Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X), FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)
RPK Pharmaceuticals, Inc.
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA). Important Limitations of Use: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is also indicated to reduce exacerbations of COPD. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitat
Product: 53002-2667 NDC: 53002-2667-1 1 AEROSOL in a POUCH / 1 in a CARTON
New Drug Application Authorized Generic
DIHYDRATE AEROSOL RPK Pharmaceuticals, Inc. ---------- Medication Guide SYMBICORT (SIM-bi-kort) (budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol SYMBICORT (SIM-bi-kort) (budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol What is the most important information I should know about SYMBICORT? SYMBICORT can cause serious side effects, including: 1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in SYMBICORT) have an increased risk of death from asthma problems. It is not known whether budesonide, the other medicine in SYMBICORT, reduces the risk of death from asthma problems seen with formoterol. Call your healthcare provider if breathing problems worsen over time while using SYMBICORT. You may need different treatment. Get emergency medical care if: • your breathing problems worsen quickly. • you use your rescue inhaler medicine, but it does not relieve your breathing problems. 2. SYMBICORT should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid. 3. When your asthma is well controlled, your healthcare provider may tell you to stop taking SYMBICORT. Your healthcare provider will decide if you can stop SYMBICORT without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid. 4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems. What is SYMBICORT? SYMBICORT combines an inhaled corticosteroid medicine, budesonide and a LABA medicine, formoterol. • Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. • LABA medicines are used in people with chronic obstructive pulmonary disease (COPD) and asthma. LABA medicines help the muscles ar Διαβάστε το πλήρες έγγραφο
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE- BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL RPK PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL, FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 2006 INDICATIONS AND USAGE BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta -adrenergic agonist indicated for: • • Important limitations: • DOSAGE AND ADMINISTRATION For oral inhalation only. • • • DOSAGE FORMS AND STRENGTHS Metered-dose inhaler containing a combination of budesonide (80 or 160 mcg) and formoterol (4.5 mcg) as an inhalation aerosol. (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • 2 Treatment of asthma in patients 6 years of age and older. (1.1) Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2) Not indicated for the relief of acute bronchospasm. (1.1, 1.2) Treatment of asthma in patients 12 years and older: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 or 160/4.5 twice daily. Starting dosage is based on asthma severity. (2.2) Treatment of asthma in patients aged 6 to less than 12 years: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 twice daily. (2.2) Maintenance treatment in COPD: 2 inhalations of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 twice daily. (2.3) Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. (4) Hypersensitivity to Διαβάστε το πλήρες έγγραφο