Breztri inhalers 160/7.2/5MCG Astrazeneca reduces acute bronchospasm (120 doses)

Dosage form Box
Specifications Budesonide, glycopyrronium, formoterol fumarat dihydrate
Ingredient Astrazeneca Dunkerque Production

Ingredient

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Composition information	Content
Budesonide	160mcg
Glycopyrronium	7.2MCG
Formoterol fumarat dihydrate	5mcg

Uses

Indications

Broztri Aerosphere is indicated for treatment for chronic obstructive pulmonary disease (COPD).

Restrictions used: Broztri aerosphere is not indicated to reduce acute bronchospasm or bronchial asthma treatment.

Pharmacology

Pharmacological group: Medicines used in respiratory obstruction, which is a drug that includes 3 active ingredients: sympathetic active ingredients combined with active ingredients for vice -sympathetic and corticosteroids.

ATC code: R03al11.

Mechanism of action

Broztri Aerosphere contains Budesonid, Glycopyrrolate and Formoterol Fumarat. The mechanism of action is described below for each component applied to Broztri Aerosphere. These active ingredients represent three different groups of drugs (a synthetic corticosteroid, a cholinergic anti -cholinergic drug and a beta -operated, long -acting selection) that have different effects on clinical physiology and inflammatory indicators in COPD.

budesonid

Budesonid is a strong anti -inflammatory corticosteroids and weak mineralocorticoid activity. In standardized in vitro studies and on the experimental animal model, Budesonid has about 200 times higher than the glucocorticoid receptor and has a 1,000 times higher -sized anti -inflammatory effect than cortisol (crotone -causing mouse edema tests). Budesonid's body anti -inflammatory activity is 40 times stronger than cortisol when subcutaneously injection and 25 times stronger when taking orally in miniature mouse thymus.

In studies on affinity with glucocorticoid receptor, Budesonid's Epimer 22R isomers are twice as activated than Epimer 22S. In vitro studies show that these two forms of budesonid are not converted.

Inflammation is an important component in the pathogenesis of COPD. Corticosteroids have wide anti -inflammatory activity inhibiting many types of sacrifices (for example, mast cells, eosinophilia, neutral leukocytes, macrophages and lymphocytes) and chemical intermediaries (for example, histamine, eicosanoid, leukotriene and cytokine) involved in inflammatory reactions related to allergic and non -allergic inflammation. Corticosteroid anti -inflammatory activity can contribute to the effectiveness of the drug.

glycopyrrolat

glycopyrrolate is a long -active active ingredient, often referred to as anti -cholinergic drugs. Glycopyrrolat has similar affinity to the subgroups of Muscarinic receptors from M1 to M5. On the airway, the pharmacological effect of this drug is manifested by the inhibition of M3 receptor in plain muscle, leading to bronchiectasis. Competitive and reversible essence of antagonistic effects are manifested on receptors originating from humans and animals or on organs separately separated. In preclinical studies in vito and in vivo, the effect of preventing bronchospasm caused by methylcholin and acetylcholin depends on the dose and lasts more than 12 hours. The clinical significance of these findings is not well known. The bronchodilator effect after inhaling glycopyrrolate is mainly specific effect on the spot.

formoterol fumarat

Formoterol Fumarat is a Beta2-adrenergic owner selected long-term effect and has a fast onset. Formoterol Fumarat Hit form is acting at the lung -shaped place similar to a bronchodilator. In vitro studies show that the formoterol has a sperm in the beta2 receptor more than 200 times higher than in the beta1 receptor. The selective essence with the beta2 receptor is higher than the beta1 of the formoterol than albuterol (5 times), while the salmeterol has a higher selective beta2 selection ratio (3 times) than the formoterol in in vitro.

Despite the beta receptor, the adrenergic receptors are mainly in the bronchial muscle and the beta2 receptor is mainly in the heart, but also has a beta1 receptor in the heart of the human, accounting for 10% to 50% of the total number of beta-adrenergic receptors. The exact function of these receptors is still not known, but it is likely that beta -owners, highly selective, can also work on the heart.

Pharmacological effects of Beta2 transport owners, including Formoterol Fumarat, participate in partial stimulation of intracellular adenyl cyclase, adenosin triphosphate conversion catalyst (ATP) into cyclic-3 ', 5'-adenosin monophosphate (AMP ring). The increase in AMP of AMP causes bronchodial muscle relaxation and inhibit the release of chemical intermediate substances, especially from mast cells, causing acute hypersensitivity reactions.

