Budesonide aerosol

Aerosol containing budesonide is a non-halogenated glucocorticoid. Due to its extremely high (about 90%) first-pass liver metabolism effect, the drug has good selectivity for local anti-inflammatory effects within a large dose range. Induction tests on animals and patients, it was shown that budesonide has anti-allergic and anti-inflammatory effects and can relieve bronchial obstruction caused by immediate and delayed allergic reactions. In highly reactive patients, budesonide can reduce the airway response to histamine and methacholine. Budesonide can also effectively prevent the onset of exercise-induced asthma. Rabbits inhaled budesonide 400μg/day for one week without local irritation. The minimum lethal dose of this product inhaled by mice is 100mg/kg (about 250 times the maximum recommended daily inhalation dose for humans). Mice took budesonide 200μg/kg per day (about 1/2 of the maximum recommended daily inhalation dose for humans) orally for 91 weeks without carcinogenic effects. In a 104-week carcinogenicity study in Sprague-Dawley rats, the incidence of gliomas in male rats receiving an oral dose of 50 μg/kg/day (approximately 1/4 of the maximum recommended daily inhalation dose for humans) increased significantly and was statistically significant; however, no carcinogenicity was found in male rats receiving oral doses of 10 and 25 μg/kg/day (approximately 1/20 and 1/8 of the maximum recommended daily inhalation dose for humans, respectively) and male rats receiving an oral dose of 50 μg/kg/day (approximately 1/4 of the maximum recommended daily inhalation dose for humans). Studies in the Ames test, mouse micronucleus test, mouse lymphoma test, human lymphocyte chromosome aberration test, Drosophila melanogaster recessive lethal test, and rat liver cell culture DNA repair test have confirmed that budesonide has no mutagenic or clastogenic effects. Subcutaneous administration of budesonide at 20 μg/kg/day (approximately 1/10 of the maximum recommended daily inhalation dose for humans) to rats increased maternal weight, and decreased prenatal survival rate, birth survival rate, and pup survival rate during lactation. This effect was not seen at a dose of 5 μg/kg (approximately 1/40 of the maximum recommended daily inhalation dose for humans). Subcutaneous administration of budesonide at 25 and 500 μg/kg/day (approximately 1/4 and 2.5 times the maximum recommended daily inhalation dose for humans, respectively) to rabbits and rats can cause fetal death, decreased pup weight, and skeletal deformities. No teratogenic or fetal death effects were observed when rats inhaled budesonide at a dose of 100 to 250 μg/kg/day (approximately 1/2 to 1/4 of the maximum recommended daily inhalation dose for humans).

The main ingredient of this product is budesonide. Its chemical name is 16a,17a-22R,S-propylmethylenedioxy-pregnane-1,4-diene-11b,21-dihydroxy-3,20-dione.

The liquid of this product in the pressure-resistant container should be a white suspension; when the valve is pressed, the liquid will spray out in the form of mist particles.

Bronchial asthma.

Inhalation administration. The dosage of budesonide aerosol should be individualized. For patients with severe asthma and those who have stopped or reduced the use of oral hormones, the initial dose of budesonide aerosol is: Adults: 200-1600 μg/day, divided into 2-4 times (200-800 μg/day for milder cases and 800-1600 μg/day for more severe cases). Children aged 2-7 years: 200-400 μg/day, divided into 2-4 times. Children over 7 years old: 200-800 μg/day, divided into 2-4 times. Twice a day (morning and evening) is generally sufficient. When the clinical effect has been achieved, the maintenance dose should be gradually reduced to the lowest dose that can control symptoms. For patients who need to enhance the therapeutic effect, the dose of budesonide aerosol can be increased, because the incidence of systemic side effects is lower than that of the treatment with oral hormones. Non-hormone-dependent patients: Generally, the therapeutic effect is achieved within ten days. For patients with excessive bronchial mucus secretion, a short-term (about 2 weeks) oral hormone treatment can be given at the same time at the beginning. Hormone-dependent patients: When switching from oral hormones to budesonide aerosol, the patient should be in a relatively stable period. High-dose budesonide aerosol should be used in combination with the previous oral hormone for about ten days, and then the oral hormone can be gradually reduced to the lowest dose (for example, the monthly dose of prednisolone is reduced by 2.5mg or equivalent dose). In many cases, budesonide aerosol can completely replace oral hormones.

The main symptoms are mild throat irritation, cough, and hoarseness. Pharyngeal candidiasis has been reported. In rare cases, rash has been reported.

1. This product is contraindicated for those who are allergic to its ingredients. 2. The initial stage of bronchospasm when more powerful treatment is needed. 3. When more powerful treatment is needed for acute asthma attack.

Precautions for children: The safety and efficacy of this product for children under 2 years old have not been studied, so its use should be avoided. Studies on childhood asthma have shown that the incidence of adverse events of this product in children aged 6 to 12 years (172 cases) and children aged 13 to 17 years (124 cases) is the same. Since oral corticosteroids can cause growth inhibition in children, children who take other corticosteroids to cause growth inhibition should consider that they may also have a higher sensitivity to this product. Precautions for pregnancy and lactation: There is insufficient research on the use of this product in pregnant women, so pregnant women should weigh the pros and cons when using this product. Unless there is a reason to use it, this product should be avoided during pregnancy. During pregnancy, if glucocorticoids cannot be avoided, inhaled hormones can be used because the former has lower systemic side effects than oral hormones when the equivalent dose of anti-asthma is reached. Babies born to women who use this product during pregnancy may develop adrenal hypofunction, so the baby should be carefully observed. Because this product can be excreted into human breast milk, breastfeeding women should avoid using this product, and breastfeeding should be stopped when it must be used. Precautions for the elderly: A clinical study on the use of this product in 100 elderly patients over 65 years old showed that the efficacy and safety of this product for elderly patients are the same as those for young patients.

A clinical study on the use of this product in 100 elderly patients over 65 years old showed that the efficacy and safety of this product for elderly patients are the same as those for young patients.

Sealed, store in a cool place (not exceeding 20°C).

Each bottle contains 20 mg of budesonide, each bottle contains 200 presses, and each press contains 0.1 mg of budesonide.

Tentative 24 months

Lunan BETTER Pharmaceutical Co., Ltd.

• Founded in:

  2003-12-16

• Address:

  No. 209, Hongqi Road, Linyi City

• Tax NO.:

  91371300756399007K

• Registered Funds:

  115 million yuan

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