Introduction

Synthetic, non-halogenated corticosteroid.

Uses for Budesonide (EENT)

Allergic Rhinitis

Symptomatic treatment of seasonal or perennial allergic rhinitis.

Budesonide (EENT) Dosage and Administration

General

• For therapeutic effectiveness, use at regular intervals.

Administration

Intranasal Inhalation

Administer by nasal inhalation using a metered-dose pump spray.

Shake inhaler gently immediately prior to use.

Prior to initial use, the metered-dose pump spray must be primed with 8 actuations.

If spray pump is not used for 2 consecutive days, partially prime (1 actuation or until a fine spray is observed). If the spray pump is not used for more than 14 days, rinse the applicator and reprime with 2 sprays or until a fine spray appears. Rinse the applicator when not used for more than 14 days.

Clear nasal passages prior to administration.

Tilt the head slightly forward, insert the spray tip into one nostril, and point the tip toward the back of the nose. Pump the drug into one nostril while holding the other nostril closed and concurrently inspire through the nose. Repeat this procedure for the other nostril.

Dosage

After priming, nasal spray pump delivers about 32 mcg of budesonide per metered spray and about 120 metered doses per 8.6-g container.

Pediatric Patients

Titrate dosage to the lowest possible effective level. (See Pediatric Use under Cautions.)

Seasonal Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 64 mcg (2 sprays) in each nostril once daily (128 mcg total).

Children ≥12 years of age: initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 128 mcg (4 sprays) in each nostril once daily (256 mcg total).

Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 64 mcg (2 sprays) in each nostril once daily (128 mcg total).

Children ≥12 years of age: initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 128 mcg (4 sprays) in each nostril once daily (256 mcg total).

Adults

Seasonal Allergic Rhinitis

Intranasal Inhalation

Initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 128 mcg (4 sprays) in each nostril once daily (256 mcg total).

Perennial Allergic Rhinitis

Intranasal Inhalation

Initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 128 mcg (4 sprays) in each nostril once daily (256 mcg total).

Prescribing Limits

Pediatric Patients

Seasonal Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: maximum 128 mcg (2 sprays in each nostril) once daily.

Children ≥12 years of age: maximum 256 mcg (4 sprays in each nostril) once daily.

Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: maximum 128 mcg (2 sprays in each nostril) once daily.

Children ≥12 years of age: maximum 256 mcg (4 sprays in each nostril) once daily.

Adults

Seasonal Allergic Rhinitis

Intranasal Inhalation

Maximum 256 mcg (4 sprays in each nostril) once daily.

Perennial Allergic Rhinitis

Intranasal Inhalation

Maximum 256 mcg (4 sprays in each nostril) once daily.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time.

Contraindications

• Known hypersensitivity to budesonide or any ingredient of the formulation.

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, or severe symptomatic exacerbation of asthma or other clinical conditions if prolonged systemic corticosteroid therapy is replaced with topical corticosteroid therapy; careful monitoring recommended.

Use particular caution in patients with associated asthma or other conditions that may be exacerbated by too rapid a reduction in systemic corticosteroid dosage.

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs. Certain infections (e.g., varicella [chickenpox], measles) can be serious or even fatal in such patients, particularly in children.

Exposure to varicella and measles should be avoided in previously unexposed patients. If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or immune globulin (IG) respectively. Consider treatment with an antiviral agent if varicella develops.

Sensitivity Reactions

Rarely, immediate or delayed hypersensitivity reactions may occur. Wheezing reported very rarely.

General Precautions

Systemic Corticosteroid Effects

Possible growth suppression in children and adolescents. (See Pediatric Use under Cautions.)

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may increase risk of systemic corticosteroid effects (e.g., hypercorticism and adrenal suppression).

To minimize the systemic effects, titrate dosage to the lowest possible effective level; avoid use of higher than recommended dosages. If systemic effects occur, slowly reduce dosage and discontinue drug.

Nasopharyngeal and Ocular Effects

Rarely, localized candidal infections of the nose and/or pharynx have been reported. Local treatment of such infections and/or discontinuance of intranasal therapy may be required.

