ciclesonide intranasal (Rx)

Brand and Other Names:Omnaris, Zetonna
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal spray

  • 50mcg/actuation (Omnaris)
  • 37mcg/actuation (Zetonna)
more...

Seasonal/Perennial Allergic Rhinitis

Omnaris: 2 sprays/nostril qDay; not to exceed 200 mcg/day

Zetonna: 1 spray/nostril qDay; not to exceed 74 mcg/day

Dosing Considerations

Must be used on a daily basis as effectiveness depends on regular use

Onset of effect is usually seen 36 hr after 1st dose

Administration

Gently shake and prime nasal spray by actuating 3 times before using for the first time or when not in use for 4 consecutive days

Dosage Forms & Strengths

intranasal spray

  • 37mcg/actuation (Zetonna)
  • 50mcg/actuation (Omnaris)
more...

Seasonal Allergic Rhinitis

Omnaris

  • <6 years: Safety and efficacy not established
  • >6 years: 2 sprays/nostril qDay (ie, 200 mcg/day)

Zetonna

  • <12 years: Safety and efficacy not established
  • >12 years: 1 spray/nostril qDay (ie, 74 mcg/day)

Perennial Allergic Rhinitis

Omnaris

  • <12 years: Safety and efficacy not established
  • >12 years: 2 sprays/nostril qDay (ie, 200 mcg/day)

Zetonna

  • <12 years: Safety and efficacy not established
  • >12 years: 1 spray/nostril qDay (ie, 74 mcg/day)

Administration

Gently shake and prime nasal spray by actuating 3 times before using for the first time or when not in use for 4 consecutive days

Next:

Adverse Effects

1-10%

Headache (3.1-6.6%)

Epistaxis (2.9-6%)

Nasopharyngitis (3.7%)

Nasal discomfort (3.2%)

Ear pain (2.2%)

<1%

Nasal congestion

Nasal ulcer

Dizziness

Localized infections of nose/mouth with Candida albicans

Previous
Next:

Warnings

Contraindications

Hypersensitivity

Cautions

Epistaxis, Candida albicans infection, nasal septal perforation, and impaired wound healing reported; monitor patients periodically for signs of adverse effects on nasal mucosa

Avoid spraying directly onto nasal septum

Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma

Monitor for change in vision or with history of increased IOP, glaucoma, and/or cataracts

Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex

Corticosteroids are known to cause immunosuppression; more serious or even fatal infections (eg, chickenpox or measles) may occur in susceptible patients

Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals; discontinue gradually if these changes occur

Potential reduction in growth velocity in children

Nasal/inhaled corticosteroids may increase risk for glaucoma and cataracts

Previous
Next:

Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk; however, other corticosteroids are excreted in human milk; exercise caution

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.

more...
Previous
Next:

Pharmacology

Mechanism of Action

Glucocorticoid

Ciclesonide is a prodrug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application; desciclesonide has anti-inflammatory activity with 120 times the affinity for the glucocorticoid receptor than the parent compound

Absorption

Bioavailability: Negligible

Distribution

Protein Bound: >99%

Vd: 2.9 L/kg (parent compound); 12.1 L/kg (active metabolite)

Metabolism

Metabolites: Prodrug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1)

Metabolized by: Desciclesonide metabolized in liver by CYP3A4 and to a lesser extent by CYP2D6

Elimination

Excretion: Feces (66%); urine (~20%)

Previous
Next:

Images

Previous
Next:

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.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous