ciclesonide inhaled (Rx)

Brand and Other Names:Alvesco
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

MDI

  • 80mcg/inhalation
  • 160mcg/inhalation

Asthma, Prophylaxis

Receiving Bronchodilators or Inhaled Corticosteroids: 80 mcg inhaled PO twice daily initially; may increase to 160 mcg twice daily

Receiving Oral Corticosteroids: 80 mcg inhaled PO twice daily initially; may increase to 320 mcg twice daily

Dosage Forms & Strengths

MDI

  • 80mcg/inhalation
  • 160mcg/inhalation

Asthma Prophylaxis

<12 years

  • Safety and efficacy not established

>12 years

  • Receiving bronchodilators or inhaled corticosteroids: 80 mcg inhaled PO twice daily initially; may increase to 160 mcg twice daily
  • Receiving Oral Corticosteroids: 80 mcg inhaled twice daily initially; may increase to 320 mcg twice daily
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Interactions

Interaction Checker

and ciclesonide inhaled

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (5)

              • abametapir

                abametapir will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • apalutamide

                apalutamide will decrease the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • lonafarnib

                lonafarnib will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

              • saquinavir

                saquinavir will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • tucatinib

                tucatinib will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

              Monitor Closely (24)

              • atazanavir

                atazanavir increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. Increased risk of Cushing's syndrome or adrenal suppression.

              • cenobamate

                cenobamate will decrease the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • clarithromycin

                clarithromycin will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cobicistat

                cobicistat will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • crizotinib

                crizotinib increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

              • darunavir

                darunavir increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. Increased risk of Cushing's syndrome or adrenal suppression.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

              • fedratinib

                fedratinib will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • fosamprenavir

                fosamprenavir increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. Increased risk of Cushing's syndrome or adrenal suppression.

              • idelalisib

                idelalisib will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • indinavir

                indinavir increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. Increased risk of Cushing's syndrome or adrenal suppression.

              • itraconazole

                itraconazole will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ketoconazole

                ketoconazole increases levels of ciclesonide inhaled by decreasing metabolism. Use Caution/Monitor.

                ketoconazole will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • levoketoconazole

                levoketoconazole will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                levoketoconazole increases levels of ciclesonide inhaled by decreasing metabolism. Use Caution/Monitor.

              • lopinavir

                lopinavir increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. Increased risk of Cushing's syndrome or adrenal suppression.

              • mifepristone

                mifepristone will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nefazodone

                nefazodone will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nelfinavir

                nelfinavir increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. Increased risk of Cushing's syndrome or adrenal suppression.

              • posaconazole

                posaconazole will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ritonavir

                ritonavir increases levels of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. Increased risk of Cushing's syndrome or adrenal suppression.

              • rucaparib

                rucaparib will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • stiripentol

                stiripentol, ciclesonide inhaled. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              • tazemetostat

                tazemetostat will decrease the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • voriconazole

                voriconazole will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              Minor (1)

              • ribociclib

                ribociclib will increase the level or effect of ciclesonide inhaled by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Headache (11%)

              Nasopharyngitis (11%)

              1-10%

              Epistaxis (4.9%)

              Ear pain (2.2%)

              Facial edema (3%)

              Urticaria (3%)

              Oral candidiasis (3%)

              Back pain (3%)

              Extremety pain (3%)

              Conjunctivitis (3%)

              Upper respiratory infection (9%)

              Gastroenteritis (3%)

              Sinusitis (3%)

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              Warnings

              Contraindications

              Documented hypersensitivity

              Treatment of acute asthma or status asthmaticus

              Cautions

              Caution in active serious infections

              Secondary infections may occur as a result of prolonged use of corticosteroids

              Avoid exposure to chickenpox or measles

              Not for acute asthma treatment

              When switching from oral corticosteroids

              Bronchospasm may occur following inhalation (treat with fast acting bronchodilator)

              High doses may cause suppression of hypothalamic-pituitary-adrenal axis, which can result in adrenal crisis

              Long-term use may result in: reduced BMD; glaucoma or cataracts; increased IOP

              Development of Kaposi's sarcoma associated with prolonged use of corticosteroids

              Psychiatric disturbances reported with corticosteroid use

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              Pregnancy & Lactation

              Pregnancy Category: C

              Lactation: Not known if excreted in breast milk, use 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 prodrug, converted to active ingredient des-ciclesonide; has immunosuppressive properties, anti-inflammatory activity, and anti-inflammatory effects.

              Distribution

              Bioavailability: 63% (active metabolite)

              Absorption: 52%

              Protein Bound: 99% (IV)

              Vd: 2.9 L/kg (ciclesonide); 12.1 L/kg (des-ciclesonide) following IV administration

              Metabolism

              Metabolized to active des-ciclesonide by esterases, then further metabolized by liver CYP3A4 and to a lesser extent, CYP2D6

              Eliminiation

              Following IV administration

              • Half-life: 0.71 hr (ciclesonide); 6-7 hr (des-ciclesonide)
              • Clearance: 152 L/L/hr (ciclesonide); 228 L/L/hr (des-ciclesonide)
              • Excretion: Feces (66%); urine (20%)
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Alvesco inhalation
              -
              160 mcg/actuation aerosol
              Alvesco inhalation
              -
              80 mcg/actuation aerosol

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

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              Patient Education
              ciclesonide nasal

              CICLESONIDE HFA SPRAY - NASAL

              (sye-KLES-oh-nide)

              COMMON BRAND NAME(S): Zetonna

              USES: Ciclesonide is used to relieve seasonal and year-round allergy symptoms of the nose such as stuffy/runny nose, itching, and sneezing. This medication belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

              HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using ciclesonide nasal spray and each time you get a refill. Follow the instructions on how to properly use this medication. If you have any questions, ask your doctor or pharmacist.Gently blow your nose before using this drug. Follow the instructions on how to properly prime the canister if you are using it for the first time, if you have not used it for 10 days or more, or if the canister and actuator become separated.Use this medication in the nose as directed by your doctor, usually once a day in both nostrils. Do not use more than 1 spray in each nostril daily as this may increase the risk of side effects. Do not spray this medication in your eyes or directly onto the nasal septum (the wall between your nostrils).Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.Clean the outside of the nose piece regularly with a clean dry tissue. Keep track of the number of sprays used from the container with the dose indicator. Discard the container after the dose indicator reads zero.You may feel the drug start to work within 2 days, but it may take 1 to 2 weeks before the full benefit of this drug takes effect. Tell your doctor if your condition does not improve or if it worsens.

              SIDE EFFECTS: Nasal dryness/irritation or mild nosebleeds may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.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.Tell your doctor right away if you have any serious side effects, including: severe nosebleeds, pain in your nose, a whistling sound when you breathe, eye pain, signs of infection (such as sore throat that doesn't go away, white patches in your nose/back of your throat, fever, chills).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.A very serious allergic reaction to this drug is rare. However, get medical help right away 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 contact with people who have infections that may spread to others (such as chickenpox, measles). Consult your doctor if you have been exposed to an infection or for more details.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 unknown if this medication 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 puncture the canister. Do not use, store, or discard it near heat or open flame. Keep all medications 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.

              Information last revised April 2022. Copyright(c) 2022 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

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              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.
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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.