budesonide intranasal (Rx, OTC)

Brand and Other Names:Rhinocort Aqua, Rhinocort Allergy
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal spray

  • 32mcg/actuation (Rhinocort Aqua, Rhinocort Allergy, various Rx generics)
  • Rhinocort Aqua (Rx)
  • Rhinocort Allergy (OTC)
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Allergic Rhinitis

Indicated for seasonal or perennial allergic rhinitis

Rhinocort Aqua (Rx)

  • Initial dose: 1 spray/nostril qDay (64 mcg/day)
  • Not to exceed 4 sprays/nostril qDay (256 mcg/day)

Rhinocort Allergy (OTC)

  • <12 years: Safety and efficacy not established
  • 2 sprays/nostril qDay (128 mcg/day); once allergy symptoms improve, reduce dose to 1 spray/nostril qDay (64 mcg/day)

Dosage Forms & Strengths

intranasal spray

  • 32mcg/actuation (Rhinocort Aqua, Rhinocort Allergy, various Rx generics)
  • Rhinocort Aqua (Rx)
  • Rhinocort Allergy (OTC)
more...

Allergic Rhinitis

Indicated for seasonal or perennial allergic rhinitis

Rhinocort Aqua (Rx)

  • <6 years: Safety and efficacy not established
  • Initial dose: 1 spray/nostril qDay (64 mcg/day)
  • 6-11 years: Not to exceed 2 sprays/nostril qDay (128 mcg/day)
  • ≥12 years: Not to exceed 4 sprays/nostril qDay (256 mcg/day)

Rhinocort Allergy (OTC)

  • <6 years: Safety and efficacy not established
  • 6-12 years: 1 spray/nostril qDay (64 mcg/day); iff allergy symptoms do not improve, may increase to 2 sprays/nostril qDay (128 mcg/day)
  • ≥ 12 years: 2 sprays/nostril qDay (128 mcg/day); once allergy symptoms improve, reduce dose to 1 spray/nostril qDay (64 mcg/day)
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Adverse Effects

1-10%

Epistaxis (8%)

Pharyngitis (4%)

Bronchospasm (2%)

Cough (2%)

Nasal irritation (2%)

Postmarketing Reports

Immune system disorders: immediate and delayed hypersensitivity reactions (including anaphylactic reaction, urticaria, rash, dermatitis, angioedema and pruritus)

Eye disorders: glaucoma, increased intraocular pressure, cataracts

Respiratory, thoracic, and mediastinal disorders: nasal septum perforation, anosmia, pharynx disorders (throat irritation, throat pain, swollen throat, burning throat, and itchy throat), and wheezing

Cardiac disorders: palpitations

Musculoskeletal and connective tissue disorders: growth suppression

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Warnings

Contraindications

Hypersensitivity

Cautions

Reports of epistaxis, Candida albicans infections, nasal septal perforation, and impaired wound healing; avoid with recent nasal ulcers, surgery, or trauma

Anaphylaxis, urticaria, rash, dermatitis, angioedema, and pruritus may occur

Potential worsening of infections (eg, existing tuberculosis, fungal bacterial, viral, or parasitic infections; or ocular herpes simplex); more serious or even a fatal course of chickenpox or measles can occur in susceptible patients

Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dose in susceptible individuals

Because of potential for HPA-axis suppression, monitor growth of pediatric patients

May increase risk for glaucoma and cataracts

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Distributed in breast milk; estimated total daily oral dose of budesonide available in breast milk to infant is ~0.3-1% of dose inhaled by mother

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Anti-inflammatory corticosteroid that elicits potent glucocorticoid activity (week mineralocorticoid activity)

Corticosteroids have a wide range of inhibitory activities against multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and nonallergic-mediated inflammation

Absorption

Bioavailability: Low (~10% PO); 34% (nasal mucosa absorption)

Peak Plasma Time: 0.5 hr

Peak Plasma Concentration: 0.3 nmol/L

Distribution

Protein Bound: 85-90%

Vd: 2-3 L/kg

Metabolism

Metabolized by CYP3A4

Metabolites: 16-alpha-hydroxyprednisolone; 6-beta-hydroxybudesonide (negligible activity)

Elimination

Half-life, terminal: 2-3 hr

Total body clearance: 1-1.4 L/min

Excretion: as metabolites in feces (33%) and urine (66%)

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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