Heart physiological

TQT research is not done with Broztri Aerosphere because Budesonid does not affect the QT range. However, the ability to extend the QTC range of Glycopyrrolat/Formoterol Fumarat has been evaluated in a cross -clinical, double -dose, single -dose, and positive test on 69 healthy people. The maximum average difference of the original QTC value is initially (reliable limit of over 90%) after 2 inhale glycopyrrolat/formoterol fumarat 9/4.8 mcg and glycopyrrolat/formoterol fumarat 72/19.2 mcg compared to placebo, corresponding to 3.1 (4.7) MS and 7.6 (9,2) MS and not in the relevant relevant relevant threshold of 10 10 -sided relevant relevant relevant thresholds ms. The increase in the dose dependent heart rate has also been recorded. The maximum average difference in the corrected heart rate with the original (reliable limit is over 90%) compared to the placebo is 3.3 (4.9) beat/minute and 7.6 (9.5) beat/minute recorded within 10 minutes after 2 inhales corresponding to Glycopyrrolate/Formoterol Fumarat 9/4.8 mcg and Glycopyrrolat/Formoterol Fumarat 72/19.2 MCG.

Chronic obstructive pulmonary disease

The effect of Broztri Aerosphere on the heart rate in COPD patients is evaluated by Holter 24 hours at 16 weeks in a 52 -week test (test 1).

Patients with heart rate monitored by Holter in test 1 include 180 patients using Broztri Aerosphere 320 mcg/18 mcg/9.6 mcg, 160 patients using glycopyrrolat and formoterol fumarat [GFF MDI 18 mcG/9.6 mcg) and 183 patients using Budesonid/Formoterol Fumarat (BFF MDI 32020 BFF MDI 320 mcg/9.6 mcg].

Not recorded clinical effects on the heartbeat.

Effects on the HPA axis

The effect of Broztri Aerosphere on the HPA axis is evaluated by measuring cortisol levels in serum 24 hours at the beginning and at 24 weeks in COPD patients. The average ratio (week 24/original) of Broztri Aerosphere 320 mcg/18mcg/9.6mcg and GFF MDI 18 mcg/9.6 mcg respectively are 0.86 (variable coefficient (CV) = 39%) and 0.94 (CV = 36.6%).

Dynamic pharmacokinetics

Linear pharmacokinetic equations have been proven for Budesonid (80 to 320 mcg), glycopyrrolate (18 to 144 mcg) and Formoterol Fumarat (2.4 to 38.4 mcg). Information about pharmacokinetics of glycopyrrolate and formoterol fumarat is determined based on the corresponding activated components, Glycopyrronium and Formoterol. The pharmacokinetics of Budesonid, Glycopyrronium and Formoterol in Broztri Aerosphere are equivalent to the pharmacokinetics of Budesonid, Glycopyrronium and Formoterol when used in the form of budesonid/formoterol or glycopyrrolate/formoterol in studies on healthy people (single -dose) and macadamia.
Dynamic pharmacokinetics each component in Broztri Aerosphere is presented below.
absorption
Budesonid: After the patient inhales Broztri Aerosphere, CMAX is within 20 to 40 minutes. The stable state is estimated to be achieved after about 1 day of the repeated dose of Broztri Aerosphere is determined through the analysis of the pharmacokinetics of the population and the AUC0-12 is about 1.3 times higher than the first dose.
glycopyrrolate: After the patient of COPD inhales Broztri Aerosphere, CMAX is achieved within 2 to 6 minutes. The stable state is estimated to be achieved after about 3 days of repeated dose of Broztri Aerosphere through the pharmacokinetic analysis of population and AUC pharmacokinetics about 1.8 times higher than after the first dose.
Formoterol Fumarat: After the COPD patient inhales Broztri Aerosphere, CMAX is achieved within 20 to 60 minutes.
The stable state is estimated after about 2 days of repeated dose of Broztri Aerosphere through the analysis of the pharmacokinetics of the population and the AUC0-12 is about 1.4 times higher than the first dose.
Distribution
Budesonid: The apps of budesonid's estimates in a stable state in COPD patient is about 1200 l, through population pharmacokinetic analysis. In a concentration of 1-100 nmol/l, the ratio of binding to plasma proteins of Budesonid averages ranging from 86% to 87%.
glycopyrrolate: The apparent distribution of glycopyrronium estimates in a stable state in COPD patient is about 5500 l, through population dynamic analysis. In a concentration of 2-500 nmol/l, the ratio of binding to plasma proteins of glycopyrronium ranges from 43% to 54%.
Formoterol Fumarat: The estimated distribution of Formoterol's estimates in a stable state in COPD patient is about 2400 l, through the analysis of population dynamic analysis. In the concentration of 10 - 500 nmol/l, the ratio of the plasma protein of Formoterol ranges from 46% to 58%.
Elimination
Budesonid: Budesonid is excreted in urine and stool in the form of metabolites. Only a negligible amount of Budesonid has not metabolized in urine. The effective sale time of Budesonid in people with COPD is about 5 hours, extracted from the pharmacokinetic analysis of the population. glycopyrrolate: After an intravenous injection of 0.2 mg of glycopyrronium marking radioactive marking, 85% of the drug is present in the urine after 48 hours and a bit of radioactive redness is also found in the bile. The effective sale time of glycopyrronium in patients with COPD is about 15 hours, according to the pharmacokinetic analysis of the population.
Formoterol Fumarat: The excretion of Formoterol has been studied on 6 healthy people after using the formoterol simultaneously marking oral radioactive and intravenous sugar. In this study, 62% of the formoterol's drug dose associated with radioactive activity was excreted in the urine while 24% were eliminated in feces. The effective sale time of fommoterol in patients with COPD is about 10 hours, according to the pharmacokinetics analysis of the population.
Metabolism
Budesonid: In vitro studies with human liver tissue suspension fluid show that Budesonid is metabolized and quickly through the liver. The two main metabolites of Budesonid are formed through biochemical metabolism by catalyst of CYP3A4, which have been isolated and identified as 16α-hydroxyprednisolon and 6ß-hydroxybudesonid. The corticosteroid activity of each of these metabolites is less than 1% of the original active ingredient. There has been no difference in quality differences between in vitro and in vivo metabolism. The inactivity has been recorded negligible on human lungs and serum preparations.
glycopyrrolate: Based on existing literature and from Vitro in human liver cell research shows that metabolism plays a small role in the process of glycopyrronium in general. CYP2D6 is an enzyme mainly involved in the metabolism of glycopyrronium.
Formoterol Fumarat: The main metabolic path of Formoterol is direct glucuronide and through methy reduction reaction at O- position, then combined into non-active metabolites. Secondary metabolic roads include reducing the formyl and sulfate combinations. CYP2D6 and CYP2C have been identified as the main enzyme catalyst for the reduction process at position O-.

