Symbicort Rapihaler Astrazeneca spray for asthma treatment (120 doses)
Dosage form Box
Specifications Budesonide, formoterolum
Ingredient
| Composition information | Content |
| Budesonide | 160mg |
| Formoterolum | 4.5mcg |
Uses
Indications
Asthma treatment (asthma) when combined (inhaled corticosteroids and beta -shipping owners - 2 appropriate effects in adults and adolescents.
includes:
Symbicort Rapihaler is not used for maintenance treatment and reduced asthma symptoms (Smart: Symbicort Maintenance and Reliever Therapy).
Pharmacokic
Symbicort Rapihaler contains Budesonid and Formoterol, these substances have different impact mechanisms and have a combination effect to reduce asthma and COPD play. Specialized characteristics of BudesonID and Formoterol show that the combined product can be used as regular maintenance therapy and asthma symptoms and symptomatic treatment for COPD patients from medium to severe.
budesonid
Budesonid is a glucocorticosteroid with strong local anti -inflammatory effects. Budesonid shows anti -anti -inflammatory and anti -inflammatory effects in animal and human stimulating studies, manifested by reducing instant bronchial obstruction as well as the late stage of allergic reactions. Budesonid also shows reducing the airway reaction to direct stimuli (histamine, methacholin) and indirect (exercise) on hypersensitivity patients.
Budesonid uses inhaled lines that have rapid anti -inflammatory effects for a few hours and depend on doses, reduce symptoms and few plays. Budesonid inhaled sugar has less adverse effects compared to the use of systemic corticosteroids. The exact mechanism for anti -inflammatory effects of glucocoticorsteroids has not yet been known.
formoterol
Formoterol is a selective selected Beta-2 Adrenegic, which has the effect of relaxing the bronchial smooth muscle. Therefore, the drug has a bronchodilator effect in patients with respiratory obstruction can recover and in patients with bronchial spasms due to the direct stimulation (methacholin) and indirect (exercise). The effect of bronchodilator depends on the dose with the onset time within 1-3 minutes after inhalation. The impact time lasts at least 12 hours after the single dose.
pharmacokinetic
budesonid
absorption
Budesonid inhaled inhaled is absorbed quickly and the maximum concentration in plasma is reached within 30 minutes after inhalation.
Distribution
Budesonid's plasma protein binding is approximately 90% and the distribution integral is 3L/kg.
Metabolism
Budesonid is strongly metabolized (about 90%) when first passing the liver to form a low -active metabolic substance. The glucocorticosteroid activity of the main metabolites, 6β-hydroxy-budesonid and 16α-hydroxy-Prednisolon, 1% less than the activity of Budesonid.
Elimination
Budesonid is eliminated by transforming mainly through CYP3A4. Budesonid metabolites are excreted in urine in free or combined form. Only a constant amount of Budesonid is found in the urine. Budesonid has a high body clearance (approximately 1.2L/minute) and the semi -discharged time in plasma after an average intravenous injection is 4 hours.
formoterol
absorption
Formoterol inhaled inhaled is quickly absorbed and the maximum concentration in plasma is achieved within 10 minutes after inhalation.
Distribution
Plasma protein cohesion is about 50% for formoterol and distribution integral is about 4l/kg.
Metabolism
Formoterol is inactivated by conjugated reactions (o-methyl and formyl reduction substances that are activated, but they are mainly found in the non-active combination form).
Elimination
The majority of the formoterol is eliminated by metabolism through the liver and then excreted through the kidney. After inhaling the formoterol via the Turbuhaler 8% - 13% of the release dose of formoterol is excreted in the form of non -metabolized into the urine. Formoterol has a high body clearance (approximately 1.4L/min) and the average last phase selling time is 17 hours.
Before taking Symbicort Rapihaler Astrazeneca spray for asthma treatment (120 doses)
How to use
Instructions to use RapiHaler properly.
In each Symbicort Rapihaler spray, an amount of medicine is released from a high -speed sprayer. When the patient inhales the tip of the tip at the same time as the spray bottle, the drug will follow the airflow.
