Powder medicine to inhale Symbicort Astrazeneca for asthma treatment (60 doses)
Dosage form Bottle
Specifications Budesonide, formoterol
Ingredient
| Composition information | Content |
| Budesonide | 160mcg |
| Formoterol | 4.5mcg |
Uses
indications
Symbicort 60 drug are indicated in the following cases:
asthma
Symbicort is indicated for adults and adolescents (aged 12 years and older) in regular treatment asthma (asthma) when needed treatment of inhaled corticosteroids and beta-2 agonors have a prolonged inhaling effect:
Symbicort is indicated for adults aged 18 and over in the treatment of symptoms for patients with chronic obstructive pulmonary disease with exhalation volume in the first second (FEV1) Pharmacokology
Pharmacological impact mechanism and impact mechanism
Symbicort contains Formoterol and Budesonid, these substances have different methods of impact and indicate a combination effect that reduces asthma play (asthma).
Specialized characteristics of BudesonID and Formoterol show that the product combines these two active ingredients can be used as a maintenance treatment and reduced asthma symptoms or such as maintenance therapy.
budesonid
Budesonid is a glucocorticosteroid that when using inhalation line will give anti -inflammatory effects dependent at the respiratory tract, reduce symptoms and less rare asthma play. Budesonid inhaled sugar has less adverse effects compared to when using body corticosteroids. The exact mechanism for this anti -inflammatory effect of glucocorticosteroid has not yet been known.
formoterol
Formoterol is a selective beta-2-shipping owner that when using inhaled lines will cause rapid and prolonged bronchodilator muscle relaxation in patients with recovery respiratory obstruction. The bronchodilator impact depends on the dose with the onset of 1-3 minutes. The impact time lasts at least 12 hours after the single dose.
Symbicort Turbuhaler
asthma
Clinical effect of maintenance therapy with Symbicort:
Clinical trials in adults show that adding formoterol to Budesonid helps improve asthma symptoms and lung function, and reduce asthma drama. In two 12 -week studies, the impact on the lung function of Symbicort is equivalent to the impact of the combination of the same 2 products Budesonid and Formoterol and is more effective than the impact of BudesonID used individually. All the treatment branches use a Beta-2 shipping owner short when needed. There are no signs of decline in asthma treatment when prolonged use.
Two children's studies in 12 weeks were conducted, of which 265 children aged 6-11 were treated with the maintenance dose of Symbicort (2 dose of 80/4.5 mcg/doses, 2 times/day) and a Beta-2 owner short-term effect when necessary. The results in both studies show that the lung function has been improved and the patient tolerates well with therapy compared to the corresponding dose of Budesonid Turbuhaler.
Clinical effectiveness of maintenance treatment and reduced asthma symptoms with Symbicort:
A total of 12,076 patients with asthma participated in the 5 double blind tests evaluating the effectiveness and safety of Symbicort (4,447 people were randomly selected in maintenance treatment and reduced asthma symptoms with Symbicort) in 6 or 12 months. Selected for testing, patients still have asthma symptoms despite inhaled glucocorticosteroids.
Symbicort maintenance and reduction of asthma treatment shows that drugs that reduce severe and important statistical henotes have clinical significance for all comparisons in all 5 studies. A study comparative study Symbicort for maintenance + extra use when needed (Symbicort Smart: Symbicort Maintenance and Reliever Therapy) with Symbicort with high doses of maintenance + Terbutalin to reduce symptoms when necessary (Research 735) and a comparative study study Symbicort for maintenance treatment + extra use when needed (Symbicort Smart) with Symmistry in Dosage Dosage Terbutalin to reduce symptoms (study 734) in 735 study, lung function, symptom control and use an equivalent cutting drug in all treatment groups. In the 734 test, symptoms and the number of times the medication cut off and the lung function improved in the Symbicort Smart group compared to the two treatment groups. The results combined with 5 studies in patients using Symbicort to maintain and reduce symptoms of asthma (Smart) show that on average, the time does not need to use symptoms to reduce symptoms accounting for 57% of the treatment time. There are no signs of drug -away.
