Action

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.

Availability

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.

Dosage adjustment

• Moderate to severe hepatic disease

Contraindications

• Hypersensitivity to drug

• Status asthmaticus

Precautions

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.

Administration

• 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.

Adverse reactions

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

Interactions

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

Patient monitoring

• Monitor respiratory status to evaluate drug efficacy.

See Stay alert for hypersensitivity reactions, especially angioedema.

• Evaluate liver function test results.

• Periodically observe patient for proper inhaler use.

• Assess oral cavity for infection.

Patient teaching

• Teach patient proper use of inhaler.

• Tell patient to swallow capsules whole without crushing or chewing them.

See 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.