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Budesonide (Oral Inhalation)

Pronunciation

Pronunciation

(byoo DES oh nide)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Pulmicort Flexhaler: 90 mcg/actuation (1 ea); 180 mcg/actuation (1 ea) [contains milk protein]

Suspension, Inhalation:

Pulmicort: 0.25 mg/2 mL (2 mL); 0.5 mg/2 mL (2 mL); 1 mg/2 mL (2 mL) [contains disodium edta, polysorbate 80]

Generic: 0.25 mg/2 mL (2 mL); 0.5 mg/2 mL (2 mL); 1 mg/2 mL (2 mL)

Brand Names: U.S.

  • Pulmicort
  • Pulmicort Flexhaler

Pharmacologic Category

  • Corticosteroid, Inhalant (Oral)

Pharmacology

Controls the rate of protein synthesis; depresses the migration of polymorphonuclear leukocytes, fibroblasts; reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation. Has potent glucocorticoid activity and weak mineralocorticoid activity.

Distribution

Children 4 to 6 years: 3 L/kg

Adults: 2.2 to 3.9 L/kg

Metabolism

Hepatic via CYP3A4 to two metabolites: 16 alpha-hydroxyprednisolone and 6 beta-hydroxybudesonide; both are <1% as active as parent

Excretion

Urine (60%) and feces as metabolites

Clearance: Children 4 to 6 years: 0.5 L/minute (~50% greater than healthy adults after weight adjustment); Adults: 0.9 to 1.8 L/minute

Onset of Action

Nebulization: 2 to 8 days; Inhalation: 24 hours

Peak effect: Nebulization: 4 to 6 weeks; Inhalation: 1 to 2 weeks

Time to Peak

Nebulization: Pulmicort Respules: Children: 20 minutes

Oral inhalation: Pulmicort Flexhaler:

Children and Adolescents: 15 to 30 minutes

Adults: 10 minutes

Half-Life Elimination

Children 4 to 6 years: 2.3 hours (after nebulization)

Children and Adolescents 10 to 14 years: 1.5 hours

Adults: 2 to 3.6 hours

Protein Binding

85% to 90%

Special Populations: Hepatic Function Impairment

Patients with cirrhosis had more than doubled systemic availability after oral ingestion.

Use: Labeled Indications

Nebulization: Maintenance and prophylactic treatment of asthma

Oral inhalation: Maintenance and prophylactic treatment of asthma; includes patients who require oral corticosteroids and those who may benefit from systemic dose reduction/elimination

Guideline recommendations: Asthma: A low-dose inhaled corticosteroid (in addition to an as-needed short acting beta 2-agonist) is the initial preferred long term control medication for children, adolescents, and adult patients with persistent asthma who are candidates for treatment according to a step-wise treatment approach (GINA 2016; NAEPP 2007).

Contraindications

Hypersensitivity to budesonide or any component of the formulation; primary treatment of status asthmaticus, acute episodes of asthma; not for relief of acute bronchospasm

Canadian labeling: Additional contraindications (not in US labeling): Moderate-to-severe bronchiectasis, pulmonary tuberculosis (active or quiescent), untreated respiratory infection (bacterial, fungal, or viral)

Dosing: Adult

Asthma: Oral inhalation: Titrate to lowest effective dose once patient is stable.

US labeling: Pulmicort Flexhaler: Initial: 360 mcg twice daily (selected patients may be initiated at 180 mcg twice daily); maximum: 720 mcg twice daily; Note: May increase dose after 1 to 2 weeks of therapy in patients who are not adequately controlled

Canadian labeling: Pulmicort Turbuhaler:

Initial (or during periods of severe asthma or when switching from oral corticosteroid therapy): 400 to 2400 mcg daily in 2 to 4 divided doses

Maintenance: 200 to 400 mcg twice daily (higher doses may be needed for some patients). Patients taking 400 mcg/day may take as a single daily dose.

