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Symbicort

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Symbicort

INDICATIONS

Maintenance Treatment of Asthma

SYMBICORT (budesonide and formoterol fumarate dihydrate) is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 12 years of age and older.

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death [see WARNINGS AND PRECAUTIONS]. One of the active ingredients of SYMBICORT (budesonide and formoterol fumarate dihydrate) is formoterol, a long-acting beta2-agonist, therefore, when treating patients with asthma, SYMBICORT (budesonide and formoterol fumarate dihydrate) should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies.

Important Limitations of Use
  • SYMBICORT (budesonide and formoterol fumarate dihydrate) is NOT indicated for the relief of acute bronchospasm.
  • SYMBICORT (budesonide and formoterol fumarate dihydrate) is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.

Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

SYMBICORT (budesonide and formoterol fumarate dihydrate) 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 (budesonide and formoterol fumarate dihydrate) 160/4.5 is the only approved dosage for the treatment of airflow obstruction in COPD.

Important Limitations of Use

SYMBICORT (budesonide and formoterol fumarate dihydrate) is not indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

SYMBICORT (budesonide and formoterol fumarate dihydrate) 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. [see Patient Counseling Information]

Prime SYMBICORT (budesonide and formoterol fumarate dihydrate) 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 (budesonide and formoterol fumarate dihydrate) is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol. Patients using SYMBICORT (budesonide and formoterol fumarate dihydrate) should not use additional long-acting beta2-agonists for any reason. [See WARNINGS AND PRECAUTIONS]

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 SYMBICORT (budesonide and formoterol fumarate dihydrate) for patients 12 years of age and older are based upon patients' asthma severity.

For patients who are not currently receiving inhaled corticosteroid therapy, but whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, the recommended starting dose is SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5 or 160/4.5, two inhalations twice daily depending upon asthma severity.

The maximum recommended dosage is SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 mg twice daily.

For all patients it is desirable to titrate to the lowest effective strength after adequate asthma stability is achieved.

Improvement in asthma control following inhaled administration of SYMBICORT (budesonide and formoterol fumarate dihydrate) 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 (budesonide and formoterol fumarate dihydrate) 80/4.5, replacement with SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 may provide additional asthma control.

If a previously effective dosage regimen of SYMBICORT (budesonide and formoterol fumarate dihydrate) 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 (budesonide and formoterol fumarate dihydrate) 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 SYMBICORT (budesonide and formoterol fumarate dihydrate) 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.

HOW SUPPLIED

Dosage Forms And Strengths

SYMBICORT (budesonide and formoterol fumarate dihydrate) is available as a metered-dose inhaler containing a combination of budesonide (80 or 160 mcg) and formoterol (4.5 mcg) as an inhalation aerosol in the following two strengths: 80/4.5 and 160/4.5. Each dosage strength contains 60 or 120 actuations per/canister. Each strength of SYMBICORT (budesonide and formoterol fumarate dihydrate) is supplied with a red plastic actuator with a gray dust cap.

SYMBICORT (budesonide and formoterol fumarate dihydrate) is available in two strengths and is supplied in the following package sizes:

Package Size NDC
SYMBICORT 80/4.5, 120 inhalations 0186-0372-20
SYMBICORT 80/4.5, 60 inhalations (institutional pack) 0186-0372-28
SYMBICORT 160/4.5, 120 inhalations 0186-0370-20
SYMBICORT 160/4.5, 60 inhalations (institutional pack) 0186-0370-28

Each strength is supplied as a pressurized aluminium canister with an attached counting device, a red plastic actuator body with a white mouthpiece, and attached gray dust cap. Each 120 inhalation canister has a net fill weight of 10.2 grams and each 60 inhalation canister has a net fill weight of 6.9 grams (SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5) or 6 grams (SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5). Each canister is packaged in a foil overwrap pouch with desiccant sachet and placed into a carton. Each carton contains one canister and a Medication Guide.

The SYMBICORT (budesonide and formoterol fumarate dihydrate) canister should only be used with the SYMBICORT (budesonide and formoterol fumarate dihydrate) actuator, and the SYMBICORT (budesonide and formoterol fumarate dihydrate) actuator should not be used with any other inhalation drug product.

The correct amount of medication in each inhalation cannot be ensured after the labeled number of inhalations from the canister have been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of inhalations have been used or within 3 months after removal from the foil pouch. Never immerse the canister into water to determine the amount remaining in the canister (“float test”).

Store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP]. Store the inhaler with the mouthpiece down.

For best results, the canister should be at room temperature before use. Shake well for 5 seconds before using.

Keep out of the reach of children.

CONTENTS UNDER PRESSURE.

Do not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures over 120F may cause bursting. Never throw container into fire or incinerator.

Manufactured for: AstraZeneca LP, Wilmington, DE 19850. By: AstraZeneca Dunkerque Production, Dunkerque, France. Product of France.

Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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