What Is Formoterol Fumerate?

Budesonide formoterol powder inhalant, indications are 1. Asthma This product is suitable for routine treatment of asthma patients who need to combine inhaled corticosteroids and long-acting 2-receptor agonists. Inhaled corticosteroids and "on-demand" use of short-acting 2-receptor agonists cannot control symptoms well Patients, or patients using inhaled corticosteroids and long-acting 2-receptor agonists, whose symptoms have been well controlled. 2. Chronic obstructive pulmonary disease (COPD) is symptomatic for patients with COPD (FEV1 50% of expected normal value) and recurrent disease progression, despite the long-term standardized use of long-acting bronchodilators, Significant clinical symptoms will still appear.

Drug Name: Budesonide formoterol powder inhaler

Drug type: Prescription drugs, medicines for medical workers' injuries
Special medicine: Doping

Budesonide formoterol powder inhaler ingredients

This product is a compound preparation, and its components are: budesonide (160 g / suction) and formoterol fumarate (4.5 g / suction).

Budesonide formoterol powder inhalant properties

This product is a multi-dose powder inhaler, and the contents in the storage-type dry powder inhalation device are white or white-like particles.
The drug output per dose (dose output from the mouthpiece) includes the effective drug ingredients as follows: budesonide 160 micrograms per inhalation and formoterol fumarate dihydrate 4,5 micrograms per inhalation.
The doses of budesonide and formoterol given by Symbios Dubao 160 g / 4.5 g / suction correspond to the single-dose doses of the corresponding Dubao products, such as budesonide 200 g / dose (calibrated dose) And formoterol 6 g / suction (calibrated dose).

Indications for budesonide formoterol powder inhaler

1. Asthma This product is suitable for routine treatment of asthma patients who need to use inhaled corticosteroids and long-acting ₂ -receptor agonists. Inhaled corticosteroids and short-acting ₂ -receptor agonists cannot be used well. Symptom-controlling patients, or patients with well-controlled symptoms using inhaled corticosteroids and long-acting ₂ -receptor agonists.
2. Chronic obstructive pulmonary disease (COPD)
Symptomatic treatment for patients with COPD (FEV1 50% of the expected normal value) and recurrent disease deterioration. Although these patients have long-term standardized treatment with long-acting bronchodilators, they still have obvious clinical symptoms .

Budesonide formoterol powder inhaler specifications

(1) 160 g / 4.5 g / suction, 60 suction / support;
(2) 160 micrograms / 4.5 micrograms / suction, 120 suction / branch.

Budesonide formoterol powder inhaler usage dosage

1. Asthma This product is not intended for the initial treatment of asthma. This product should be individualized, and the dosage should be adjusted according to the severity of the disease. This requires attention not only when starting the compound preparation, but also when adjusting the maintenance dose. If the dose of combination therapy required by a patient exceeds the range of the compound preparation, a single dose of a 2-receptor agonist and / or a corticosteroid inhalation preparation should be added.
The dose should be gradually reduced to the minimum dose that can effectively control the symptoms of asthma in the patient. Patients should be reviewed regularly by a physician to ensure that they are using the optimal dose of this product. If symptoms can be controlled for a long time after using the minimum recommended amount, the next step is to consider trying inhaled corticosteroids alone.
There are two ways to use this product:
A. Maintenance treatment: This product is used as routine maintenance treatment, and it is also equipped with a fast-acting bronchodilator as a relief agent.
B. Maintenance and remission treatment: This product is used as daily maintenance treatment and on-demand remission treatment.
A. Maintenance treatment:
This product is used for routine maintenance therapy, and it is also equipped with a fast-acting bronchodilator as a relief agent. Patients are advised to carry an additional rapid bronchodilator at all times.
Adults (18 and over): 1-2 inhalations / times, 2 times a day. Some patients may require 4 doses per dose, twice daily.
Youth (12-17 years old): 1-2 inhalations / times, 2 times a day.
In conventional treatment, when two doses a day can effectively control symptoms, the dose should be gradually reduced to the lowest effective dose, or even once a day.
An increase in the use of rapid bronchodilators indicates an increase in the underlying condition, and asthma treatment should be reassessed.
Children (6 years and older): A lower dose is now available for children aged 6-11 years.
B. Maintenance and remission treatment:
In addition to using the daily maintenance dose, patients can also use this product as needed when symptoms worsen. Patients should be told to carry this product with them for relief treatment.
The following patients should be specially considered to use this product for maintenance and remission treatment:
Poor asthma control and too frequent use of relieving medications.
Previous exacerbations of asthma that require medical intervention.
If patients frequently inhale this product on demand, closely monitor dose-related adverse reactions.
Adults (18 years old and above 18 pairs): The recommended maintenance dose is 2 inhalations per day, one inhalation in the morning and evening, and two inhalations in the morning or evening. For some patients, the maintenance dose may be 2 times a day, 2 inhalations each time. In case of symptoms, inhale one more. If symptoms do not resolve after a few minutes of use, take another breath. In any case of exacerbation, (using this product to relieve the treatment) can not exceed 6 inhalation.
The total daily dose does not usually require more than 8 inhalations, but can be temporarily used to 12 inhalations. If the patient does not control the exacerbation of symptoms after using the appropriate maintenance dose and increasing the on-demand medication for 3 days, it is strongly recommended that the patient see a doctor to assess the cause of the persistent symptoms.
Children and adolescents under 18 years of age:
Children and adolescents are not recommended to use Symbios maintenance and remission therapy.
2. Chronic obstructive pulmonary disease (COPD)
Adult: 2 inhalations / time, 2 times a day.
General information:
Special patient groups: elderly patients do not need to adjust the dose. There are no data on the use of this product in patients with hepatic and renal impairment. Because budesonide and formoterol are primarily metabolized by the liver, drug exposure is estimated to increase in patients with severe cirrhosis.
Instructions for proper use of Dubao:
Dubao is driven by inhaled air, that is, when a patient inhales medicine through a mouthpiece, the medicine will enter the airway with the inhaled air.
Note: It is very important to guide patients in the proper use of Dubao, please refer to Dubao User Guide for details.

