PROCLO JAM

Clobetasol propionate is a prednisolone derivative with higher specificity for glucocorticoid receptors than mineralocorticoid receptors.

It has demonstrated superior activity compared to fluocinonide and was first described in the literature in 1974.

Clobetasol Propionate was granted

FDA approval on 27 December 1985.

Clobetasol propionate is indicated to treat moderate to severe plaque psoriasis 11, 12, 13 as well as inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. 10, 14 The ophthalmic suspension of clobetasol propionate is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals.

Clobetasol propionate is generally applied twice daily so the duration of action is long. 10, 11, 12, 13, 14, 15 Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces.

Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

Twice daily application of clobetasol foam leads to a C max of 59±36pg/mL with a T max of 5 hours.

Clobetasol cream showed an increase in clobetasol concentrations from 50.7±96.0pg/mL to 56.3±104.7pg/mL.

Data regarding the volume of distribution of clobetasole propionate are not readily available. 10, 11, 12, 13, 14, 15.

The metabolism of clobetasol propionate is not well studied but it does induce metabolic enzymes, even when delivered topically.

The metabolism of clobetasol propionate is predicted to follow similar metabolic pathways to other corticosteroids including the addition of oxygen, hydrogen, glucuronides, and sulfates to form water soluble metabolites.

Data regarding the half life of clobetasol propionate are not readily available.

Data regarding the clearance of clobetasol propionate are not readily available.

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Data regarding acute overdoses of glucocorticoids are rare. 10, 11, 12 Overdoses of clobetasol propionate can lead to reversible HPA axis suppression and glucocorticoid insufficiency.

Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency.

Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.

Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely.

Clobetasol propionate ointment are super.

• high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved.

If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol propionate ointment should not be used with occlusive dressings.

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

USP, 0.05% is supplied in: 45 g tube (NDC 63629-2456-1) Store at controlled room temperature 15°-30°C (59°-86°F).

Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Burbank, CA 91504.

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.

Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse.

Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate ointment.

Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate ointment.

Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women.

Clobetasol propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 either clobetasol propionate ointment is administered to a nursing woman.

Safety and effectiveness of clobetasol propionate ointment in pediatric patients have not been established.

Use in pediatric patients under 12 years of age is not recommended.

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 or after withdrawal of treatment.

Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

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.

A limited number of patients at or above 65 years of age have been treated with clobetasol propionate ointment (n = 101) in US and non-US clinical trials.

While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients.

Based on available data, no adjustment of dosage of clobetasol propionate ointment in geriatric patients is warranted.