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Budesonide Nasal

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Overview

What is Budesonide Nasal?

Budesonide, the active ingredient of Budesonide 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 or almost white, crystalline 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.  

Budesonide 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 4.0 to 5.0.  

Budesonide nasal spray delivers 32 mcg of budesonide per spray. 

Each bottle of budesonide 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 Budesonide Nasal look like?



What are the available doses of Budesonide Nasal?

Nasal Spray: 32 mcg budesonide in each metered spray. ()

Supplied in 8.6 g bottle providing 120 metered sprays after initial priming. ()

What should I talk to my health care provider before I take Budesonide Nasal?

How should I use Budesonide Nasal?

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 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 budesonide nasal spray 32 mcg and the maximum recommended dose for pediatric patients (6 to
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 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 budesonide nasal spray 32 mcg.


What interacts with Budesonide Nasal?

Sorry No Records found


What are the warnings of Budesonide Nasal?

Sorry No Records found


What are the precautions of Budesonide Nasal?

Sorry No Records found


What are the side effects of Budesonide Nasal?

Sorry No records found


What should I look out for while using Budesonide Nasal?

Budesonide nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [].


What might happen if I take too much Budesonide Nasal?

Acute overdosage with this dosage form is unlikely since one 120 spray bottle of budesonide 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 Budesonide Nasal?

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Budesonide Nasal Spray, 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a protection cap. Budesonide Nasal Spray, 32 mcg (NDC 60505-0839-2) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The 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.  Budesonide Nasal Spray should be stored upright at 20º to 25°C (68º to 77°F) [See USP controlled room temperature]. Do not freeze. Protect from light.Shake gently before use.Budesonide Nasal Spray, 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a protection cap. Budesonide Nasal Spray, 32 mcg (NDC 60505-0839-2) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The 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.  Budesonide Nasal Spray should be stored upright at 20º to 25°C (68º to 77°F) [See USP controlled room temperature]. Do not freeze. Protect from light.Shake gently before use.Budesonide Nasal Spray, 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a protection cap. Budesonide Nasal Spray, 32 mcg (NDC 60505-0839-2) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The 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.  Budesonide Nasal Spray should be stored upright at 20º to 25°C (68º to 77°F) [See USP controlled room temperature]. Do not freeze. Protect from light.Shake gently before use.


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Clinical Information

Chemical Structure

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Clinical 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 budesonide 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
Budesonide nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [].

Methylphenidate hydrochloride should not be used in patients being treated (currently or within the proceeding two weeks) with MAO Inhibitors (see CONTRAINDICATIONS, Monoamine Oxidase Inhibitors). Because of possible effects on blood pressure, methylphenidate hydrochloride should be used cautiously with pressor agents.

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Methylphenidate is metabolized primarily to ritalinic acid by de-esterification and not through oxidative pathways.

Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.

Systemic and intranasal corticosteroids use may result in the following:

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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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Tips

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Interactions

Interactions

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