ZETONNA- ciclesonide aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Covis Pharma US, Inc

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZETONNA® (ciclesonide) is indicated for the treatment of symptoms associated with seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. ZETONNA® (ciclesonide) is indicated for the treatment of symptoms associated with perennial allergic rhinitis in adult and pediatric patients 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)] . There are no available data on ZETONNA 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 ZETONNA 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 to 120 times the maximum recommended human dai

Product summary:

ZETONNA (ciclesonide) 37 mcg nasal aerosol is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. 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°C - 30°C (59°F - 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. ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g. NDC Number 70515-737-60

Authorization status:

New Drug Application

Summary of Product characteristics

ZETONNA- CICLESONIDE AEROSOL, METERED
COVIS PHARMA US, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZETONNA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZETONNA.
ZETONNA (CICLESONIDE) NASAL AEROSOL
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
ZETONNA is a corticosteroid indicated for:
•
•
DOSAGE AND ADMINISTRATION
For nasal use only
•
•
DOSAGE FORMS AND STRENGTHS
Nasal aerosol: 37 mcg of ciclesonide per actuation. (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to ciclesonide or any of the
ingredients of ZETONNA. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥2% incidence) included nasal
discomfort, headache and epistaxis.
(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: 2/2023
®
®
treatment of symptoms associated with seasonal allergic rhinitis in
adult and pediatric patients 12
years of age and older. (1.1)
Treatment of symptoms associated with perennial allergic rhinitis in
adult and pediatric patients 12
years of age and older. (1.1)
Recommended dosage: 1 actuation (37 mcg of ciclesonide) per nostril
once daily. (2.1)
Priming: Gently shake and prime ZETONNA before using for the first
time or when not used for 10
consecutive days. (2)
Local nasal adverse reactions, 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 ZET