Symbicort 160/4.5 mcg

Contraindications

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What is the most important information I should know about Symbicort 160/4.5 mcg?

The use of Symbicort 160/4.5 mcg is contraindicated in the following conditions:

Undesirable effects

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What are the possible side effects of Symbicort 160/4.5 mcg?

Since Symbicort 160/4.5 mcg pMDI contains both Symbicort 160/4.5 mcg, 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 Symbicort 160/4.5 mcg pMDI with Symbicort 160/4.5 mcg, 679 adults and adolescents (study 681 and 715) were exposed to Symbicort 160/4.5 mcg 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 Symbicort 160/4.5 mcg pMDI and Symbicort 160/4.5 mcg 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 Symbicort 160/4.5 mcg pMDI and Symbicort 160/4.5 mcg with regard to total daily dose, age, sex and ethnic group, and no new safety concerns were identified with Symbicort 160/4.5 mcg pMDI.

If oropharyngeal candidiasis develops, it may be treated with appropriate antifungal therapy whilst still continuing with Symbicort 160/4.5 mcg 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 (Symbicort 160/4.5 mcg), Formoterol (Symbicort 160/4.5 mcg) and Symbicort 160/4.5 mcg 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.

Therapeutic indications

Symbicort 160/4.5 mcg is indicated for the treatment of asthma in patients 12 years of age and older.

Long-acting beta2-adrenergic agonists, such as Formoterol (Symbicort 160/4.5 mcg) one of the active ingredients in Symbicort 160/4.5 mcg, 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, Symbicort 160/4.5 mcg 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 Symbicort 160/4.5 mcg) 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 Symbicort 160/4.5 mcg for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Important Limitations of Use:

Symbicort 160/4.5 mcg 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. Symbicort 160/4.5 mcg 160/4.5 is the only approved dosage for the treatment of airflow obstruction in COPD.

Important Limitations of Use:

Symbicort 160/4.5 mcg 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. Symbicort 160/4.5 mcg will not relieve an asthma attack that has already started.

Symbicort 160/4.5 mcg 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 (Symbicort 160/4.5 mcg) 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 (Symbicort 160/4.5 mcg) 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.

Symbicort 160/4.5 mcg is available only with your doctor's prescription.

Name of the medicinal product

Qualitative and quantitative composition

Each delivered dose (the dose that leaves the mouthpiece) contains: Budesonide (Symbicort 160/4.5 mcg) 80 micrograms/inhalation and Formoterol (Symbicort 160/4.5 mcg) fumarate dihydrate 4.5 micrograms/inhalation, Budesonide (Symbicort 160/4.5 mcg) 160 micrograms/inhalation and Formoterol (Symbicort 160/4.5 mcg) fumarate dihydrate 4.5 micrograms/inhalation, respectively.

Symbicort 160/4.5 mcg 80/4.5 micrograms/inhalation delivers the same amount of Symbicort 160/4.5 mcg as the corresponding Turbuhaler monoproducts, i.e. Budesonide (Symbicort 160/4.5 mcg) 100 micrograms/inhalation (metered dose) and Formoterol (Symbicort 160/4.5 mcg) 6 micrograms/inhalation (metered dose) alternatively labelled as 4.5 micrograms/inhalation (delivered dose).

Symbicort 160/4.5 mcg 160/4.5 micrograms/inhalation delivers the same amount of Symbicort 160/4.5 mcg as the corresponding Turbuhaler monoproducts, i.e. Budesonide (Symbicort 160/4.5 mcg) 200 micrograms/inhalation (metered dose) and Formoterol (Symbicort 160/4.5 mcg) 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 (Symbicort 160/4.5 mcg) 320 micrograms/inhalation and Formoterol (Symbicort 160/4.5 mcg) fumarate dihydrate 9 micrograms/inhalation.

Symbicort 160/4.5 mcg 320/9 micrograms/inhalation delivers the same amount of Symbicort 160/4.5 mcg as the corresponding Turbuhaler monoproducts, i.e. Budesonide (Symbicort 160/4.5 mcg) 400 micrograms/inhalation (metered dose) and Formoterol (Symbicort 160/4.5 mcg) 12 micrograms/inhalation (metered dose) alternatively labelled as 9 micrograms/inhalation (delivered dose).

Excipients/Inactive Ingredients: Symbicort 160/4.5 mcg 80/4.5 micrograms/inhalation: Lactose monohydrate 810 micrograms per dose.

