Powder to inhales Symbicort Astrazeneca for asthma treatment (120 doses)
Dosage form Bottle
Specifications Budesonide, formoterolum, formoterol
Ingredient
| Composition information | Content |
| Budesonide | 160mcg |
| Formoterolum | 4.5mcg |
| Formoterol | 4.5mcg |
Uses
Indication
Symbicort turbuhaler ® 120 doses is indicated in the following cases:
Pharmacology
Symbicort contains formoterol and budesonid, these substances have different methods of impact and show 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 asthma reduction 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 beta -2 -selective subject that when inhaled, the inhalation line will cause rapid and prolonged bronchial 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.
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.
Despite this, the inhibition of cortisol increases 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. Budesonid inhaled is quickly absorbed and the maximum concentration in plasma is achieved within 30 minutes after inhalation.
Studies show that the average number of budesonids in the lungs via Turbuhaler varies from 32 to 44 % of the release dose. Biological comfort 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 the end.
In studies, the average amount of formoterol in the lungs when inhaled through Turbuhaler varies from 28 to 49 % of release dose. Biodiality of the whole 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 conformity 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 -glucocorticosteroid metabolites. Activated glucocorticosteroids of main metabolites (63 - hydroxy - budesonid and 16 g -hydroxy - prednisolone) are 1 % less than that activity of budesonid.
There is no information on any transformation 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 semi -exhaust time after an 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 may increase in patients with liver disease.
Budesonid's systemic concentration and formoterol correlated with the dose.
Before taking Powder to inhales Symbicort Astrazeneca for asthma treatment (120 doses)
How to use
turbuhaler is a multi -dose inhaler, releasing a very small amount of powder. When the patient inhales, the powder from the Turbuhaler tube will be released into the lungs. Therefore, it is important that the patient must breathe strongly and deep through the head.
Prepare before using a new inhaler.
You need to prepare the inhaler before use for the first time.
1. Turn and remove the protective lid. You will hear the splash when twisting the lid of the inhaler.
2. Hold the tube vertically with the pipe base that is out of red. Do not lead when twisting the inhaler. Turn the tube to inhale as much as possible and then turn back to the end. The turning direction does not matter. In this process, you will hear a way. Repeat this process 2 times.
Inhalation tube is now ready to use, and you should not perform the above process. To get 1 dose, continue to follow the instructions below.
Use Symbicort Turbuhaler inhaler.
To use 1 dose, follow the instructions below.
1. Turn and remove the protective lid. You will hear the splash when twisting the lid of the inhaler.
2. Hold him vertically with the red inhaled pipe base below. Do not lead when twisting to inhales. To load a dose of inhalation, turn the straw as much as possible to one side and then turn it back to the end. The turning direction does not matter. In this process, you will hear a way.
3. Expiratory. Do not breathe in and out. Put the tip of the inhaler between the two teeth, soak the lips and inhale by the mouth strongly and deep. Do not chew or bite hard.
5. Before exhaling, take the inhaler out of the mouth.
6. If you need additional dose, repeat from step 2 to step 5.
7. Close the lid by twisting tightly.
8. Rinse mouth with water after light and dark dose. Do not swallow.
Note:
Do not try to remove your head as it has been fixed to the inhaler. Can rotate head, but do not twist it unnecessarily.
The amount of medicine in each dose is very small, you may not feel the taste after inhalation. However, you can still believe that you have received the medicine if the instructions are in accordance with the instructions.
If you mistakenly take several steps to recharge instead of just once before taking the dose, you still get one dose. However, the indicator window will record all the loaded dose.
The sound heard when shaking the inhaler is not due to the drug but the desiccant.
How to know when to replace a new inhaler?
The dose indicator window shows how many remaining doses in the inhaler and starting with the number 60 or 120 depending on the packaging type when the inhaler is unused.
This dose indicator is indicated in 10 doses. Therefore, it does not indicate each separate dose.
You are guaranteed that Turbuhaler releases the dose even when not notice the instructions of the dose.
