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RHINOCORT AQUA
Overview
What is RHINOCORT AQUA?
Budesonide, the active ingredient of RHINOCORT AQUA Nasal Spray, is an anti-inflammatory synthetic corticosteroid.
It is designated chemically as (RS)-11-beta, 16-alpha, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with butyraldehyde.
Budesonide is provided as the mixture of two epimers (22R and 22S).
The empirical formula of budesonide is CHOand its molecular weight is 430.5.
Its structural formula is:
Budesonide is a white to off-white, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform.
Its partition coefficient between octanol and water at pH 5 is 1.6 x 10.
RHINOCORT AQUA Nasal Spray is an unscented, metered-dose, manual-pump spray formulation containing a micronized suspension of budesonide in an aqueous medium. Microcrystalline cellulose and carboxymethyl cellulose sodium, dextrose anhydrous, polysorbate 80, disodium edetate, potassium sorbate, and purified water are contained in this medium; hydrochloric acid is added to adjust the pH to a target of 4.5.
RHINOCORT AQUA Nasal Spray delivers 32 mcg of budesonide per spray.
Each bottle of RHINOCORT AQUA Nasal Spray 32 mcg contains 120 metered sprays after initial priming.
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.
What does RHINOCORT AQUA look like?
What are the available doses of RHINOCORT AQUA?
Nasal Spray: 32 mcg budesonide in each metered spray. (3)
Supplied in 8.6 g bottle providing 120 metered sprays after initial priming. (16)
What should I talk to my health care provider before I take RHINOCORT AQUA?
How should I use RHINOCORT AQUA?
RHINOCORT AQUA Nasal Spray is a corticosteroid indicated for:
· Treatment of seasonal or perennial allergic rhinitis in adults and children ≥ 6 years. (1.1)
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 accompany each package of RHINOCORT AQUA 32 mcg.
What interacts with RHINOCORT AQUA?
Sorry No Records found
What are the warnings of RHINOCORT AQUA?
Sorry No Records found
What are the precautions of RHINOCORT AQUA?
Sorry No Records found
What are the side effects of RHINOCORT AQUA?
Sorry No records found
What should I look out for while using RHINOCORT AQUA?
RHINOCORT AQUA Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [].
What might happen if I take too much RHINOCORT AQUA?
Acute overdosage with this dosage form is unlikely since one 120 spray bottle of RHINOCORT AQUA Nasal Spray 32 mcg only contains approximately 5.4 mg of budesonide. Chronic overdosage may result in signs/symptoms of hypercorticism [].
How should I store and handle RHINOCORT AQUA?
RHINOCORT AQUA Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. RHINOCORT AQUA Nasal Spray 32 mcg () provides 120 metered sprays after initial priming; net fill weight 8.6 g. The RHINOCORT AQUA 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 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. Do not spray in eyes.RHINOCORT AQUA Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. RHINOCORT AQUA Nasal Spray 32 mcg () provides 120 metered sprays after initial priming; net fill weight 8.6 g. The RHINOCORT AQUA 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 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. Do not spray in eyes.RHINOCORT AQUA Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. RHINOCORT AQUA Nasal Spray 32 mcg () provides 120 metered sprays after initial priming; net fill weight 8.6 g. The RHINOCORT AQUA 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 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. Do not spray in eyes.RHINOCORT AQUA Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. RHINOCORT AQUA Nasal Spray 32 mcg () provides 120 metered sprays after initial priming; net fill weight 8.6 g. The RHINOCORT AQUA 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 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. Do not spray in eyes.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. In standard and animal models, budesonide has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol (rat croton oil ear edema assay). As a measure of systemic activity, budesonide is 40 times more potent than cortisol when administered subcutaneously and 25 times more potent when administered orally in the rat thymus involution assay. The clinical significance of this is unknown.
The activity of RHINOCORT AQUA Nasal Spray is due to the parent drug, budesonide. In glucocorticoid receptor affinity studies, the 22R form was two times as active as the 22S epimer. studies indicated that the two forms of budesonide do not interconvert.
The precise mechanism of corticosteroid actions on inflammation in seasonal and perennial allergic rhinitis is not well known. Inflammation is an important component in the pathogenesis of seasonal and perennial allergic rhinitis. Corticosteroids have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic-mediated inflammation. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in seasonal and perennial allergic rhinitis.
Non-Clinical Toxicology
RHINOCORT AQUA Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [].Epistaxis
In clinical studies of 3 to 52 weeks’ duration epistaxis was observed more frequently in patients treated with RHINOCORT AQUA Nasal Spray than those who received placebo [].
Candida Infection
In clinical studies with budesonide administered intranasally, the development of localized infections of the nose and pharynx with has occurred. When such an infection develops, it may require treatment with appropriate local or systemic therapy and discontinuation of treatment with RHINOCORT AQUA Nasal Spray. Patients using RHINOCORT AQUA Nasal Spray over several months or longer should be examined periodically for evidence of infection or other signs of adverse effects on the nasal mucosa.
Nasal Septal Perforation
Instances of nasal septum perforation have been reported following the intranasal application of corticosteroids, including budesonide [].
Impaired Wound Healing
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.
Systemic and intranasal corticosteroids use may result in the following:
· Epistaxis infection, nasal septum perforation, and impaired wound healing [].
· Hypersensitivity Including Anaphylaxis [].
· Immunosuppression [].
· Hypercorticism and Adrenal Suppression [].
· Growth Effect [].
· Glaucoma and Cataracts [].
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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