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Symbicort (Budesonide Inhalation) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Treatment of Asthma

SYMBICORT is indicated for the treatment of asthma in patients 12 years of age and older.

Long-acting beta2-adrenergic agonists, such as formoterol one of the active ingredients in SYMBICORT, 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 [see Warnings and Precautions ] . Therefore, when treating patients with asthma, SYMBICORT 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) 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 for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Important Limitations of Use:

  • •SYMBICORT is NOT indicated for the relief of acute bronchospasm.

Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

SYMBICORT 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 is the only approved dosage for the treatment of airflow obstruction in COPD.

Important Limitations of Use: SYMBICORT is not indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

SYMBICORT 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 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 is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol. Patients using SYMBICORT should not use additional long-acting beta2-agonists for any reason. [See Warnings and Precautions (5.3, 5.12) ]

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 for patients 12 years of age and older are based upon patients' asthma severity.

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

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

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 lower strength of SYMBICORT 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 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.

DOSAGE FORMS AND STRENGTHS

SYMBICORT 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 is supplied with a red plastic actuator with a gray dust cap.

HOW SUPPLIED/STORAGE AND HANDLING

SYMBICORT is available in two strengths and is supplied in the following package sizes:

Dosage Forms and Strengths

Package Size

NDC

SYMBICORT

Inhalations

80/4.5,

120

0186-0372-20

SYMBICORT

inhalations (institutional pack)

80/4.5,

60

0186-0372-28

SYMBICORT

Inhalations

160/4.5,

120

0186-0370-20

SYMBICORT

inhalations (institutional pack)

160/4.5,

60

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 80/4.5) or 6 grams (SYMBICORT 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 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.

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.

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