Before taking Breztri inhalers 160/7.2/5MCG Astrazeneca reduces acute bronchospasm (120 doses)

How to use

Preparation

Start the Broztri Aerosphere spray bottle before use for the first time. Starting a spray bottle is necessary to ensure the appropriate amount of drugs at each dose. Start the Broztri Aerosphere spray by spraying 4 times into the air area away from the face, shaking well before each spray.

If the spray is not used for more than 7 days, the spray is dropped or after washing weekly, restart the spray by spraying 2 times into the air away from the face, shaking well before each spray.

Drug dose count

Breztri Aerosphere container contains a dose determined part, indicating the remaining amount of spray after each use. The dose alarm screen has a dose indicator line that will move after each spray. When the indicator of the dose is located in the golden zone, almost the number of drugs can be used. Do not use Broztri Aerosphere when the dose indicator line is located at the zero position in the red area.

Dosage

Broztri aerosphere dose is recommended that Budesonid 320 mcg, Glycopyrrolat 18 mcg and Formoterol Fumarat 9.6 mcg (corresponding to 2 inhales Broztri Aerosphere [Budesonid/Glycopyrrolat/Formoterol Fumarat 160 mcG/9 MCG]) twice a day, in the morning and night in the mouth. Do not use more than two breaths twice a day.

Garges with water after inhaling but not swallowing.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose? Broztri Aerosphere contains Budesonid, Glycopyrrolate and Formoterol Fumarat; Therefore, the overdose -related risks for each individual component described below applies to Broztri Aerosphere. Overdose management measures include stopping Broztri Aerosphere in combination with symptomatic treatment and/or appropriate support treatment. It is possible to consider using selected beta receptor blockers on the heart but it should be noted that this drug may cause bronchospasm. Cardiovascular effects should be monitored in case of overdose.

budesonid

If used for long -lasting doses, the body effects of corticosteroids may occur, such as adrenal energy.

glycopyrrolat

high doses of Glycopyrrolat, a component of Broztri Aerosphere, can lead to signs and symptoms of cholinergic resistance such as nausea, vomiting, dizziness, dizziness, blurred vision, glaucoma (pain, vision disorders or red eye), severe constipation or urinary retention.

formoterol fumarat

Overdose of Formoterol Fumarat can lead to excessive reactions for Beta2's ownership: convulsions, angina, hypertension, hypotension, tachycardia, tachycardia and ventricular, stress, headache, tremor, chest, nausea, dizziness, sleep disorders, hypogonadic hyperka, hypotension, hypotension. Similar to all sympathetic, cardiac and even death drugs may be related to the overdose of Formoterol Fumarat.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Safety data is related to the effects of corticosteroid group, cholinergic resistance and β2-adrenergic stimulation related to individual components in coordination. The most commonly reported adverse effects in patients using this drug are pneumonia (4.6%), headache (2.7%) and urinary tract infections (2.7%).

