Drug Reference
Clobetasol
Corticosteroids, very potent (group IV)
Rx only
Fact box
- Therapeutic class
- Corticosteroids, very potent (group IV)
- Action class
- Corticosteroid
- Mechanism
- Corticosteroid Hormone Receptor Agonists
- Habit forming
- No
- Availability
- Prescription (Rx)
Brand names
ByqloviClobexClodanImpekloImpoyzOluxTemovateTovet
Available as
0.5 MG/ML0.5 MG/ML · Topical Cream0.25 MG/ML · Topical Cream0.5 MG/ML · Ophthalmic Suspension0.0005 MG/MG · Topical Gel0.0005 MG/MG · Topical Ointment0.5 MG/ML · Topical Solution
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
INDICATIONS AND USAGE Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. 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 the diagnosis may be necessary.
How it works
CLINICAL PHARMACOLOGY Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released frommembrane phospholipids by phospholipase A 2 . Pharmacokinetics : The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Studies performed with clobetasol propionate ointment indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
How to use / dosing
DOSAGE AND ADMINISTRATION Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE .) 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 . Geriatric Use : 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.
Side effects
ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyUnsafe
Pregnancy: Teratogenic Effects: 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 3 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.
BreastfeedingCaution
Nursing Mothers: 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.
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Contraindications
CONTRAINDICATIONS Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Pediatric use
Pediatric Use: 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.
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Overdose
OVERDOSAGE Topically applied clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
Current FDA labels (DailyMed)
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [ENCUBE ETHICALS, INC.]
- CLOBETASOL PROPIONATE SHAMPOO [ALEMBIC PHARMACEUTICALS INC.]
- CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [ENCUBE ETHICALS, INC.]
- CLOBETASOL PROPIONATE SOLUTION [A-S MEDICATION SOLUTIONS]
- CLOBETASOL PROPIONATE OINTMENT [A-S MEDICATION SOLUTIONS]
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.