Omnaris

Generic Name: Ciclesonide
Class: Corticosteroids
Chemical Name: (11β,16α)-16,17-[[(R)-Cyclohexylmethylene] bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-pregna-1,4-diene-3,20-dione
Molecular Formula: C₃₂H₄₄O₇
CAS Number: 126544-47-6

Introduction

Synthetic, nonhalogenated corticosteroid.^{1 3 4 7 9}

Uses for Omnaris

Allergic Rhinitis

Symptomatic treatment of seasonal or perennial allergic rhinitis.^{1 2 6}

Generally provides symptomatic relief of rhinorrhea, nasal congestion, sneezing, and nasal itching.^{1 3 7}

Omnaris Dosage and Administration

General

• 
  

  For therapeutic effectiveness, use at regular intervals.¹

  
  

Administration

Intranasal Administration

Administer by nasal inhalation using a metered-dose spray pump.^{1 2 3 9}

Shake spray pump gently immediately prior to priming or use.^{1 2}

Prior to initial use, prime spray pump by actuating 8 times.^{1 2} Prime pump after a period of nonuse (i.e., ≥4 days) by actuating once or until a fine spray appears.^{1 2}

Clear nasal passages prior to administration.²

Tilt the head slightly forward; insert spray tip into one nostril, keeping bottle upright.² Point the tip away from the nasal septum.²

Pump the drug into one nostril while holding the other nostril closed and concurrently inspiring through the nose.² Repeat procedure for the other nostril.²

Wipe applicator with a clean tissue after use.²

To unblock nasal applicator, remove dust cap and gently pull upward to free applicator.² Wash dust cap and applicator in warm water, dry, replace applicator on bottle, and reprime the pump.²

Dosage

After initial priming, nasal spray pump delivers 50 mcg of ciclesonide per metered spray.¹ Each bottle containing 12.5 g of ciclesonide nasal spray delivers 120 metered sprays, after which the correct amount of drug in each spray cannot be assured.¹

Symptomatic relief usually is evident within 24–48 hours after initiation of therapy; further symptomatic improvement may occur over 1–2 weeks in seasonal allergic rhinitis or 5 weeks in perennial allergic rhinitis.^{1 2}

Once symptoms are controlled, gradually reduce dosage to the lowest effective level.¹

Pediatric Patients

Seasonal Allergic Rhinitis

Intranasal Inhalation

Children ≥6 years of age: 100 mcg (2 sprays) in each nostril once daily (total dosage: 200 mcg daily).^{1 2 3}

Perennial Allergic Rhinitis

Intranasal Inhalation

Children ≥12 years of age: 100 mcg (2 sprays) in each nostril once daily (total dosage: 200 mcg daily).^{1 2 3}

Adults

Seasonal Allergic Rhinitis

Intranasal Inhalation

100 mcg (2 sprays) in each nostril once daily (total dosage: 200 mcg daily).^{1 2 3}

Perennial Allergic Rhinitis

Intranasal Inhalation

100 mcg (2 sprays) in each nostril once daily (total dosage: 200 mcg daily).^{1 2 3}

Prescribing Limits

Exceeding the maximum recommended daily dosage may only increase the risk of adverse systemic effects.¹

Pediatric Patients

Seasonal Allergic Rhinitis

Children ≥6 years of age: Maximum 200 mcg (2 sprays in each nostril) once daily.¹

Perennial Allergic Rhinitis

Children ≥12 years of age: Maximum 200 mcg (2 sprays in each nostril) once daily.¹

Adults

Maximum 200 mcg (2 sprays in each nostril) once daily.¹

Special Populations

Hepatic Impairment

Dosage adjustment not required.¹ (See Special Populations under Pharmacokinetics.)

