Drugs Details

Drugs Info of Omnaris
Drugs Details
  • Drugs Type  : Multum
  • Date : 14th Jan 2015 06:59 am
  • Brand Name : Omnaris
  • Generic Name : ciclesonide nasal (Pronunciation: sik le SON ide)
Descriptions

The active component of OMNARIS Nasal Spray is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[Rcyclohexylmethylene] bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α)-. Ciclesonide is delivered as the R-epimer. The empirical formula is C32H44O7 and its molecular weight is 540.7. Its structural formula is as follows:

 

OMNARIS® (ciclesonide) Structural Formula Illustration

Ciclesonide is a white to yellow-white powder, practically insoluble in water and freely soluble in ethanol and acetone. OMNARIS Nasal Spray is a metered-dose, manualpump spray formulation containing a hypotonic aqueous suspension of ciclesonide. OMNARIS Nasal Spray also contains microcrystalline cellulose, carboxymethylcellulose sodium, hypromellose, potassium sorbate and edetate sodium; and hydrochloric acid to adjust the pH to 4.5.

What are the possible side effects of ciclesonide nasal (Omnaris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nasal steroid medicine can be absorbed into your bloodstream, which may cause steroid side effects throughout the body. Although it is not likely that your body will absorb enough of this medication to cause serious side effects, tell your doctor if you have any of these steroid-related symptoms:

  • irregular menstrual periods;
  • acne or increased hair growth;
  • swelling, rapid weight gain,...

Read All Potential Side Effects and See Pictures of Omnaris »

What are the precautions when taking ciclesonide nasal spray (Omnaris)?

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...

Read All Potential Precautions of Omnaris »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Treatment of Seasonal Allergic Rhinitis

OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.

Treatment of Perennial Allergic Rhinitis

OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Dosage Administration

Administer OMNARIS Nasal Spray by the intranasal route only. Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. If the product is not used for four consecutive days, it should be gently shaken and reprimed with one spray or until a fine mist appears. Illustrated patient's instructions for proper use accompany each package of OMNARIS Nasal Spray.

Seasonal Allergic Rhinitis

Adults and Children (6 Years of Age and Older)

The recommended dose of OMNARIS Nasal Spray is 2 sprays per nostril once daily (200 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).

Perennial Allergic Rhinitis

Adults and Adolescents (12 Years of Age and Older)

The recommended dose of OMNARIS Nasal Spray is 2 sprays per nostril once daily (200 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).

How Supplied

Dosage Forms And Strengths

OMNARIS Nasal Spray is a metered-dose, manual-pump spray formulation containing a hypotonic aqueous suspension of ciclesonide. Once primed, each actuation of the pump delivers 50 mcg ciclesonide in a volume of 70 microliters from the nasal actuator.

Storage And Handling

OMNARIS is supplied in an amber glass bottle and provides for nasal delivery with a manual metered pump. OMNARIS Nasal Spray is supplied with an oxygen absorber sachet and enclosed in a foil pouch. The contents of one 12.5 gram bottle provide 120 actuations, after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. The OMNARIS Nasal Spray bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after removal from the foil pouch either after 120 sprays following initial priming (since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose) or after 4 months. Patient instructions are also provided.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Do not freeze. Shake gently before use. Keep out of reach of children.

Omnaris Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g.

NDC 63402-701-01

Manufactured for Sunovion Pharmaceuticals Inc., Marlborough MA 01752 USA. Made in Germany. Revised: March 2013

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, nasal septal perforations, Candida albicans infection, impaired wound healing [see WARNINGS AND PRECAUTIONS]
  • Cataracts and glaucoma [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see WARNINGS AND PRECAUTIONS, Use in Specific Populations]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below for adults and adolescents 12 years of age and older are based on 3 clinical trials of 2 to 6 weeks duration and one 52-week trial. In the 3 trials of 2 to 6 weeks duration, 1524 patients (495 males and 1029 females, ages 12 to 86 years old) with seasonal or perennial allergic rhinitis were treated with OMNARIS Nasal Spray 200, 100, 50, or 25 mcg or placebo once daily. The racial distribution in these three trials included 1374 Caucasians, 69 Blacks, 31 Asians, and 50 patients classified as Other. The 52-week trial was conducted in 663 patients (227 males and 436 females, ages 12 to 73 years old) treated with OMNARIS Nasal Spray 200 mcg or placebo once daily. The racial distribution in this trial included 538 Caucasians, 69 Blacks, 16 Asians, and 40 patients classified as Other. The data from pediatric patients are based upon 4 clinical trials in which 1541 children (871 males and 670 females, ages 2 to 11 years old) with seasonal or perennial allergic rhinitis were treated with OMNARIS Nasal Spray 200, 100, or 25 mcg or placebo once daily for 2 to 12 weeks. The racial distribution in these four trials included 1136 Caucasians, 273 Blacks, 20 Asians, and 112 patients classified as Other.

