budesonide(redirected from Novolizer Budesonide)
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Pharmacologic class: Corticosteroid (inhalation)
Therapeutic class: Antiasthmatic, steroidal anti-inflammatory
Pregnancy risk category B (intranasal, inhalation); C (oral)
FDA Box Warning
• Pulmicort Respules is meant only for inhalation by compressed air-driven jet nebulizers (not ultrasonic devices). It must not be injected. Read patient instructions before using.
Decreases inflammation by inhibiting migration of inflammatory mediators to injury site, where it reverses dilation and increases vessel permeability. Also decreases plasma exudation and mucus secretions within airway.
Capsules (extended-release): 3 mg
Inhalation powder: 90 mcg (Pulmicort Flexhaler), 180 mcg (Pulmicort Flex-haler)
Inhalation suspension (Respules): 0.25 mg/2 ml, 0.5 mg/2 ml, 1 mg/ml
Nasal spray: 32 mcg/metered spray (7-g canister)
Indications and dosages
➣ Maintenance treatment of asthma as prophylactic therapy
Adults: 360 mcg (powder for oral inhalation) inhaled b.i.d. For some patients, 180 mcg inhaled b.i.d. may be appropriate. Maximum dosage is 720 mcg b.i.d.
Children ages 6 to 17: 180 mcg (powder for oral inhalation) inhaled b.i.d. For some patients, dosage of 360 mcg inhaled b.i.d. may be appropriate. Maximum dosage is 360 mcg b.i.d.
➣ Seasonal or perennial allergic rhinitis
Adults and children ages 6 and older: Two sprays in each nostril in morning and evening, or four sprays in each nostril in morning. Maintenance dosage is fewest number of sprays needed to control symptoms.
➣ Mild to moderate active Crohn's disease involving ileum, ascending colon, or both
Adults: 9 mg P.O. daily for up to 8 weeks. For recurring episodes of active Crohn's disease, 8-week course can be repeated and tapered to 6 mg P.O. daily for 2 weeks before complete cessation.
• Moderate to severe hepatic disease
• Hypersensitivity to drug
• Status asthmaticus
Use cautiously in:
• renal disease, hepatic disease, heart failure, active untreated infections, systemic infections, hypertension, osteoporosis, diabetes mellitus, glaucoma, underlying immunosuppression, hypothyroidism, diverticulitis, nonspecific ulcerative colitis, recent intestinal anastomoses, thromboembolic disorders, seizures, myasthenia gravis, ocular herpes simplex infection
• patients receiving concurrent systemic corticosteroids
• pregnant or breastfeeding patients
• children younger than age 6.
• If patient also uses a bronchodilator, give that drug at least 15 minutes before budesonide.
• Know that using a spacer reduces risk of candidiasis and hoarseness.
• Make sure patient swallows capsules whole without crushing or chewing them.
CNS: headache, nervousness, depression, euphoria, psychoses, increased intracranial pressure
CV: hypertension, Churg-Strauss syndrome, thrombophlebitis, thromboembolism
EENT: cataracts, nasal congestion, nasal burning or dryness, epistaxis, perforated nasal septum, hoarseness, nasopharyngeal and oropharyngeal fungal infections
GI: nausea, vomiting, peptic ulcers, anorexia, esophageal candidiasis, dry mouth
Metabolic: hyperglycemia, decreased growth (in children), cushingoid appearance (moon face, buffalo hump), adrenal suppression or insufficiency
Musculoskeletal: muscle wasting, muscle pain, osteoporosis, aseptic joint necrosis
Respiratory: cough, wheezing, rebound congestion, bronchospasm
Skin: facial edema, rash, petechiae, contact dermatitis, acne, bruising, hirsutism, urticaria
Other: bad taste, anosmia, weight gain or loss, increased susceptibility to infection, angioedema, hypersensitivity reaction
Drug-drug. Amphotericin B, mezlocillin, piperacillin, thiazide and loop diuretics, ticarcillin: additive hypokalemia
Digoxin: increased risk of digoxin toxicity
Erythromycin, indinavir, itraconazole, ketoconazole, ritonavir, saquinavir: increased blood level and effects of budesonide
Fluoroquinolones: increased risk of tendon rupture
Hormonal contraceptives: blockage of budesonide metabolism
Insulin, oral hypoglycemics: increased budesonide requirement
Live-virus vaccines: decreased antibody response to vaccine, increased risk of adverse effects from budesonide
Nonsteroidal anti-inflammatory drugs (including aspirin): increased risk of adverse GI effects
Phenobarbital, phenytoin, rifampin: decreased budesonide efficacy
Somatrem, somatropin: decreased response to budesonide
Drug-food. Grapefruit, grapefruit juice: increased blood level and effects of budesonide
High-fat meal: delayed peak budesonide concentration
• Monitor respiratory status to evaluate drug efficacy.
☞ Stay alert for hypersensitivity reactions, especially angioedema.
• Evaluate liver function test results.
• Periodically observe patient for proper inhaler use.
• Assess oral cavity for infection.
• Teach patient proper use of inhaler.
• Tell patient to swallow capsules whole without crushing or chewing them.
☞ Instruct patient to contact prescriber immediately if he develops itching, rash, fever, swelling of face and neck, or difficulty breathing.
• Encourage patient to document medication use and his response in diary.
• Advise patient to report signs and symptoms of fungal infections of mouth.
• Tell female patient to inform prescriber if she is pregnant or plans to become pregnant.
• Caution patient to avoid exposure to chickenpox and measles, if possible.
• Emphasize importance of rinsing mouth after each inhaler treatment and washing and drying inhaler thoroughly after each use.
• Instruct patient to avoid high-fat meals, grapefruit, and grapefruit juice.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and foods mentioned above.
budesonideA nebulisable synthetic glucocorticosteroid, structurally related to 16α-hydroxyprednisolone, which has high topical anti-inflammatory activity, low systemic activity and enhanced receptor-binding activity, but more rapid presystemic metabolism than other corticosteroids.
Coup, asthma, allergic rhinitis, inflammatory colitides—e.g., ulcerative colititis and Crohn’s disease; seasonal or perennial.
Nasal irritation, sores and bleeding, upset stomach, cough, dry mouth, rash, muscle cramps.