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Rhinocort Aqua

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Rhinocort Aqua

INDICATIONS

Treatment of Seasonal or Perennial Allergic Rhinitis

RHINOCORT AQUA (budesonide) Nasal Spray is indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older.

DOSAGE AND ADMINISTRATION

The recommended starting dosage for adults and children 6 years of age and older is 64 mcg per day administered as one spray per nostril of RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg once daily. Some patients who do not achieve symptom control at the recommended starting dosage may benefit from an increased dosage. The maximum recommended dosage for adults (12 years of age and older) is 256 mcg per day administered as four sprays per nostril once daily of RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg and the maximum recommended dose for pediatric patients (6 to < 12 years of age) is 128 mcg per day administered as two sprays per nostril once daily of RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg.

It is always desirable to titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects. An improvement in nasal symptoms may be noted in patients within 10 hours of first using RHINOCORT AQUA (budesonide) Nasal Spray, however, clinical improvement usually takes 1 -2 days with maximum benefit in approximately 2 weeks. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage may be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled on higher dosages.

Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears. Shake the container gently before each use.

Illustrated Patient's Instructions for Use accompany each package of RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg.

HOW SUPPLIED

Dosage Forms and Strengths

RHINOCORT AQUA (budesonide) Nasal Spray is a nasal spray suspension. Each spray delivers 32 mcg of budesonide. Each bottle of RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg contains 120 metered sprays after initial priming.

RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg (NDC 0186-1070-08) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The RHINOCORT AQUA (budesonide) Nasal Spray 32 mcg bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after 120 sprays following initial priming, since the amount of budesonide delivered per spray thereafter may be substantially less than the labeled dose. Each spray delivers 32 mcg of budesonide to the patient.

RHINOCORT AQUA (budesonide) Nasal Spray should be stored at controlled room temperature, 20 to 25°C (68 to 77°F) with the valve up. Do not freeze. Protect from light. Shake gently before use. Do not spray in eyes.

Distributed by: AstraZeneca LP, Wilmington, DE 19850. Revised: 12/2010

Last reviewed on RxList: 2/24/2011
This monograph has been modified to include the generic and brand name in many instances.

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