Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Physicians Total Care, Inc.
CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate cream-emollient is a super-high potency corticosteroid formulation 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. In the treatment of moderate to severe plaque-type psoriasis, clobetasol propionate cream-emollient applied to 5% to 10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Treatment beyond 4 consecutive weeks is not recommended. Patients should be instructed to use clobetasol propionate cream-emollient for the minimum amount of time necessary to achieve t
Clobetasol Propionate Cream-Emollient, 0.05% is supplied in 30-g tubes (NDC 54868-6305-0). Store between 15° and 30° C (59° and 86° F). Clobetasol propionate cream-emollient should not be refrigerated. Rx Only Distributed by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Manufactured by: DPT Laboratories Ltd San Antonio, TX 78215 Rev. 270:00 10/09 129160-1009 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE EMULSION PHYSICIANS TOTAL CARE, INC. ---------- CLOBETASOL PROPIONATE CREAM-EMOLLIENT, 0.05% RX ONLY _FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR_ _INTRAVAGINAL USE._ DESCRIPTION Clobetasol Propionate Cream-Emollient, 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 (11ß,16ß)-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 H CIFO and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream-emollient contains clobetasol propionate 0.5 mg/g in an emollient base of cetomacrogol 1000, cetostearyl alcohol, citric acid, dimethicone 360, imidurea as a preservative, isopropyl myristate, propylene glycol, purified water, and sodium citrate. CLINICAL PHARMACOLOGY Like other topical corticosteroids, clobetasol propionate has antiinflammatory, 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 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 from membrane phospholipids by phospholipase A . PHARMACOKINETICS The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and integrity of the epidermal barrier. Occlusive dressing with hydrocortisone for up to 24 h Διαβάστε το πλήρες έγγραφο