Budesonide (EENT)

Brand names: Rhinocort Aqua
Drug class: Antineoplastic Agents

Usage of Budesonide (EENT)

Allergic Rhinitis

Symptomatic treatment of seasonal or perennial allergic rhinitis.

Relate drugs

How to use Budesonide (EENT)

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.

    Warnings

    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.

    What other drugs will affect Budesonide (EENT)

    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

    Drug

    Interaction

    Cimetidine

    Decreased budesonide clearance and increased oral bioavailability

    Clarithromycin

    Increased plasma budesonide concentrations

    Erythromycin

    Increased plasma budesonide concentrations

    Itraconazole

    Increased plasma budesonide concentrations

    Ketoconazole

    Increased plasma budesonide concentrations

    Omeprazole

    No apparent pharmacokinetic interaction

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