List of adultery effects

List of adultery effects in the base table on products about products from clinical trials and from studies on individual ingredients.

The frequency of the effects is determined according to the following convention: Very common (≥1/10); Common (≥1/100 to

System of adverse effects adultery effect frequency

pneumonia

Commonly Body, Example: Essay impairment is very rare

Insomnia

Common

excitement

restlessness

worry

less common

trembling

Uncommon

cataracts

glaucom

Unknown

the cardiovascular disorders Broken breast drum

tachycardia

Rhymes (atrial fibrillation, ventricular tachycardia and extra systolic)

Uncommon

Common

Bronchospasm

Uncommon Meet Musculoskeletal and connective tissue disorders Common Meet common disorders and at the position of drug use chest pain less common

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Broztri Aerosphere drugs are contraindicated in the following cases:

Contraindicated to use Broztri Aerosphere in patients with hypersensitivity to Budesonid, Glycopyrrolat, Formoterol or any excipients.

Caution when using

serious events related to bronchial asthma - hospitalization, intubation, death

The safety and effectiveness of Broztri Aerosphere in patients with bronchial asthma has not been determined. Broztri Aerosphere is not indicated to treat bronchial asthma.

Use the Beta-adrenergic-acting lone for prolonged (LABA) (not in combination with inhaled corticosteroids (ICS)] in patients with bronchial asthma related to increased risk of asthma death. Existing data from controlled clinical tests also shows that the use of solitary laba increases the risk of hospitalization due to teenagers and teenagers. Use alone.

Existing data has not shown the increased risk of death when using laba in COPD patients.

The severe progression of the disease and the acute phases

Do not start treatment with Broztri Aerosphere in patients with severe coopd COPD that can lead to life -threatening. No research on Broztri Aerosphere in a group of patients with severe coasts. Therefore, the use of Broztri Aerosphere in this case is inappropriate.

Broztri Aerosphere should not be used to reduce acute symptoms, the treatment for treatment of acute bronchial spasms. There is no study on reducing the symptoms of refining when using Broztri Aerosphere and should not be used for the above indications. Acute symptoms should be treated with Beta Translation Drugs, short inhalation effects.

When starting with Broztri Aerosphere treatment, patients who are using beta -shipping drugs, short -term inhalation effects (for example, four times/day) should be instructed to stop using these drugs regularly and only use them to reduce acute respiratory symptoms. When prescribing Broztri Aerosphere, medical staff should also prescribe beta transport owner, short -effective inhalation and guide patients on how to use. Increasing the frequency of use of Beta's ownership, inhalation forms that the disease may be more serious and need medical care in time.

COPD can be acutely progressive for a few hours or converted into chronic for a few days or longer. If the use of Broztri Aerosphere no longer controls the symptoms or the Beta transport owner, the short -effective inhalation effect becomes less effective or the patient needs to inhale more beta -owners, the effect shorter than usual, then these may be signs that the disease worsens. In this case, it is necessary to re -evaluate the condition of the patient simultaneously with the COPD treatment regimen. Breztri Aerosphere's daily dose should not be increased.

Avoid overdose of Broztri Aerosphere and avoid combining with other prolonged beta2 -used owners

Similar to other Beta-adrenergic inhalers, Breztri Aerosphere should not be used more frequently than the recommended frequency, not recommended higher doses, or in combination with other laba drugs, due to overdose. There has been a report on unwanted effects on the clinical and death of the heart related to the use of too many inhaled sympathetic drugs. Patients who are using Broztri Aerosphere should not use another drug containing laba (for example: Salmeterol, Formoterol Fumarat, Arformoterol Tartrat, Indacaterol) for any reason.

Candida fungus pharynx

Broztri Aerosphere contains budesonid, an ICS. Candida albicans infection at the oral cavity and pharyngeals occurred in patients treated with oral inhaler containing budesonid. When infected, patients should be treated with antifungal drugs on the spot or systemic (namely oral) while continuing to use Broztri Aerosphere.

In some cases, it is necessary to suspend the use of Broztri Aerosphere. Advice patients with water rinse with water but do not swallow after using Broztri Aerosphere to help reduce the risk of Candida Pharyngopathy.

pneumonia

There have been reports on lower respiratory infections, including pneumonia, after using inhaled corticosteroids. Doctors should be wary of the development of pneumonia may occur in patients with COPD due to clinical characteristics of pneumonia and plays that are often duplicated.