Efficiency and safety among young members and adults have been shown in 6 double blind studies, including 5 studies mentioned above and 1 study using a dose higher than 160/4.5 mcg, 2 breaths twice a day. These assessments are based on 14385 patients with 1847 as minors. The number of minors used in 8 inhale at least 1 day such as maintenance therapy and reduced symptoms of Budesonide/Formoterol is limited, and not used regularly.
In two other studies with patients who need a doctor's examination due to acute asthma symptoms, Symbicort reduces rapidly and effectively for bronchial stenosis similar to salbutamol and formoterol.
COPD
The effect of Symbicort on lung function and the rate of drama (determined by the number of oral steroids and/or the number of antibiotics and/or hospitalization in patients with average to severe COPD have been assessed in two 12 -month studies. The combination criteria of both studies are FEV1
The average number of drama per year (defined as above) is significantly reduced in the Symbicort group compared to the group that only uses Formoterol or the placebo group (an average ratio of 1.4 compared to 1.8-1.9 in the placebo group/Formoterol). The average number of oral corticosteroids for each patient during 12 months decreases in the Symbicort group (7-8 days/patient/year compared to 11-12 days in the placebo group and 9-12 days in the formoterol group). Symbicort is not superior to the formoterol only treatment group in terms of changes in lung function parameters like FEV1.
Pharmacokinetics
absorption
Symbicort Turbuhaler and corresponding product menu have been proved to be biological equivalent to the concentration and body contact time of Budesonid and Formoterol. However, cortisol inhibitors increased slightly after using Symbicort compared to the recorded treatment. The difference is considered not to affect clinical safety.
There is no evidence of pharmacokinetic interaction between Budesonid and Formoterol.
The pharmacokinetic parameters of the corresponding substances are similar after using Budesonid and formoterol separately or using Symbicort Turbuhaler. For Budesonid, AUC increases slightly, the speed of absorption is faster and the maximum concentration in plasma is higher after combination. For Formoterol, the maximum concentration in plasma is similar after combination. The inhaled budesonid is quickly absorbed and the maximum concentration in plasma is reached within 30 minutes after inhalation. Studies show that the average amount of budesonid in the lungs via Turbuhaler varies from 32 to 44% of the release dose. Biomedical biodiversity about 49% of release dose. Lung deposition in children 6-16 years old is similar to adults when using the same dose. Results of plasma concentrations have not been determined.
Formoterol inhaled is quickly absorbed and the maximum concentration in plasma is achieved within 10 minutes after inhalation. In studies, the amount of formoterol average in the lungs when inhaled through Turbuhaler varies from 28 to 49% of the release dose. Biomedical body is about 61% of the release dose.
Distribution and metabolism
Plasma protein binding is about 50% for formoterol and 90% for budesonid. The distribution volume is about 4 l/kg for formoterol and 3 l/kg for budesonid. Formoterol is inactivated through conjugated reactions (O-Metyl and Formyl reduction substances are formed, but they are found mainly in the non-active combination form). Budesonid through a strong biological shift (about 90%) when the first time through the liver into low -active metabolites glucocorticosteroids. The glucocorticosteroid activity of the main metabolites (6β-hydroxy-budesonid and 16α-hydroxy-plednisolone) is 1% less than that activity of Budesonid. There is no information on any metabolic interaction or a shift reaction between Formoterol and Budesonid.
Elimination
Most of the formoterol dose is metabolized through the liver and then excreted the kidneys. After inhalation, 8 - 13% of the formoterol's release dose is excreted in the form of non -metabolized into the urine. Formoterol has a high body clearance (about 1.4 l/min) and the average last phase selling time is 17 hours.