Adults and Adolescents 12 Years of Age and Older in Short-Term (2-6 weeks) Trials

In three short-term trials conducted in the US and Canada, 546 patients were treated with OMNARIS Nasal Spray 200 mcg daily. Adverse reactions did not differ appreciably based on age, gender, or race. Approximately 2% of patients treated with OMNARIS Nasal Spray 200 mcg in clinical trials discontinued because of adverse reactions; this rate was similar for patients treated with placebo. The table below displays reactions that occurred with an incidence of 2% or greater and more frequently with OMNARIS Nasal Spray 200 mcg than with placebo in clinical trials of 2 to 6 weeks in duration.

Table 1 : Adverse Events from Controlled Clinical Trials 2 to 6 Weeks in Duration in Patients 12 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis

Adverse Event OMNARIS Nasal Spray 200 mcg Once Daily
(N = 546)
%
Placebo
(N = 544)
%
Headache 6.0 4.6
Epistaxis 4.9 2.9
Nasopharyngitis 3.7 3.3
Ear Pain 2.2 0.6
Pediatric Patients Aged 6 to 11 Years in Short-Term (2-12 weeks) Trials

In two short-term trials, conducted in the US and Canada, 913 patients were treated with OMNARIS Nasal Spray 200 mcg, 100 mcg or 25 mcg daily. Adverse events did not differ appreciably based on age, gender, or race. In clinical trials, 1.6% and 2.7% of patients treated with OMNARIS Nasal Spray 200 mcg or 100 mcg, respectively, discontinued because of adverse reactions; these rates were lower than the rate in patients treated with placebo (2.8%). Table 2 displays adverse events that occurred with an incidence of 3% or greater and more frequently with OMNARIS Nasal Spray 200 mcg than with placebo.

Table 2 : Adverse Events from Controlled Clinical Trials 2 to 12 Weeks in Duration in Patients 6 to 11 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis

Adverse Event OMNARIS Nasal Spray 200 mcg Once Daily
(N = 380)
%
Placebo
(N = 369)
%
Headache 6.6 5.7
Nasopharyngitis 6.6 5.4
Pharyngolaryngeal pain 3.4 3.3
Pediatric Patients Aged 2 to 5 Years in Short-Term (6-12 weeks) Trials

In two short-term trials conducted in the US, 183 patients were treated with OMNARIS Nasal Spray 200 mcg, 100 mcg or 25 mcg daily. The distribution of adverse events was similar to that seen in the 6 to 11 year old children.

Long-Term (52-Week) Safety Trial

In a 52-week double-blind, placebo-controlled safety trial that included 663 adults and adolescent patients (441 treated with ciclesonide: 227 males and 436 females) with perennial allergic rhinitis, the adverse reaction profile over the treatment period was similar to the adverse event profile in trials of shorter duration. Adverse reactions, irrespective of drug relationship, that occurred with an incidence of 3% or greater and more frequently with OMNARIS Nasal Spray 200 mcg than with placebo were epistaxis, pharyngolaryngeal pain, sinusitis, headache, nasal discomfort, cough, bronchitis, influenza, back pain, and urinary tract infection. No patient experienced a nasal septal perforation or nasal ulcer during this long-term trial of OMNARIS Nasal Spray.

Post-Marketing Experience

The following adverse reactions have been reported in association with postmarketing use of OMNARIS Nasal Spray and are not listed above: nasal congestion, nasal ulcer and dizziness. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Read the Omnaris (ciclesonide nasal spray) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions [see CLINICAL PHARMACOLOGY].

In a drug interaction study, co-administration of orally inhaled ciclesonide and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged. Erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of ciclesonide [see CLINICAL PHARMACOLOGY].

Read the Omnaris Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Local Nasal Effects

Epistaxis

In clinical studies of 2 to 52 weeks' duration, epistaxis was observed more frequently in patients treated with OMNARIS Nasal Spray than those who received placebo [see ADVERSE REACTIONS].

Candida Infection

In clinical studies with OMNARIS Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of OMNARIS Nasal Spray. Therefore, patients using OMNARIS Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

Nasal Septal Perforation

Instances of nasal septal perforation have been reported in patients following the intranasal application of corticosteroids. No cases of nasal septal perforation were identified in clinical studies with OMNARIS Nasal Spray. Avoid spraying OMNARIS Nasal Spray directly onto the nasal septum.

Impaired Wound Healing

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Glaucoma and Cataracts

Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

The risk of glaucoma was evaluated by assessments of intraocular pressure in 3 studies including 943 patients. Of these, 390 adolescents or adults were treated for up to 52 weeks and 186 children ages 2 to 11 received treatment with OMNARIS Nasal Spray 200 mcg daily for up to 12 weeks. In these studies, no significant differences in intraocular pressure changes were observed between OMNARIS Nasal Spray 200 mcg and placebotreated patients. Additionally, no significant differences between OMNARIS Nasal Spray 200 mcg and placebo-treated patients were noted during the 52-week study of adults and adolescent patients in whom thorough ophthalmologic assessments were performed, including evaluation of cataract formation using slit lamp examinations.

Immunosuppression

Patients who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; or in patients with untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.

Hypothalamic-Pituitary-Adrenal Axis Effect

Hypercorticism and Adrenal Suppression

When intranasal corticosteroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of OMNARIS Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely (e.g., via stadiometry) in pediatric patients receiving OMNARIS Nasal Spray.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).