Note: important instructions for patients:
Shake the spray bottle carefully before each use so that the mixture is mixed properly.
Put your head into the mouth. Inhale slowly and deep and press the spray bottle to release the drug. Continue to breathe and hold your breath for about 10 seconds or until you feel comfortable. Shake the spray bottle again and repeat this step for the second inhalation.
Using Symbicort Rapihaler with a buffer chamber is recommended for patients who have difficulty in combining inhalation with spray, children or the elderly, to bring better treatment effect.
Note this is especially important to guide patients:
Symbicort Rapihaler is used as a regular maintenance therapy, along with bronchodilators to quickly reduce symptoms. The patient is advised to always have bronchodilators quickly to reduce symptoms.
Increasing the use of bronchodilators to reduce symptoms shows that asthma is getting worse and it is necessary to re -evaluate asthma treatment. The dosage of Symbicort Rapihaler should be individualized according to the severity of the disease. When the control of asthma has been achieved, the dose should be adjusted to the lowest dose and the control efficiency is still maintained.
Adults and adolescents (≥12 years old)
2 Symbicort Rapihaler spray (100/6), 2 times/day.
Daily maintenance dose is up to 4 sprays (2 sprays, 2 times/day equivalent to 400μg of Budesonid/24μg of Formoterol).
General information
For the best effect patients should use Symbicort Rapihaler even without symptoms.
Elderly
No dose adjustment in older patients.
Children
Symbicort Rapihaler is not recommended for children under 12 years old because there is no enough data on efficiency and safety.
Patients with liver/kidney failure
There is no data on the use of Symbicort Rapihaler in patients with liver or renal failure. However, because Budesonid and Formoterol are mainly eliminated through liver metabolism, the body can be increased in patients with severe liver failure.
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? Controlling serum potassium levels may be recommended. Hypotension, metabolic acidosis, hypokalemia, hyperglycemia may occur. Support support and treatment can be indicated. Beta blockers should be cautious when used because it is likely to cause bronchospasm in sensitive patients. Standard dose 120μg used in 3 hours in patients with acute bronchial obstruction does not cause safety concern. Budesonid overdose, even when using excessive doses, is not a clinical problem. However, plasma cortisol levels will decrease and the number, neutropenia ratio will increase. The number and ratio of lymphocytes and eosinophils will simultaneously decrease. When long -term use of excessive doses, the effects of systemic glucocorticosteroids can occur as adrenal energy and adrenal inhibition.
Discontinuing Symbicort Rapihaler or reducing the dose of Budesonid will eliminate this effect, although the mechanism of HPA axis inhibiting the HPA axis can take place more slowly.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
Common, ADR> 1/100
Uncommon, 1/1000 Digestive system: Nausea, diarrhea. Mental system: agitation, restlessness, heat, sleep disorders. Rare ADR Cardiovascular system: arrhythmia such as atrial fibrillation, ventricular tachycardia, extra systolic, angina, extension of QT interval, Cushing syndrome, adrenal inhibition, growth retardation, reduced density of minerals in bone, oscillation of blood pressure. Skin and subcutaneous tissue: Skin bruises. Instructions on how to handle ADR Candida fungal infection is due to the deposition of the drug. Patients should rinse their mouths with water after each medication will minimize the risk. Candida fungal infections often respond to anti -fungal treatment on the spot without having to stop using inhaled corticosteroids. 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 minors, reducing mineral density in bones, cataracts and glaucoma. Increasing sensitivity to infections and decline in adaptability to stress can also occur. The effect may depend on the dose, time of contact with steroids, use steroids simultaneously and before and personal sensitivity. As well as other types of inhaled drugs, inverse bronchospasm can occur in very rare cases. Treatment with beta sympathetic enhancements can increase blood insulin, free fatty acids, glycerol and blood ceton. When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Contraindicated
Symbicort Rapihaler drug is contraindicated in the following cases:
Caution when using
When stopping the drug after a long -term treatment, the dosage should be gradually reduced and should not stop the drug suddenly.