Budesonid is eliminated by metabolism mainly by catalyst by CYP3A4. Budesonid metabolites are secreted in a free or combined form. Only a constant amount of Budesonid is found in the urine. Budesonid has a high body clearance (about 1.2 l/min) and the sale time after the average intravenous injection is 4 hours.
pharmacokinetics of budesonid or formoterol in patients with renal failure is still unknown. The concentration and contact time of budesonid and formoterol can increase in patients with liver disease.
Linear/non -linear
Budesonid's systemic concentration and formoterol correlated with the dose.
Before taking Powder medicine to inhale Symbicort Astrazeneca for asthma treatment (60 doses)
How to use
turbuhaler is a tool that is operated by the inhaled gas flow, which means that when the patient inhales the end of the latch, the drug will follow the air inhaled into the airways.
Note: Need to guide patients the following:
Read the user instruction in the "manual" section at the end of the prescription.
Symbicort is not used for initial treatment for asthma. The needed dose of budesonid or formoterol depends on each patient and should be adjusted according to the severity of the disease. This should be considered even when starting treatment with combined preparations as well as when adjusting the maintenance dose. If a patient needs a combination doses different from the doses available in the coordinated inhaler, the addition of the necessary doses of the Beta-2 and/or Corticosteroids owner should be prescribed in separate inhalers.
Should adjust to the lowest dose while maintaining symptom control effect. Patients should be re -evaluated by the doctor so that the dosage of Symbicort is still maintained optimally. When the symptom control is maintained for a long time with the lowest recommended dose, the next step is to take into account the use of individual inhaled corticosteroids.
For Symbicort has two treatment trends:
a. Symbicort maintenance treatment: Symbicort is used for regular maintenance treatment with bronchodilators with separate fast -acting bronchodilators when it is necessary to cut attacks.
b. Symbicort Symbicort and Reliever Therapy Therapy): Symbicort): Symbicort is used for regular maintenance and extra use when necessary to reduce asthma symptoms.
a. Symbicort maintenance therapy
Patients are advised to always have a quick bronchodilator to cut.
Symbicort recommended dose:
Increasing the use of inhaled tubes containing bronchodilators quickly shows that asthma is worse and needs to re -evaluate asthma treatment.
Patients taking the daily sustain dosage doses and extra sybicort when needed to reduce asthma symptoms. The patient is advised to always bring Symbicort to use when it is necessary to reduce symptoms.
Symbicort maintenance and reduction of asthma treatment should be considered in the following patients:
Recommended dose:
Adults and adolescents (≥ 12 years old): The recommended maintenance dose is 2 inhale/day, a inhalation dose in the morning and 1 evening inhalation or 2 inhales in the morning or evening. Some patients may need maintenance dose 2 inhale, 2 times/day. Patients should take an extra dose when necessary to reduce symptoms. If the symptoms are still after a few minutes, one more dose should be used. Do not use more than 6 doses in 1 time.
Total daily dose does not exceed 8 inhale; However, the total daily dose up to 12 inhale can be used for a limited period of time. Patients use more than 8 breaths/day to go to the doctor again. These patients should be re -evaluated and reviewed.
Children
Chronic obstructive pulmonary disease (COPD)
Recommended dose:
Adults: 2 inhale/time, 2 times/day.
General information:
Special patient groups: No special dose in the elderly. There is no data on the use of sybicort in patients with liver or renal failure. Because Budesonid and Formoterol are excreted mainly through metabolism in the liver, the drug concentration will increase in severe cirrhosis patients.
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 to do when overdose? Symptoms recorded from individual cases such as heart rate, hyperglycemia, hypokalemia, prolonged QTC segment, arrhythmia, nausea and vomiting. Supporting and symptomatic treatment can be appointed. The dose of 90 mcg used in 3 hours in patients with acute bronchial obstruction is not safe.
Budesonid overdose, even when using excessive doses, is not a clinical problem. When long -term use of excessive doses, the effects of systemic glucocorticosteroids can occur as adrenal energy and adrenal inhibition.