Adverse reactions of budesonide formoterol powder inhaler

Because this product contains budesonide and formoterol, adverse reactions of these two drugs can also occur when using budesonide formoterol powder inhaler. After the combination of the two drugs, the incidence of adverse reactions did not increase. The most common adverse reactions are the predictable pharmacological adverse reactions such as tremor and palpitations that occur during beta ₂ -agonist treatment. These reactions usually weaken or disappear within a few days of treatment.
The adverse reactions associated with budesonide and formoterol are listed below.

As with other inhalation treatments, very rare abnormal bronchospasm can occur.
Systemic reactions caused by inhaled glucocorticoids can also be seen, especially long-term high doses. Treatment with ₂ -agonists can also lead to elevated blood insulin concentrations, free fatty acids, glycerol and ketone bodies.

Budesonide formoterol powder inhalation contraindications

Patients who have an allergic reaction to budesonide, formoterol, or inhaled lactose (with a small amount of cow's milk protein) are contraindicated.

Precautions for budesonide formoterol powder inhalants

Use with caution by athletes.
It is necessary to gradually reduce the dose when discontinuing this product. Do not stop using it suddenly. -If treatment is found to be ineffective, or if the required dose exceeds the highest recommended dose of this product, the patient should seek medical assistance. Sudden or progressive exacerbation of asthma or COPD symptoms can be life-threatening and patients need urgent medical attention. In this case, consideration should be given to the need to increase corticosteroid therapy, such as a course of oral corticosteroids, or the addition of antibiotics in the presence of infection. Patients should be advised to carry relief medications such as this product (for patients using this product for relief and maintenance therapy) or other fast-acting bronchodilators (for patients using this product for maintenance therapy).
Patients should be reminded that even when asymptomatic, maintenance doses of this product should be inhaled as prescribed. There are no data on the use of this product before exercise. Relief treatment of this product should be used when asthma symptoms worsen, rather than routine preventive use, such as before exercise. If prophylactic use is required, the use of a separate fast acting bronchodilator should be considered.
Once the symptoms of asthma are under control, consider gradually reducing the dose of Symbiotic. When the treatment is reduced, it is very important to follow up the patient regularly. The lowest effective dose of Symbiotic should be given. (See dosage)
Belgian therapy cannot be started at the time of an acute attack of asthma or when symptoms worsen or worsen. Severe asthma-related adverse events and acute asthma attacks may occur when using Symbiotic. If the symptoms of asthma are not controlled or exacerbated after starting Symbios, the patient should be asked to continue treatment and seek medical attention in a timely manner.
Like other inhalation treatments, abnormal bronchospasm can occur. Wheezing worsened immediately after inhaling the drug. When this occurs, the use of this product should be discontinued, and other treatments should be re-evaluated if necessary.
Systemic effects can occur with any inhaled corticosteroid, especially when used chronically, at high doses. These effects are much less likely to occur with inhaled corticosteroids. Possible systemic effects include: adrenal function depression, growth retardation in children and adolescents, decreased bone density, cataracts and glaucoma.
For children and adolescents who have been using corticosteroids for a long period of time, follow their growth closely. If growth is slowed, treatment should be re-evaluated to reduce the dose of inhaled corticosteroids; the benefits of corticosteroid therapy should be weighed against the risks of growth inhibition. Furthermore, patients should be referred to a specialist pediatric respiratory doctor.
Data from limited long-term studies show that most children and adolescents receiving inhaled budesonide eventually reach target adult heights. However, it is also observed that the initial but transient (relative) increase in height (approximately 1 cm) is reduced and generally occurs during the first year of treatment.