Sudden or continuous deterioration in asthma control or COPD potentially threatening life and patients should be conducted emergency medical assessments. In this situation, it is advisable to consider increasing treatment with corticosteroids (such as oral corticosteroid) or antibiotic treatment if there is infection. Patients should consult a doctor if the treatment is ineffective or have been used in excess of the Symbicort Rapihaler prescription.
Patients should always have inhalers to reduce symptoms. Symbicort Rapihaler should not be used as the beginning therapy to treat a severe hen.
As well as other inhaled sugars, naughty bronchospasm can often occur with sudden 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.
Use oral corticosteroids
Symbicort Rapihaler should not be used to start inhaled steroids in patients transferred from oral steroids. Should be cautious when starting treatment with Symbicort Rapihaler, especially if there is any reason to suspect adrenal function due to the previous system of steroid therapy.
Systemic effects may occur when using inhaled corticosteroids
The inhaled steroids are designed to bring glucocorticoids directly into the lungs to reduce the level of systemic glucocorticoid contact and side effects. However, at a higher dose than the recommended dose, inhaled steroids may have adverse effects, body effects that may occur when using inhaled steroids including HPA axis inhibitors, reducing bone density, cataracts and glaucoma, slow growth in children.In steroid dependent patients, the use of systemic steroids earlier may be a contribution factor but these effects can also occur in patients using inhaled steroids regularly.
HPA axis inhibitors and adrenal failure
HPA axis inhibitors depend on the dose (manifested by 24 -hour urine or cortisol's AUC in plasma) that have been recorded with inhaled budesonids, although plasma cortisol's physiological rhythms are maintained.
This shows that the inhibition of HPA axis is a manifestation of physiological response to the inhaled budesonid, not necessarily with adrenal insufficiency. The lowest dose has not yet been set up, leading to clinical symptoms. It is very rare for adrenal dysfunction with clinical manifestations that have been recorded in patients using inhaled budesonids at the recommended dose.
Serious clinical disorders of HPA axis or adrenal insufficiency caused by severe stress (such as trauma, surgery, bacterial infection, especially gastritis or severe conditions due to severe power outages) may be related to inhaled budesonid in special patients. These are patients who move from oral corticosteroids (see oral corticosteroids) and patients who are taking simultaneously metabolic drugs by CYP3A4 enzymes (see interaction).
Should monitor signs of adrenal dysfunction in these patients. For these patients, it is also advisable to consider the use of systemic glucocorticoids during stress, severe asthma attacks, or an urgent surgery.
Bone densityAlthough high doses of corticosteroids can affect bone weight, long -term monitoring studies (3-6 years) on Budesonid treatment in adults in recommended doses, as well as a research on patients with high risk of osteoporosis do not prove adverse effects on bone density compared to placebo. The lowest dose has not yet set the lowest dose affecting bone density.
Bone mineral density indicators in children should be carefully analyzed because the growth of bone area in children in developing can reflect the increase in bone volume.
growth
Long -term studies show that children treated with Budesonid inhaled form finally reach the target height as adults. However, the reduction of growth at first (about 1cm) was recorded and often occurred during the first year of treatment. Medical staff should closely monitor the growth in children and adolescents using long -term corticosteroids.
To minimize the systemic effects of inhaled corticosteroids, the lowest dose should be effective for each patient.
Do not stop the drug suddenly when treated with systemic steroids.
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.
Should avoid simultaneous treatment with iTraconazole, ritonavir or powerful CYP3A4 inhibitors. If it cannot be avoided, the distance between the use of drugs should be interacted with each other as long as possible.
Symbicort should be used carefully for patients with thyroid poisoning, chromium cell tumors, diabetes, untreated potassium potassium, obstructive hypertrophic heart disease, non -radical aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders such as ischemic heart disease, fast heart rate, severe heart failure and patients with sensitive sensitivity to non -controlled hyperthyroidism.
