, telangiectasia of the skin; immunosuppression and opportunistic infections (including isolated cases of systemic infections), in case of prolonged use of potent topical corticosteroids in rare instances: cataracts, when applied to eyes or eyelids.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Conditions which increase systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings or use on occluded areas. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
The effect of CLOBEX (clobetasol propionate) Shampoo, 0.05% on HPA axis suppression was evaluated in one study in adolescents 12 to 17 years of age, In this study, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with CLOBEX (clobetasol propionate) Shampoo, 0.05% applied once daily for 15 minutes to a dry scalp before lathering and rinsing.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See Use in Children as follows).
If irritation develops, CLOBEX Shampoo should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX Shampoo should be discontinued until the infection has been adequately controlled.
Although CLOBEX Shampoo is intended for the topical treatment of moderate to severe scalp psoriasis, it should be noted that certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. CLOBEX Shampoo should not be used on the face, groin or axillae. Avoid any contact of the drug product 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.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Cases of osteonecrosis, serious infections (including necrotizing fasciitis), and systemic immunosuppression (sometimes resulting in reversible Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol propionate beyond the recommended doses (see Dosage & Administration). In some cases, patients used other potent oral/topical corticosteroids or immunosuppressors concomitantly (e.g. methotrexate, mycophenolate mofetil). If treatment with local corticosteroids is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered.
Information for patients: Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.
This medication should not be used for any disorder other than that for which it was prescribed.
The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician.
Patients should report any signs of local or systemic adverse reactions to their physician.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
Patients should wash their hands after applying the medication.
Patients should inform their physician(s) that they are using CLOBEX Shampoo if surgery is contemplated.
Patients should not use more than 50 g (50 ml or 1.75 fl. oz.) per week of CLOBEX Shampoo.
Laboratory tests: The cortrosyn stimulation test may be helpful in evaluating patients for HPA axis suppression.
Carcinogenesis, mutagenesis, impairment of fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.
Clobetasol propionate did not produce any increase in chromosomal aberrations in Chinese hamster ovary cells in vitro in the presence or absence of metabolic activation. Clobetasol propionate was also negative in the micronucleus test in mice after oral administration.
Studies of the effect of CLOBEX (clobetasol propionate) Shampoo, 0.05% on fertility have not been conducted.
Use in Pregnancy: Teratogenic Effects: Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.
A teratogenicity study of clobetasol propionate in rats using the dermal route resulted in dose related maternal toxicity and fetal effects from 0.05 to 0.5 mg/kg/day, These doses are approximately 0.1 to 1.0 times, respectively, the maximum human topical dose of clobetasol propionate from CLOBEX Shampoo. Abnormalities seen included low fetal weights, umbilical herniation, cleft palate, reduced skeletal ossification other skeletal abnormalities.
Clobetasol propionate administered to rats subcutaneously at a dose of 0.1 mg/kg from day 17 of gestation to day 21 postpartum was associated with prolongation of gestation, decreased number of offspring, increased perinatal mortality of offspring, delayed eye opening and delayed hair appearance in surviving offspring. Some increase in offspring perinatal mortality was also observed at a dose of 0.05 mg/kg. Doses of 0.05 and 0.1 mg/kg are approximately 0.1 and 0.2 fold the maximum human topical dose of clobetasol propionate from CLOBEX Shampoo.
There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. CLOBEX Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when CLOBEX Shampoo, 0.05%, is administered to a nursing woman. Clobetasol propionate should not be prescribed to nursing women unless clearly indicated.
Use in Children: Use of CLOBEX Shampoo, 0.05%, in patients under 18 years old is not recommended due to potential for HPA axis suppression (see General as previously mentioned).
The effect of CLOBEX (clobetasol propionate) Shampoo, 0.05%, on HPA axis suppression was evaluated in one study in adolescents 12 to 17 years of age. In this study, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with CLOBEX (clobetasol propionate) Shampoo, 0.05%, applied once daily for 15 minutes to a dry scalp before lathering and rinsing. Only one of the five subjects who had suppression was tested for recovery of HPA axis, and this subject recovered after 2 weeks.
No studies have been performed in patients under the age of 12. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
Therefore, use is not recommended in patients under the age of 18.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Use in the Elderly: Clinical studies of Clobetasol Propionate Shampoo, 0.05%, did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