If the Symbicort therapy must be stopped due to the overdose of the formoterol ingredient in the drug, it is necessary to consider the appropriate inhaled corticosteroid therapy.
What to do when you forget 1 dose?
No data.
Side Effects
When using Symbicort drug , you may experience unwanted effects (ADR):
Common: 1/100 Very rare, ADR Notify the doctor the unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Symbicort 60 drug contraindicated in the following cases:
Caution when using
Dosage should be gradually reduced when stopped treatment and should not stop the drug suddenly.
If the patient feels that the treatment is ineffective or exceeding the highest recommended drug dose of Symbicort, the doctor's monitoring must be monitored (see the dosage and how to use). If asthma or COPD control is suddenly reduced, the disease may progress severe and life -threatening, so the patient must be assessed for medical immediately. In this situation, it is advisable to consider the need to increase the dose of treatment with corticosteroids such as oral corticosteroid or antibiotic treatment if there is infection.
Patients are recommended to always have a cutting drug such as Symbicort (for patients using Symbicort as a maintenance and symptom reduction) or bronchodilators acting individually (for patients using Symbicort just for maintenance treatment).
Patients should remember to use the Symbicort maintenance dose as prescribed even when there is no symptom. Use Symbicort to prevent symptoms such as before practicing sports that have not been studied. Symbicort symptoms of inhalation are used to deal with asthma symptoms but have no intentional intentions as often as before exertion. To use for such purposes, it is advisable to consider the use of bronchodilators quickly.
When asthma symptoms are controlled, it is necessary to consider reducing the doses of symicort slowly. It is important to regularly monitor patients with reduced treatment dose. The lowest lowest dosage should be used (see the dose and usage).
Do not start treatment with symbicort when the patient is in a asthma play, or if the disease is evident or acute.
Serious adverse events related to asthma and asthma play may occur when treatment with symbicort. Patients may be continued treatment but should consult a doctor if asthma symptoms are not controlled or worse after treatment with Symbicort. There is no clinical research data on Symbicort Turbuhaler in COPD patients with FEV1> 50% compared to normal predictable value before using bronchodilators and FEV1
As well as other inhaled sugars, bronchospasm of drama can occur with a sudden increase in wheezing symptoms and shortness of breath after inhalation. If the patient is inversely bronchospasm, the symbicort stops immediately, the patient needs to be evaluated and replaced by another therapy, if necessary. Inverse bronchial spasms are often responded to bronchodilators inhaled quickly and should be treated immediately.
Systemic effects may occur when using any inhaled corticosteroids, especially when taking high doses for a long time. These effects are rarely occurring when using inhaled corticosteroids compared to oral corticosteroids. The systemic effects may occur include Cushing syndrome, cushing characteristics, adrenal inhibition, developmental retardation in children and minors, reducing bone mineral density, cataracts and glaucoma, and more rare, a range of psychological effects or behaviors including hyperactivity, sleep disorders, anxiety, depression or agitation (especially in children).
Should consider the impact that can occur on bone density, especially for patients who take high doses for a long time, but have risk factors and cause osteoporosis. Long -term studies on budesonid inhaled lines on children at an average daily dose per day 400 μg (standard dose) or adults at an average dose of 800 μg (standard dose) did not show any significant impact on the bone mineral density of the bone. There is no information on the effects of Symbicort in higher doses.
If there is any reason that the adrenal gland function is impaired when treated with systemic steroids before, should be cautious when switching to Symbicort for patients.
The benefits of inhaled budesonid treatment are often reducing oral steroids, but in patients moving from oral steroids may still have the risk of adrenal reserves in a significant time. Recovery can take a significant amount of time after stopping oral steroids and thus oral steroid patients switching to inhaled budesonid may still be at risk of adrenal impairment in a significant period of time. In such cases, the HPA shaft function should be monitored regularly.