Asthma guidelines:

National Asthma Education and Prevention Program guidelines (NAEPP 2007): Dry powder inhaler (refers to the Pulmicort Flexhaler available in US). Note: Administer in divided doses twice daily.

“Low” dose: 180 to 600 mcg/day

“Medium” dose: >600 to 1,200 mcg/day

“High” dose: >1,200 mcg/day

Global Initiative for Asthma guidelines (GINA 2016): Dry powder inhaler (refers to the Pulmicort Turbuhaler available in Canada):

“Low” dose: 200 to 400 mcg daily

“Medium” dose: >400 to 800 mcg daily

“High” dose: >800 mcg daily

Conversion: Conversion from oral systemic corticosteroid to orally inhaled corticosteroid: Initiation of oral inhalation therapy should begin in patients whose asthma is reasonably stabilized on oral corticosteroids (OCS). A gradual dose reduction of OCS should begin ~7 to 10 days after starting inhaled therapy. US labeling recommends reducing prednisone dose by 2.5 mg/day (or equivalent of other OCS) on a weekly basis (patients using oral inhaler) or by ≤25% every 1 to 2 weeks (patients using respules). Canadian labeling recommends reducing prednisone dose by 2.5 mg/day (or equivalent of other OCS) every 4 days in closely monitored patients or every 10 days if not closely monitored. If adrenal insufficiency occurs, temporarily increase the OCS dose and follow with a more gradual withdrawal. Note: When transitioning from systemic to inhaled corticosteroids, supplemental systemic corticosteroid therapy may be necessary during periods of stress or during severe asthma attacks.

Chronic obstructive pulmonary disease (acute exacerbation) (off-label use): Nebulization: 2 mg every 6 hours (Maltais 2002)

Chronic obstructive pulmonary disease (stable) (off-label use): Oral inhalation: 100 to 400 mcg daily in combination with a long-acting bronchodilator (GOLD 2014)

Eosinophilic esophagitis (off-label use): Oral: 2 mg/day as an oral budesonide viscous liquid/suspension. Dose may be divided into 2 doses. Avoid ingesting any solid or liquid food for 30 minutes after budesonide administration. (Dellon, 2013; Dohil, 2010; Liacouras, 2011; Rubinstein 2014). See Extemporaneously Prepared.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Asthma: Titrate to lowest effective dose once patient is stable.

Oral inhalation:

US labeling: Pulmicort Flexhaler: Children ≥6 years: Initial: 180 mcg twice daily (some patients may be initiated at 360 mcg twice daily); maximum: 360 mcg twice daily; Note: May increase dose after 1 to 2 weeks of therapy in patients who are not adequately controlled.

Canadian labeling: Pulmicort Turbuhaler:

Children 6 to 11 years:

Initial (or during periods of severe asthma or when switching from oral corticosteroid therapy): 200 to 400 mcg daily in 2 divided doses

Maintenance: Individualized, lowest effective dose in 2 divided doses

Children ≥12 years: Refer to adult dosing.

Asthma guidelines:

National Asthma Education and Prevention Program guidelines (NAEPP 2007): Dry powder inhaler (refers to the Pulmicort Flexhaler available in US). Note: Administer in divided doses twice daily.

Children 5 to 11 years:

“Low” dose: 180 to 400 mcg/day

“Medium” dose: >400 to 800 mcg/day

“High” dose: >800 mcg/day

Children ≥12 years and Adolescents: Refer to adult dosing.

Global Initiative for Asthma guidelines (GINA 2016): Dry powder inhaler (refers to the Pulmicort Turbuhaler available in Canada):

Children 6 to 11 years:

“Low” dose: 100 to 200 mcg daily

“Medium” dose: >200 to 400 mcg daily

“High” dose: >400 mcg daily

Children ≥12 years and Adolescents: Refer to adult dosing.

