ULTRAVATE Lotion (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Sun Pharmaceutical Industries, Inc.

Λέξεις κλειδιά

10631-122

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1. Indications and Usage

ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 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 ...

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.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Effects on Endocrine System ULTRAVATE lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic effects of topical corticosteroids may include reversible HPA axis suppression, ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

8.1. Pregnancy

Risk Summary There are no available data on Ultravate lotion use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published ...

8.2. Lactation

Risk Summary There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application ...

8.4. Pediatric Use

Safety and effectiveness of ULTRAVATE lotion for the treatment of moderate to severe plaque psoriasis have been established in patients 12 years of age and older. It is supported by evidence from adequate ...

8.5. Geriatric Use

Clinical studies with ULTRAVATE lotion included 89 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and those younger than 65 years. ...

10. Overdosage

Topically applied ULTRAVATE lotion can be absorbed in sufficient amounts to produce systemic effects <em>[see Warnings and Precautions (5.1)]</em>.

11. Description

ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, ...

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.

12.2. Pharmacodynamics

Vasoconstriction A vasoconstrictor assay in healthy subjects with ULTRAVATE lotion indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, ...

12.3. Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of halobetasol ...

14. Clinical Studies

ULTRAVATE lotion was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, double-blind, vehicle-controlled trials. These trials were conducted in 443 subjects ...

16.1. How Supplied

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 ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Do not freeze.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise patients using ULTRAVATE lotion of the following information and instructions: <u>Important Administration Instructions: ...