For those patients who also have other risk factors for osteoporosis, the potential impact on bone density should be considered when long-term high-dose use of this product. A long-term study of inhaled budesonide, with an average daily dose of 400 micrograms for children (calibrated metering, equivalent to a 320 microgram output dose), and an average daily dose of 800 micrograms for adults (calibrated metering, equivalent to a 640 microgram output dose) did not show significant bone Impact of density. So far, there is no information on the impact of the high-dose use of this product.
If growth is slowed, to reduce the possible risk of systemic effects, the therapeutic dose should be reassessed and the inhaled corticosteroids adjusted to the minimum effective maintenance dose.
If there is any reason to suspect that the use of systemic corticosteroids has caused adrenal impairment in the past, care should be taken when switching to this product.
The benefits of inhaled budesonide are usually reduced use of oral corticosteroids, but when switching from oral corticosteroids to inhaled hormones, the risk of impaired adrenal reserve function remains for a long time. Patients who have been treated with high-dose stress corticosteroids or chronic high-dose inhaled corticosteroids also have the same risk. Consider additional systemic corticosteroids during stress or elective surgery.
To reduce the risk of oropharyngeal candidiasis, patients should be instructed to rinse their mouth with water after each maintenance treatment. If an oropharyngeal candida infection has occurred, the patient should also rinse their mouth with water after remission.
Concomitant use of itraconazole or ritonavir or other strong CYP3A4 inhibitors should be avoided. If combined use cannot be avoided, the interval between the two drugs should be as long as possible. Use performance in patients. Patients with unstable asthma who use remission bronchodilators should be especially careful in acute severe asthma. Hypoxia and other conditions can increase the risk of adverse reactions caused by hypokalemia. In these cases, it is recommended that Monitor blood potassium levels.
As with all ₂ -receptor agonists, diabetes patients need increased control of blood glucose.
This product contains lactose (<1 mg / suction). This dose is usually not a problem for patients with breast milk intolerance. Excipient lactose contains a small amount of cow's milk protein, which can cause allergic reactions.
Impact on the ability to drive and operate machines:
This product has no or only negligible impact on the ability to drive and operate machines.

Budesonide formoterol powder inhalant for pregnant and lactating women

There is no clinical information on the use of formoterol and budesonide in pregnant women. Data from an embryo study in rats show that there is no evidence that compound preparations have additional effects.
There is insufficient information on the use of Fuingtro in pregnant women. Animal tests have shown that formoterol has adverse effects on reproduction at high systemic exposures.
Data from approximately 2,000 pregnant women indicate that inhalation of budesonide did not increase the risk of teratogenicity. Animal tests have shown that glucocorticoids can be teratogenic. At the recommended dose, this situation has little relevance to humans.
Animal tests have also shown that prenatal (but below teratogenic dose range) exposure to glucocorticoids increases growth retardation in the uterus, cardiovascular disease and glucocorticoid receptor density in adults, neurotransmitter renewal and behavior Risk of permanent change.
This product is only used during pregnancy when the benefits outweigh the potential dangers. Budesonide should be used at the lowest effective dose to properly control asthma.
Budesonide is secreted into milk, however, a therapeutic dose of budesonide has no effect on infants. It is unclear whether formoterol can enter human milk. In rats, small doses of formoterol can be detected in breast milk. This product should only be used in lactating women when the expected benefit to the mother is great for the possible danger to the child.