Local Nasal Effects

Patients should be informed that treatment with OMNARIS Nasal Spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with OMNARIS Nasal Spray. In addition, nasal corticosteroids are associated with nasal septal perforation and impaired wound healing. Avoid spraying OMNARIS Nasal Spray directly onto the nasal septum. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use OMNARIS Nasal Spray until healing has occurred [see WARNINGS AND PRECAUTIONS].

Cataracts and Glaucoma

Patients should be informed that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. The patient should inform his/her health care provider if a change in vision is noted while using OMNARIS Nasal Spray [see WARNINGS AND PRECAUTIONS].

Immunosuppression

Patients who are on immunosuppressive doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex [see WARNINGS AND PRECAUTIONS].

Use Daily

Patients should use OMNARIS Nasal Spray at regular intervals since its effectiveness depends on its regular use. In clinical trials, the onset of effect was seen within 24 to 48 hours with further symptomatic improvement observed over 1 to 2 weeks in seasonal allergic rhinitis and 5 weeks in perennial allergic rhinitis. Initial assessment of response should be made during this time frame and periodically until the patient's symptoms are stabilized. The patient should take the medication as directed and should not exceed the prescribed dosage. The patient should contact the physician if symptoms do not improve by a reasonable time or if the condition worsens.

Keep Spray Out of Eyes

Patients should be informed to avoid spraying OMNARIS Nasal Spray in their eyes.

Storage and Handling

It is important that the bottle is gently shaken prior to use to ensure that a consistent amount is dispensed per actuation. The bottle should be discarded after 120 actuations following initial priming or after 4 months after the bottle is removed from the foil pouch, whichever occurs first.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ciclesonide demonstrated no carcinogenic potential in a study of oral doses up to 900 mcg/kg (approximately 20 and 10 times the maximum human daily intranasal dose in adults and adolescents ≥ 12 years of age and children, 6 to 11 years of age, respectively, based on mcg/m²) in mice for 104 weeks and in a study of inhalation doses up to 193 mcg/kg (approximately 8 and 5 times the maximum human daily intranasal dose in adults and adolescents ≥ 12 years of age and children, 6 to 11 years of age, respectively, based on mcg/m²) in rats for 104 weeks. Ciclesonide was not mutagenic in an Ames test or in a forward mutation assay and was not clastogenic in a human lymphocyte assay or in an in vitro micronucleus test. However, ciclesonide was clastogenic in the in vivo mouse micronucleus test. The concurrent reference corticosteroid (dexamethasone) in this study showed similar findings. No evidence of impairment of fertility was observed in a reproductive study conducted in male and female rats both dosed orally up to 900 mcg/kg/day (approximately 35 times the maximum human daily intranasal dose in adults based on mcg/m²).

Use In Specific Populations

Pregnancy

Teratogenic Effects - Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. OMNARIS Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.

Oral administration of ciclesonide in rats at approximately 35 times the maximum human daily intranasal dose in adults based on mcg/m² produced no teratogenicity or other fetal effects. However, subcutaneous administration of ciclesonide in rabbits at less than the maximum human daily intranasal dose in adults based on mcg/m² produced fetal toxicity. This included fetal loss, reduced fetal weight, cleft palate, skeletal abnormalities including incomplete ossifications, and skin effects [see Nonclinical Toxicology].

Nonteratogenic Effects

Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

Nursing Mothers

It is not known if ciclesonide is excreted in human milk. However, other corticosteroids are excreted in human milk. In a study with lactating rats, minimal but detectable levels of ciclesonide were recovered in milk. Caution should be used when OMNARIS Nasal Spray is administered to nursing women.

Pediatric Use

The safety and effectiveness for seasonal and perennial allergic rhinitis in children 12 years of age and older have been established. The efficacy of OMNARIS Nasal Spray in patients 6 to 11 years of age for treatment of the symptoms of seasonal allergic rhinitis was demonstrated in one study in patients 6 to 11 years of age with seasonal allergic rhinitis. The efficacy of OMNARIS Nasal Spray for the treatment of the symptoms of seasonal allergic rhinitis in patients 5 years of age and younger has not been established. The efficacy of OMNARIS Nasal Spray for the treatment of the symptoms of perennial allergic rhinitis in patients 11 years of age and younger has not been established [see Clinical Studies]. The safety of OMNARIS Nasal Spray in children 2 to 11 years of age was evaluated in 4 controlled clinical studies of 2 to 12 weeks duration [see CLINICAL PHARMACOLOGY, Clinical Studies, and ADVERSE REACTIONS].

Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including OMNARIS Nasal Spray, should be monitored routinely (e.g., via stadiometry). A 52-week, multicenter, double-blind, randomized, placebo-controlled parallelgroup study was conducted to assess the effect of orally inhaled ciclesonide on growth rate in 609 pediatric patients with mild persistent asthma, aged 5 to 8.5 years. Treatment groups included orally inhaled ciclesonide 40 mcg or 160 mcg or placebo given once daily. Growth was measured by stadiometer height during the baseline, treatment and follow-up periods. The primary comparison was the difference in growth rates between ciclesonide 40 and 160 mcg and placebo groups. Conclusions cannot be drawn from this study because compliance could not be assured. Ciclesonide blood levels were also not measured during the one-year treatment period. There was no difference in efficacy measures between the placebo and the orally inhaled ciclesonide groups.

