TRIAMCINOLONE ACETONIDE spray, metered

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE - UNII:1ZK20VI6TY)

Доступна з:

Physicians Total Care, Inc.

ІПН (Міжнародна Ім'я):

TRIAMCINOLONE ACETONIDE

Склад:

TRIAMCINOLONE ACETONIDE 55 ug

Адміністрація маршрут:

NASAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Triamcinolone Acetonide Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older. Labeling describing use of triamcinolone acetonide nasal spray in pediatric patients 2 to 5 years of age is approved for Sanofi-Aventis U.S. Inc.’s Nasacort® AQ Nasal Spray. However, due to Sanofi-Aventis U.S. Inc.’s marketing exclusivity rights, a description of that use is not approved for this triamcinolone acetonide nasal spray labeling. Triamcinolone acetonide should not be administered to patients with a history of hypersensitivity to triamcinolone acetonide or to any of the other ingredients of this preparation. There are no adequate and well-controlled studies of triamcinolone acetonide nasal spray in pregnant women. Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. Triamcinolone acetonide nasal spray, like other corticosteroids, should be used during pregnancy only if the potential benefit justifies

Огляд продуктів:

Triamcinolone Acetonide Nasal Spray, 55 mcg per spray, is supplied in a white high-density polyethylene container with a metered-dose pump unit, white nasal adapter, and patient instructions. The contents of one 16.5 gram bottle provide 120 actuations (NDC 54868-6270-0). After 120 actuations, the amount of triamcinolone acetonide delivered per actuation may not be consistent and the unit should be discarded. Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming of 5 sprays [see Administration Information ( 2.3) ]. In the Patient Package Information, patients are provided with a check-off form to track usage [see Patient Counseling Information ( 17 ) ]. WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Rx only Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE SPRAY, METERED
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIAMCINOLONE ACETONIDE NASAL SPRAY SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIAMCINOLONE
ACETONIDE NASAL SPRAY.
TRIAMCINOLONE ACETONIDE NASAL SPRAY
FOR INTRANASAL USE ONLY. SHAKE WELL BEFORE USING.
INITIAL U.S. APPROVAL: 1957
INDICATIONS AND USAGE
Triamcinolone Acetonide Nasal Spray is a corticosteroid indicated for
treatment of nasal symptoms of seasonal and
perennial allergic rhinitis in adults and children 6 years of age and
older. (1)
DOSAGE AND ADMINISTRATION
_Adults and adolescents_ ≥_12 years: _Starting and maximum dose is
220 mcg/day (two sprays in each nostril once daily).
(2.1)
_Children 6 to 12 years of age: _Starting dose is 110 mcg/day (one
spray in each nostril once daily). Maximum dose is 220
mcg/day (two sprays per nostril once daily). (2.2)
_Priming/Use_: Shake well before each use. Before using for the first
time, release 5 sprays into the air away from the
face. If the product is not used for more than 2 weeks, release 1
spray into the air before using. (2.3)
DOSAGE FORMS AND STRENGTHS
Nasal Spray: 55 mcg triamcinolone acetonide in each spray. Supplied in
16.5 g bottle containing 120 actuations. Each
120 actuation bottle contains 9.075 mg triamcinolone acetonide. (3)
CONTRAINDICATIONS
Do not administer to patients with history of hypersensitivity to
triamcinolone acetonide or any ingredients of this
product. (4)
WARNINGS AND PRECAUTIONS
Epistaxis, nasal septal perforation, _Candida albicans _infection,
impaired wound healing. Monitor patients periodically for
signs of adverse effects on the nasal mucosa. Avoid use in patients
with recent nasal septal ulcers, nasal surgery, or
trauma. (5.1)
Development of glaucoma or posterior subcapsular cataracts. Monitor
patients closely with a change in vision or with a
history of increased intraocular pressure, glaucoma, and/or c