In a 52 -week test on patients with COPD (N = 8529), the new incidence of pneumonia was confirmed to be 4.2% in the Breztri Aerosphere 320 mcg/18 mcg/9.6 mcg group (N = 2144), 3.5% for Budesonid, Glycopyrrolat and Formoterol Fumarat [BGF MDF MDI MCG] (n = 2124), 2.3% for GFF MDI 18 mcg/9.6 mcg (n = 2125) and 4.5% for BFF MDI 320 mcg/9.6 mcg (n = 2136).

Cases of pneumonia occurring in 2 patients using BGF MDI 160 mcg/18 mcg/9.6 mcg, 3 patients using MDI 18 mcg/9.6 mcg and no cases for patients using Broztri Aerosphere 320 mcg/18 mcg/9.6 mcg.

In a 24 -week test in patients with COPD (N = 1896), the new incidence of pneumonia is confirmed to be 1.9% for Broztri Aerosphere 320 mcg/18 mcg/9.6 mcg (n = 639), 1.6% for glycopyrrolat and formoterol fumarat [GFF MDI 18 mcG/9.6 mcG] (N = 625) and 1.9% N = 625) and 1.9% N = 625). For Budesonid and Formoterol Fumarat (BFF MDI 320 mcg/9.6 mcg] (n = 320). There is no death case due to pneumonia in the study.

immunosuppressive and risk of infection

Patients who are using immunosuppressive drugs may be more susceptible to infections than healthy people. For example, chickenpox and measles may be more serious or even fatal in children or sensitive adults when using corticosteroids. In children or adults who have never suffered from these diseases or have not been fully vaccinated, special attention should be paid to avoid exposure. The effects of dosage, sugar and drug have not been determined on the risk of onset of a wave of spreading infection. Background pathology and/or the previous corticosteroid use that affects the risk has not been clarified. If the patient is exposed to chickenpox, the prophylactic treatment may be indicated with Immunoglobulin Varicella Zoster (Vzig). If measles exposure, the prophylaxis of Immunoglobulin (IG) can be indicated (IG) intramuscularly (see the corresponding user manual to know the prescribed information of Vzig and IG). If chicken pox appears, can consider treatment with anti -virus drugs.

ICS should be used cautiously in patients with tuberculosis progressive or hidden; Fungal infections, bacteria, viruses or systemic parasites are not treated; or infection of herpes simplex in the eye.

medication transformation for patients who are taking corticosteroids for systemic effects

Inhibition of the HPA axis/adrenal failure

Pay special attention to patients who shift from corticosteroids to the body to ICS due to deaths from adrenal insufficiency that occur in patients during and after the transition from the systemic corticosteroid to ICS has less body effect. After stopping using the whole body corticosteroid, it takes a few months to restore the function of the hypothalamus-the nephropathy (HPA).

Previous patients who are treated for maintained Prednison of 20 mg or more daily (or equivalent content) have the highest risk, especially when the patient has stopped corticosteroids, almost completely. During the inhibited HPA axis, patients may appear signs and symptoms of adrenal insufficiency during trauma, surgery or infection (especially gastritis) or other conditions related to serious power outages.

Although Broztri Aerosphere can help control COPD symptoms, the recommended doses of the drug produces systemic glucocorticoid levels less than the bonus physiological amount and does not provide the amount of mineralocorticoids that have the necessary activity to cope with the above -mentioned cases.

In the case of stress or severe COPD play, the patient should be stopped using corticosteroids for the whole body to use oral corticosteroids (at large dose) immediately and contact the doctor for further instructions.

These patients should also be instructed to carry a warning card that they need to supplement the systemic corticosteroids during stress or severe COPD plays.

Patients need oral corticosteroids should gradually reduce the use of systemic corticosteroids, after switching to Broztri Aerosphere. Gradually reduce Prednison by reducing the daily dose of Prednison to 2.5 mg in a week while still being treated with Broztri Aerosphere. Lung function (exertion volume in the first second [FEV] or the peak of the morning exhaled (PEF)), the use of beta -hand -owners and COPD symptoms should be monitored by the kidneys during the stop use of oral corticosteroids. In addition, patients need to monitor the signs and symptoms of adrenal insufficiency, such as fatigue, drowsiness, weakness, nausea and vomiting, hypotension.

Refless the previous allergic condition has been controlled by systemic corticosteroids

Patients who move from systemic corticosteroids to Broztri Aerosphere may relapse previously controlled by systemic corticosteroids (for example, rhinitis, conjunctivitis, eczema, arthritis, eosinophilia).

