ULTRAVATE- halobetasol propionate lotion
Ranbaxy Laboratories, Inc.
1. INDICATIONS AND USAGE
ULTRAVATE lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients eighteen (18) years of age and older.
2. DOSAGE AND ADMINISTRATION
Apply a thin layer of ULTRAVATE lotion to the affected skin twice daily for up to two weeks. Rub in gently.
Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary.
Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 mL) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions 5.1]. Do not use with occlusive dressings unless directed by a physician.
ULTRAVATE lotion is for external use only.
Avoid use on the face, scalp, groin, or axillae.
ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use.
3. DOSAGE FORMS AND STRENGTHS
ULTRAVATE (halobetasol propionate) lotion, 0.05% is a white to off-white lotion. Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate.
DESCRIPTION
ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6?, 9-difluoro-11?, 17-dihydroxy-16?-methylpregna-1, 4-diene-3-20-dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone.
Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water.
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
DESCRIPTION
ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6?, 9-difluoro-11?, 17-dihydroxy-16?-methylpregna-1, 4-diene-3-20-dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone.
Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water.
12. CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
HOW SUPPLIED/STORAGE AND HANDLING
ULTRAVATE lotion, 0.05 % is white to off-white lotion. It is supplied in an oval tapered white high-density polyethylene bottle with a white polypropylene disc cap. Each bottle contains 60 mL (59 g) of ULTRAVATE lotion.
NDC 10631-122-04 60 mL (59g) bottle
Store at 25�C (77�F); excursions permitted to 15�C and 30�C (59�F to 86�F) [see USP Controlled Room Temperature]. Do not freeze.
