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Zetonna

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Zetonna

Indications
Dosage
How Supplied

INDICATIONS

Treatment of Allergic Rhinitis

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.

DOSAGE AND ADMINISTRATION

Administer ZETONNA Nasal Aerosol by the intranasal route only. Prior to initial use, ZETONNA Nasal Aerosol must be primed by actuating three times. If ZETONNA Nasal Aerosol is not used for ten consecutive days, it must be primed by actuating three times. If ZETONNA Nasal Aerosol is dropped, the canister and actuator may become separated. If this happens, reassemble ZETONNA Nasal Aerosol and test spray once into the air before using. Illustrated patient's instructions for proper use accompany each package of ZETONNA Nasal Aerosol.

Allergic Rhinitis

Adults and Adolescents (12 Years of Age and Older)

The recommended dose of ZETONNA Nasal Aerosol is 1 actuation per nostril once daily (37 mcg per actuation). The maximum total daily dosage should not exceed 1 actuation in each nostril (74 mcg per day).

HOW SUPPLIED

Dosage Forms And Strengths

ZETONNA Nasal Aerosol is provided at strength of 37 mcg per actuation strength containing 60 actuations per canister.

Storage And Handling

ZETONNA Nasal Aerosol 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 Nasal Aerosol must be primed by actuating three times. If ZETONNA Nasal Aerosol is dropped, the canister and actuator may become separated. If this happens, ZETONNA Nasal Aerosol 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 Nasal Aerosol canister should only be used with the ZETONNA Nasal Aerosol 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 Nasal Aerosol.

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 Nasal Aerosol 37 mcg, 60 metered actuations; net fill weight 6.1 g.

NDC Number 63402-737-60

Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA 01752, USA. Made in the United Kingdom. Revised: January 2012

Last reviewed on RxList: 2/6/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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