Budesonide

budesonide

(bue des' oh nide)

Inhalation:

Entocort (CAN), Pulmicort Respules, Pulmicort Turbuhaler, Rhinocort Aqua, Rhinocort Turbuhaler (CAN)

Oral:

Entocort EC

Pregnancy Category B

Drug class

Corticosteroid

Therapeutic actions

Anti-inflammatory effect; local administration into nasal passages maximizes beneficial effects on these tissues, while decreasing the likelihood of adverse effects from systemic absorption.

Indications

·        Management of symptoms of seasonal or perennial allergic rhinitis in adults and children; nonallergic perennial rhinitis in adults

Turbuhaler

·        Maintenance treatment of asthma as prophylactic therapy in adults and children > 6 yr and for patients requiring corticosteroids for asthma

Inhalation suspension

·        Maintenance treatment and prophylaxis therapy of asthma in children 12 mo–8 yr

Oral

·        Treatment of mild to moderate active Crohn's disease involving the ileum or ascending colon

Contraindications and cautions

Inhalation

·        Contraindicated with hypersensitivity to drug or for relief of acute asthma or broncho­spasm.

·        Use cautiously with TB, systemic infections, lactation.

Oral

·        Contraindicated with hypersensitivity to drug, lactation.

·        Use cautiously with TB, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataracts, family history of diabetes or glaucoma, other conditions in which glucocorticosteroids may have unwanted effects.

Nasal

·        Contraindicated with hypersensitivity to drug, nasal infections, nasal trauma, nasal septal ulcers, recent nasal surgery.

·        Use cautiously with lactation, TB, systemic infection.

Available forms

Aerosol—32 mcg/actuation; dry powder for inhalation—200 mcg (each actuation delivers 160 mcg); inhalation suspension—0.25 mg/2 mL, 0.5 mg/2 mL; capsules—3 mg

Dosages

Nasal inhalation

ADULTS AND PATIENTS > 6 YR

Initial dose, 64 mcg/day given as 1 spray in each nostril morning and evening. After desired clinical effect is achieved, reduce dose to the smallest dose possible to maintain the control of symptoms. Generally takes 3–7 days to achieve maximum clinical effect.

Pulmicort Turbuhaler

ADULTS

Previously on inhaled corticosteroids: Initially, 200–400 mcg twice daily, maximum dose, 800 mcg bid (4 inhalations).

Previously on bronchodilators alone: 200–400 mcg bid.

Previously on oral corticosteroids: 400–800 mcg bid.

PEDIATRIC PATIENTS

Children > 6 yr previously on inhaled corticosteroids: 200 mcg bid.

Children > 6 yr previously on bronchodilators alone: 200 mcg bid.

Children > 6 yr previously on oral corticosteroids: 400 mcg bid.

Respules

PEDIATRIC PATIENTS 12 MO–8 YR

0.25–1 mg once daily or in two divided doses of Respules, using jet nebulizer.

Oral

ADULTS

9 mg/day PO taken in the morning for up to 8 wk. Recurrent episodes may be retreated for 8-wk periods. Maintenance treatment, 6 mg/day PO for up to 3 mo, then taper until cessation is complete.

PEDIATRIC PATIENTS

Safety and efficacy not established.

PATIENTS WITH HEPATIC IMPAIRMENT

Monitor patients very closely for signs of hypercorticism; reduced dosage should be considered with these patients.

Pharmacokinetics

Route	Onset	Peak	Duration
Intranasal, inhaled	Immediate	Rapid	8–12 hr
Oral	Slow	0.5–10 hr	Unknown

Metabolism: Hepatic; T_1/2: 2–3.6 hr (oral); T_1/2: 2.8 hr (inhalation)

Distribution: Crosses placenta; may enter breast milk

Excretion: Urine

Adverse effects

·        CNS: Headache, dizziness, lethargy, fatigue, paresthesias, nervousness

·        Dermatologic: Rash, edema, pruritus, alopecia

·        Endocrine: HPA suppression, Cushing's syndrome with overdosage and systemic absorption

·        GI: Nausea, dyspepsia, dry mouth

·        Local: Nasal irritation, fungal infection

·        Respiratory: Epistaxis, rebound congestion, pharyngitis, cough

·        Other: Chest pain, asthenia, moon face, acne, bruising, back pain

Interactions

Oral use

Drug-drug

·        Increased risk of corticosteroid toxic effects if combined with ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or other known CYP3A4 inhibitors; if drugs must be used together, decrease dosage of budesonide and monitor patient closely

Drug-food

·        Risk of increased toxic effects if combined with grapefruit juice; avoid this combination.

Nursing considerations

Assessment

·        History: Untreated local nasal infections, nasal trauma, septal ulcers, recent nasal surgery, lactation

·        Physical: BP, P, auscultation; R, adventitious sounds; examination of nares

Interventions

Inhalation

·        WARNING: Taper systemic steroids carefully during transfer to inhalational steroids; deaths from adrenal insufficiency have occurred.

·        Arrange for use of decongestant nose drops to facilitate penetration if edema, excessive secretions are present.

·        Prime unit before use for Pulmicort Turbuhaler; have patient rinse mouth after each use.

·        Use aerosol within 6 mo of opening. Shake well before each use.

·        Store Respules upright and protected from light; gently shake before use; open envelopes should be discarded after 2 wk.

Oral

·        Make sure patient does not cut, crush, or chew capsules; they must be swallowed whole.

·        Administer the drug once each day, in the morning; do not administer with grapefruit juice.

·        Encourage patient to complete full 8 wk of drug therapy.

·        WARNING: Monitor patient for signs of hypercorticism—acne, bruising, moon face, swollen ankles, hirsutism, skin striae, buffalo hump—which could indicate need to decrease dosage.

Teaching points

Inhalation

·        Do not use more often than prescribed; do not stop without consulting your health care provider.

·        It may take several days to achieve good effects; do not stop if effects are not immediate.

·        Use decongestant nose drops first if nasal passages are blocked.

·        Prime unit before use for Pulmicort Turbuhaler; rinse mouth after each use.

·        Store Respules upright, protect from light; discard open envelopes after 2 weeks; gently shake before use.

·        You may experience these side effects: Local irritation (use your device correctly), dry mouth (suck sugarless lozenges).

·        Report sore mouth, sore throat, worsening of symptoms, severe sneezing, exposure to chickenpox or measles, eye infections.

Oral

·        Take the drug once a day in the morning. Do not cut, crush, or chew the capsules, they must be swallowed whole.

·        If you miss a day, take the capsules as soon as you remember them. Take the next day's capsules at the regular time. Do not take more than three capsules in a day.

·        Take the full course of the drug therapy (8 weeks in most cases).

·        Do not take this drug with grapefruit juice; avoid grapefruit juice entirely while using this drug.

·        Store Respules upright, protected from light; discard open envelopes after 2 weeks. Shake before use.

·        You may experience these side effects: Dizziness, headache (avoid driving or operating dangerous machinery if these effects occur); nausea, flatulence (frequent small meals may help; try to maintain your fluid and food intake).

·        Report chest pain, ankle swelling, respiratory infections, increased bruising.

Adverse effects in Italic are most common; those in Bold are life-threatening.