Conversion: Conversion from oral systemic corticosteroid to orally inhaled corticosteroid: Initiation of oral inhalation therapy should begin in patients whose asthma is reasonably stabilized on oral corticosteroids (OCS). A gradual dose reduction of OCS should begin ~7 to 10 days after starting inhaled therapy. US labeling recommends reducing prednisone dose by 2.5 mg/day (or equivalent of other OCS) on a weekly basis (patients using oral inhaler) or by ≤25% every 1 to 2 weeks (patients using respules). Canadian labeling recommends reducing prednisone dose by 2.5 mg/day (or equivalent of other OCS) every 4 days in closely monitored patients or every 10 days if not closely monitored. If adrenal insufficiency occurs, temporarily increase the OCS dose and follow with a more gradual withdrawal. Note: When transitioning from systemic to inhaled corticosteroids, supplemental systemic corticosteroid therapy may be necessary during periods of stress or during severe asthma attacks.

Nebulization: Pulmicort Respules: Children 12 months to 8 years: Titrate to lowest effective dose once patient is stable; start at 0.25 mg/day or use as follows:

Previous therapy of bronchodilators alone: 0.5 mg/day administered as a single dose or divided twice daily (maximum daily dose: 0.5 mg)

Previous therapy of inhaled corticosteroids: 0.5 mg/day administered as a single dose or divided twice daily (maximum daily dose: 1 mg)

Previous therapy of oral corticosteroids: 1 mg/day administered as a single dose or divided twice daily (maximum daily dose: 1 mg)

Asthma guidelines:

National Asthma Education and Prevention Program guidelines (NAEPP 2007):

Children 0 to 4 years:

“Low” dose: 0.25 to 0.5 mg/day

“Medium” dose: >0.5 to 1 mg/day

“High” dose: >1 mg/day

Children 5 to 11 years:

“Low” dose: 0.5 mg/day

“Medium” dose: 1 mg/day

“High” dose: 2 mg/day

Global Initiative for Asthma guidelines (GINA 2016):

Children ≤5 years: “Low” dose: 0.5 mg daily

Children 6 to 11 years:

“Low” dose: 0.25 to 0.5 mg daily

“Medium” dose: >0.5 to 1 mg daily

“High” dose: >1 mg daily

Oral: Eosinophilic esophagitis (off-label use):

Children ≥10 years of age or ≥5 ft in height: 2 mg/day as an oral budesonide viscous liquid/suspension. Dose may be divided into 2 doses. Avoid ingesting any solid or liquid food for 30 minutes after budesonide administration. (Dellon, 2013; Dohil, 2010; Liacouras, 2011; Rubinstein 2014).

Children <10 years or <5 ft in height: 1 mg/day as an oral budesonide viscous liquid/suspension. Avoid ingesting any solid or liquid food for 30 minutes after budesonide administration. (Dellon, 2013; Dohil, 2010; Liacouras, 2011; Rubinstein, 2014).

Note: See Extemporaneously Prepared field.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, budesonide undergoes hepatic metabolism; drug may accumulate with hepatic impairment; use with caution; monitor closely for signs and symptoms of hypercorticism.

Extemporaneously Prepared

Oral budesonide viscous liquid/suspension: Prepare immediately prior to ingestion from aqueous budesonide solution (1 mg per 2 mL) or nebulized solution (0.5 mg per 2 mL [Pulmicort Respules]) mixed to slurry consistency with 10 packets of Splenda or 2.5 cm3 of Neocate Nutra per milligram of budesonide. (Dellon, 2013; Dohil, 2010; Rubinstein, 2014)

Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693.23567357Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010;139(2):418-429.20457157Rubinstein E, Lee JJ, Fried A, et al. Comparison of 2 delivery vehicles for viscous budesonide to treat eosinophilic esophagitis in children. J Pediatr Gastroenterol Nutr. 2014;59(3):317-320.24821535

Administration

Powder for inhalation:

Pulmicort Flexhaler: Hold inhaler in upright position (mouthpiece up) to load dose. Do not shake prior to use. Unit should be primed prior to first use only. It will not need primed again, even if not used for a long time. Place mouthpiece between lips and inhale forcefully and deeply. Do not exhale through inhaler; do not use a spacer. Dose indicator does not move with every dose, usually only after 5 doses. Discard when dose indicator reads “0”. Rinse mouth with water after each use to reduce incidence of candidiasis.