Corticosteroid syndrome

Some patients may have symptoms of body corticosteroids during the period of stopping oral corticosteroid (such as muscle pain and/or joints, fatigue, depression), although the patient's respiratory function has been maintained or even improved.

Cye syndrome and adrenal inhibition

The inhaled budesonid is absorbed at the overall circulation and can cause a whole body effect. The effect of budesonid on the HPA axis has not been observed when used in budesonid's treatment in Broztri Aerosphere. However, exceeding the recommended or coordinated dose with strong Cytochrom P450 3A4 (CYP3A4) inhibitors can lead to HPA axial dysfunction.

Because ICS is significantly absorbed in the general circulation, patients treated with Broztri Aerosphere should be closely monitored any evidence of the systemic effect of Corticosteroid. It is necessary to be particularly careful to monitor signs that the adrenal glands do not fully respond in patients after surgery or during stress.

The systemic effects of corticosteroids, such as adrenal enhancement and adrenal inhibitors (including sudden adrenal impairment) may appear in a small number of patients sensitive to these effects. If the above effects occur, appropriate treatment should be taken in case of necessity.

Interactive drug with Cytochrom P450 3A4 inhibitors

Be cautious when combining Broztri Aerosphere for a long time with Ketoconazole and other strong CYP3A4 inhibitors (such as Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazol, Nefazodon, Nelfinavir, SaquaVir, Telithromycin) due to the relevant adequate effect Increase budesonid levels.

Inverse bronchial spasms

As well as other singing therapies, Broztri Aerosphere can cause naughty bronchospasm, which can be life -threatening. If this condition occurs after using Broztri Aerosphere, the patient needs to be treated immediately with bronchodilators with short, hit -form; Stop off the Broztri Aerosphere and use other drugs instead.

Hypersensitivity reaction includes anaphylactic shock

There have been a sophisticated hypersensitive reaction report after using budesonid, glycopyrrolate or formoterol fumarat - the components of Broztri Aerosphere. If the signs of allergic reactions occur, in particular, the angioedema (including shortness of breath or difficulty swallowing, swelling of the tongue, lips and face), urticaria or rash, should immediately stop Broztri Aerosphere and consider replacement drugs.

Heart effects

Like other Beta2 agonists, Formoterol Fumarat can cause clinical effects on the clinical heart in some patients including increased heart rate, systolic blood pressure or diastolic, disruptive, such as ventricular tachycardia and extras.

If these adverse effects appear, Broztri Aerosphere can be stopped. In addition, beta -shipping owners have also been reported to cause changes on the electrocardiogram, such as creating flat waves, extending the QTC and the difference of ST segment, although they do not know the clinical meaning of these findings. Therefore, it is necessary to be cautious when using Broztri Aerosphere for patients with cardiovascular disorders, especially coronary heart failure, arrhythmia and hypertension.

Reduce bone density

Reducing bone density (BMD) has been recorded when long -term use of drugs containing ICS. The clinical significance of small changes in BMD is related to long -term consequences such as unknown fractures. Patients with main risk factors reduce the amount of minerals in bones, such as long -term immobility, family history of osteoporosis, postmenopausal women, smoking, high age, poor diet or long -term use of drugs that can reduce bone mass (for example, anti -convulsions, oral corticosteroids) should be monitored and treated appropriately. Because COPD patients often have many risk factors that reduce BMD, BMD evaluates before starting to use Broztri Aerosphere and periodically later. If BMD is significantly reduced and Broztri Aerosphere is still an important drug to treat the patient's COPD, it is necessary to consider the use of treatment or osteoporosis.

In a 24 -week test and a 28 -week safety monitoring time, the influence of Broztri Aerosphere 320/18/19.6 mcg and GFF MDI 18/9.6 mcg on the BMD index has been rated in a small group of COPD patients. The BMD evaluation is made at the beginning and after 52 weeks using the method of measuring the absorption of dual X -rays (DEXA). The percentage of the average change of BMD compared to the original is - 0.1% for Broztri Aerosphere 320/18/9.6 mcg and 0.4% for GFF MDI 18/9.6 mc.

glaucoma and cataract, glaucoma of severe angular pressure

There have been reports on glaucoma, increased pressure inside the eyes and cataracts on COPD patients after long -term use of ICS or when using inhaled anti -cholinergic drugs. Be careful when using Broztri Aerosphere in patients with closed angle glaucom disease. Doctors prescribed and patients should be alert about the signs and symptoms of acute angle glaucom disease (for example, pain or discomfort in the eyes, blurred vision, bright halo or multicolored images related to red -eye due to conjunctiva and corneal coverage). Instruct patients to discuss with the doctor immediately if there are any signs or symptoms as above. If the patient has symptoms in the eye or using Broztri Aerosphere for a long time, should consider advice from an ophthalmologist.

