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Symbicort (Budesonide Inhalation) - Indications and Dosage

 
 



INDICATIONS AND USAGE

SYMBICORT is indicated for the long-term 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). Therefore, when treating patients with asthma, SYMBICORT 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 two maintenance therapies. SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.

SYMBICORT is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

SYMBICORT should be administered by the orally inhaled route in patients with asthma 12 years of age and older. SYMBICORT should not be used for transferring patients from systemic corticosteroid therapy.

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, SYMBICORT 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 two maintenance therapies. SYMBICORT is not indicated for patients whose asthma can be successfully managed by inhaled corticosteroids or other controller medications along with occasional use of inhaled short-acting beta2-agonists.

SYMBICORT is available in 2 strengths, SYMBICORT 80/4.5 and SYMBICORT 160/4.5, containing 80 and 160 mcg of budesonide, respectively, and 4.5 mcg of formoterol fumarate dihydrate per inhalation. Each dose is administered as 2 inhalations twice daily (in the morning and the evening) by the orally inhaled route only. Rinsing the mouth after every dose is advised.

For patients who are currently receiving medium to high doses of inhaled corticosteroid therapy, and whose disease severity clearly warrants treatment with two maintenance therapies, the recommended starting dose is SYMBICORT 160/4.5, 2 inhalations twice daily.

For patients who are currently receiving low to medium doses of inhaled corticosteroid therapy, and whose disease severity clearly warrants treatment with two maintenance therapies, the recommended starting dose is SYMBICORT 80/4.5, 2 inhalations twice daily.

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

If a previously effective dosage regimen of SYMBICORT fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of SYMBICORT with a higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, should be considered.

The maximum daily recommended dose is 640/18 mcg budesonide/formoterol (given as two inhalations of SYMBICORT 160/4.5 twice daily) for patients 12 years of age and older. Do not use more than twice daily or use a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of SYMBICORT as this will result in a daily dose of formoterol in excess of the dose determined to be safe. For all patients, consideration should be given to titrating to the lowest effective strength after adequate asthma stability has been achieved.

SYMBICORT is not approved for the treatment or prevention of exercise-induced bronchospasm. Patients who are receiving SYMBICORT twice daily should not use formoterol or other long-acting beta2-agonists for prevention of exercise-induced bronchospasm, or for any other reason. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

In clinical studies, significant improvement in FEV1 occurred within 15 minutes of beginning treatment with SYMBICORT in most patients and improvement in asthma control (asthma symptoms, albuterol rescue use, PEF) occurred within one day. The maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients may 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 80/4.5, replacing the strength with SYMBICORT 160/4.5 may provide additional asthma control.

SYMBICORT should be primed before using for the first time by releasing 2 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 2 test sprays into the air away from the face.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS, Geriatric Use) have been treated with SYMBICORT, efficacy and safety did not differ from that in younger patients. Based on available data for SYMBICORT and its active components, no dosage adjustment is recommended.

HOW SUPPLIED

SYMBICORT is available in two strengths:

SYMBICORT 80/4.5 (NDC 0186-0372-20) and SYMBICORT 160/4.5 (NDC 0186-0370-20). Each strength is supplied as a pressurized aluminum canister with a shield component, with a red plastic actuator body with white mouthpiece and attached gray dust cap. Each canister contains 120 inhalations and has a net fill weight of 10.2 grams. 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 canister should only be used with the SYMBICORT actuator and the SYMBICORT 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. Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures over 120ºF may cause bursting. Never throw container into fire or incinerator.

SYMBICORT is a trademark of the AstraZeneca group of companies.

©AstraZeneca 2006.

Manufactured for: AstraZeneca LP, Wilmington, DE 19850

By: AstraZeneca Dunkerque Production, Dunkerque, France

Product of France

31152-00

Rev. 7/06

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