The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

Geriatric Use

Clinical studies of OMNARIS Nasal Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Chronic overdosage may result in signs or symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS].

There are no data available on the effects of acute or chronic overdosage with OMNARIS Nasal Spray.

ContrainDications

OMNARIS Nasal Spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray [see WARNINGS AND PRECAUTIONS].

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

Ciclesonide is a pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application. Des-ciclesonide has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120 times higher than the parent compound. The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic inflammation.

Pharmacodynamics

Adrenal Function

In a 6-week trial in adolescents and adults 12-73 years of age with perennial allergic rhinitis, a daily dose of 200 mcg of OMNARIS Nasal Spray was compared to placebo nasal spray. Dexamethasone 6 mg was used as an active control during the last 4 days of the treatment period. Adrenal function was assessed by measurement of 24 hour serum cortisol levels before and after 6 consecutive weeks of treatment. The difference from placebo for the change from baseline in serum cortisol AUC(0-24) was 10.4 mcg•hour/dL (95% CI: -4.7, 25.5) for 200 mcg of OMNARIS Nasal Spray. The effects observed with the active control (dexamethasone, n=18) validate the sensitivity of the study to assess the effect of ciclesonide on the HPA axis.

In a 12-week study in children 6 to 11 years of age with perennial allergic rhinitis, daily doses of 200 mcg, 100 mcg, and 25 mcg of OMNARIS Nasal Spray were compared to placebo nasal spray. Adrenal function was assessed by measurement of 24-hour urinary-free cortisol (in 32 to 44 patients per group) and morning plasma cortisol levels (in 45 to 61 patients per group) before and after 12 consecutive weeks of treatment. The ciclesonidetreated groups had a numerically greater decline in 24-hour urinary-free cortisol compared to the placebo-treated group. The differences (and 95% confidence intervals) from placebo in the mean change from baseline to 12 weeks were -0.81 (-4.0, 2.4), -0.08 (-3.1, 2.9), and -2.11 (-5.3, 1.1) mcg/day for 200 mcg, 100 mcg, and 25 mcg dose groups, respectively. The mean AM plasma cortisol value did not show any consistent treatment effect with differences (and 95% confidence intervals) from placebo in the mean change from baseline to 12 weeks of 0.35 (-1.4, 2.1), 0.12 (-1.5, 1.7), and -0.38 (-2.1, 1.3) mcg/dL for 200 mcg, 100 mcg, and 25 mcg dose groups, respectively. In this study, serum was assayed for ciclesonide and des-ciclesonide [see Pharmacokinetics].

In a 6-week study in children 2 to 5 years of age with perennial allergic rhinitis, daily doses of 200 mcg, 100 mcg, and 25 mcg of OMNARIS Nasal Spray were compared to placebo nasal spray. Adrenal function was assessed by measurement of 24-hour urinary-free cortisol (in 15 to 22 patients per group) and morning plasma cortisol levels (in 28 to 30 patients per group) before and after 6 consecutive weeks of treatment. The ciclesonidetreated groups had a numerically greater decline in 24-hour urinary-free cortisol compared to the placebo-treated group. The differences (and 95% confidence intervals) from placebo in the mean change from baseline to 6 weeks were -2.04 (-4.4, 0.3), -1.96 (-4.5, 0.6), and -1.76 (-4.3, 0.8) mcg/day for the 200 mcg, 100 mcg, and 25 mcg dose groups, respectively.

The plasma cortisol also decreased numerically after treatment with ciclesonide. The differences (and 95% confidence intervals) from placebo in the mean change in plasma cortisol from baseline to 6 weeks were -1.04 (-2.7, 0.7), -0.36 (-2.1, 1.4), and -0.12 (-1.8, 1.6) mcg/dL for the 200 mcg, 100 mcg, and 25 mcg dose groups, respectively. In this study, serum was assayed for ciclesonide and des-ciclesonide [see Pharmacokinetics].

Pharmacokinetics

Absorption

Ciclesonide and des-ciclesonide have negligible oral bioavailability (both less than 1%) due to low gastrointestinal absorption and high first-pass metabolism. The intranasal administration of ciclesonide at recommended doses results in negligible serum concentrations of ciclesonide. However, the known active metabolite (desciclesonide) is detected in the serum of some patients after nasal inhalation of ciclesonide. The bioanalytical assay used has a lower limit of quantification of 25 pg/mL and 10 pg/mL, for ciclesonide and des-ciclesonide, respectively.

In healthy adults treated for two weeks with 50 to 800 mcg of ciclesonide nasal spray daily (n=6 in each treatment group), the peak serum concentrations of des-ciclesonide in all subjects were found to be below 30 pg/mL. Of those treated with 800 mcg and 400 mcg daily, 100% and 67% had detectable levels of des-ciclesonide, respectively. With daily doses of 200 mcg or less, detectable serum levels of des-ciclesonide were not observed. The low systemic exposure following ciclesonide nasal spray administration was confirmed in a crossover study in twenty-nine healthy adults. The median Cmax was less than 10 pg/mL and 602 pg/mL following a single dose of ciclesonide nasal spray (300 mcg) and orally inhaled ciclesonide (320 mcg), respectively.

