OMNARIS- ciclesonide spray

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

CICLESONIDE (UNII: S59502J185) (CICLESONIDE - UNII:S59502J185)

थमां उपलब्ध:

Covis Pharma US, Inc

प्रशासन का मार्ग:

NASAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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)] . There are no data on ONMARIS nasal spray use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is low systemic exposure following OMNARIS nasal spray administration at the recommended dose [see Clinical Pharmacology (12.3)] . In animal reproduction studies, ciclesonide, administered by the oral route to pregnant rats, during the period of organogenesis, did not cause any evidence of fetal harm at doses up 45 times the maximum

उत्पाद समीक्षा:

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 70515-701-01

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

OMNARIS- CICLESONIDE SPRAY
COVIS PHARMA US, 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
•
•
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 OMNARIS Nasal Spray. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (>2% incidence) included headache,
epistaxis, nasopharyngitis, ear
pain, and pharyngolaryngeal pain. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT COVIS PHARMA AT
1-866-488-4423 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Treatment of Seasonal Allergic Rhinitis
®
®
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)
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 intraocula