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What is the most important information I should know about Symbicord?
The use of Symbicord is contraindicated in the following conditions:
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What are the possible side effects of Symbicord?
Since Symbicord pMDI contains both Budesonide (Symbicord) and Formoterol (Symbicord), the same adverse effects as reported for these substances may be expected. No increased incidence of adverse reactions has been seen following concurrent administration of the 2 compounds. The most common drug-related adverse reactions are pharmacologically predictable side effects of β2-agonist therapy eg, tremor and palpitations. These tend to be mild and usually disappear within a few days of commencing treatment.
In the clinical program, comparing Symbicord pMDI with Symbicord, 679 adults and adolescents (study 681 and 715) were exposed to Symbicord pMDI 640/18 mcg daily with a median duration of 359 days and a range of 1-427 days.
There were no apparent differences in the overall pattern of adverse effects between the Symbicord pMDI and Symbicord groups in the clinical program. The adverse effects were generally mild to moderate in intensity and the pattern was that usually seen in a population with persistent asthma and dominated by symptoms of upper respiratory events.
Overall, the adverse effect profile was similar for patients receiving Symbicord pMDI and Symbicord with regard to total daily dose, age, sex and ethnic group, and no new safety concerns were identified with Symbicord pMDI.
If oropharyngeal candidiasis develops, it may be treated with appropriate antifungal therapy whilst still continuing with Symbicord therapy. The incidence of candidiasis can generally be held to a minimum by having patients rinse their mouth out with water after each inhalation.
Adverse reactions, which have been associated with Budesonide (Symbicord), Formoterol (Symbicord) and Symbicord are given to the following table:
As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases.
Treatment with β-sympathomimetics may result in an increase in blood levels of insulin, free fatty acids, glycerol, and ketone bodies.
Symbicord is indicated for the treatment of asthma in patients 12 years of age and older.
Long-acting beta2-adrenergic agonists, such as Formoterol (Symbicord) one of the active ingredients in Symbicord, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, Symbicord should only be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Symbicord) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as inhaled corticosteroid. Do not use Symbicord for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Important Limitations of Use:
Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)Symbicord 160/4.5 is indicated for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. Symbicord 160/4.5 is the only approved dosage for the treatment of airflow obstruction in COPD.
Important Limitations of Use:
Budesonide (Symbicord) and Formoterol (Symbicord) is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. Budesonide (Symbicord) and Formoterol (Symbicord) will not relieve an asthma attack that has already started.
Budesonide (Symbicord) and Formoterol (Symbicord) is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.
Inhaled Budesonide (Symbicord) belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.
Inhaled Formoterol (Symbicord) belongs to the family of medicines known as bronchodilators. It works by helping the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath.
Budesonide (Symbicord) and Formoterol (Symbicord) is available only with your doctor's prescription.
Each delivered dose (the dose that leaves the mouthpiece) contains: Budesonide (Symbicord) 80 micrograms/inhalation and Formoterol (Symbicord) fumarate dihydrate 4.5 micrograms/inhalation, Budesonide (Symbicord) 160 micrograms/inhalation and Formoterol (Symbicord) fumarate dihydrate 4.5 micrograms/inhalation, respectively.
Symbicord 80/4.5 micrograms/inhalation delivers the same amount of Budesonide (Symbicord) and Formoterol (Symbicord) as the corresponding Turbuhaler monoproducts, i.e. Budesonide (Symbicord) 100 micrograms/inhalation (metered dose) and Formoterol (Symbicord) 6 micrograms/inhalation (metered dose) alternatively labelled as 4.5 micrograms/inhalation (delivered dose).
Symbicord 160/4.5 micrograms/inhalation delivers the same amount of Budesonide (Symbicord) and Formoterol (Symbicord) as the corresponding Turbuhaler monoproducts, i.e. Budesonide (Symbicord) 200 micrograms/inhalation (metered dose) and Formoterol (Symbicord) 6 micrograms/inhalation (metered dose) alternatively labelled as 4.5 micrograms/inhalation (delivered dose).
