Clobex Special Precautions

Hypersensitivity to corticosteroids can be observed.
Clobetasol propionate is not recommended in patients who are hypersensitive to other corticosteroids.
Topical corticosteroids are known to potentially induce: post treatment rebound, relapses, development of tolerance (tachyphylaxis) and development of local or systemic toxicity such as skin atrophy, infection (including isolated cases of systemic infections), telangiectasia of the skin or hypothalamic-pituitary-adrenal axis suppression.
In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked generalized pustular psoriasis in case of intensive and prolonged topical use.
Clobetasol propionate is not recommended in patients with Acne vulgaris, rosacea or perioral dermatitis.
Treatment of large surface areas, long-term continuous therapy with corticosteroids, or use of occlusive dressings can enhance absorption and lead to a higher risk of systemic effects. In such cases, medical supervision should be increased and patients may be evaluated periodically for evidence of hypothalamic-pituitary- adrenal axis suppression.
Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for gluco corticosteroid insufficiency, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients. Such systemic effects resolve when treatment is stopped.
Abrupt discontinuation can lead to acute adrenal insufficiency, especially in children.
Clobetasol propionate must not be applied on intertriginous areas (axillae and genitoanal regions) and on other erosive skin surfaces as this could increase the risk of topical adverse events such as atrophic changes, telangiectasia or cortico-induced dermatitis.
If Clobetasol propionate does enter the eye, the affected eye should be rinsed with copious amounts of water.
The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids.
Patients should be instructed to use Clobetasol propionate for the minimum amount of time necessary to achieve the desired results.
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.
Visual disturbance: 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.
This medicine contains alcohol (ethanol) that may cause burning sensation on damaged skin.
Effects on ability to drive and use machines: As Clobetasol propionate is a topical corticosteroid no influence on the ability to drive and use machines is expected.
Use in Renally Impaired: No clinical data available. No preclinical data.
Use in Hepatically Impaired: Patients with severe liver dysfunction and severe diabetes mellitus should be treated with special caution and closely monitored for side-effects.
Use in Children: Use in patients between 2 and 18 years of age is not recommended and is contraindicated in children below 2 years of age. Growth retardation may be observed in case of systemic absorption of topical corticosteroids.
Use in the Elderly: Clinical Studies of Clobetasol propionate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.