Budesonide formoterol powder inhaler for children

See [Usage and Dosage]

Budesonide formoterol powder inhaler for elderly

See [Usage and Dosage]

Budesonide formoterol powder inhaler drug interactions

Pharmacokinetic interactions Budesonide's metabolic transformation is influenced by other substrates metabolized by CYPP450 3A4 (eg, itraconazole, ritonavir). Concomitant use of these strong inhibitors of CYP P450 3A4 may increase plasma budesonide levels. Try to avoid concurrent use of these medications unless the benefits of the medication outweigh the risks to the body. If the patient is using a strong CYP3A4 inhibitor, maintenance and remission treatment with this product is not recommended.
Pharmacodynamic interactions Beta-blockers can reduce or inhibit the effects of formoterol. This product should not be used with beta-blockers (including eye drops) unless there is a good reason.
The simultaneous use of quinidine, propionamine, procainamide, phenothiazine, antihistamines (terfenadine), monoamine oxidase inhibitors and tricyclic antidepressants can prolong QTc interval, Increased risk of ventricular arrhythmias.
In addition, levodopa, levothyroxine, oxytocin, and alcohol can also impair the heart's tolerance to ₂ -sympathomimetic drugs.
It can also be used in combination with monoamine oxidase inhibitors, including substances with similar properties, such as furazolidone and procarbazine, which may suddenly cause hypertension.
The risk of arrhythmia is increased when patients receive anesthesia with halogenated hydrocarbons.
Concurrent use of other beta-adrenaline drugs has potential synergistic effects.
For patients who are taking digitalis, hypokalemia may increase their likelihood of developing arrhythmias.
No interaction was observed between budesonide and formoterol with any other asthma medication.

Budesonide formoterol powder inhaler overdose

Formoterol overdose is likely to cause the typical manifestations of beta ₂ -agonists: tremor, headache, palpitations, and tachycardia. Hypotension, metabolic acidosis, hypokalemia, and hyperglycemia can also occur. Supportive and symptomatic treatments can be given. Patients with acute bronchial obstruction have no safety issues with 90 microgram doses within 3 hours.
In the case of acute overdose of budesonide, there is no clinical problem, even if the overdose is excessive. Prolonged overdose may cause systemic effects of adrenal cortex hormones, such as hyperadrenal function and inhibition of adrenal function.
Due to the partial overdose of formoterol in the drug, the treatment of this product is discontinued, and corresponding inhaled corticosteroid treatment should be considered.

Clinical trial of budesonide formoterol powder inhaler

1. Adult clinical trials of clinical efficacy of asthma maintenance therapy show that the addition of formoterol to budesonide can improve asthma symptoms and lung function, and reduce exacerbations. In a 12-week study, the effect of this product on lung function was equivalent to that of budesonide and formoterol, but better than budesonide alone. All treatment groups used short-acting ₂ -adrenergic receptor agonists as needed. The anti-asthmatic effect does not diminish with prolonged use. Clinical efficacy of maintenance and remission treatment of this product 12,076 asthma patients participated in 5 double-blind clinical efficacy and safety trials for 6 or 12 months (4447 patients were randomly assigned to maintenance, In remission treatment), the selected patients were those who still had asthma symptoms after using glucocorticoids.
In all five trials, the maintenance and remission therapy of this product was statistically and clinically significant in reducing severe asthma attacks compared with the control group used. This includes trials comparing higher maintenance doses with terbutaline as a reliever (trial 735) and trials comparing the same maintenance dose with formoterol or terbutaline as a reliever (734 test) (Table 1). In 735 trials, pulmonary function, symptom relief, and relieving drug use were similar across treatment groups. In the 734 trial, symptoms and reliever use were reduced, and lung function was improved compared to the two controls. Based on the results of 5 trials, 57% of patients receiving maintenance and remission therapy did not use remission medicine. Over time, no tolerance occurred.
Table 1 Summary of severe exacerbations in clinical trials

a Hospitalization / emergency treatment or oral steroid treatment.
b Compared with the two control groups, the decrease in exacerbation rate is statistically significant (P value <0.01)
In the other two trials, for patients seeking medical treatment due to severe asthma symptoms, this product can quickly and effectively relieve bronchoconstriction, and its effect is similar to that of salbutamol and formoterol.
2. COPD
The speed of lung function and exacerbations (defined as the course of oral steroids and / or antibiotics and / or hospitalizations) was evaluated in two 12-month studies in patients with severe COPD. The median FEVl at the time of enrollment was 36% of the expected normal. After taking this product (as defined above), the average number of patients experiencing worsening disease each year was significantly reduced compared to taking formoterol or placebo alone (average rate was 1.4, compared with 1.8-1.9 in the placebo / formoterol group). In 12 months, the average number of oral corticosteroids per patient was slightly reduced in this product group (7-8 days / patient / year, compared with 11-12 days in the placebo and formoterol groups). And 9-12 days). For changes in lung function parameters, such as FEVl, the effect of this product is not stronger than that of formoterol alone.

