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Budesonide (Nasal)

Pronunciation

Pronunciation

(byoo DES oh nide)

Index Terms

  • Rhinocort Allergy OTC

Dosage Forms

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

Suspension, Nasal:

Rhinocort Allergy: 32 mcg/actuation (5 mL, 8.43 mL) [contains disodium edta, polysorbate 80]

Rhinocort Aqua: 32 mcg/actuation (8.6 g) [contains disodium edta, polysorbate 80]

Generic: 32 mcg/actuation (8.6 g, 8.43 mL)

Brand Names: U.S.

  • Rhinocort Allergy [OTC]
  • Rhinocort Aqua

Pharmacologic Category

  • Corticosteroid, Nasal

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

~2 to 3 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 (~66%) and feces as metabolites

Onset of Action

Rhinocort Aqua: Within 10 hours; Peak effect: Up to 2 weeks

Time to Peak

Plasma: Nasal: 30 minutes

Half-Life Elimination

2 to 3 hours

Protein Binding

85% to 90%

Use: Labeled Indications

US labeling:

Rx: Allergic rhinitis: Management of symptoms of seasonal or perennial allergic rhinitis in adults and children ≥6 years.

OTC: Upper respiratory symptoms: Relief of symptoms of hay fever or other upper respiratory allergies (eg, nasal congestion, runny nose, itchy nose, sneezing) in adults and children ≥6 years.

Canadian labeling:

Nasal polyps: Treatment of nasal polyps; prevention of nasal polyps after polypectomy.

Rhinitis: Management of symptoms of seasonal allergic, perennial, and vasomotor rhinitis unresponsive to conventional therapy.

Use: Unlabeled

Adjunct to antibiotics in empiric treatment of acute bacterial rhinosinusitis (ABRS) (Chow, 2012)

Contraindications

Hypersensitivity to budesonide or any component of the formulation

OTC labeling: When used for self-medication, do not use in children <6 years of age.

Canadian labeling: Additional contraindications (not in US labeling): Tuberculosis (active or quiescent); untreated bacterial, fungal, or viral infections; use in children <6 years of age

Dosing: Adult

US labeling:

Rx: Allergic rhinitis: Intranasal: One spray (32 mcg) in each nostril once daily (total daily dose: 64 mcg/day). Some patients who do not achieve adequate control may benefit from increased dosage. A reduced dosage may be effective after initial control is achieved (maximum dose: 4 sprays [128 mcg] in each nostril once daily [total daily dose: 256 mcg/day]).

OTC: Upper respiratory symptoms: Intranasal: Two sprays (64 mcg) in each nostril once daily (total daily dosage: 128 mcg/day); once symptoms improve, reduce to 1 spray (32 mcg) in each nostril once daily (total daily dosage: 64 mcg/day)

Canadian labeling: Note: Discontinue therapy if significant improvement is not observed within 3 weeks

Nasal polyps: Intranasal:

Rhinocort Aqua: One spray (64 mcg) in each nostril twice daily; total daily dose: 256 mcg/day

Rhinocort Turbuhaler: One application (100 mcg) in each nostril twice daily; total daily dose: 400 mcg/day

Rhinitis: Intranasal: Note: If possible initiate therapy prior to allergen exposure.

Rhinocort Aqua: Initial: Two sprays (128 mcg) in each nostril once daily or 1 spray (64 mcg) in each nostril twice daily (total daily dose: 256 mcg/day); Maintenance: Individualize, use lowest effective dose.

Rhinocort Turbuhaler: Initial: Two applications (200 mcg) in each nostril once daily (total daily dose: 400 mcg/day); Maintenance: Individualize; use lowest effective dose.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Nasal polyps: Children ≥6 years and Adolescents: Intranasal: Canadian labeling: Refer to adult dosing.

Allergic rhinitis (Rx):

US labeling:

Children ≥6 years to <12 years: Intranasal: One spray (32 mcg) in each nostril once daily (total daily dosage: 64 mcg/day). Some patients who do not achieve adequate control may benefit from increased dosage. A reduced dosage may be effective after initial control is achieved (maximum dose: 2 sprays [64 mcg] in each nostril once daily [total daily dosage: 128 mcg/day]).

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

Canadian labeling: Children ≥6 years and Adolescents: Refer to adult dosing.

Upper respiratory symptoms (OTC):

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

Children 6 years to <12 years: Intranasal: One spray (32 mcg) in each nostril once daily (total daily dosage: 64 mcg/day). If symptoms do not improve, may increase to 2 sprays (64 mcg) in each nostril once daily (total daily dosage: 128 mcg/day); once symptoms improve, reduce to 1 spray (32 mcg) in each nostril once daily (total daily dosage: 64 mcg/day).

