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Budesonide powder inhaler (Pulmicort DUBAO)

This product is suitable for patients with bronchial asthma who need glucocorticoid maintenance treatment to control basic inflammation. This product is also suitable for patients with chronic obstructive pulmonary disease (COPD). Regular use of this product can slow down the accelerated decline of FEV1 in patients with COPD. More role
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Common name:
Budesonide Powder for Inhalation
Product No.:
C14200070682
Approval No.:
H20130322 (inquired by the State Drug Administration)
Jianke price:
¥124.78
Product specification:
0.1mg * 200 suction (Pulmicort DUBAO)
Manufacturer:
AstraZeneca AB (Sweden)

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    Product name Budesonide powder inhaler (Pulmicort DUBAO)
    Main raw materials Budesonide.
    Main role This product is suitable for patients with bronchial asthma who need glucocorticoid maintenance treatment to control basic inflammation. This product is also suitable for patients with chronic obstructive pulmonary disease (COPD). Regular use of this product can slow down the accelerated decline of FEV1 in patients with COPD.
    Product specification 0.1mg * 200 suction (Pulmicort DUBAO)
    Usage and dosage bronchial asthma The dose of this product should be individualized. According to the patient's original asthma treatment status, the recommended starting dose and maximum dose of this product are shown in the table below. In severe asthma and asthma exacerbation, it may be beneficial for some patients to give the dose 3-4 times a day. Original recommended starting dose and maximum recommended dose Hormone free treatment 200-400 at a time μ g. Once a day; Or 800 at a time μ g. Twice a day Once 100-400 μ g. Twice a day Adults inhale glucocorticoids once 200-400 μ g. Once a day; Or 800 at a time μ g. Twice a day Once 100-400 μ g. Twice a day Oral glucocorticoids 400-800 at a time μ g. Twice a day 800 μ g. Twice a day Hormone free treatment 200-400 at a time μ g. Once a day; Or 400 at a time μ g. Twice a day 6 years old and 6 times 100-200 μ g. Twice a day Inhale glucocorticoids 200-400 years old μ g. Once a day; Or 400 at a time μ g. Twice a day Children once 100-200 μ g. Twice a day Oral glucocorticoid 200-400 once μ g. Once a day 400 μ g. Twice a day Note: when asthma is controlled, all patients can be reduced to the lowest effective maintenance dose. Dose range of maintenance dose: Adult day 100 ~ 1600 μ g Children's day 100 ~ 800 μ g Although the maximum effect may not be achieved 1 ~ 2 weeks or even longer after the start of treatment, asthma control can be improved within 24 hours after the start of inhalation treatment. The daily dose is usually given 1 ~ 2 times. The maintenance dose for adults and children with mild to moderate asthma (from 6 years old) is 100 ~ 400 a day μ G, once a day may be considered. For patients who do not use glucocorticoids and who can control asthma well with inhaled glucocorticoids, the initial medication can be once a day. The medication time was morning or night. If asthma symptoms worsen, the number of administration and daily dose should be increased. The drug in this product is inhaled by the patient and reaches the lung. Therefore, it is very important to guide the patient to inhale deeply through the suction nozzle. In order to minimize the incidence of fungal stomatitis, patients should be instructed to gargle with water after each inhalation. Not receiving glucocorticoid treatment It will be beneficial for asthma patients who need maintenance treatment to use this product according to the dose in the table above. When the initial dose response is not ideal, increasing the dose can strengthen the control of asthma. See the inner packaging instructions for details.
    manufacturing enterprise AstraZeneca AB (Sweden)
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    [drug name]

       Generic name: budesonide powder inhaler

       Trade name: budesonide powder inhaler (Pulmicort DUBAO)

       English Name: budesonide powder for inhalation

       Pinyin full code: budinaidefenxiruji (pumikedubao)

    [main ingredients] Budesonide.

    [ingredients]

       Chemical name: 16 α, seventeen α- 22r, s-propylmethylene dioxygestrol-1,4-diene-11 β, 21-dihydroxy-3,20 Dione

       Molecular weight: c25h34o6

    [character] White to grayish white round particles are lightly pressed into powder and filled into a special multi-dose powder inhaler driven by inhalation air flow.