Rarely, nasal septum perforation and increased intraocular pressure (IOP) have been reported.

Periodically examine nasal passages for mucosal changes during long-term therapy (several months or longer).

Use not recommended in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.

Concomitant Infections

Use with caution, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infection of the respiratory tract; in untreated fungal, bacterial, or systemic viral infections; or ocular herpes simplex infections.

Specific Populations

Pregnancy

Category B.

Use during pregnancy may result in hypoadrenalism in infants; monitor these infants carefully.

Lactation

Not known whether budesonide is distributed into milk. Caution if used in nursing women.

Pediatric Use

Safety and efficacy not established in children <6 years of age.

Intranasal corticosteroids may reduce growth velocity in pediatric patients. Routine monitoring of growth (e.g., via stadiometry) recommended. Titrate dosage to the lowest possible effective level.

Geriatric Use

No overall substantial differences in safety and efficacy relative to younger patients. However, possible increased sensitivity to the drug. Frequency of epistaxis may increase with age.

Hepatic Impairment

Possible decreased clearance and increased systemic availability.

Renal Impairment

Pharmacokinetics not studied in patients with renal impairment.

Common Adverse Effects

Epistaxis, pharyngitis, bronchospasm, cough, nasal irritation.

General

• For therapeutic effectiveness, use at regular intervals.

Administration

Intranasal Inhalation

Administer by nasal inhalation using a metered-dose pump spray.

Shake inhaler gently immediately prior to use.

Prior to initial use, the metered-dose pump spray must be primed with 8 actuations.

If spray pump is not used for 2 consecutive days, partially prime (1 actuation or until a fine spray is observed). If the spray pump is not used for more than 14 days, rinse the applicator and reprime with 2 sprays or until a fine spray appears. Rinse the applicator when not used for more than 14 days.

Clear nasal passages prior to administration.

Tilt the head slightly forward, insert the spray tip into one nostril, and point the tip toward the back of the nose. Pump the drug into one nostril while holding the other nostril closed and concurrently inspire through the nose. Repeat this procedure for the other nostril.

Dosage

After priming, nasal spray pump delivers about 32 mcg of budesonide per metered spray and about 120 metered doses per 8.6-g container.

Pediatric Patients

Titrate dosage to the lowest possible effective level. (See Pediatric Use under Cautions.)

Seasonal Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 64 mcg (2 sprays) in each nostril once daily (128 mcg total).

Children ≥12 years of age: initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 128 mcg (4 sprays) in each nostril once daily (256 mcg total).

Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 64 mcg (2 sprays) in each nostril once daily (128 mcg total).

Children ≥12 years of age: initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 128 mcg (4 sprays) in each nostril once daily (256 mcg total).

Adults

Seasonal Allergic Rhinitis

Intranasal Inhalation

Initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 128 mcg (4 sprays) in each nostril once daily (256 mcg total).

Perennial Allergic Rhinitis

Intranasal Inhalation

Initially, 32 mcg (1 spray) in each nostril once daily (64 mcg total). May be increased to 128 mcg (4 sprays) in each nostril once daily (256 mcg total).

Prescribing Limits

Pediatric Patients

Seasonal Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: maximum 128 mcg (2 sprays in each nostril) once daily.

Children ≥12 years of age: maximum 256 mcg (4 sprays in each nostril) once daily.

Perennial Allergic Rhinitis

Intranasal Inhalation

Children 6–11 years of age: maximum 128 mcg (2 sprays in each nostril) once daily.

Children ≥12 years of age: maximum 256 mcg (4 sprays in each nostril) once daily.

Adults

Seasonal Allergic Rhinitis

Intranasal Inhalation

Maximum 256 mcg (4 sprays in each nostril) once daily.

Perennial Allergic Rhinitis

Intranasal Inhalation

Maximum 256 mcg (4 sprays in each nostril) once daily.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time.

Metabolized by CYP3A4 isoenzyme.

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction (increased plasma budesonide concentrations) with concomitant use of CYP3A4 isoenzyme inhibitors.

Inhibitors of the CYP2C19 isoenzyme do not appear to affect the pharmacokinetics of oral budesonide.

Specific Drugs