Pulmicort Turbuhaler [Canadian product]: Hold inhaler in upright position (mouthpiece up) to load dose. Do not shake inhaler after dose is loaded. Unit should be primed prior to first use. Place mouthpiece between lips and inhale forcefully and deeply; mouthpiece should face up. Do not exhale through inhaler; do not use a spacer. When a red mark appears in the dose indicator window, 20 doses are left. When the red mark reaches the bottom of the window, the inhaler should be discarded. Rinse mouth with water after use to reduce incidence of candidiasis.

Suspension for nebulization: Shake well before using. Use Pulmicort Respules with jet nebulizer connected to an air compressor; administer with mouthpiece or facemask. Do not use ultrasonic nebulizer. Do not mix with other medications in nebulizer. Rinse mouth following treatments to decrease risk of oral candidiasis (wash face if using face mask).

Storage

Oral inhaler (Pulmicort Flexhaler): Store at controlled room temperature of 20°C to 25°C (68°F to 77°F). Protect from moisture.

Suspension for nebulization: Store upright at 20°C to 25°C (68°F to 77°F). Protect from light. Do not refrigerate or freeze. Once aluminum package is opened, solution should be used within 2 weeks. Continue to protect from light.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Oral Inhalation). Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

Telaprevir: May increase the serum concentration of Budesonide (Oral Inhalation). Management: Concomitant use of these agents is not recommended, unless the risk for excessive systemic corticosteroid effects is outweighed by the potential benefits. If combined, monitor patients closely for signs and symptoms of corticosteroid excess/toxicity. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Adverse Reactions

Frequencies are for both formulations unless otherwise indicated.

>10%:

Otic: Otitis media (suspension: 12%; powder: 1%)

Respiratory: Respiratory infection (suspension: 38%; powder: ≥3%), rhinitis (5% to 12%)

1% to 10%:

Cardiovascular: Syncope (powder: 1% to 3%), chest pain (suspension: 1% to <3%)

Central nervous system: Headache (powder: ≥3%; suspension: <1%), pain (powder: ≥3%), hypertonia (powder: 1% to 3%), insomnia (powder: 1% to 3%), voice disorder (powder: 1% to 3%), emotional lability (suspension: 1% to <3%), fatigue (suspension: 1% to <3%)

Dermatologic: Skin rash (suspension: 4%; powder: <1%), contact dermatitis (suspension: 1% to <3%), eczema (suspension: 1% to <3%), pruritus (suspension: 1% to <3%), pustular rash (suspension: 1% to <3%)

Endocrine & metabolic: Weight gain (1% to 3%)

Gastrointestinal: Dyspepsia (≥5%), nausea (2% to ≥5%), gastroenteritis (suspension: 5%), diarrhea (suspension: 4%), vomiting (1% to 4%), abdominal pain (1% to 3%), dysgeusia (powder: 1% to 3%), xerostomia (powder: 1% to 3%), anorexia (suspension: 1% to <3%), viral gastroenteritis (powder: 2%), oral candidiasis (powder: 1%)

Hematologic & oncologic: Ecchymosis (powder: 1% to 3%), cervical lymphadenopathy (suspension: 1% to <3%), purpura (suspension: 1% to <3%)

Hypersensitivity: Hypersensitivity reaction (1% to <3%)

Infection: Candidiasis (suspension: 4% to 5%), viral infection (suspension: 4% to 5%), infection (1% to 3%), herpes simplex infection (suspension: 1% to <3%)

