OMNARIS- ciclesonide spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ciclesonide (UNII: S59502J185) (ciclesonide - UNII:S59502J185)

Available from:

Sunovion Pharmaceuticals Inc.

INN (International Name):

ciclesonide

Composition:

ciclesonide 50 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

New Drug Application

Summary of Product characteristics

OMNARIS- CICLESONIDE SPRAY
SUNOVION PHARMACEUTICALS INC.
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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