Each delivered dose (the dose that leaves the mouthpiece) contains: Budesonide (Symbicord) 320 micrograms/inhalation and Formoterol (Symbicord) fumarate dihydrate 9 micrograms/inhalation.
Symbicord 320/9 micrograms/inhalation delivers the same amount of Budesonide (Symbicord) and Formoterol (Symbicord) as the corresponding Turbuhaler monoproducts, i.e. Budesonide (Symbicord) 400 micrograms/inhalation (metered dose) and Formoterol (Symbicord) 12 micrograms/inhalation (metered dose) alternatively labelled as 9 micrograms/inhalation (delivered dose).
Excipients/Inactive Ingredients: Symbicord 80/4.5 micrograms/inhalation: Lactose monohydrate 810 micrograms per dose.
Symbicord 160/4.5 micrograms/inhalation: Lactose monohydrate 730 micrograms per dose.
Use Symbicord as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Symbicord.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsAsthma (controller/maintenance): Treatment of asthma in patients ≥6 years of age.
Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce COPD exacerbations.
Off Label UsesAsthma (reliever for acute exacerbations)
Data from 2 randomized, double-blind, parallel group trials support the use of Budesonide (Symbicord)/Formoterol (Symbicord) (single combination inhaler) as quick relief on an as-needed basis for acute asthma exacerbations in outpatients with mild to mild to moderate asthma, and reduced overall corticosteroid exposure.
Symbicord should be administered twice daily every day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing.
Prime Symbicord before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well before each spray and releasing two test sprays into the air away from the face.
More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of Symbicord is not recommended as some patients are more likely to experience adverse effects with higher doses of Formoterol (Symbicord). Patients using Symbicord should not use additional long-acting beta2-agonists for any reason.
Asthma
If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Adult and Adolescent Patients 12 Years of Age and Older: For patients 12 years of age and older, the dosage is 2 inhalations twice daily (morning and evening, approximately 12 hours apart).
The recommended starting dosages for Symbicord for patients 12 years of age and older are based upon patients' asthma severity.
The maximum recommended dosage is Symbicord 160/4.5 mcg twice daily.
Improvement in asthma control following inhaled administration of Symbicord can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.
For patients who do not respond adequately to the starting dose after 1-2 weeks of therapy with Symbicord 80/4.5, replacement with Symbicord 160/4.5 may provide additional asthma control.
If a previously effective dosage regimen of Symbicord fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, (e.g., replacing the lower strength of Symbicord with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.
Chronic Obstructive Pulmonary Disease (COPD)
For patients with COPD the recommended dose is Symbicord 160/4.5, two inhalations twice daily.
If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
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What other drugs will affect Symbicord?
In clinical studies, concurrent administration of Symbicord and other drugs, such as short-acting beta-agonists, intranasal corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions. No formal drug interaction studies have been performed with Symbicord.
Inhibitors of Cytochrome P4503A4The main route of metabolism of corticosteroids, including Budesonide (Symbicord), a component of Symbicord, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered Budesonide (Symbicord) increased. Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, Budesonide (Symbicord). Caution should be exercised when considering the coadministration of Symbicord with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin).
Monoamine Oxidase Inhibitors and Tricyclic AntidepressantsSymbicord should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of Formoterol (Symbicord), a component of Symbicord, on the vascular system may be potentiated by these agents. In clinical trials with Symbicord, a limited number of COPD and asthma patients received tricyclic antidepressants, and, therefore, no clinically meaningful conclusions on adverse events can be made.
Beta-Adrenergic Receptor Blocking AgentsBeta-blockers (including eye drops) may not only block the pulmonary effect of beta-agonists, such as Formoterol (Symbicord), a component of Symbicord, but may produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
DiureticsThe ECG changes and/or hypokalemia that may result from the administration of non−potassiumsparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of Symbicord with non-potassium-sparing diuretics.