Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ciclesonide (UNII: S59502J185) (ciclesonide - UNII:S59502J185)
Sunovion Pharmaceuticals Inc.
ciclesonide
ciclesonide 50 ug
NASAL
PRESCRIPTION DRUG
OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older. OMNARIS Nasal Spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray [see Warnings and Precautions (5.3)] . Teratogenic Effects : Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. OMNARIS Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in corticosteroid p
OMNARIS is supplied in an amber glass bottle and provides for nasal delivery with a manual metered pump. OMNARIS Nasal Spray is supplied with an oxygen absorber sachet and enclosed in a foil pouch. The contents of one 12.5 gram bottle provide 120 actuations, after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. The OMNARIS Nasal Spray bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after removal from the foil pouch either after 120 sprays following initial priming (since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose) or after 4 months. Patient instructions are also provided. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature] . Do not freeze. Shake gently before use. Keep out of reach of children. Omnaris Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. NDC 63402-701-01
New Drug Application
OMNARIS- CICLESONIDE SPRAY SUNOVION PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMNARIS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMNARIS. OMNARIS (CICLESONIDE) NASAL SPRAY INITIAL U.S. APPROVAL: 2006 INDICATIONS AND USAGE OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older. (1.1, 1.2) DOSAGE AND ADMINISTRATION For Intranasal Use Only 2 sprays per nostril once daily. (200 mcg) (2.1, 2.2) Priming Information: Gently shake and prime OMNARIS Nasal Spray before using for the first time or when not used for four consecutive days. (2) DOSAGE FORMS AND STRENGTHS Nasal Spray: 50 mcg of ciclesonide in each 70-microliter spray. (3) CONTRAINDICATIONS Patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARISNasal Spray. (4) WARNINGS AND PRECAUTIONS Epistaxis, _Candida albicans_ infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid spraying OMNARIS directly onto the nasal septum. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. (5.1) Development of glaucoma or cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. (5.2) Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. (5.3) Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue OMNA Прочитать полный документ