Entocort (Budesonide)
Class and Category of Drug
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Chemical class: Glucocorticoid
Therapeutic class: Antiasthmatic, anti-inflammatory
Pregnancy category: B
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Drug Indications and Dosages
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To manage symptoms of seasonal or perennial allergic rhinitis
Nasal Aerosol
Adults and children over age 6. 64 meg in each nostril b.i.d. or 128 meg in each nostril daily. Maximum: 256 meg daily. Maintenance: Lowest dosage that controls symptoms.
Nasal Powder
Adults and children over age 6. 200 meg in each nostril daily. Maximum: 800 meg daily (adults and adolescents); 400 meg daily (children). Maintenance: Lowest dosage that controls symptoms.
Nasal Suspension
Adults and children over age 6. 32 meg in each nostril daily. Maximum: 256 meg daily (adults and adolescents); 128 meg daily (children). Maintenance: Lowest dosage that controls symptoms.
To manage symptoms of perennial non-allergic rhinitis
Nasal Aerosol
Adults and adolescents. 64 meg in each nostril b.i.d. or 128 meg in each nostril daily. Maximum: 256 meg daily. Maintenance: Lowest dosage that controls symptoms.
Nasal Powder
Adults and adolescents. 200 meg in each nostril daily. Maximum: 800 meg daily. Maintenance: Lowest dosage that controls symptoms.
To provide maintenance therapy in chronic bronchial asthma
Oral Inhalation
Adults previously on bronchodilators alone. 1 or 2 inhalations (200 to 400 meg) b.i.d. Maximum: 800 meg daily.
Adults previously on inhaled corticosteroids. 1 or 2 inhalations (200 to 400 meg) b.i.d. Maximum: 800 meg b.i.d. as needed and tolerated.
Adults previously on systemic corticosteroids. 2 to 4 inhalations (400 to 800 meg) b.i.d. Maximum: 1,600 meg daily.
Children age 6 and over. 1 inhalation (200 meg) b.i.d. Maximum: 400 meg b.i.d. as needed and tolerated.
Oral Inhalation (Pulmicort Elexhaler)
Adults and adolescents age 18 and over. Initial: 180 or 360 meg b.i.d., increased as needed. Maximum: 720 meg b.i.d.
Children ages 6 to 17. Initial: 180 or 360 meg b.i.d. Maximum: 360 meg b.i.d.
To prevent or provide maintenance therapy in chronic bronchial asthma
Nebulized Inhalation (Pulmicort Respules)
Children ages 1 to 8 previously on bronchodilators alone. 0.25 mg b.i.d. or 0.5 mg daily by jet nebulizer. Maximum: 0.5 mg/day
Children ages 1 to 8 previously on inhaled steroids. 0.25 mg b.i.d. or 0.5 mg daily inhaled by jet nebulizer. Maximum: 1 mg/day.
Children ages 1 to 8 previously on systemic corticosteroids. 0.5 mg b.i.d. or 1 mg daily inhaled by jet nebulizer. Maximum: 1 mg/day.
To treat mild to moderate active Crohn's disease involving the ileum, the ascending colon, or both
Capsules
Adults. 9 mg daily in the morning for 8 wk.
To maintain clinical remission of mild to moderate Crohn's disease involving the ileum, the ascending colon, or both
Capsules
Adults. 6 mg daily in the morning for up to 3 months.
Dosage AdjustmentDosage reduced for patients with heptic insufficiency and those taking ketoconazole or other CYP3A4 inhibitor.
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Contraindications of Drug
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Hypersensitivity to budesonide or its components, recent septal ulcers or nasal surgery or trauma (nasal spray); status asthmaticus or other acute asthma episodes (oral inhalation)
Generic Drug Interactions
Drugs
clarithromycin, erythromycin, itraconazole, ketoconazole, other CYP3A4 inhibitors: Possibly increased blood budesonide level
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Drugs Adverse Reactions
Central Nervous System: Amnesia, asthenia, benign intracranial hypertension, dizziness, fatigue, fever, headache
Eyes, Ears, Nose, And Throat: Bad taste, cataracts, dry mouth, epistaxis, glaucoma, nasal irritation, oral or pharyngeal candidiasis, pharyngitis, rhinitis, sinusitis
Endocrine: Growth suppression in children
Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, flatulence, indigestion, nausea, vomiting
Genitourinary: Urinary tract infection
Musculoskeletal: Arthralgia, back pain
Respiratory: Bronchospasm, increased cough, respiratory tract infection
Skin: Contact dermatitis, purpura, rash, urticaria
Other: Anaphylaxis, angioedema
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Nursing Considerations for Generic Drugs
Use budesonide cautiously if patient has tubercular infection; untreated fungal, bacterial, or systemic viral infection; or ocular herpes simplex.
Closely monitor a child's growth pattern; budesonide may stunt growth.
WARNING Assess patient who switches from a systemic corticosteroid to inhaled budesonide for adrenal insufficiency (fatigue, hypotension, lassitude, nausea, vomiting, weakness), which may be life-threatening. Hypothalamic-pituitary-adrenal axis function may take several months to recover after stopping systemic corticosteroids. Stopping budesonide abruptly may cause adrenal insufficiency.
Administer Respules by jet nebulizer connected to an air compressor.
Patient exposed to chickenpox may receive varicella zoster immune globulin or pooled intravenous immunoglobulin. If chicken-pox develops, give antiviral as ordered. A patient exposed to measles may need pooled intramuscular immunoglobulin.
Assess patient for effectiveness of budesonide therapy, especially if being weaned from a systemic corticosteroid. If patient has increased asthma or an immunologic condition previously suppressed by systemic corticosteroid such as rhinitis, conjunctivitis, an eosinophilic condition, eczema, or arthritis notify prescriber.
Pulmicort Flexhaler contains small amounts of lactose, which may trigger coughing, wheezing, or bronchospasm in a patient with a severe milk-protein allergy.
Monitor patient for evidence of hypersensitivity, such as contact dermatitis, rash, urticaria, angioedema, bronchospasm, or anaphylaxis. If present, notify prescriber immediately. Expect to stop budesonide and provide emergency supportive care.
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