Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE - UNII:1ZK20VI6TY)
Physicians Total Care, Inc.
TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE 55 ug
NASAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
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 Citiți documentul complet