Prolonged treatment with high doses of inhaled corticosteroids, especially higher than the recommended dose, can also lead to clinical adrenal inhibition. Therefore, adding body corticosteroids should be considered during stress such as severe infections or buffet surgery. Reducing the rapid dose of steroids can cause acute adrenal failure. Symptoms and signs that may appear in acute adrenal failure may be unclear but include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, reducing the level of awareness, convulsions, hypotension and hypoglycemia.
Do not stop the drug suddenly when treated with additional body steroids or inhaled budesonids.
During the transition from oral to Symbicort, there will be a lower body steroid effect that can lead to symptoms of allergies or arthritis such as rhinitis, eczema and muscle and joint pain. Need to start specific treatment for these symptoms. In some rare cases, glucocorticosteroid effects may be suspected of sufficiently if symptoms such as fatigue, headache, nausea and vomiting. In these cases, sometimes the temporary dose of oral glucocorticosteroid is needed.
To minimize the risk of Candida infection with throat, patients should be instructed to rinse their mouths with water and spit after each inhalation of maintenance. If there is a mushroom in the pharynx, the patient must also rinse his mouth with water after inhaling the dose when needed.
Should avoid simultaneous treatment with iTraconazole, ritonavir or strong CYP3A4 inhibitors (see drug interactions). If it cannot be avoided, the distance between the use of drugs should be interacted with each other as long as possible. It is not recommended to use maintenance and reduce asthma symptoms with Symbicort in patients using strong CYP3A4 inhibitors.
Symbicort should be used carefully for patients with thyroid poisoning, chrome cell tumor, diabetes, unprocessed hypoache reduction, obstructive hypertrophic heart disease, non -radical aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders such as ischemic heart disease, tachycardia or severe heart failure.
Precautions when treating in patients has a long period of QTC. Formoterol itself can extend the time QTC.
Should reassess the need and dose of inhaled corticosteroids in patients with tuberculosis progress or hidden, fungal infection and respiratory virus.
The ability to lower severe blood potassium may occur when high doses of beta-2 agar. Simultaneous use of Beta-2 transport owner with drugs that cause or hypoglycemia such as Xanthin's derivatives, steroids and diuretics can increase the impact of hypotension due to the use of beta-2 agar. Should be particularly cautious in unstable asthma patients taking different bronchodilators, in acute severe asthma patients due to the increased risk of coordination due to oxygen decrease and in patients with other conditions when the possibility of adultery reactions lowering potassium. Should monitor serum potassium concentration in these cases.
Like the beta-2 agonists, it is advisable to consider increasing blood sugar control in diabetes patients.
Visual disorders can be reported for systemic corticosteroid use. If the patient appears symptoms such as blurred vision or other visual disorders, the patient should be considered to be transferred to an ophthalmologist to assess the possible causes including cataracts, glaucoma or rare diseases such as central retinopathy (CSCR), the type of disease that has been reported after the use of generalized corticosteroids.
Symbicort Turbuhaler contains lactose (
Children
The height of children being treated with long -term treatment with inhaled corticosteroids is recommended to be monitored regularly. If there is a retardation, the treatment should be re -evaluated to reduce the dose of corticosteroids to the lowest lowest doses at which if possible, it can effectively maintain asthma control. Careful consideration between the benefits of corticosteroid treatment and the risk of retardation may occur. In addition, it is necessary to consider the guidance of patients to pediatric respiratory specialists.
A few data from long -term studies suggested that most children and adolescents treated with Budesonid basic inhalation line will achieve the target height as adults. However, it was noted that there was a slight and temporary decline in development (about 1 cm). This usually happens during the first year of treatment.
Pneumonia in COPD patients
Increased incidence of pneumonia, including hospital pneumonia, has been observed in Corticosteroid corticosteroid patients. There are some evidence of increased risk of pneumonia along with increased dose of steroids but this has not been clearly proven in all studies.
There is no clinical evidence concluding the difference in the group of corticosteroids inhaled in the risk of pneumonia.