    [indications / functional indications] This product is suitable for patients with bronchial asthma who need glucocorticoid maintenance treatment to control basic inflammation. This product is also suitable for patients with chronic obstructive pulmonary disease (COPD). Regular use of this product can slow down the accelerated decline of FEV1 in patients with COPD.

    [specification and model] 0.1mg * 200 suction (Pulmicort DUBAO)

    [usage and dosage] bronchial asthma The dose of this product should be individualized. According to the patient's original asthma treatment status, the recommended starting dose and maximum dose of this product are shown in the table below. In severe asthma and asthma exacerbation, it may be beneficial for some patients to give the dose 3-4 times a day. Original recommended starting dose and maximum recommended dose Hormone free treatment 200-400 at a time μ g. Once a day; Or 800 at a time μ g. Twice a day Once 100-400 μ g. Twice a day Adults inhale glucocorticoids once 200-400 μ g. Once a day; Or 800 at a time μ g. Twice a day Once 100-400 μ g. Twice a day Oral glucocorticoids 400-800 at a time μ g. Twice a day 800 μ g. Twice a day Hormone free treatment 200-400 at a time μ g. Once a day; Or 400 at a time μ g. Twice a day 6 years old and 6 times 100-200 μ g. Twice a day Inhale glucocorticoids 200-400 years old μ g. Once a day; Or 400 at a time μ g. Twice a day Children once 100-200 μ g. Twice a day Oral glucocorticoid 200-400 once μ g. Once a day 400 μ g. Twice a day Note: when asthma is controlled, all patients can be reduced to the lowest effective maintenance dose. Dose range of maintenance dose: Adult day 100 ~ 1600 μ g Children's day 100 ~ 800 μ g Although the maximum effect may not be achieved 1 ~ 2 weeks or even longer after the start of treatment, asthma control can be improved within 24 hours after the start of inhalation treatment. The daily dose is usually given 1 ~ 2 times. The maintenance dose for adults and children with mild to moderate asthma (from 6 years old) is 100 ~ 400 a day μ G, once a day may be considered. For patients who do not use glucocorticoids and who can control asthma well with inhaled glucocorticoids, the initial medication can be once a day. The medication time was morning or night. If asthma symptoms worsen, the number of administration and daily dose should be increased. The drug in this product is inhaled by the patient and reaches the lung. Therefore, it is very important to guide the patient to inhale deeply through the suction nozzle. In order to minimize the incidence of fungal stomatitis, patients should be instructed to gargle with water after each inhalation. Not receiving glucocorticoid treatment It will be beneficial for asthma patients who need maintenance treatment to use this product according to the dose in the table above. When the initial dose response is not ideal, increasing the dose can strengthen the control of asthma. See the inner packaging instructions for details.

    [adverse reactions] In the treated patients, it is expected that nearly 10% of patients may have localized adverse reactions. Common (> 1 / 100) airway: Candida infection in mouth and throat, mild throat irritation, cough and hoarseness. Rare (< 1 / 1000) systemic: angioedema Skin: urticaria, rash, dermatitis, skin bruising Airway: bronchospasm Mental illness: psychomotor excitement, sleep disorder, anxiety, depression, aggressive behavior and behavior change (mostly in children) See the inner packaging instructions for details.

    [taboo] It is forbidden for those who are allergic to any component of this product.