When the last 10 doses are left, the indicator of the dose will have a red background. When the number 0 approaches the middle of the dose indicator window, then the inhaler should be removed.
Note that even if the indicator of the dose is stated at 0, the inhaler can still be twisted. However, the indicator of the suspension dose and the number 0 is kept in the window.
Clean the outer part of the tip regularly (per week) with a dry towel. Do not use water to wash your head.
Dosage
Case of asthma
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 corticosteroid owner should be prescribed in separate inhalers.
Should adjust 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 therapy:
b. Symbicort sustained and reduced treatment for asthma (Symbicort Smart).
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:
Need to monitor the adverse events related to doses in patients who often use high doses of Symbicort when necessary.
Recommended dose:
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?
When long -term use of excessive doses, the drug may be considered.
What to do when forgetting 1 dose?
Consult your doctor or pharmacist.
Side Effects
When using Symbicort Turbuhaler ® , you may experience unwanted effects (ADR).
micro symbicort contains both budesonid and formoterol, which may occur similar adverse effects as reported to these substances. There is no increase in the frequency of adverse impacts when using both substances simultaneously.
The most common adultery reaction is the most common side effects that can be predicted on pharmacological pharmacology when using beta -2 -shipped substances as shaky and nervous. These side effects are usually mild and disappear after a few days of treatment.
Common, ADR> 1/100
Respiratory disorders, chest and mediastinum: mild irritation in the throat, cough, dry sound.
Uncommon, 1/1000 eye disorders: blurred vision. Mental disorders: agitation, hyperactivity, anxiety, sleep disorders. Rare, 1/10000 immune system disorders: instant or slow allergic reactions such as foreign rash, urticaria, itching, dermatitis, angioedema and anaphylactic reaction. Respiratory disorders: bronchial spasm. Very rare, ADR Endocrine disorders: Cushing syndrome, adrenal inhibition, growth retardation, reduced bone mineralization density. Nervous system disorders: taste disorders. Mental disorders: depression, behavioral disorders (mainly in children). Vascular disorders: Demonstracy. Candida fungus pharyngeal infection is due to the deposition of the drug. Lactose excipients contain a small amount of milk protein, so it can cause allergic reactions. Instructions on how to handle ADR Patients should rinse their mouths with water after each maintenance dose will minimize the risk. Candida fungal infections often respond to anti -fungal treatment on the spot without having to stop using inhaled corticosteroids. If thrush, patients should also rinse their mouth with water after taking the drug when necessary. As well as other inhaled treatments, naughty bronchospasm can occur in very rare cases, less than 1/10,000 people, with sudden increased wheezing symptoms and shortness of breath after smoking. Inverse bronchial spasms are often responded to bronchodilators inhaled quickly and should be treated immediately. Symbicort should be stopped immediately, patients need to be evaluated and used for replacement therapy if needed. The systemic effect of inhaled corticosteroids may occur when high doses for a long time. These effects are less likely to occur than oral corticosteroids. Systemic effects may include Cushing syndrome, cushing characteristics, adrenal inhibition, developmental retardation in children and adolescents, reducing the density in bones, cataracts and glaucoma. Increasing sensitivity to infections and impaired ability to adapt to stress may also occur. The effect may depend on the dose, time of contact with steroids, using steroids simultaneously and before and before and personal sensitivity. Treatment of beta -2 motorcycle owners can increase insulin levels, free fatty acids, glycerol and meters in the blood. Children Should regularly monitor the height of children when long -term treatment with inhaled corticosteroids.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Symbicort turbuhaler ® 120 doses contraindicated in the following cases:
Be cautious when used
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 dose and how to use).
If asthma control or COPD is suddenly impaired, the disease can progress and life -threatening, so patients must be assessed for medical immediately.
In this situation, it is advisable to consider the need to increase the dose of corticosteroids such as taking oral corticosteroids or antibiotic treatment if infected.
Patients are recommended to always have a cutting drug such as Symbicort (for patients using Symbicort as a maintenance and symptom -reducing therapy) 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 for example, before exercising has not been studied.