Doctors should be wary of the development of pneumonia in COPD patients because of the clinical characteristics of this infection that covers the symptoms of COPD play.
Pneumonia risk factors in COPD patients include smoking, old age, low body mass index (BMI) and severe COPD.
The ability to drive and operate machinery
Symbicort does not affect or negligible effect on the ability to drive and operate the machine.
Pregnancy
There is no clinical data on the use of Symbicort or using formoterol and budesonid in pregnant women. Data from a study of embryo development in mice shows no evidence of any other effect when using this combination.
There is no adequate data on the use of formoterol for pregnant women. In animal studies, in very high doses, formoterol causes adverse effects in reproductive studies.
The data on about 2,000 pregnant women using drugs shows no risk of teratogenicity associated with the use of Budesonid inhaled. Studies on animals show that glucocorticosteroids are deformed. This is not related to people when using the recommended doses.
Cattle studies also show that there is an over -use of glucocorticoid before giving birth with increasing risks such as: growth retardation in the uterus, cardiovascular disease as adults, long -term changes density of glucocorticoid receptors, number of neurotransmitters and behaviors at exposure under the limit of teratogenic doses.
During pregnancy, Symbicort should only be used when considering the outstanding effect. The lowest budesonid dose should be used to maintain good asthma control.
breastfeeding period
budesonid is excreted through breast milk. However, in the treatment dose, no records have any impact in breastfed babies. People still do not know whether formoterol is in breast milk or not. On the mouse, a small amount of formoterol was discovered in breast milk. Using Symbicort for breastfeeding women should only be considered if the benefits for mothers are higher than the risks that may occur for children.
Drug interaction
pharmacokinetic interaction
Strong CYP3A4 inhibitors (such as ketoconazol, iTraconazole, voriconazole , Posaconazole, Clarithromycin, Telithromycin , Nefazodon and HIV Protase inhibitors) can significantly increase plasma budesonide levels and avoid simultaneous use of these drugs. If not, the time between the use of inhibitors and budesonid should be as far as possible. It is not recommended to use maintenance and reduce asthma symptoms with Symbicort in patients using strong CYP3A4 inhibitors.
Simultaneous use of strong CYP3A4 inhibitors Ketoconazole, 200 mg x 1 time/day, increasing the average of the concentration of oral budesonid (single dose of 3 mg) in plasma. When Ketoconazole is taken 12 hours after using budesonid, the concentration only increases by an average triple showing that the distance between two doses may reduce the increase in plasma concentrations. A small number of this interactive data for high -doseed budesonid indicates that increased plasma concentrations (4 times the average) can occur if iTraconazole, 200 mg once daily, is used simultaneously with Budesonid inhaled (single dose 1000 μg).
Pharmacological interaction
Beta blockers may reduce or inhibit the effects of formoterol. Therefore, Symbicort should not be used with beta blockers (including eye drops) unless convincing reason.
Simultaneously use with quinidine, disopyramid, process, phenothiazin , antihistamine (terfenadin), and 3 -round antidepressant can extend QTC and increase the risk of ventricular arrhyths.
Moreover, L-Dopa, L-Thyroxin, Oxytocin and alcohol can affect the tolerance of the heart for the Beta-2 sympathetic drug.
Simultaneously used with imao including agents with characteristics similar to furazolidon and processbazin can promote hypertension reactions.
Increased risk of arrhythmia in patients with anesthesia with Halogenization hydrocarbon.
Concentrated with other beta sympathetic drugs or anti -cholinergic drugs may have a strong plus bronchodilator effect.
Hematopathy can increase the tendency of arrhythmia in patients treated with digitalis glycosid.
Hemotenta reduction may be due to the use of beta-2 agonists and can be used by simultaneously with Xanthin, corticosteroid and diuretic derivatives.
Budesonid and Formoterol do not show interactions with other drugs used to treat asthma (asthma).
Children
Interactive studies are only done in adults.
Storage
Do not store over 300C. Store in tightly closed packaging.
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