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Budesonide aerosol

Function and Efficacy

Budesonide is a glucocorticoid with highly effective local anti-inflammatory effects. The exact mechanism of glucocorticoids in the treatment of rhinitis is not fully understood. The anti-inflammatory effects of glucocorticoids, such as inhibiting the release of inflammatory mediators and inhibiting cytokine-mediated immune responses, may play an important role. Compared with the affinity for glucocorticoid receptors, budesonide is about 15 times more active than prednisolone. Prophylactic use of budesonide has a protective effect against eosinophil migration and allergic reactions caused by nasal irritation. Using the recommended dose of this product, there is no clinically significant change in the patient's basal plasma cortisol levels and response to ACTH stimulation. However, after short-term use of this product in healthy volunteers, plasma and urine cortisol levels were observed to be affected.

Ingredients

16alpha;,17alpha;-22R,S-propylmethylenedioxy-pregna-1,4-diene-11beta;,21-dihydroxy-3,20-dione

Name Description Content CAS NO. Manufacturer
(r)-budesonideIngredients

Budesonide is a glucocorticoid with highly effective local anti-inflammatory effects. The anti-inflammatory effects of glucocorticoids, such as inhibiting the release of inflammatory mediators and inhibiting cytokine-mediated immune responses, may play an important role in this. Compared with the affinity for glucocorticoid receptors, budesonide is about 15 times more active than prednisolone. The prophylactic use of budesonide has a protective effect on eosinophil migration and allergic reactions caused by nasal irritation. Using the recommended dose of this product, the patient's basal plasma cortisol level and response to ACTH stimulation do not undergo clinically significant changes. However, after short-term use of this product in healthy volunteers, plasma and urine cortisol levels were observed to be affected.

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51372-29-3 24

Appearance

This product is a white to off-white viscous suspension

Indication

Seasonal and perennial allergic rhinitis, vasomotor rhinitis; prevention of nasal polyp regeneration after nasal polypectomy, symptomatic treatment of nasal polyps.

Usage and Dosage

The dosage should be individualized. Rhinitis in adults and children over 6 years old: The recommended starting dose is 256μg per day, which can be sprayed once in the morning or twice in the morning and evening. That is: spray 128μg (2X64μg) in each nostril in the morning; or spray 64μg in each nostril twice in the morning and evening. No increase in effect was observed when the daily dosage exceeds 256μg. After achieving the expected clinical effect, reduce the dosage to the minimum dose required to control symptoms. Clinical trials have shown that for some patients, a daily spray of 32μg in each nostril as a maintenance dose is sufficient. Some patients can relieve symptoms 5-7 hours after starting treatment. The full effect can only be achieved after several days of treatment (a small number of patients

Adverse Reactions

Adverse reactions of local irritation occur in approximately 5% of patients. Common (1/100): Airways: local irritation, mild bloody discharge, epistaxis. Uncommon (1/1000): Systemic: angioedema. Skin: urticaria, rash, dermatitis, pruritus. Airways: nasal septum perforation and mucosal ulceration. Immediate or delayed hypersensitivity reactions, including urticaria, rash, dermatitis, angioedema, and pruritus, have been reported. Very few patients have developed mucosal ulceration and nasal septum perforation after intranasal administration of glucocorticoids. The causes of these adverse reactions (which may be caused by glucocorticoids, these diseases, or other factors) are unknown.

Precautions

Those with a history of allergy to budesonide or any of the ingredients in the prescription.

Special Population Medication

Precautions for children: Children under 2 years old should use it with caution or not at all. Precautions for pregnancy and lactation: No adverse effects on the embryo and newborn have been found when using inhaled budesonide during pregnancy. It is not known whether budesonide can enter breast milk, but it should be used with caution. Compared with oral glucocorticoids, the systemic effect of inhaled glucocorticoids is lower when the anti-asthma equivalent dose is reached. Precautions for the elderly:

Drug Interactions

Oral ketoconazole 200 mg once daily increases the blood concentration of budesonide (3 mg single dose) taken orally at the same time by an average of 6 times. When ketoconazole is given 12 hours after budesonide, the blood concentration of budesonide increases by an average of 3 times. There are no reports of this interaction with nasal budesonide, but a significant increase in blood concentration can be expected. Due to the lack of data on the recommended dose for nasal budesonide and ketoconazole, the co-administration of the two drugs should be avoided. If co-administration cannot be avoided, the interval between the administration of the two drugs should be as long as possible. At the same time, consideration should be given to reducing the dose of budesonide. Other strong CYP3A4 inhibitors may also cause a significant increase in budesonide blood concentrations.

Storage

No more than 30℃, do not freeze. Valid for 24 months.

Packaging Specification

10 ml: 10 mg, 50 u/spray

Validity Period

24 months

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