Neuromuscular & skeletal: Arthralgia (≥5%), weakness (≥5%), back pain (powder: ≥3%), bone fracture (1% to 3%), myalgia (1% to 3%), neck pain (powder: 1% to 3%), hyperkinesia (suspension: 1% to <3%)

Ophthalmic: Conjunctivitis (suspension: 4%), eye infection (suspension: 1% to <3%)

Otic: Otic infection (suspension: 5%), otalgia (suspension: 1% to <3%), otitis externa (suspension: 1% to <3%)

Respiratory: Nasopharyngitis (powder: 9%), cough (5% to 9%), epistaxis (suspension: 2% to 4%), respiratory tract infection (powder: ≥3%), sinusitis (powder: ≥3%; suspension: <1%), nasal congestion (powder: 3%), pharyngitis (powder: 3%; suspension: <1%), flu-like symptoms (suspension: 1% to <3%), stridor (suspension: 1% to <3%), allergic rhinitis (powder: 2%), viral upper respiratory tract infection (powder: 2%)

Miscellaneous: Fever (≥3%)

<1% (Limited to important or life-threatening): Adrenocortical insufficiency, aggressive behavior, anxiety, avascular necrosis of femoral head, bronchitis, bruise, depression, glaucoma, growth suppression, hypercorticoidism, increased intraocular pressure, irritability, nervousness, osteoporosis, pain, pharyngitis, psychosis, throat irritation, wheezing

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children, in patients receiving high doses for prolonged periods, or with concomitant CYP3A4 inhibitor use. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products or corticosteroids with lower systemic effect due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. Do not use this product to transfer patients directly from oral corticosteroid therapy. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS), should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Bronchospasm: May occur with wheezing after inhalation; if this occurs stop steroid and treat with a fast-acting bronchodilator (eg, albuterol).

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for viral hepatitis. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only in conjunction with antituberculosis treatment).

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered.

• Local oral infections: Candida albicans infections may occur in the mouth and pharynx; rinsing (and spitting) with water after inhaler use may decrease risk.

• Myopathy: Acute myopathy has been reported with high-dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

• Asthma: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus or for the relief of acute bronchospasm.

• Cardiovascular disease: Use with caution in patients with HF or hypertension; long-term use has been associated with fluid retention and hypertension.

• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention. Increased oral bioavailability has been reported in patients with cirrhosis.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.

• Myocardial infarction (MI): Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

• Vasculitis: Rare cases of vasculitis (Churg-Strauss syndrome) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.

Concurrent therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Orally-inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range 0.3-1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally-inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Lactose: Pulmicort Flexhaler contains lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Discontinuation of therapy: Withdraw systemic therapy with gradual tapering of dose. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.

Monitoring Parameters

Monitor growth in pediatric patients; blood pressure, serum glucose, weight with high-dose or long-term oral use; signs and symptoms of hypercorticism or adrenal suppression

Asthma: FEV1, peak flow, and/or other pulmonary function tests

Pregnancy Risk Factor

B (inhalation)

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman 2006; Lunghi 2010). Budesonide may be used for the induction of remission in pregnant women with inflammatory bowel disease (Habal 2012).

Based on available data, an overall increased risk of congenital malformations or a decrease in fetal growth has not been associated with maternal use of inhaled corticosteroids during pregnancy (Bakhireva 2005; NAEPP 2005; Namazy 2004). In addition, studies of pregnant women specifically using inhaled budesonide have not demonstrated an increased risk of congenital abnormalities. Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, pre-eclampsia, preterm birth, low birth weight infants). Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy; budesonide is preferred (ACOG 2008; NAEPP 2005).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nosebleed, rhinitis, rhinorrhea, or pharyngitis. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of skin changes (acne, stretch marks, slow healing, or hair growth), signs of infection, moon face, buffalo hump, ankle edema, severe loss of strength and energy, bone pain, joint pain, vision changes, bruising, bleeding, difficulty breathing, wheezing, cough, or thrush (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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