Zetonna

— THERAPEUTIC CATEGORIES —
  • Rhinitis/rhinorrhea (intranasal products)

Zetonna Generic Name & Formulations

General Description

Ciclesonide 37mcg/actuation; metered-dose nasal aerosol; contains HFA.

Pharmacological Class

Glucocorticoid.

How Supplied

Nasal aerosol—6.1g (60 actuations)

Mechanism of Action

The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic inflammation.

Zetonna Indications

Indications

Treatment of symptoms associated with seasonal and perennial allergic rhinitis.

Zetonna Dosage and Administration

Adult

One actuation in each nostril once daily (37mcg/actuation); max 74mcg/day.

Children

<12yrs: not established.

Zetonna Contraindications

Not Applicable

Zetonna Boxed Warnings

Not Applicable

Zetonna Warnings/Precautions

Warnings/Precautions

Conduct nasal examination before starting treatment. Discontinue if nasal erosion, ulceration, perforation, or Candida infection occurs. Avoid use in patients with recent nasal ulcers/surgery/trauma until healed. Active or quiescent respiratory tract tuberculosis. Infections (eg, fungal, bacterial, viral, parasitic, or ocular herpes simplex). If exposed to measles or chickenpox, consider immunoglobulin prophylactic therapy. Monitor for acute adrenal insufficiency if prolonged systemic corticosteroid therapy is replaced with topical steroids. Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually) and other nasal cavity changes. Monitor for vision changes or in those with a history of increased intraocular pressure, glaucoma or cataracts. Monitor for growth suppression in children. Avoid spraying in eyes or directly onto the nasal septum. Pregnancy. Nursing mothers.

Zetonna Pharmacokinetics

Absorption

Ciclesonide and des-ciclesonide have negligible oral bioavailability (both <1%) due to low GI absorption and high first-pass metabolism.

Distribution

Following IV administration of 800 mcg of ciclesonide, the volumes of distribution of ciclesonide and des-ciclesonide were ~2.9 L/kg and 12.1 L/kg, respectively. The percentage of ciclesonide and des-ciclesonide bound to human plasma proteins averaged ≥99% each, with ≤1% of unbound drug detected in the systemic circulation. Des-ciclesonide is not significantly bound to human transcortin.

Metabolism

Hepatic (Esterases, CYP3A4 [primary], CYP2D6).

Elimination

Fecal (66%), renal (≤20%).

Zetonna Interactions

Interactions

May be potentiated by ketoconazole.

Zetonna Adverse Reactions

Adverse Reactions

Nasal discomfort, headache, epistaxis; hypersensitivity reactions, nasal ulceration, nasal septal perforation, Candida infection, impaired wound healing.

Zetonna Clinical Trials

See Literature

Zetonna Note

Not Applicable

Zetonna Patient Counseling

See Literature

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