Renal Impairment

No specific dosage recommendations at this time.¹

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Omnaris

Contraindications

• 
  

  Known hypersensitivity to ciclesonide or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Carefully monitor patients being switched from prolonged systemic corticosteroids to intranasal corticosteroids since corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, and/or severe symptomatic exacerbation of asthma or other clinical conditions may occur.¹

In patients with asthma or other clinical conditions requiring long-term systemic steroids, rapid decreases in systemic corticosteroid dosages may cause severe symptom exacerbations.¹

Immunosuppression

Although risk with intranasal use is unknown, consider the possibility that corticosteroid-induced immunosuppression could occur.¹ Avoid exposure to varicella and measles in previously unexposed patients and those who have not been properly immunized.¹

If exposure to varicella or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or immune globulin (IG), respectively.¹ Consider treatment with an antiviral agent if varicella develops.¹

Sensitivity Reactions

Immediate hypersensitivity reactions or contact dermatitis may occur rarely.¹

Use with caution in patients hypersensitive to other corticosteroids; cross-sensitivity may occur.¹

General Precautions

Systemic Corticosteroid Effects

Exceeding recommended dosages or use in patients who are particularly sensitive to corticosteroid effects may cause systemic corticosteroid effects (e.g., menstrual irregularities, acneiform lesions, cushingoid features).¹

If systemic effects occur, slowly discontinue drug therapy, according to accepted procedures for discontinuing oral corticosteroids.¹

Nasopharyngeal Effects

Rarely, localized candidal infections of the nose and/or pharynx reported.¹ Treat suspected infections appropriately; may require discontinuance of ciclesonide therapy.¹

Periodically examine nasal passages for signs of mucosal changes during long-term therapy (several months or longer).¹

Avoid use until healing occurs in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma.¹

Concomitant Infections

Use cautiously, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, ocular herpes simplex, or systemic viral or parasitic infections.¹

Ophthalmic Effects

Increased IOP, glaucoma, and cataracts reported rarely with other intranasal corticosteroids; such effects not reported with ciclesonide.¹

Closely monitor patients with a change in vision or a history of glaucoma and/or cataracts.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹

Other corticosteroids known to be distributed into milk.¹ Caution if used in nursing women.¹

Pediatric Use

Safety not established in children <2 years of age.¹

Seasonal allergic rhinitis: Efficacy not established in children <6 years of age.¹

Perennial allergic rhinitis: Efficacy not established in children <12 years of age.¹

Intranasal corticosteroids may reduce growth velocity in pediatric patients.¹ Routine monitoring of growth (e.g., via stadiometry) recommended. ¹ Titrate dosage to lowest possible effective level.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether such patients respond differently than younger adults; select dosage with caution.¹ (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Increased systemic exposure following oral inhalation.¹ (See Special Populations under Pharmacokinetics and see Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Headache,^{1 3} epistaxis,^{1 3 8} ear pain,^{1 3} nasopharyngitis,^{1 3 8} nasal discomfort,¹ pharyngolaryngeal pain.^{1 8}

Interactions for Omnaris

Inhibitory potential of ciclesonide on CYP isoenzymes not studied; des-ciclesonide (the active metabolite) does not appear to inhibit or induce CYP isoenzymes in vitro.^{1 3}

Specific Drugs

Drug	Interaction	Comments
Erythromycin	No pharmacokinetic interaction with orally inhaled ciclesonide1
Ketoconazole	Increases des-ciclesonide levels with orally inhaled ciclesonide1	Manufacturer recommends caution if used concomitantly with intranasal ciclesonide1
Salicylic acid	No effect on plasma protein binding of des-ciclesonide1
Warfarin	No effect on plasma protein binding of des-ciclesonide1

Omnaris Pharmacokinetics

Absorption

Bioavailability

Systemic absorption <1% following intranasal administration of recommended doses in adults.^{1 3 6 7}

Children 6–11 years of age: Des–ciclesonide detected in serum of 50% receiving recommended intranasal dosages.¹

Onset

24–48 hours in adults and children ≥12 years of age;^{1 2 4 5} further symptomatic improvement occurs in 1–2 weeks in seasonal allergic rhinitis and 5 weeks in perennial allergic rhinitis.^{1 2}

Distribution

Plasma Protein Binding

≥99% (mainly albumin and α₁-acid glycoprotein).^{1 3}

Extent

Distributed into milk in rats; not known whether distributed into human milk.¹

Elimination

Metabolism

Prodrug; hydrolyzed by nasal mucosa esterases to active metabolite des-ciclesonide.¹ Des-ciclesonide metabolized by CYP3A4 and to a lesser extent, by CYP2D6.^{1 3}

