ZETONNA- ciclesonide aerosol, metered

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Sunovion Pharmaceuticals Inc.

INN (International Name):

ciclesonide

রচনা:

ciclesonide 37 ug

প্রশাসন রুট:

NASAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

ZETONNA® (ciclesonide) Nasal Aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. ZETONNA is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA [see Warnings and Precautions (5.3) ]. Teratogenic Effects : Pregnancy Category C. There are no adequate and well-controlled trials in pregnant women. ZETONNA 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. Oral administration of ciclesonide in rats at approximately 120 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mcg/m2 basis at a maternal dose of 900 mcg/kg/day) produced no teratogenicity or other fetal

পণ্য সারাংশ:

ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient's instructions for proper use accompany each package of ZETONNA. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used. Contents under Pressure Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator. Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum. ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g. NDC Number 63402-737-60

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

ZETONNA- CICLESONIDE AEROSOL, METERED
SUNOVION PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZETONNA NASAL AEROSOL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZETONNA NASAL
AEROSOL.
ZETONNA (CICLESONIDE) NASAL AEROSOL
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Warnings and Precautions. (5.1)
10/2014
INDICATIONS AND USAGE
ZETONNA Nasal Aerosol is a corticosteroid indicated for treatment of
symptoms associated with seasonal and perennial
allergic rhinitis in adults and adolescents 12 years of age and older.
(1.1)
DOSAGE AND ADMINISTRATION
For Intranasal use only
1 actuation per nostril once daily. (74 mcg per day) (2.1)
DOSAGE FORMS AND STRENGTHS
Nasal Aerosol: 37 mcg of ciclesonide per actuation. (3)
Supplied in a 6.1 g canister containing 60 actuations. (16)
CONTRAINDICATIONS
Patients with a known hypersensitivity to ciclesonide or any of the
ingredients of ZETONNA. (4)
WARNINGS AND PRECAUTIONS
Local Nasal Effects, including epistaxis, ulceration, nasal septal
perforations, _Candida albicans_ infection impaired wound
healing: Prior to initiating therapy, examine patients for evidence of
septal perforation, erosions, ulceration, nasal
surgery, and trauma. Avoid spraying ZETONNA directly onto the nasal
septum. Avoid use in patients with recent septal
perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal
trauma. Monitor patients periodically for signs of adverse
effects on the nasal mucosa. Discontinue ZETONNA if erosions,
ulcerations or perforations occur. (5.1)
Development of glaucoma or cataracts: Monitor patients closely with a
change in vision or with a history of increased
intraocular pressure, glaucoma, or cataracts. (5.2)
Hypersensitivity reactions have been reported following administration
of ciclesonide with manifestations such as
angioedema, with swelling of the lips, tongue and pharynx. (5.3)
Potential worsening of existing tuberculosis; fungal, bacterial,
viral, or parasitic infe