RX ITEM-Rhinocort 120 32Mcg Spray 8.6Gm By Astra Zeneca Pharma

RHINOCORT AQUA- budesonide spray, metered
AstraZeneca LP

1 INDICATIONS AND USAGE

1.1 Treatment of Seasonal or Perennial Allergic Rhinitis
RHINOCORT AQUA 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.

2 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 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 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 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 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 Nasal Spray 32 mcg.

3 DOSAGE FORMS and STRENGTHS

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

RX ITEM-Rhinocort 120 32Mcg Spray 8.6Gm
NDC 00186-1070-08 UPC/GTIN No.3-01861-07008-3 Mfg.Part No.107008 aerosol , clear

Rhinocort 120 32Mcg Spray 8.6Gm By Astra
BRAND: RHINOCORT NDC: 00186-1070-08,186107008 UPC: 3-01861-07008-3,301861070083 Astra Zeneca Pharma

BUDESONIDE NASAL SPRAY/PU
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