Pharmacology and toxicology of budesonide formoterol powder inhaler

Pharmacodynamics This product contains formoterol and budesonide, and has a synergistic effect in reducing the exacerbation of asthma through different modes of action. The mechanisms of action of the two components are as follows:
Budesonide Budesonide is a glucocorticoid that can reduce the symptoms of asthma and prevent the condition from worsening. Inhaled budesonide has fewer serious adverse effects than systemic application. The detailed mechanism of budesonide's anti-inflammatory effect is unknown.
Formoterol Formoterol is a selective ₂ -adrenergic receptor agonist that relaxes bronchial smooth muscle and relieves bronchospasm. The bronchiectasis is dose-dependent and takes effect within 1 to 3 minutes. A single dose can be maintained for at least 12 hours.
Toxicology studies reset dosing toxicity:
A 3-month inhalation toxicity study of budesonide and formoterol microspheroidized dry powder and lactose (same composition as this product) in rats and dogs. The observed effects are glucocorticoid and 2 receptor Body agonist.
Rats inhaled daily a mixture of budesonide and formoterol at doses of 51 and 2.7 g / kg, respectively. A decrease in weight gain was observed, and the number of white blood cells, eosinophils, and lymphocytes decreased, and Lymphatic atrophy, the above effects are the effects of glucocorticoids. No significant effects related to formoterol have been seen in mixed drug studies.
Dogs were given a mixture of budesonide and formoterol daily at inhaled doses of 50 and 2.7 g / kg, respectively. Effects of glucocorticoids and 2 receptor agonists were observed: glucocorticoid effects including ACTH-regulated cortisol release Inhibition and atrophy of thymus; mild to moderate sinus tachycardia associated with formoterol treatment. Budesonide genotoxicity:
In 6 different test systems including: Ames Salmonella / microsome plate test, mouse micronucleus test, mouse lymphoma test, human lymphocyte chromosome aberration test, Drosophila melanogaster recessive lethal test and rat In DNA repair analysis of hepatocyte culture, budesonide has no mutagenic effect.
Reproductive toxicity:
Rats were given subcutaneously budesonide 80 g / kg (calculated as g / m ² , which is approximately equivalent to the maximum recommended daily human inhalation dose), but budesonide had no effect on fertility in rats. However, when subcutaneously administered doses of 20 g / kg and above (calculated as g / m ² , lower than the maximum recommended daily human inhalation dose), budesonide can cause maternal prenatal viability and fetal rats at birth and lactation. Decreased viability, accompanied by a decrease in body weight of the maternal rat. When the dose was 5 g / kg (calculated as g / m ² , lower than the maximum recommended daily human inhalation dose), the above effects were not seen.
Carcinogenicity:
Long-term studies of oral administration in mice and rats have been performed to evaluate the potential carcinogenicity of budesonide.
In a 2-year study of SD rats, the oral dose of budesonide was 50 g / kg (calculated as g / m ² , which is lower than the maximum recommended daily human inhalation dose). Budesonide can cause male rats. The incidence of gliomas increased significantly and was statistically significant. Male rats and female rats were given doses of 25 and 50 g / k9 (calculated as g / m ² , which is lower than the maximum recommended daily human inhalation dose), and no tumorigenicity was observed. In two additional 2-year studies using Flsher rats and SD rats, the oral dose of budesonide was 50 g / kg (calculated as g / m ² , which is lower than the maximum recommended daily human inhaled dose) Did not cause glioma. However, for male SD rats, the incidence of hepatocellular tumors increased significantly when oral administration of budesonide at a dose of 50 g / kg was statistically significant. In both studies, control corticosteroids (prednisolone and triamcinolone) administered concurrently also showed similar results. In a 91-week study of mice, oral doses of up to 200 g / k9 (calculated as g / m ² .approximately equivalent to the maximum recommended daily human inhaled dose) did not appear to be related to budesonide treatment. Painful.
Formoterol genotoxicity:
Formoterol did not show mutagenic effects in the Salmonella / microsome plate test, mouse lymphoma test, human lymphocyte chromosome aberration test, and rat micronucleus test.
Reproductive toxicity:
Male rats were given 15 mg / kg formoterol (based on g / m ² , approximately 7000 times the maximum recommended daily human inhalation dose), and fertility and / or fertility decreased. In another separate study of male rats administered orally at a dose of 15 mg / kg, testicular tubule atrophy, sperm fragmentation, and epididymal semen reduction occurred. The dose given to rats was 3 mg / kg (calculated as g / m ² , about 1400 times the maximum recommended daily human inhalation dose), and the above effects were not seen. When female rats were given a dose of 15 mg / kg, no effect on fertility was found.
Carcinogenicity:
Long-term studies of oral administration in mice and long-term studies of inhaled administration in rats were performed to evaluate the potential carcinogenicity of formoterol fumarate. In a 24-month carcinogenicity study of CD-1 mice, formoterol was orally administered at a dose of 0.1 mg / kg and above (calculated as g / m ² , which is about the maximum recommended daily human inhalation dose). 20 times), can lead to a dose-related increase in the incidence of uterine leiomyoma. In a 24-week pain study of SD rats, ovarian membrane smooth muscle was found at an inhalation dose of 130 ug / kg (calculated as g / m ² , which is approximately 60 times the recommended daily human inhaled dose). Incidence of tumors and uterine leiomyomas is increased. When the dose was 22 pg / kg (calculated as g / m ² , about 10 times the maximum recommended daily human inhalation dose), no tumor occurred. Other beta-agonists have also been shown to increase the incidence of female rodent genital leiomyomas similarly. The relevance of these results to human medication is unknown.

