Product Elements:
Clobetasol propionate clobetasol propionate clobetasol propionate clobetasol carbomer homopolymer type b (allyl pentaerythritol crosslinked) isopropyl alcohol sodium hydroxide water
Indications and Usage:
Indications and usage clobetasol propionate topical solution, usp is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 ml/week because of the potential for the drug to suppress the hpa axis. this product is not recommended for use in pediatric patients under 12 years of age.
Dosage and Administration:
Dosage and administration clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night. clobetasol propionate topical solution is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 ml/week should not be used. clobetasol propionate topical solution is not to 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 topical solution, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
Contraindications:
Contraindications clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.
Adverse Reactions:
Adverse reactions clobetasol propionate topical solution is generally well tolerated when used for 2-week treatment periods. the most frequent adverse events reported for clobetasol propionate topical solution have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients. the following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. these reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the s
Read more...kin, secondary infection, skin atrophy, striae, and miliaria. systemic absorption of topical corticosteroids has produced reversible hpa axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria in some patients. in rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended. to report suspected adverse reactions, contact saptalis pharmaceuticals, llc at 1-833-727-8254 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Overdosage:
Overdosage topically applied clobetasol propionate can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description clobetasol propionate topical solution, usp contains the active compound clobetasol propionate, usp a synthetic corticosteroid, for topical dermatologic use. clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. chemically, clobetasol propionate, usp is (11β,16β)-21-chloro-9âfluoroâ11âhydroxyâ16âmethylâ17â(1âoxo-Âpropoxy) pregna-1,4-diene-3,20-dione, and it has the following structural formula: clobetasol propionate, usp has the molecular formula c 25 h 32 clfo 5 and a molecular weight of 466.97. it is a white to cream-colored crystalline powder, soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane. sparingly soluble in ethanol; slightly soluble in benzene and diethyl ether; practically insoluble in water. clobetasol propionate topical solution, usp contains clobetasol propionate, usp 0.5 mg/g in a base of carbomer 974p, isopropyl alcohol (40% w/w), purified water, and sodium hydroxide. clobetasol-structure
Clinical Pharmacology:
Clinical pharmacology the corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. in pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. however, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. pharmacokinetics the extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including t
Read more...he vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see dosage and administration ). as with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. inflammation and/or other disease processes in the skin may increase percutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see dosage and administration ). once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees. corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. some of the topical corticosteroids, including clobetasol propionate and its metabolites, are also excreted into the bile. following repeated nonocclusive application in the treatment of scalp psoriasis, there is some evidence that clobetasol propionate topical solution has the potential to depress plasma cortisol levels in some patients. however, hypothalamic-pituitary-adrenal (hpa) axis effects produced by systemically absorbed clobetasol propionate have been shown to be transient and reversible upon completion of a 2-week course of treatment.
How Supplied:
How supplied clobetasol propionate topical solution, usp 0.05% is a clear, colorless liquid supplied in plastic squeeze bottles, 25 ml (ndc 42571-362-81) and 50 ml (ndc 42571-362-99). store at 20° to 25°c (68° to 77°f), with excursions permitted between 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. do not refrigerate. keep tightly closed. do not use near an open flame. distributed by: micro labs usa, inc. somerset, nj 08873 manufactured by: saptalis pharmaceuticals, llc hauppauge, ny 11788 revised: january 2022-r2
Package Label Principal Display Panel:
Package/label display panel - 25 ml label ndc 42571-362-81 clobetasol propionate topical solution, usp 0.05% scalp application for dermatologic use onlyâ not for ophthalmic use. rx only 25 ml clobetasol-label1
Package/label display panel - 25 ml carton ndc 42571-362-81 clobetasol propionate topical solution, usp 0.05% scalp application for dermatologic use onlyâ not for ophthalmic use. rx only 25 ml clobetasol-carton1
Package/label display panel - 50 ml label ndc 42571-362-99 clobetasol propionate topical solution, usp 0.05% scalp application for dermatologic use onlyâ not for ophthalmic use. rx only 50 ml clobetasol-label2
Package/label display panel - 50 ml carton ndc 42571-362-99 clobetasol propionate topical solution, usp 0.05% scalp application for dermatologic use onlyâ not for ophthalmic use. rx only 50 ml clobetasol-carton2