Symbicort 160/4.5 mcg 160/4.5 micrograms/inhalation: Lactose monohydrate 730 micrograms per dose.

Special warnings and precautions for use

Use Symbicort 160/4.5 mcg as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Symbicort 160/4.5 mcg comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Symbicort 160/4.5 mcg refilled.
• Store Symbicort 160/4.5 mcg in the foil package until right before use.
• You will need to prime the inhaler before using it for the first time, any time it has not been used for more than 7 days, or if it has been dropped. To prime the inhaler, shake it for 5 seconds, then release a test spray into the air away from your face. Shake well again for 5 seconds and release a second test spray into the air.
• To use Symbicort 160/4.5 mcg, remove the inhaler from the foil pouch. Write the date that you open the foil pouch on the dose tracker card that comes with Symbicort 160/4.5 mcg.
• Be sure that the canister is properly placed in the inhaler unit. Shake well. Remove the mouthpiece cover. Check the mouthpiece for foreign objects. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow, deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Symbicort 160/4.5 mcg. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes. Close the mouthpiece cover after each use.
• Wipe the mouthpiece clean with a dry cloth at least once a week.
• Rinse your mouth with water after you finish using the medicine (do not swallow). This will help remove excess medicine and decrease your risk of developing an oral fungal infection.
• Use the enclosed dose tracker card to keep track of the number of puffs you have used. Throw the inhaler away after you have used the labeled number of puffs or after it has been removed from the foil pouch for longer than 3 months, even if the container does not feel empty.
• Use the new inhaler that comes with each refill. Do not reuse an old inhaler. Do not use Symbicort 160/4.5 mcg with a different kind of inhaler.
• Never wash the mouthpiece or any other part of the inhaler with water. Keep it dry and always store in a dry place. Do NOT try to take the inhaler apart.
• Continue to use Symbicort 160/4.5 mcg even if you feel well. Do not miss any doses.
• If you miss a dose of Symbicort 160/4.5 mcg, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Symbicort 160/4.5 mcg.

Asthma (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.

Data from 2 randomized, double-blind, parallel group trials support the use of Symbicort 160/4.5 mcg (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.

Dosage (Posology) and method of administration

Symbicort 160/4.5 mcg 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 Symbicort 160/4.5 mcg 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 Symbicort 160/4.5 mcg is not recommended as some patients are more likely to experience adverse effects with higher doses of Formoterol (Symbicort 160/4.5 mcg). Patients using Symbicort 160/4.5 mcg should not use additional long-acting beta2-agonists for any reason.

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 Symbicort 160/4.5 mcg for patients 12 years of age and older are based upon patients' asthma severity.

The maximum recommended dosage is Symbicort 160/4.5 mcg 160/4.5 mcg twice daily.

Improvement in asthma control following inhaled administration of Symbicort 160/4.5 mcg 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 Symbicort 160/4.5 mcg 80/4.5, replacement with Symbicort 160/4.5 mcg 160/4.5 may provide additional asthma control.

If a previously effective dosage regimen of Symbicort 160/4.5 mcg 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 Symbicort 160/4.5 mcg with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

For patients with COPD the recommended dose is Symbicort 160/4.5 mcg 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.

Interaction with other medicinal products and other forms of interaction

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What other drugs will affect Symbicort 160/4.5 mcg?

In clinical studies, concurrent administration of Symbicort 160/4.5 mcg 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 Symbicort 160/4.5 mcg.

The main route of metabolism of corticosteroids, including Budesonide (Symbicort 160/4.5 mcg), a component of Symbicort 160/4.5 mcg, 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 (Symbicort 160/4.5 mcg) increased. Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, Budesonide (Symbicort 160/4.5 mcg). Caution should be exercised when considering the coadministration of Symbicort 160/4.5 mcg with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin).

Symbicort 160/4.5 mcg 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 (Symbicort 160/4.5 mcg), a component of Symbicort 160/4.5 mcg, on the vascular system may be potentiated by these agents. In clinical trials with Symbicort 160/4.5 mcg, a limited number of COPD and asthma patients received tricyclic antidepressants, and, therefore, no clinically meaningful conclusions on adverse events can be made.

Beta-blockers (including eye drops) may not only block the pulmonary effect of beta-agonists, such as Formoterol (Symbicort 160/4.5 mcg), a component of Symbicort 160/4.5 mcg, 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.

The 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 Symbicort 160/4.5 mcg with non-potassium-sparing diuretics.