    [precautions] 1. You should not try to relieve the acute attack of asthma quickly with this product. At this time, you still need to inhale short-acting bronchodilators. If the patient is found to be ineffective in using short acting bronchodilators, or the inhalation dose they need is higher than usual, they should see a doctor. At this time, it should be considered to enhance anti-inflammatory treatment, such as inhalation of a higher dose of this product or oral administration of a course of glucocorticoids. 2. In case of acute exacerbation of COPD, the responsible doctor shall decide to give additional treatment. 3. Special observation is required for patients who transition from systemic administration to inhalation administration. During this HPA inhibition period, when the patient is injured, operated or infected (especially gastroenteritis) or in other situations with severe electrolyte loss, the patient can show symptoms and signs of adrenal insufficiency. At this time, although this product can control the symptoms of asthma or COPD, the recommended therapeutic dose of glucocorticoid supplied to the whole body is lower than the normal physiological amount, and can not provide the glucocorticoid activity necessary for these emergency states. 4. During the removal period, some patients have nonspecific discomfort, such as muscle and joint pain. In individual cases, if the patient has symptoms of fatigue, headache, nausea and vomiting, it is necessary to suspect systemic glucocorticoid dysfunction. For these patients, it is sometimes necessary to temporarily increase the oral glucocorticoid dose. 5. Using inhalation therapy instead of systemic corticosteroids can sometimes not control allergic diseases that can only be controlled by systemic medication, such as rhinitis and eczema. These allergic diseases need to be controlled by systemic antihistamines and / or local preparations. 6. The decrease of liver function can affect the clearance of corticosteroids. However, the pharmacokinetics of intravenous budesonide in patients with liver cirrhosis is similar to that in healthy people. The pharmacokinetics of oral budesonide is affected by the damage of liver function, which is manifested in the increase of systemic utilization. However, it has little significance for this product, because when administered by inhalation, the contribution of oral absorption to systemic utilization is very small. 7. In vivo studies have shown that oral ketoconazole, a known CYP3A4 enzyme inhibitor, increases the systemic exposure of budesonide. The clinical significance of this effect is limited when ketoconazole is used in the short term (1-2 weeks), but it needs to be carefully considered when it is used in the long term. 8. The local and systemic effects of long-term use of this product are not completely clear. Once asthma is controlled, the dose should be gradually reduced to the minimum effective dose. Doctors should closely monitor the growth and development of children who use glucocorticoids through any route of administration and weigh the advantages and disadvantages of hormone therapy and its benefits for asthma control against possible growth inhibition. 9. The use of this product in patients with pulmonary tuberculosis may need careful consideration. 10. Impact on the ability to drive and use machines: Budesonide does not affect the ability to drive and use machines. 11. Athletes should use it with caution. Please read the instructions carefully and follow the doctor's advice.

    [medication for children] See [usage and dosage]

    [medication for elderly patients] This experiment was not conducted and there were no reliable references.

    [medication for pregnant and lactating women] The results of a large number of prospective epidemiological studies and worldwide post marketing experience have not found that inhaled budesonide during pregnancy will have adverse effects on embryos and newborns. Like other drugs, pregnant women need to weigh the benefits to the mother and the harm to the fetus when using budesonide. Inhaled glucocorticoids should be considered because they have lower systemic side effects than oral glucocorticoids that achieve the same lung effects. Budesonide can secrete milk, but the therapeutic dose of Pulmicort DUBAO is expected to have no effect on lactating infants. Pulmicort DUBAO can also be used during lactation.

    [drug interaction] No interaction has been observed between this product and other drugs for the treatment of asthma or COPD. As a strong inhibitor of CYP3A4, a subgroup of cytochrome P450, the main metabolic enzyme of corticosteroids, ketoconazole can increase the blood concentration of oral budesonide. At the recommended dose, cimetidine slightly affected the pharmacokinetics of oral budesonide, but had no significant clinical significance.

    [drug overdose] Acute overdose of this product will not cause clinical problems even in large doses. Long term overuse may lead to systemic effects of glucocorticoids, such as adrenocortical hyperfunction and adrenal inhibition.