A 52 -week test for Broztri Aerosphere 320/18/9.6 mcg, GFF MDI 18/9.6 mcg and BFF MDI 320/9.6 mc in COPD patients show that cataract ratio ranges from 0.7% to 1.0% in groups.

Heavy progression

Similar to all anti -cholinergic drugs, be cautious when using Broztri Aerosphere in patients with urinary retention. Doctors and patients should be wary of the signs and symptoms of the great prostate or obstruction of the bladder neck (for example: difficulty urinating, painful urination), especially in patients who have prostate hypertrophy or bladder obstruction. Instruct patients to consult a doctor as soon as there are any signs or symptoms.

Incontinent diseases

Similar to all sympathetic amino -containing drugs, need to be cautious when using Broztri Aerosphere in patients with convulsions or toxicity and people with abnormal reactions to sympathetic amines. When the intravenous injection Albuterol, a beta receptor receptor, in the group, made diabetes worse and increased the complications of ceton infection.

hypokalemia and hyperglycemia

Beta-adrenergic transport owner can cause significant hypoglycemia in some patients, maybe through intracellular shunts, causing adverse effects on the heart. Hypotension is usually transient, without additional. Beta transport owners, can increase transient blood sugar in some patients.

Special patient object

Children

Broztri Aerosphere is not indicated for children. The safety and effectiveness of Broztri Aerosphere in Children's patients has not been proven.

Elderly

Based on existing data, no need to adjust the dose of Broztri Aerosphere in elderly patients, but cannot exclude some elderly patients sensitive to drugs.

In tests 1 and 2, 1100 subjects and 343 subjects, respectively, are 65 years of age and older using Broztri Aerosphere 320 mcg/18 mcg/9.6 mcg twice daily. In both experiments, there is no overall difference in safety or efficiency between this object and the younger object.

Patients with liver failure

There is no official research on pharmacokinetics Broztri Aerosphere in patients with hepatic impairment. However, as Budesonid and Formoterol Fumarat are mainly eliminated through the metabolism in the liver, the impaired liver function can lead to the accumulation of Budesonid and Formoterol Fumarat in plasma. Therefore, patients with severe liver disease should be closely monitored.

Patients with renal failure

There is no official research on the pharmacokinetics Broztri Aerosphere in patients with renal failure. However, in disease

Severe kidney failure (Creatinin clearance ≤ 30 ml/min/1.73m2) or end -stage kidney disease requires dialysis, should only use Broztri Aerosphere if the benefits are out of risk.

Use drugs for women during pregnancy and lactation

Pregnant women

There are no complete and well -controlled studies on pregnant women using Broztri Aerosphere or with two of the individual ingredients of the drug, Glycopyrrolat or Formoterol Fumarat, to provide information on drug -related risks; However, there is currently a study of other components is Budesonid.

In studies on animal fertility, Budesonid used alone in the subcutaneous line, which can cause abnormalities in the structure of the fetus, cause embryo death and lose weight in mice and rabbits at the corresponding dose level equal to 0.3 and 0.75 times the maximum daily inhalation is recommended in humans (MRHDID), however, do not record these effects in the mouse with 4 times hit mice fold up to the MRHDID mouse. Studies on pregnant women using budesonid inhaled form in pregnancy have not shown an increase in the risk of abnormalities. Experience with oral corticosteroids shows that rodents are more likely to be teratiable when exposed to corticosteroids than humans.

Formoterol Fumarat is lonely by oral in mice and rabbits that cause abnormalities in the fetal structure at the corresponding dose levels of 1500 and 61,000 times MRHDID. Formoterol Fumarat also works to cause an embryo death, increasing the rate of losing baby at birth and during breastfeeding, and reducing the weight of the mouse with a dose of 110 times the MRHDID. Adultery effects often occur in many times the dose of mrhdid when using Formoterol Fumarat by oral to achieve high body concentration. There is no abnormalities in fetal structure, embryo death or developing in mice receiving hit dose up to 350 times MRHDID.

glycopyrrolate is alone in the subcutaneous path in mice and rabbits, does not cause abnormalities and fetal structure or affects the life of the fetus at the corresponding dose of about 2700 and 5400 times MRHDID. Glycopyrolat does not affect the physical development, function and behavior of the mouse at a dose of 2700 times the mRHDID.