Distribution

Following intravenous administration of 800 mcg of ciclesonide, the volumes of distribution of ciclesonide and des-ciclesonide were approximately 2.9 L/kg and 12.1 L/kg, respectively. The percentage of ciclesonide and des-ciclesonide bound to human plasma proteins averaged ≥ 99% each, with ≤ 1% of unbound drug detected in the systemic circulation. Des-ciclesonide is not significantly bound to human transcortin.

Metabolism

Ciclesonide is hydrolyzed to a biologically active metabolite, desciclesonide, by esterases. Des-ciclesonide undergoes further metabolism in the liver to additional metabolites mainly by the cytochrome P450 (CYP) 3A4 isozyme and to a lesser extent by CYP 2D6. The full range of potentially active metabolites of ciclesonide has not been characterized. After intravenous administration of 14C-ciclesonide, 19.3% of the resulting radioactivity in the plasma is accounted for by ciclesonide or des-ciclesonide; the remainder may be a result of other, as yet, unidentified multiple metabolites.

Elimination

Following intravenous administration of 800 mcg of ciclesonide, the clearance values of ciclesonide and des-ciclesonide were high (approximately 152 L/h and 228 L/h, respectively). 14C-labeled ciclesonide was predominantly excreted via the feces after intravenous administration (66%) indicating that excretion through bile is the major route of elimination. Approximately 20% or less of drug-related radioactivity was excreted in the urine.

Special Populations

The pharmacokinetics of intranasally administered ciclesonide have not been assessed in patient subpopulations because the resulting blood levels of ciclesonide and des-ciclesonide are insufficient for pharmacokinetic calculations. However, population pharmacokinetic analysis showed that characteristics of des-ciclesonide after oral inhalation of ciclesonide were not appreciably influenced by a variety of subject characteristics such as body weight, age, race, and gender.

Hepatic Impairment

Compared to healthy subjects, the systemic exposure (Cmax and AUC) in patients with liver impairment increased in the range of 1.4 to 2.7-fold after exactuator administration of 1280 mcg ciclesonide via oral inhalation. Dose adjustment in liver impairment is not necessary. Renal Impairment: Studies in renally-impaired patients were not conducted since renal excretion of des-ciclesonide is a minor route of elimination ( ≤ 20%).

Pediatric

In pediatric subjects treated with 25 to 200 mcg of ciclesonide nasal spray daily, serum concentrations of des-ciclesonide were below 45 pg/mL, with the exception of one value of 64.5 pg/mL. In a 12-week study in children 6 to 11 years of age with perennial allergic rhinitis, des-ciclesonide was detected in 50% of the subjects treated with 200 mcg and in 5% of those treated with 100 mcg ciclesonide nasal spray daily. In a 6-week study in children 2 to 5 years of age with perennial allergic rhinitis, des-ciclesonide was detected in 41%, 22%, and 13% of the subjects treated with 200 mcg, 100 mcg, and 25 mcg ciclesonide nasal spray daily, respectively.

Drug-Drug Interactions

Based on in vitro studies in human liver microsomes, desciclesonide appears to have no inhibitory or induction potential on the metabolism of other drugs metabolized by cytochrome P450 enzymes. The inhibitory potential of ciclesonide on cytochrome P450 isoenzymes has not been studied. In vitro studies demonstrated that the plasma protein binding of des-ciclesonide was not affected by warfarin or salicylic acid, indicating no potential for protein binding-based drug interactions.

In a drug interaction study, co-administration of orally inhaled ciclesonide and oral ketoconazole, a strong inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of the active metabolite of ciclesonide, des-ciclesonide, by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged.

In another drug interaction study, co-administration of orally inhaled ciclesonide and oral erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin.

Animal Toxicology and Pharmacology

Reproductive Toxicology Studies: Oral administration of ciclesonide in rats up to 900 mcg/kg (approximately 35 times the maximum human daily dose in adults based on mcg/m²) produced no teratogenicity or other fetal effects. However, subcutaneous administration of ciclesonide in rabbits at 5 mcg/kg (less than the maximum daily intranasal dose in adults based on mcg/m²) or greater produced fetal toxicity. This included fetal loss, reduced fetal weight, cleft palate, skeletal abnormalities including incomplete ossifications, and skin effects. No toxicity was observed at 1 mcg/kg (less than the maximum human daily intranasal dose in adults based on mcg/m²).