Elimination Route

Following IV administration, excreted in feces (approximately 66%) and in urine (≤20%).¹

Half-life

Des-ciclesonide IV: 2.7 hours.⁹

Des-ciclesonide oral: 5.9 hours.⁹

Special Populations

Hepatic impairment increases systemic exposure by 1.4–2.7-fold following oral inhalation.¹

Stability

Storage

Intranasal Inhalation

Nasal Spray

25°C (may be exposed to 15–30°C).¹ Do not freeze.¹

After removal from foil pouch, discard after 4 months or 120 sprays following priming.¹

ActionsActions

• 
  

  Glucocorticoid.¹ Prodrug.¹ Hydrolyzed to active metabolite, des-ciclesonide; ^{1 3 4 5 6 7 8} affinity of des-ciclesonide for glucocorticoid receptors 120 times that of the parent compound.^{1 3}

  
  


• 
  

  Wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic inflammation.^{1 3}

  
  


• 
  

  May alter adrenal function in pediatric patients;¹ effects on adrenal function in adults and adolescents not established.¹

  
  

Advice to Patients

• 
  

  Importance of giving patient a copy of the manufacturer’s patient instructions.^{1 2}

  
  


• 
  

  Importance of instructing patient about proper techniques for assembly and priming of nasal spray pump and for administration and storage of the nasal solution.^{1 2}

  
  


• 
  

  Importance of shaking nasal spray gently prior to each use.¹

  
  


• 
  

  Importance of discarding container after 120 actuations following initial priming or after 4 months following removal from the foil pouch, whichever occurs first.¹

  
  


• 
  

  Avoid spraying into eyes or directly onto nasal septum.^{1 2}

  
  


• 
  

  Advise patients that symptomatic relief usually occurs within 24–48 hours, with further symptomatic improvement in 1–2 weeks for seasonal allergic rhinitis or 5 weeks for perennial allergic rhinitis.¹

  
  


• 
  

  Importance of using at regular intervals.¹ Importance of not exceeding prescribed dosage.^{1 2}

  
  


• 
  

  Importance of contacting clinician if symptoms worsen or fail to improve within 2 weeks for seasonal allergic rhinitis or 5 weeks for perennial allergic rhinitis.^{1 2 9}

  
  

• 
  

  Importance of reporting recurrent nosebleeds or nasal discomfort to clinician.⁹

  
  


• 
  

  Importance of avoiding exposure to chickenpox or measles if receiving immunosuppressive doses of corticosteroids; if exposed, notify a clinician.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ciclesonide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Suspension, for intranasal use only	50 mcg/metered spray	Omnaris	Sepracor

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Omnaris 50MCG/ACT Suspension (SUNOVION PHARMACEUTICALS): 12/$105.99 or 37/$285.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Sepracor Inc. Omnaris (ciclesonide) nasal spray prescribing information. Marlborough, MA; 2007 Nov.

2. Sepracor Inc. Omnaris (ciclesonide) nasal spray patient’s instructions for use. Marlborough, MA; 2007 Nov.

3. Dhillon S, Wagstaff AJ. Ciclesonide nasal spray: in allergic rhinitis. Drugs. 2008; 68:875-83. [PubMed 18416590]

4. Ratner PH, Wingertzahn MA, van Bavel JH et al. Effectiveness of ciclesonide nasal spray in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2006; 97:657-63. [PubMed 17165276]

5. Ratner PH, Wingertzahn MA, van Bavel JH et al. Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 2006; 118:1142-8. [PubMed 17088141]

6. Patel P, Patel D, Kunjibettu S et al. Onset of action of ciclesonide once daily in the treatment of seasonal allergic rhinitis. Ear Nose Throat J. 2008; 87:340-53. [PubMed 18561117]

7. Meltzer EO, Kunjibettu S, Hall N et al. Efficacy and safety of ciclesonide, 200 microg once daily, for the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2007; 98:175-81. [PubMed 17304887]

8. Chervinsky P, Kunjibettu S, Miller DL et al. Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2007; 99:69-76. [PubMed 17650833]

9. Sepracor Inc, Marlborough, MA: Personal communication.

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