Omnaris eent

Synthetic, non-halogenated corticosteroid.1 3 4 7 9

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

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

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

Adults

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

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

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

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

Contraindications

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

Warnings/Precautions

Warnings

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

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

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

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

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

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

Category C.1

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

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

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.)

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

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

• 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.)