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  • Pulmicort
    (budesonide)

    OTHER BRAND NAMES

    Pulmicort Respules, Pulmicort Flexhaler

    THERAPEUTIC CLASS

    Corticosteroid

    DEA CLASS

    RX

    INDICATIONS

    (Flexhaler) Maintenance treatment of asthma as prophylactic therapy in patients ≥6 yrs of age. (Respules) Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 yrs of age.

    ADULT DOSAGE

    Adults: ≥18 Yrs: (Flexhaler) Individualize dose. Initial: 180-360mcg bid. Max: 720mcg bid. Titrate to the lowest effective dose once asthma stability is achieved. Elderly: Start at lower end of dosing range.

    PEDIATRIC DOSAGE

    Pediatrics: ≥6 Yrs: (Flexhaler) Individualize dose. Initial: 180-360mcg bid. Max: 360mcg bid. 1-8 Yrs: (Respules) Previous Bronchodilators Alone: Initial: 0.5mg qd or 0.25mg bid. Max: 0.5mg/day. Previous Inhaled Corticosteroids: Initial: 0.5mg qd or 0.25mg bid up to 0.5mg bid. Max: 1mg/day. Previous Oral Corticosteroids: Initial: 1mg qd or 0.5mg bid. Max: 1mg/day. Not Responding to Nonsteroidal Therapy: Initial: 0.25mg qd. Titrate to the lowest effective dose once asthma stability is achieved. After 1 week of budesonide, gradually reduce PO corticosteroid dose. If once-daily treatment does not provide adequate control, increase total daily dose and/or administer as a divided dose.

    ADMINISTRATION

    Oral inhalation route. After use, rinse mouth with water without swallowing. (Flexhaler) Prime prior to initial use and inhale deeply and forcefully each time the device is used. (Respules) Administer via jet nebulizer connected to air compressor with adequate air flow, equipped with mouthpiece or suitable face mask. Refer to PI for proper administration.

    HOW SUPPLIED

    Powder, Inhalation: (Flexhaler) 90mcg/dose, 180mcg/dose. Sus, Inhalation: (Respules) 0.25mg/2mL, 0.5mg/2mL, 1mg/2mL [2mL]

    CONTRAINDICATIONS

    Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. (Flexhaler) Severe hypersensitivity to milk proteins.

    WARNINGS/PRECAUTIONS

    Candida albicans infections of mouth and pharynx reported; treat and/or d/c if needed. Not indicated for the rapid relief of bronchospasm or other acute episodes of asthma; may require oral corticosteroids. Increased susceptibility to infections (eg, chickenpox, measles), may lead to serious/fatal course; if exposed, consider prophylaxis/treatment. Caution with tuberculosis (TB), untreated systemic fungal, bacterial, viral or parasitic infections, and ocular herpes simplex. Deaths due to adrenal insufficiency reported with transfer from systemic to inhaled corticosteroids (ICS); if oral corticosteroids are required, wean slowly from systemic steroid use after transferring to ICS. Transfer from systemic to inhalation therapy may unmask allergic conditions (eg, rhinitis, conjunctivitis). Observe for systemic corticosteroid withdrawal effects. Hypercorticism and adrenal suppression may appear; reduce dose slowly. Decreases in bone mineral density (BMD) reported; caution with chronic use of drugs that can reduce bone mass (eg, anticonvulsants, corticosteroids). May cause reduction in growth velocity in pediatrics. Glaucoma, increased intraocular pressure, and cataracts reported. Bronchospasm, with immediate increase in wheezing, may occur; d/c immediately. Rare cases of systemic eosinophilic conditions and vasculitis consistent with Churg-Strauss syndrome reported. Hypersensitivity reactions reported; d/c if signs and symptoms occur. (Flexhaler) Caution in elderly.

    ADVERSE REACTIONS

    Respiratory infection. (Flexhaler) Nasopharyngitis, headache, fever, sinusitis, pain, N/V, insomnia, dry mouth, weight gain. (Respules) Rhinitis, otitis media, coughing, viral infection, ear infection, gastroenteritis.

    DRUG INTERACTIONS

    Oral ketoconazole increases plasma levels of oral budesonide. Inhibition of metabolism and increased exposure with CYP3A4 inhibitors. Caution with ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, itraconazole, nefazodone).

    PREGNANCY AND LACTATION

    Category B, caution in nursing.

    MECHANISM OF ACTION

    Corticosteroid; not established. Shown to have inhibitory activities against multiple cell types and mediators involved in inflammatory and asthmatic response.

    PHARMACOKINETICS

    Absorption: Flexhaler: (Adults) Tmax=10 min; Cmax=0.6nmol/L (180mcg qd), 1.6nmol/L (360mcg bid). (Peds) Tmax=15-30 min; Cmax=0.4nmol/L (180mcg qd), 1.5nmol/L (360mcg bid). Respules: (4-6 yrs of age) Absolute bioavailability (6%); Cmax=2.6nmol/L; Tmax=20 min. Distribution: Vd=3L/kg; plasma protein binding (85-90%); found in breast milk. Metabolism: Liver (extensive) via CYP450 and CYP3A4; 16α-hydroxyprednisolone and 6β-hydroxybudesonide (major metabolites). Elimination: Urine and feces (metabolites); (IV) Urine (60%). Flexhaler: T1/2=2-3 hrs. Respules: T1/2=2.3 hrs.

    ASSESSMENT

    Assess for concomitant diseases (eg, status asthmaticus, acute bronchospasm, other acute episodes of asthma), infections, major risk factors for decreased bone mineral content, history of eye disorders, hypersensitivity, pregnancy/nursing status, and possible drug interactions. Obtain baseline cortisol production levels. Assess lung function in oral corticosteroids withdrawal. (Flexhaler) Assess for severe milk protein hypersensitivity and hepatic disease.

    MONITORING

    Monitor for localized oral infections with C. albicans, worsening or acutely deteriorating asthma, systemic corticosteroid effects, decreased BMD, height in children, vision change, bronchospasm, and hypersensitivity reactions. (Flexhaler) Monitor for hepatic disease.

    PATIENT COUNSELING

    Advise to use at regular intervals and rinse mouth after inhalation; effectiveness depends on regular use. Instruct to d/c if oral candidiasis or hypersensitivity reactions occur. Inform that medication is not meant to relieve acute asthma symptoms and extra doses should not be used for that purpose. Instruct not to d/c without physician's guidance; symptoms may recur after discontinuation. Warn to avoid exposure to chickenpox or measles; if exposed, consult physician. Counsel that maximum benefit may not be achieved for ≥1-2 weeks (Flexhaler) or ≥4-6 weeks (Respules); instruct to notify physician if symptoms worsen or do not improve in that time frame. (Flexhaler) Instruct not to repeat inhalation even if the patient did not feel medication when inhaling; discard whole device after labeled number of inhalations have been used. Advise to carry a warning card indicating need for supplemental systemic corticosteroid during periods of stress or severe asthma attack if chronic systemic corticosteroids have been reduced or withdrawn. Instruct to consult physician if pregnant/breastfeeding or intend to become pregnant.

    STORAGE

    (Flexhaler): 20-25°C (68-77°F). Cover tightly. Store in a dry place. (Respules): 20-25°C (68-77°F). Protect from light. Do not freeze. After aluminum foil opened, unused ampules stable for 2 weeks. Once opened, use promptly.