Precautions when treating in patients has a long period of QTC. Formoterol itself can extend the time QTC.
Patients with infections and tuberculosis
high doses of glucocorticosteroids can cover signs of infection and infection that can occur while taking the drug. It is important to pay special attention to patients with tuberculosis or fungal infection, bacteria or respiratory viruses that progress or hidden.
Cardiovascular disorders
Beta-2 agonists are at risk of right ventricular disorders, so they should be considered before starting bronchodial spasms.
Studies on acute toxicity as well as chronic toxicity shows the effects of formoterol on the cardiovascular system are the main including congestion, tachycardia, arrhythmia and myocardial lesions. The pharmacological manifestations are observed after using the high doses of the Beta-2 Adrenegic fortunes.
Patients with previous cardiovascular problems may increase the risk of adverse effects on the heart when using beta-2 Adrenegic agar. Precautions need to be formoterol for patients with serious cardiovascular problems such as ischemia, tachycardia or severe heart failure.
Hemoto hypoassiasis
The high doses of beta-2 owner can reduce serum potassium caused by re-distributing potassium from the extracellular cavity into the intracellular cavity through stimulating Na+/k+-Aatpase in muscle cells.
Serious hypokalemia can occur. It is necessary to be particularly cautious in the plays because other risks may be increased due to hypoxia. The impact of hypotension may be hidden by combined treatments. Patients who use digoxin are particularly sensitive to hematuria. Serum potassium concentration should be monitored in this case.
diabetes
Due to the effect of increasing the blood sugar of beta-2 stimulants, the enhancement of blood sugar is recommended as soon as diabetic patients started treatment with formoterol.
visual disorders
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.
Hepatic failure and kidney failure
The impact of reducing liver function and kidney function on pharmacokinetics of formoterol and budesonid is not known. However, because Budesonid and Formoterol are mainly eliminated through liver metabolism, the drug concentration may occur in patients with severe liver disease.
pneumonia
Clinical and gross analysis have shown that COPD treatment with inhaled corticosteroids may increase the risk of pneumonia. However, the absolute risk of Budesonid is low.
Cancer ability
The risk of cancer of a combination of Budesonid/Formoterol has not been seen in animal studies.
toxicity on genes
Individual, budesonid and formoterol toxicity on gene in a series of gene mutations (except for slight increase in reverse frequency of Salmonella Typhimurium at high concentrations of formoterol), chromosomes and DNA repair. The combination of budesonid and formoterol has not been verified in gene toxic tests.
The ability to drive and operate machinery
drivers and operating machinery should be cautious when using Symbicort Rapihaler until the impact of Symbicort Rapihaler on the individual is determined. Symbicort Rapihaler almost does not affect the ability to drive and operate machinery.
Pregnancy
There is no clinical data on the use of Budesonid and Formoterol in pregnant women.
Symbicort Rapihaler should only be used during pregnancy when the benefits are much better than the risk to the fetus. Symbicort Rapihaler is only used in the first three months of pregnancy and short time before birth after careful consideration.
Because beta -operated owners, including formoterol, is likely to hinder uterine spasm due to the effect of stretching the uterus smooth muscle, Symbicort Rapihaler is only used during birth only when the benefits are much better than the risk.
budesonid
Results from a major research study on epidemiology and experience in the circulation of drugs worldwide show that using inhaled budesonid during pregnancy does not cause adverse effects on fetus or infants.
If treatment by glucocorticosteroid during pregnancy is inevitable, inhaled corticosteroids like budesonid may be considered because of low body effects. The lowest dose has the effect of budesonid to maintain asthma control should be used.
formoterol
There is no monster effect found in the mouse using Formoterol Fumarat at oral dose 60mg/kg/day or inhaling dose 1.2mg/kg/day.
cardiovascular defects in the fetus are found in a study in which pregnant rabbits are used for oral doses of 125mg or 500mg/kg/day during the formation of the organ system, but the same results are not recorded at another study with the same dose level. In a third study, the increase in the percentage of cysts under the liver is observed in a rabbit fetus using oral dose 60mg/kg/day.