Pharmacokinetics of budesonide formoterol powder inhaler

Absorption < br This product and the corresponding single-dose products are bioequivalent to systemic administration of budesonide and formoterol, respectively. Nonetheless, cortisol inhibition was slightly increased in patients using budesonide formoterol powder inhalation compared to monotherapy. This difference is considered to have no effect on clinical safety.
There is no evidence of a pharmacokinetic interaction between budesonide and formoterol.
The pharmacokinetic parameters of inhaled budesonide and formoterol are comparable to the inhaled pharmacokinetic parameters of this product. For budesonide, the area under the plasma concentration-time curve increased slightly when the compound was administered, the absorption was faster, and the peak plasma concentration was higher. For formoterol, peak plasma concentrations were similar when the compound was administered.
Inhaled budesonide was quickly absorbed and peaked in plasma concentration within 30 minutes of inhalation. Studies have shown that the average deposition of budesonide in the lungs after inhalation of Dubronide is 32 to 44% of the output dose. Systemic bioavailability is approximately 49% of the output dose.
Formoterol is quickly absorbed by inhalation and peaks in plasma concentration within 10 minutes of inhalation. Studies have shown that the average deposition of formoterol in the lungs after inhalation of Dumoterol is 28 to 49% of the output dose. Systemic bioavailability is approximately 61% of the output dose.
Distribution and metabolism <br /> Formoterol and budesonide have plasma protein binding rates of approximately 50% and 90%, respectively, and distribution volumes are 4L / min and 3L / min, respectively. Formoterol is inactivated by a binding reaction (active oxygen site demethyl and formyl metabolites can be formed, but they are mainly found in inactive conjugates). About 90% of budesonide biotransformed into low-glucocorticoid-active metabolites during first-pass metabolism through the liver. The main metabolites, 6--hydroxy-budesonide and 16--hydroxy-prednisolone, have less than 1% of the glucocorticoid activity of budesonide. There is no metabolic interaction or any displacement reaction between formoterol and budesonide.
Clearance < br Most doses of formoterol are converted by liver metabolism and cleared by the kidneys. After inhaling formoterol, 8 to 13% of the administered dose is excreted from the urine as it is. Formoterol has a high systemic clearance (approximately 1.4 L / mim), and its terminal clearance half-life averages 17 hours.
Budesonide is mainly eliminated after catabolism by CYP3A4 enzyme. Budesonide's metabolites are cleared into the urine in free or bound form. In urine, the detected budesonide prototype was almost negligible. Budesonide has a high systemic clearance (about 1.2 L / min) and a plasma clearance half-life of about 4 hours after intravenous administration.
No data are available on the pharmacokinetics of budesonide or formoterol in children and patients with renal failure. In patients with liver disease, exposure to budesonide and formoterol may increase.

Budesonide Formoterol Powder Inhalant Storage

The storage temperature should be below 30 ° C. Keep tightly closed.

Budesonide formoterol powder inhaler pack

Multi-dose powder inhaler, 1 stick / box.

Expiration date of budesonide formoterol powder inhaler

24 months

Budesonide formoterol powder inhalation standard

Import drug registration standard: JX20040065 ^[1]