Product Elements:
Clobetasol propionate clobetasol propionate clobetasol propionate clobetasol isopropyl alcohol carbomer 934 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.
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 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 lupin pharmaceuticals, inc. at 1-866-403-7592 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Use in Pregnancy:
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. 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 topical solution. abnormalities seen included cleft palate and skeletal abnormalities. in rabbi
Read more...ts, 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 topical solution. 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 topical solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use:
Pediatric use use of clobetasol propionate topical solution in pediatric patients under 12 years of age is not recommended.
Geriatric Use:
Geriatric use clinical studies of clobetasol propionate topical solution did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly younger patients. in general, dose selection for an elderly patient should be cautious.
Overdosage:
Overdosage topically applied clobetasol propionate topical solution can be absorbed in sufficient amounts to produce systemic effects (see precautions ).
Description:
Description clobetasol propionate topical solution usp, 0.05% contains the active compound clobetasol propionate, 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 is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1, 4-diene-3,20-dione, and it has the following structural formula: clobetasol propionate has the molecular formula c 25 h 32 cifo 5 and a molecular weight of 467. it is a white to almost white colored crystalline powder insoluble in water. clobetasol propionate topical solution, usp contains clobetasol propionate 0.5 mg/g in a base of purified water, isopropyl alcohol (39.3%), carbomer 934p and sodium hydroxide. 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.
Pharmacokinetics:
Pharmacokinetics the extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the 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
Read more...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 supplied in plastic squeeze bottles, 25ml (ndc 43386-028-61) 50ml (ndc 43386-028-60) store at 20 o to 25 o c (68 o to 77 o f) [see usp controlled room temperature]. do not refrigerate. do not use near an open flame. rx only manufactured for: lupin pharmaceuticals, inc. baltimore, maryland 21202 united states manufactured by: lupin limited pithampur (m.p.) 454775, india id# 253308 september 2017
Information for Patients:
Information for patients patients using clobetasol propionate topical solution 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 treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive. patients should report any signs of local adverse reactions to the physician.
Package Label Principal Display Panel:
Package label.principal display panel clobetasol propionate topical solution usp, 0.05 % 50 ml- container label 50 ml-carton label clobetasol propionate topical solution usp, 0.05 % 25 ml- container label 25 ml-carton label container carton container label carton label