It is not estimated that the initial risk of severe birth defects and miscarriage for pregnant women are appointed to use the drug. In the United States, it is estimated that the initial risk of severe birth defects and miscarriage during pregnancy has been clinically recognized as 2 - 4% and 15-20% respectively.

Clinical consideration

labor or childbirth: There has been no good -controlled research on humans to assess the impact of Broztri Aerosphere on premature labor or labor trigger. Due to the ability to inhibit uterine contractions of beta -owners, only use Broztri Aerosphere while labor in patients when the benefits are more obvious than the risk.

Breastfeeding period

There is no data on the effects of Broztri Aerosphere, Budesonid, Glycopyrrolate, or Formoterol Fumarat to breastfeed or milk secretion. Similar to other ICS, Budesonid is excreted through breast milk. There is currently no data on the presence of glycopyrrolat or formoterol fumarat in breast milk. Formoterol Fumarat and Glycopyrrolate are discovered in the plasma of the mother's breast -feeding mouse. Benefits of development and health of breastfeeding should be considered with the mother's treatment needs with Broztri Aerosphere and unwanted effects for breastfed babies related to Broztri Aerosphere or related to the mother's background disease.

In the study of toxicity on mouse fertility and development, glycopyrrolate concentration in plasma is measured in the mouse on the 4th day after birth. The maximum concentration in the child is 6% compared to the dosage in the mother mouse is 10 mg/kg/day (the concentration of the drug in the rat plasma is 96 ng/ml at 1 hour after taking the drug corresponding to the concentration of the drug in the mother's plasma is 1610 ng/ml at 0.5 hours after the same medicine).

The effect of the drug on the ability to drive and operate machinery

Broztri Aerosphere has no or negligible effect on the ability to drive and operate machinery. However, dizziness is an universal side effect that needs to be noted when driving or operating machinery.

Drug interaction

There is no official research on drug interactions performed on Broztri Aerosphere.

Cytochrom P450 3A4 inhibitors

The main metabolic path of corticosteroids, including Budesonid - a component of Broztri Aerosphere, is through Cytochrom P450 Isoenzyme 3A4 (CYP3A4). After using oral ketoconazole, a strong CYP3A4 inhibitor, the average budesonid concentration in plasma after oral use increases. Simultaneously used with CYP3A4 inhibitors can inhibit metabolism and increase budesonid levels in the body. Caution should be careful when using simultaneously Broztri Aerosphere with Ketoconazole and other powerful CYP3A4 inhibitors (for example: Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazol, Nefazodon, Nelfinavir, Saquinavir, Telithromycin).

Adrenergic stimulants

Be cautious when adding adrenergic stimulants in any lines due to the sympathetic effect of Formoterol, a component of Broztri Aerosphere, which may increase.

Xanthin, steroids or diuretics

Concentrated with Xanthin, Steroid or Diuretics derivatives can increase the hypotension effects of Beta2-ADRENERGIC agonetic owners such as Formoterol, a component of Broztri Aerosphere.

Diuretics do not keep potassium

The effect of hypokalemia and/or changing the electrocardiogram due to the use of diuretics without potassium (such as diuretics or thiazid diuretics) can become serious when used simultaneously Beta's ownership, especially when using the beta2 owner exceeding the recommended dose.

Monoamine oxidase inhibitors, three -round antidepressants, long -lasting drugs

Similar to other Beta2 transport drug users, should be especially cautious when using Broztri Aerosphere for patients being treated with monoamine oxidase inhibitors or three -round antidepressants or QTC -prolonged drugs due to the effect of adrenergic agent on the cardiovascular system may be increased by these drugs. The drug that extends QTC can increase the risk of ventricular arrhythmia.

Beta-adrenergic receptor blockers

Beta-adrenergic receptor antagonists (beta blockers) and Broztri Aerosphere can hinder each other's effects when used simultaneously. Beta blockers not only prevent the treatment effect of beta -owners, but also can cause serious bronchospasm in COPD patients. Therefore, conventional COPD patients should not use beta blockers. However, in certain cases, such as the backup after myocardial infarction, there is no other option for alternatives instead of beta blockers in COPD patients. In this situation, it is possible to consider choosing beta blockers selected on the heart and should be used cautiously.

anti -cholinergic drugs

There is a possibility of interactive interactions when using anti -cholinergic drugs simultaneously. Therefore, avoid simultaneous use of Broztri Aerosphere with other drugs also contains ingredients that have anti -cholinergic effects, because it can lead to increased adverse effects.

Storage

Do not store over 30 ° C. Avoid exposure to higher temperatures than 50 ° C.

Do not puncture the medicine. Store in a dry place.

Only use within 3 months from opening aluminum package.

Other drugs

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