国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
FLUNISOLIDE (UNII: QK4DYS664X) (FLUNISOLIDE ANHYDROUS - UNII:78M02AA8KF)
Rising Pharmaceuticals, Inc
FLUNISOLIDE
FLUNISOLIDE 0.25 mg in 1 mL
NASAL
PRESCRIPTION DRUG
Flunisolide nasal solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide nasal solution should not be used in the presence of untreated localized infection involving the nasal mucosa. Hypersensitivity to any of the ingredients.
Flunisolide Nasal Solution USP 0.025% (Nasal Spray) is supplied in a nasal pump dispenser with dust cover and with patient instructions in the following size: 25 mL bottles NDC 64980-510-25. Each 25 mL flunisolide nasal solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 sprays of flunisolide. Storage: Store between 20° to 25°C (68° to 77°F). KEEP OUT OF REACH OF CHILDREN. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Rev. 931:00 1/12
Abbreviated New Drug Application
FLUNISOLIDE - FLUNISOLIDE SPRAY, METERED RISING PHARMACEUTICALS, INC ---------- FLUNISOLIDE NASAL SOLUTION USP, 0.025% (NASAL SPRAY) RX ONLY FOR INTRANASAL USE ONLY DESCRIPTION: Flunisolide Nasal Solution USP, 0.025% is intended for administration as a spray to the nasal mucosa. Flunisolide, the active component of flunisolide nasal solution, is an anti-inflammatory steroid. Flunisolide is represented by the following structural formula: Chemical Name: 6α-fluoro-11β,16α,17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (USAN). Flunisolide is a white to creamy white crystalline powder. It is soluble in acetone, sparingly soluble in chloroform, slightly soluble in methanol, and practically insoluble in water. It has a melting point of about 245°C. After initial priming (5 to 6 sprays), each spray of the unit delivers a metered droplet spray of 100 mg formulation containing 25 mcg of flunisolide. The size of the droplets produced by the unit is in excess of 8 microns to facilitate deposition on the nasal mucosa. The contents of one nasal spray bottle delivers 200 sprays. EACH ML CONTAINS: ACTIVE: Flunisolide 0.25mg (0.025%); INACTIVES: Propylene Glycol, Polyethylene Glycol 3350, Butylated Hydroxyanisole, Edetate Disodium, Sodium Citrate, Citric Acid and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (5.1-5.4), PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. CLINICAL PHARMACOLOGY: Flunisolide has demonstrated potent glucocorticoid and weak mineral corticoid activity in classical animal test systems. As a glucocorticoid it is several hundred times more potent than the cortisol standard. Clinical studies with flunisolide have shown therapeutic activity on nasal mucous membranes with minimal evidence of systemic activity at the recommended doses. A study in approximately 100 patients that compared the recommended dose of flunisolide nasal solution with an oral dose providing equivalent systemic amounts of flunisolide has shown that the clinical effec 阅读完整的文件