ciclesonide intranasal (Rx)

Brand and Other Names:Omnaris, Zetonna
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal spray

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

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)

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

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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

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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

Ocular toxicity

  • Monitor patients for signs or symptoms of ocular toxicity, which may include blurred vision and reduced visual acuity
  • Immune-mediated ocular toxicity may be associated with retinal detachment or permanent vision loss
  • Administer corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis
  • Permanently discontinue therapy for immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy
  • If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt Koyanagi-Harada-like syndrome, which has been observed in patients receiving drug and may require treatment with systemic steroids to reduce risk of permanent vision loss
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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.

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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%)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Zetonna nasal
-
37 mcg/actuation aerosol
Omnaris nasal
-
50 mcg aerosol
Alvesco inhalation
-
80 mcg/actuation aerosol
Alvesco inhalation
-
160 mcg/actuation aerosol
Alvesco inhalation
-
160 mcg/actuation aerosol

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
ciclesonide nasal

CICLESONIDE SPRAY - NASAL

(sye-KLES-oh-nide)

COMMON BRAND NAME(S): Omnaris

USES: This medication is used to treat symptoms of the nose (stuffiness or congestion, runny nose, itching, and sneezing) caused by seasonal and year-round nasal allergies. Ciclesonide works by reducing the swelling (inflammation) of the nasal passages. It belongs to the class of drugs known as corticosteroids.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using ciclesonide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Gently blow your nose before using this drug. Shake the container gently before each use. Remove the dust cap. Follow the instructions on how to properly prime the bottle when you first use each bottle or if you have not used it for 4 days. A fine spray means that the pump is primed properly.Use this medication usually once a day as directed by your doctor. Do not use more than 2 sprays in each nostril daily as this may increase the risk of side effects. Avoid spraying this medication in your eyes or directly onto the nasal septum (the wall between the two nostrils). Follow the detailed instructions for using the spray.After each use, wipe the spray tip with a clean tissue and replace the protective cap. If the spray tip becomes blocked, do not try to unblock the nasal applicator by using a sharp object. Look at the Patient Information Leaflet to learn how to correctly unblock the spray bottle.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.This medication does not work right away. Some people will feel this medication working within 2 days, but it may take up to 2 weeks for seasonal allergy relief, and up to 5 weeks for year-round allergy relief. When using ciclesonide to prevent seasonal allergy symptoms, start this medication 2-4 weeks before pollen season begins.Keep track of the number of sprays used from each container. Discard the container after you have used the number of sprays specified on the manufacturer's package or 4 months after you removed the bottle from the foil pouch it came in, whichever comes first.Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Nosebleeds, irritation of the nose, or ear pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Using corticosteroids in the nose for a long time may rarely cause fungal infections of the nose or throat. Tell your doctor right away if you develop any of the following: fever, pain in the nose, severe sore throat, pain when swallowing, white patches on the back of the throat.Tell your doctor right away if any of these rare but very serious side effects occur: severe nosebleeds, severe pain in the nose, whistling sound while breathing, eye pain.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ciclesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent nose problems (such as injury, ulcers, surgery), current/past infections (including tuberculosis, herpes eye infection), certain eye problems (glaucoma, cataracts).Avoid exposure to chickenpox or measles infection while using this medication. If you are exposed to these infections, seek immediate medical attention.Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.If you use this medication for a long time, laboratory and/or medical tests (such as nose exams, height measurement in children) may be performed to monitor your progress and check for side effects.Ask your doctor for ways to reduce your exposure to substances (such as pollen, pet dander, dust mites, mold, smoke) that can worsen allergy symptoms.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature. Do not freeze. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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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.
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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.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.