ULTRAVATE X- halobetasol propionate kit

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

HALOBETASOL PROPIONATE (UNII: 91A0K1TY3Z) (HALOBETASOL - UNII:9P6159HM7T)

Disponible depuis:

Ranbaxy Laboratories Inc.

DCI (Dénomination commune internationale):

HALOBETASOL PROPIONATE

Composition:

HALOBETASOL PROPIONATE 0.50 mg in 1 g

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Ultravate Ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two 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 children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Ultravate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Descriptif du produit:

Ultravate® (halobetasol propionate) Ointment, 0.05% is supplied in the following tube size: 50 g (NDC 10631-102-50) Store between 15°C and 30°C (59°F and 86°F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 5090133 (Flat), 5090134 (Folded) Revised November 2011

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

ULTRAVATE X- HALOBETASOL PROPIONATE
RANBAXY LABORATORIES INC.
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ULTRAVATE X
(HALOBETASOL PROPIONATE OINTMENT) OINTMENT, 0.05%
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Ultravate
(halobetasol propionate) ointment, 0.05% contains halobetasol
propionate, a synthetic
corticosteroid for topical dermatological use. The corticosteroids
constitute a class of primarily
synthetic steroids used topically as an anti-inflammatory and
antipruritic agent.
Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β,
17-dihydroxy-16β-methylpregna-
1, 4-diene-3-20-dione, 17-propionate, C
H ClF O . It has the following structural formula:
Halobetasol propionate has the molecular weight of 485. It is a white
crystalline powder insoluble in
water.
Each gram of Ultravate Ointment contains 0.5 mg/g of halobetasol
propionate in a base of aluminum
stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene
glycol, sorbitan sesquioleate, and
stearyl citrate.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, halobetasol propionate has
anti-inflammatory, antipruritic and
vasoconstrictive actions. The mechanism of the anti-inflammatory
activity of the topical corticosteroids,
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 the integrity of the epidermal barrier.
Occlusive dressings with
hydrocortisone for up to 24 hours have not been demonstrated to
increase penetration; however,
occlusion of hydrocortisone for 96 hours markedly enhances
penetration. Topic