——FDA批准聚脲尿烷16%甲用液Nuvail治疗甲营养不良
2012年9月,美国FDA批准了Innocutis公司开发的聚脲尿烷(polyureaurethane)16%甲用液Nuvail,用于一日1次涂敷治疗伴有裂纹或裂口的脆性、已见损坏或碎裂的指甲即甲营养不良(nail dystrophy)。Nuvail中含有的活性成分对指甲表面有强力的附着力,可在已损坏指甲板上形成一种透气的屏障。该透气屏障允许氧气进入指甲板、但却能阻止水吸收,由此阻断可致指甲损坏的湿-干循环,产生保护和强化指甲的作用。
NUVAIL Rx

Active Ingredient(s):
Poly-ureaurethane 16%; nail solution.

Company
Innocutis

Indication(s):
For managing signs/symptoms of nail dystrophy (eg, nail splitting, fragility) for intact or damaged nails.

Pharmacology:
Nuvail coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture. The product is a biocompatible, polymeric solution which forms a uniform film when applied to the nail. The product is dispersed in a noncytotoxic solution which dries rapidly, adhering to the contours of the nail to form a flexible, waterproof barrier. The film will wear off naturally and must be re-applied as directed to be effective. The film is colorless, transparent and possesses good moisture vapor permeability.

Legal Classification:
Rx

Adults:
Apply to affected nail(s) once daily before bedtime. Allow product to dry completely before applying pads or clothing. Clean affected nails with nail polish remover once a week.

Children:
Not established.

Contraindication(s):
Do not apply directly to deep, open, or profusely bleeding wounds.

Warnings/Precautions:
Product is flammable. Do not allow product to come in contact with floors, countertops, furniture, or other finished surfaces; will stain. Persons sensitized to isocyanate: do not use. Discontinue if redness or irritation occurs.

Interaction(s)
Ointments, creams, lotions may prevent film from forming correctly and reduce effectiveness if put on before application.

Adverse Reaction(s)
Stinging upon application.

How Supplied:
Sol—15mL (w. applicator)

LAST UPDATED:
11/26/2012