PULMICORT RESPULES

Absorption: In asthmatic children 4-6 years of age, the total absolute bioavailability (i.e., lung + oral) following administration of PULMICORT RESPULES via jet nebulizer was approximately 6% of the labeled dose. In children, a peak plasma concentration of 2.6 nmol/L was obtained approximately 20 minutes after nebulization of a 1 mg dose. Systemic exposure, as measured by AUC and C max , is similar for young children and adults after inhalation of the same dose of PULMICORT RESPULES. Distributi...

Three double-blind, placebo-controlled, parallel group, randomized U.S. clinical trials of 12-weeks duration each were conducted in 1018 pediatric patients, 6 months to 8 years of age, 657 males and 361 females (798 Caucasians, 140 Blacks, 56 Hispanics, 3 Asians, 21 Others) with persistent asthma of varying disease duration (2 to 107 months) and severity. Doses of 0.25 mg, 0.5 mg, and 1 mg administered either once or twice daily were compared to placebo to provide information about appropriate dosing to cover a range of asthma severity. A Pari-LC-Jet Plus Nebulizer (with a face mask or mouthpi...

Systemic and inhaled corticosteroid use may result in the following:

• Candida albicans Infection [see Warnings and Precautions (5.1) ]
• Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.3) ]
• Immunosuppression [see Warnings and Precautions (5.4) ]
• Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ]
• Reduction in Bone Mineral Density [see Warnings and Precautions (5.7) ]
• Growth Effects in Pediatric Patients [see Warnings and Precaut...

The use of PULMICORT RESPULES is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
• Hypersensitivity to budesonide or any of the ingredients of PULMICORT RESPULES [see Warnings and Precautions (5.3) , Description (11) , Adverse Reactions (6.2) ] .
• Primary treatment of status asthmaticus...

• Localized Infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation ( 5.1 )
• Deterioration of Disease and Acute Asthma Episodes: Do not use for the relief of acute bronchospasm ( 5.2 )
• Hypersensitivity Reactions: Anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of PULMICORT RESPULES. D...

7 DRUG INTERACTIONS Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects ( 5.12 , 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the...