    [pharmacology and toxicology] Local anti-inflammatory effect The exact mechanism of glucocorticoid in the treatment of asthma and chronic obstructive pulmonary disease is not very clear. The anti-inflammatory effects of glucocorticoids, such as inhibiting the release of inflammatory mediators and inhibiting cytokine mediated immune response, may play an important role in the treatment of asthma. Compared with the affinity of glucocorticoid receptor, the intrinsic efficacy of budesonide is about 15 times higher than that of prednisolone. A clinical study comparing the effects of inhaled and oral budesonide on asthma confirmed that there was a significant difference in the effects of inhaled budesonide compared with placebo, but there was no significant difference in the effects of oral budesonide compared with placebo. Therefore, the therapeutic effect of inhaled conventional dose of budesonide can only be explained by its direct effect on the respiratory tract. Induction tests on animals and patients show that budesonide has anti allergic and anti-inflammatory effects, and can alleviate bronchial obstruction caused by rapid and delayed allergic reactions. Effect on exacerbation of asthma Studies have found that inhalation of budesonide once or twice a day can effectively prevent the deterioration of asthma in children and adults. Effect of on exercise-induced asthma Inhalation of budesonide once or twice a day can effectively prevent exercise-induced bronchoconstriction. Effect on airway responsiveness In highly reactive patients, budesonide can reduce the airway response to direct and indirect stimuli. Effect on chronic obstructive pulmonary disease (COPD): inhale budesonide 400 in patients with mild to moderate COPD μ g. Twice a day, compared with placebo, the FEV1 of patients can be improved after 3-6 months of treatment, and this improvement can be maintained over three years of treatment. Effect on hypothalamic pituitary adrenal (HPA) axis function: ACTH test showed that the effect of inhaled budesonide at the recommended dose on adrenal function was significantly lower than that of lomg prednisone. The daily dose for adults is up to 1600 μ g. The daily dose for children is up to 800 μ g. After continuous use for 3 months, no clinically significant changes in plasma cortisol level and response to ACTH stimulation were found. Up to 52 weeks of follow-up confirmed that HPA axis inhibition did not occur. Effect on Growth Children inhaled budesonide with DUBAO for 2 ~ 6 years, with a daily dose of up to 400 μ g. Compared with non glucocorticoid therapy, there is no evidence that such medication has an effect on the growth and development of children. Toxicological research Preclinical safety study data: acute, subacute and long-term toxicity studies found that the systemic effects of budesonide, such as weight loss, lymphoid tissue and adrenal cortex atrophy, were weaker than other glucocorticoids or similar to other glucocorticoids. After six different experimental tests and systematic evaluation, budesonide has no mutagenic and teratogenic effects. The incidence of brain gliomas increased in male SD rats after taking budesonide, but the results were considered uncertain. Further studies in male SD and Fischer rats showed that the incidence of glioma in budesonide treatment group was very low, and there was no difference between glucocorticoid control group or blank control group. It has been concluded that budesonide treatment does not increase the incidence of brain glioma in rats. The existing clinical experience shows that there is no evidence that budesonide or other glucocorticoids can cause brain glioma and primary hepatocellular tumor in human body.

    [pharmacokinetics] Absorption: after inhalation and administration of DUBAO, the drug deposited in the lung is about 25-35% of the standard dose, which is about twice the PMDI. After inhalation of a single dose of budesonide 800 PG, the maximum plasma concentration was about 4 nmol / L within 30 minutes. The systemic bioavailability of budesonide inhaled through DUBAO is about 38% of the marked amount, of which about 1 / 6 comes from the part swallowed by mouth. Distribution: the distribution volume of budesonide is about 3L / kg, and the average plasma protein binding rate is 85-90%. Biotransformation: the degree of first pass metabolism of budesonide through the liver is very high (> > 90%), and the glucocorticoid activity of metabolites is low. Major metabolites 6 β- Hydroxybudesonide and 16 α- The activity of hydroxyprednisolone was less than 1% of that of budesonide. Budesonide is mainly metabolized by CYP3A4, a subgroup of cytochrome P450. Elimination: Budesonide metabolites are excreted through the kidney in their original or combined form. Prototype budesonide was not detected in urine. The systemic clearance rate of budesonide is high, about 1.2l/min. The average plasma half-life of intravenous administration is 2-3 hours. Pharmacokinetics linearity: in the clinical treatment dose, the pharmacokinetics of budesonide is proportional to the dose.

    [storage] Seal and store in a dry place.

    [packaging] 1 piece / box

    [validity period] 24 months

    [approval No.] H20130322

    [manufacturer] AstraZeneca AB (Sweden)

    [brand name] PUMIC DUBAO

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      Budesonide powder inhaler (Pulmicort DUBAO)

      ¥124.78

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