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 manufacturer’s labeling (has not been studied). Systemic availability of budesonide may be increased in patients with hepatic impairment; monitor closely for signs and symptoms of hypercorticism.

Administration

Inhalation:

Powder for nasal inhalation: Rhinocort Turbuhaler [Canadian product]: To prepare inhaler prior to use, load dose by holding inhaler in upright position and turn grey grip as far as it will go in one direction and then turn it as far as it will go in the other direction. Prior to first use, this procedure should be done twice; with subsequent dosing, perform this procedure once. Clicking sound means inhaler is loaded with dose and ready for use. Place nasal adapter into nostril and ensure firm fit. Cover opposite nostril with finger and inhale (sniff) quickly and forcefully. Do not exhale through inhaler. If the Turbuhaler is dropped, shaken, or exhaled into after it is loaded, the dose will be lost and a new dose will need to be loaded. 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

Suspension for nasal inhalation: Shake gently before use. Prime before first use by actuating 8 times. If not used for 2 consecutive days, reprime with 1 spray or until a fine spray appears; if not used for >14 days, rinse applicator and reprime with 2 sprays or until fine spray appears. Discard after 60 or 120 sprays.

Storage

US labeling: Store with valve up at 20°C to 25°C (68°F to 77°F); do not freeze. Protect from light.

Canadian labeling: Store at 15°C to 30°C (59°F to 86°F).

Drug Interactions

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

Cobicistat: May increase the serum concentration of Budesonide (Nasal). Management: Consider an alternative nasal corticosteroid when possible, particularly for longer-term concurrent use. If this combination must be used, monitor patients closely for evidence of systemic corticosteroid effects including adrenal suppression. Consider therapy modification

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

Telaprevir: May increase the serum concentration of Budesonide (Nasal). Management: Concurrent use of telaprevir with inhaled budesonide is not recommended, unless the risk for excessive systemic corticosteroid effects is outweighed by the potential benefits. Consider therapy modification

Adverse Reactions

1% to 10%: Respiratory: Epistaxis (8%), pharyngitis (4%), bronchospasm (2%), cough (2%), nasal mucosa irritation (2%)

<1% (Limited to important or life-threatening): Anosmia, cataract, crusting of nose, dizziness, fatigue, glaucoma, growth suppression, headache, hypersensitivity reaction, nasal septum perforation, nausea, pharyngeal disease (irritation, itchy throat, throat pain), 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 or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Pediatric patients may be more susceptible to systemic toxicity. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible.

• Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery or nasal trauma until healing has occurred.

• Hypersensitivity: Hypersensitivity reactions (eg, anaphylactic reactions, angioedema, pruritus, urticaria, rash, dermatitis) may occur.

• 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. Avoid exposure to chickenpox and/or measles, especially if not immunized. Avoid use or use with caution in patients with latent/active tuberculosis, untreated bacterial or fungal infections (local or systemic), viral or parasitic infections, or ocular herpes simplex. The Canadian labeling contraindicates use in patients with active or quiescent TB or with untreated bacterial, fungal, or viral infections.

• Local nasal effects: Nasal septal perforation, nasal ulceration, epistaxis, and localized Candida albicans infections of the nose and/or pharynx may occur. Monitor patients periodically for adverse nasal effects; discontinuation of therapy may be necessary if an infection occurs.

Disease-related concerns:

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

Special populations:

• Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercorticism (Cushing syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth).

Concurrent drug 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.

Other warnings/precautions:

• Self-medication (OTC use): Consult a health care provider before use if you have had recent nose ulcers or nose surgery; have a nose injury that has not healed; are using a steroid medicine for asthma, allergies or skin rash; have an eye infection; and/or have or had glaucoma or cataracts. When using this product, symptoms may get better on the first day of treatment; however, it may take up to 2 weeks of daily use to feel the most relief. Discontinue use and consult a health care provider if symptoms do not improve after 2 weeks, or if an infection (eg, persistent fever), changes in vision, or frequent nosebleeds occur. Do not spray into eyes or mouth or use more than directed or for the common cold.

Monitoring Parameters

Monitor growth in pediatric patients; signs/symptoms of HPA axis suppression/adrenal insufficiency; ocular changes; signs/symptoms of Candida infection (long-term therapy)

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. Studies of pregnant women using intranasal budesonide have not demonstrated an increased risk of abnormalities. Intranasal corticosteroids are recommended for the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP, 2005; Wallace, 2008); budesonide is preferred (Wallace, 2008).

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 cough or pharyngitis. Have patient report immediately to prescriber signs of infection, severe dizziness, passing out, severe nose irritation, severe nosebleed, wheezing, nasal sores, thrush, severe nausea, severe vomiting, severe loss of strength and energy, or vision changes (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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