Clinical Studies

Seasonal and Perennial Allergic Rhinitis

Adults and Adolescent Patients 12 Years of Age and Older

The efficacy of OMNARIS Nasal Spray was evaluated in 3 randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials of 2 to 6 weeks duration conducted in the United States and Canada in adolescents and adults with allergic rhinitis. The three trials included a total of 1524 patients (495 males and 1029 females) of whom 79 were adolescents, ages 12 to 17 years. The racial distribution in these three trials included 1374 Caucasians, 69 Blacks, 31 Asians, and 50 patients classified as Other. Of the 1524 patients, 546 patients received OMNARIS Nasal Spray 200 mcg once daily administered as 2 sprays in each nostril. Patients enrolled in the studies were 12 to 86 years of age with a history of seasonal or perennial allergic rhinitis, a positive skin test to at least one relevant allergen, and active symptoms of allergic rhinitis at study entry. Assessment of efficacy in these trials was based on patient recording of four nasal symptoms (runny nose, nasal itching, sneezing, and nasal congestion) on a 0-3 categorical severity scale (0=absent, 1=mild, 2=moderate, and 3=severe) as reflective or instantaneous scores. Reflective scoring required the patients to record symptom severity over the previous 12 hours; the instantaneous scoring required patients to record symptom severity at the time of recording. The results of these trials showed that patients treated with OMNARIS Nasal Spray 200 mcg once daily exhibited statistically significantly greater decreases in total nasal symptom scores than placebo-treated patients. Secondary measures of efficacy were also generally supportive.

Dose-Ranging Trial

One of the three trials was a 2-week dose-ranging trial that evaluated efficacy of four doses of OMNARIS Nasal Spray in patients with seasonal allergic rhinitis. The primary efficacy endpoint was the difference from placebo in the change from baseline of the sum of morning and evening reflective total nasal symptom score averaged over the 2-week treatment period. Results of the primary efficacy endpoint are shown in Table 3. In this trial OMNARIS Nasal Spray 200 mcg once daily was statistically significantly different from placebo, but the lower doses were not statistically significantly different from placebo.

Table 3 : Mean change in reflective total nasal symptom score over 2 weeks in patients with seasonal allergic rhinitis

Treatment N Baseline* Change from Baseline Difference from Placebo**
Estimate 95% CI p-value
Seasonal Allergic Rhinitis Trial - Reflective total nasal symptom score
Ciclesonide 200 mcg 144 18.8 -5.73 -1.35 (-2.43, -0.28) 0.014
Ciclesonide 100 mcg 145 18.7 -5.26 -0.88 (-1.96, 0.19) 0.11
Ciclesonide 50 mcg 143 18.4 -4.82 -0.44 (-1.52, 0.63) 0.42
Ciclesonide 25 mcg 146 18.7 -4.74 -0.35 (-1.42, 0.71) 0.51
Placebo 148 17.8 -4.38      
*Sum of AM and PM Scores; Maximum score = 24
** Estimates, 95% Confidence Intervals, and p-values were obtained from repeated measures ANCOVA analysis with treatment, baseline, day, and treatment by day interaction effects included in the model.
Seasonal Allergic Rhinitis Trial

The second trial was a 4-week single dose level trial conducted in patients with seasonal allergic rhinitis. The primary efficacy endpoint in the seasonal allergic rhinitis trial was the difference from placebo in the change from baseline of the average of morning and evening reflective total nasal symptom score averaged over the first 2 weeks of treatment. In this trial, OMNARIS Nasal Spray 200 mcg once daily was statistically significantly different from placebo (Table 4). Statistically significant differences in the morning pre-dose instantaneous total nasal symptom score indicate that the effect was maintained over the full 24-hour dosing interval.

Perennial Allergic Rhinitis Trial

The third trial was a 6-week single dose level trial conducted in patients with perennial allergic rhinitis. The primary efficacy endpoint in the perennial allergic rhinitis trial was the difference from placebo in the change from baseline of the average of morning and evening reflective total nasal symptom score averaged over the 6 weeks of treatment. In this trial, OMNARIS Nasal Spray 200 mcg once daily was statistically significantly different from placebo (Table 4). Statistically significant differences in the morning pre-dose instantaneous total nasal symptom score indicate that the effect was maintained over the full 24-hour dosing interval.

Table 4 : Mean changes in reflective total nasal symptom score and instantaneous total nasal symptom score in allergic rhinitis trials

Treatment N Baseline* Change from Baseline Difference from Placebo**
Estimate 95% CI p-value
Seasonal Allergic Rhinitis Trial - Reflective total nasal symptom score
Ciclesonide 200 mcg 162 8.96 -2.40 -0.90 (-1.36, -0.45) <0.001
Placebo 162 8.83 -1.50      
Seasonal Allergic Rhinitis Trial - Instantaneous total nasal symptom score
Ciclesonide 200 mcg 162 8.45 -1.87 -0.84 (-1.30, -0.39) <0.001
Placebo 162 8.33 -1.03      
Perennial Allergic Rhinitis Trial - Reflective total nasal symptom score
Ciclesonide 200 mcg 232 7.59 -2.51 -0.62 (-0.97, -0.28) <0.001
Placebo 229 7.72 -1.89      
Perennial Allergic Rhinitis Trial - Instantaneous total nasal symptom score
Ciclesonide 200 mcg 232 7.05 -1.99 -0.53 (-0.90, -0.17) 0.004
Placebo 229 7.05 -1.46      
*Mean of AM and PM score from reflective total nasal symptom score; Mean of AM score for instantaneous total nasal symptom score; Maximum = 12
** Estimates, 95% Confidence Intervals, and p-values were obtained from repeated measures ANCOVA analysis with treatment, baseline, day, and treatment by day interaction effects included in the model.