Symbicort symptoms of inhalation are used to deal with asthma symptoms but are not intentional for regular backup 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 how to use).
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 still 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 sudden increased wheezing symptoms and shortness of breath after smoking.
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 body's effects may occur, including Cushing syndrome, cushing characteristics, adrenal inhibition, developmental retardation in children and minors, reducing the density of bones, 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 mg (standard dose) or adults at an average dose of 800 mg (standard dose) did not show any significant impact on the 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 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 steroid treatment and thus oral steroids depend on oral steroids switching to inhaled budesonid may still be at risk of adrenal function in a significant 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 including anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, reduced level of awareness, convulsions, hypotension and hypoglycemia.
Do not stop the drug suddenly when treated with a supplementary steroid or inhaled budesonid.
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 pharyngeal, the patient must also rinse his mouth with water after inhaling the doses when necessary.
Should avoid simultaneous treatment with iTraconazole, ritonavir or strong CYP3A4 inhibitors (see the interaction of the drug with other drugs and other types of interactions).
Precautions when treating in patients has a long period of QTC. Formoterol itself can extend the QTC time.
Should reassess the need and dose of inhaled corticosteroids in patients with pulmonary tuberculosis progression or hidden, fungal infection and respiratory virus.
The ability to lower severe severe potassium potassium can occur when high doses of beta -2 -agonized owner.
should be particularly cautious in unstable asthma patients taking different bronchodilators, in acute asthma patients and the risk of coordination may increase due to oxygen decrease and in patients with other conditions when the possibility of adverse blood reactions increases. Serum potassium concentration should be monitored in these cases.
Like the beta -2 motor beneficiaries, it is advisable to consider enhancing blood sugar control in patients with diabetes.
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 dark retinopathy (CSCR), the type of disease that has been reported after the use of corticosteroids systemic or local.
Symbicort Turbuhaler contains lactose (
Note to 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 in the lowest inhaled inhalation at which if possible, it can effectively maintain asthma control.
Carefully consider the benefits of corticosteroid treatment and the risk of growth is possible. In addition, it is necessary to consider instructing 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.
Note about pneumonia in COPD patients
The increase in the incidence of pneumonia, including hospital pneumonia, has been observed in Corticosteroid corticosteroids.
There are some evidence of increased risk of pneumonia along with increasing steroid dose but this has not been clearly proven in all studies. There is no clinical evidence concluding the difference in the group of corticosteroid products 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 coincides with 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. 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. 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 ketoconazole, iTraconazole, Voriconazole, Posaconazole, Clarithromycin, Telithromycin, Nefazodon and HIV Protease inhibitors) can significantly increase plasma budesonide concentration and should avoid these medications simultaneously. If not, the time between the use of inhibitors and budesonid should be as far as possible. It is not recommended to use maintenance therapy and reduce 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 an average triple showing that the distance between two doses may reduce the increase in plasma concentrations.
A few of this interactive data for highly -doseed budesonid shows that increasing the concentration of plasma is 4 times the average) may occur if iTraconazole, 200 mg once daily, is used simultaneously with the inhaled budesonid (single dose 1000 mg).
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 reasons.
Simultaneously used with quinidine, disopyramid, process, phenothiazin, antihistamine (terfenadin), and 3 -round antidepressant can extend QTC and increase the risk of ventricular arrhythmia.
Moreover, L-Dopa, L-Thyroxin, Oxytocin and Alcohol can affect the tolerance of the heart for the sympathetic Beta-2.
Simultaneous use 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.
Hemoto reduction may increase the tendency of arrhythmia in patients treated with digitalis glycosid.
Hemoto hypoassiasis may be due to the use of beta -2 leftovers and may be simultaneously used with Xanthin, corticosteroid and diuretic derivatives.
Budesonid and Formoterol do not show interactions with other drugs used to treat asthma.
Storage
Do not store over 30 ° C. Store in tightly closed packaging.
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