Lose weight loss at birth and growth/after birth is observed when the mouse is used Formoterol Fumarat at the oral dose of 0.2mg/kg/day or higher in the late pregnancy period.
Breastfeeding period
Budesonid is excreted through breast milk. However, due to the relatively low dosage when used in the inhaler, if the drug is present in breast milk, it is also low.
People still do not know if the formoterol is excreted into breast milk or not. On the mouse, formoterol excreted into breast milk. There are no studies on breastfeeding animals using Budesonid/Formoterol combination. Increasing the postpartum mortality rate at the formoterol oral dose used for mothers is 0.2mg/kg/day or more, and slow growth in the children at the dose of oral 15mg/kg/day has been observed in a mouse study.
There are no good studies on breastfeeding women using Symbicort Rapihaler. Because many drugs are excreted through breast milk, consider using Symbicort Rapihaler for women who are breastfeeding if the benefits bring to the mother greater than the risk to the baby.
Medicinal interaction
pharmacokinetic interaction
Budesonid's metabolism is mainly intermediaries by CYP3A4 enzyme. Strong inhibitors CYP3A4 (such as ketoconazole, otraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodon and HIV protease inhibitors) can significantly increase plasma budesonide concentration and should avoid simultaneous use of these drugs. If not, the time between the use of inhibitors and Budesonid should be as far as possible.
This is less clinically significant when treated short -term (1-2 weeks) with ketoconazole, but it is necessary to consider when long -term treatment with ketoconazole or other strong CYP3A4 inhibitors.
Pharmacological interaction
Beta receptor blockers
Beta receptor blockers, especially non-selective types, can inhibit partial or complete effects of beta-2 agar. These drugs may also increase the airway resistance, so it is not recommended to use these drugs for asthma patients.
Other sympathetic drugs
β-commenergic stimulants or sympathetic amines like ephedrin should not be used simultaneously with formoterol, because of accumulated effect. Patients who have used high doses of sympathetic amino should not use Formoterol.
Xanthin, Mineralocorticosteroids and Diuretics
Hemoto reduction may occur due to the use of beta-2 agonists and may increase if the treatment is combined with Xanthin, Mineralocorticosteroid derivatives and diuretics.
Monoamine inhibitors, three -round antidepressants, quinidin, disopyramid, processianamid, phenothiazine and antihistamine
The adverse effects on the formoterol's heart may be more serious due to simultaneous use with drugs that extend the QT interval and increase the risk of ventricular arrhythmia. Because of these reasons, it is necessary to use formoterol for patients who are using monoamine inhibitors, three -round antidepressants, quinidin, disopyramid, processiaamid, phenothiazine or histamine related to extending QT (Terfenadin, Astemizol).
Moreover, L-Dopa, L-Thyroxin, Oxytocin and alcohol can affect the tolerance of the heart for the Beta-2 sympathetic drug.
Simultaneously used with monoamine oxida inhibitors including agents with characteristics similar to furazolidon and processbazin that 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.
Storage
Do not store over 30 ° C. Store the spray bottle with the head.
Cover the lid after using Symbicort Rapihaler.
Other drugs
- CAMCOLIT 250MG FILM-COATED TABLETS
- Circadin
- NUROFEN 400MG TABLETS
- OMNIC XL 400MICROGRAMS TABLETS
- Resolor
- ZINNAT SUSPENSION 250MG/5ML
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Popular Keywords
- metformin obat apa
- alahan panjang
- glimepiride obat apa
- takikardia adalah
- erau ernie
- pradiabetes
- besar88
- atrofi adalah
- kutu anjing
- trakeostomi
- mayzent pi
- enbrel auto injector not working
- enbrel interactions
- lenvima life expectancy
- leqvio pi
- what is lenvima
- lenvima pi
- empagliflozin-linagliptin
- encourage foundation for enbrel
- qulipta drug interactions