Onset of action: Onset of action was evaluated in two environmental exposure unit studies in patients with seasonal allergic rhinitis receiving a single dose of OMNARIS Nasal Spray 200 mcg. Results from these two studies did not demonstrate a replicate onset of action within the assessment period. Onset of action was also evaluated in the 4-week seasonal allergic rhinitis and in the 6-week perennial allergic rhinitis trial by frequent recording of instantaneous symptom score after the first dose. In these trials, onset of effect was seen within 24 to 48 hours with further symptomatic improvement observed over 1 to 2 weeks in seasonal allergic rhinitis and 5 weeks in perennial allergic rhinitis.

Pediatric Patients Aged 6 to 11 Years

The efficacy of OMNARIS Nasal Spray was evaluated in two randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials in 1282 patients 6 to 11 years of age with allergic rhinitis. Of the two trials, one was 2 weeks in duration conducted in patients with seasonal allergic rhinitis that evaluated efficacy of 200 mcg and 100 mcg of OMNARIS Nasal Spray once daily. The other trial was 12 weeks in duration conducted in patients with perennial allergic rhinitis that evaluated efficacy of 200 mcg, 100 mcg, and 25 mcg of OMNARIS Nasal Spray once daily. Of the total number of patients enrolled in the 2 studies, 380 were treated with 200 mcg of OMNARIS Nasal Spray once daily. The primary efficacy endpoint was the difference from placebo in the change from baseline of the average of morning and evening reflective total nasal symptom score averaged over 2 weeks of treatment in the seasonal allergic rhinitis trial and over the first 6 weeks of treatment in the perennial allergic rhinitis trial. In the 2-week trial in patients with seasonal allergic rhinitis, the OMNARIS Nasal Spray 200 mcg once daily dose was statistically significantly different from placebo, but the 100 mcg once daily dose was not statistically significantly different from placebo. The efficacy results for the seasonal allergic rhinitis trial are shown in Table 5.

Table 5 : Mean changes in reflective total nasal symptom score in 1 seasonal allergic rhinitis trial in children 6 to 11 years of age

Treatment N Baseline* Change from Baseline Difference from Placebo**
Estimate 95% CI p-value
Reflective total nasal symptom score
Ciclesonide 200 mcg 215 8.25 -2.46 -0.39 (-0.76, -0.02) 0.040
Ciclesonide 100 mcg 199 8.41 -2.38 -0.32 (-0.69, 0.06) 0.103
Placebo 204 8.41 -2.07      
*Mean of AM and PM score from reflective total nasal symptom score; Maximum = 12
** Estimates, 95% Confidence Intervals, and p-values were obtained from repeated measures ANCOVA analysis with treatment, baseline, day, and treatment by day interaction effects included in the model.

In the 12-week trial in patients with perennial allergic rhinitis, none of the ciclesonide doses were statistically significantly different from placebo. The means and 95% confidence intervals for the differences (OMNARIS Nasal Spray minus placebo) between OMNARIS Nasal Spray 200 mcg, 100 mcg, and 25 mcg treatment groups and placebo were -0.31 (-0.75, 0.13), 0.02 (-0.41, 0.46), and 0.09 (-0.35, 0.53), respectively.

Pediatric Patients Aged 2 to 5 Years

Efficacy of OMNARIS Nasal Spray in patients 2 to 5 years of age has not been established [see Pediatric Use].

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

OMNARIS®
[Om-ne'-ris]
(ciclesonide) Nasal Spray, 50 mcg

Important Note: For Intranasal Use Only. Avoid spraying in eyes or directly onto the nasal septum (the wall between the two nostrils).

Read this leaflet before you start using OMNARIS Nasal Spray and each time you refill your prescription. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about OMNARIS Nasal Spray, ask your healthcare provider or pharmacist.

What is OMNARIS Nasal Spray?

OMNARIS Nasal Spray contains a medicine called ciclesonide, which is a synthetic corticosteroid (a substance that reduces inflammation). This medicine is used to treat nasal symptoms (i.e., runny nose, itchy nose, sneezing, and nasal congestion) that happen with:

  • Seasonal nasal allergy in adults and children 6 years of age and older.
  • Year-round nasal allergy symptoms in adults and adolescents 12 years of age and older.

How do I use OMNARIS Nasal Spray?

Use your nasal spray exactly as prescribed by your healthcare provider.

Seasonal allergy symptoms may improve over 1 to 2 weeks; year-round allergy symptoms may improve over 5 weeks. If your symptoms do not improve or get worse, call your healthcare provider.

Dosage

  • OMNARIS Nasal Spray is used 1 time each day, 2 sprays in each nostril.
  • Do not use more than a total of 2 sprays in each nostril each day.

What are the side effects of OMNARIS Nasal Spray?

Common side effects with OMNARIS Nasal Spray include:

  • Headache
  • Nose bleeds
  • Stuffy nose
  • Ear pain
  • Sore throat
  • Dizziness

What are the other risks of using OMNARIS Nasal Spray?

  • Nasal fungal infection.
  • Slow healing of wounds. Do not use OMNARIS Nasal Spray until your nose has healed if: you have a sore in your nose, you have had surgery on your
  • nose, or your nose has been injured.
  • Eye problems, including glaucoma and cataracts. You should have regular eye exams.
  • Immune system effects may increase your risk of infection. You should avoid being around people with Chicken Pox or Measles.
  • Slow growth in children. A child taking OMNARIS Nasal Spray should have his/her growth checked regularly.

These are not all the possible side effects of OMNARIS Nasal Spray. Tell your healthcare provider about any side effects that bother you or do not go away.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.

What are the ingredients in OMNARIS Nasal Spray?

Active ingredient: ciclesonide

Inactive ingredients: purified water, microcrystalline cellulose, carboxymethylcellulose sodium, hypromellose, potassium sorbate and edetate sodium; and hydrochloric acid to adjust the pH to 4.5. This leaflet does not contain all of the information about your medicine. If you have any questions ask your healthcare provider or pharmacist.

You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

Patient's Instructions for Use

OMNARIS Nasal Spray is supplied in an amber glass bottle in a protective plastic sleeve and should be handled with care.

Preparing For Use

1. Remove OMNARIS Nasal Spray from its foil pouch. Count 4 months from today and write this new date on the sticker on the carton (the date that is 4 months after removing the bottle from the foil pouch). Peel off the sticker and place it in the space on your nasal spray bottle. It is important that you throw away the nasal spray bottle after this date.

2. Priming OMNARIS Nasal Spray. Before you use OMNARIS Nasal Spray for the first time, you will need to prime the bottle. Hold the bottle upright and shake the bottle gently. To prime OMNARIS Nasal Spray, fully press down on the finger rests of the applicator eight times (See Figure 1 and Figure 2). If you do not use the nasal spray for 4 days, you will need to shake the bottle gently, and prime the pump again by spraying one time, or until you see a fine mist.

Figure 1

OMNARIS Nasal Spray applicator - Illustration

Using the Spray

1. Blow your nose to clear your nostrils, if needed.

2. Shake the bottle gently and remove the dust cap (See Figure 1).

3. Hold the bottle firmly with your index and middle finger on either side of the applicator (on finger rests) while supporting the base of the bottle with your thumb (See Figure 2).

Figure 2

Hold the bottle firmly - Illustration

4. Insert applicator tip into one nostril, and close the other nostril with your finger (See Figure 3).

Figure 3

Insert applicator tip into one nostril - Illustration

5. Tilt your head forward slightly. Keep the bottle upright, and press the finger rests quickly and firmly to activate the pump. Breathe in (inhale) through your nose as you spray (See Figure 4). Try not to get any spray in your eyes or directly on your nasal septum (the wall between the two nostrils).

Figure 4

Breathe in (inhale) through your nose - Illustration

6. Repeat steps 3-5 for the second spray in the same nostril and for each spray in the other nostril.

How do I store OMNARIS Nasal Spray?

  1. Keep OMNARIS Nasal Spray clean and dry at all times.
  2. Store OMNARIS Nasal Spray between 59° F and 86° F.
  3. Do not freeze.
  4. Keep OMNARIS Nasal Spray and all medicines out of the reach of children.

How Do I Know When the OMNARIS Nasal Spray Bottle Is Empty?

Each bottle of OMNARIS Nasal Spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use a bottle of OMNARIS Nasal Spray after 120 sprays (not counting the priming sprays) have been used or after the “discard by date” you wrote on the sticker when you opened the foil pouch. You may still see some medicine in the bottle. Talk with your healthcare provider before your supply of OMNARIS Nasal Spray runs out to see if you should get a refill of your medicine.

Applicator Cleaning Instructions

Wipe the applicator tip with a clean tissue and replace the dust cap, after you use your nasal spray each day. (See Figure 5)

Figure 5

Wipe the applicator tip - Illustration

If the applicator is clogged or needs more thorough cleaning, use the following cleaning instructions (Do not try to unblock the tiny spray hole on the applicator with a pin or other sharp object. Do not twist or try to remove the white plastic pump attached to the medicine bottle.):

1. Remove the dust cap, hold the white plastic pump firmly with one hand and then carefully pull upwards to free the applicator. (See Figure 6)

Figure 6

Remove the dust cap - Illustration

2. Wash the dust cap and applicator with warm water. (See Figure 7)

Figure 7

Wash the dust cap and applicator - Illustration

3. Dry the applicator, and put it back on the bottle. The applicator will snap into place when properly positioned. (See Figure 8)

Figure 8

OMNARIS® (ciclesonide) Figure 8 Illustration

4. Prime the unit with one spray or until you see a fine mist.

5. Put the dust cap back on the applicator.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

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.

 

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 immediately. 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. Therefore, 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.

Consumer Overview Side Effect

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 your doctor has prescribed this medication because he or she 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 infrequently cause fungal infections of the nose or throat. Tell your doctor immediately 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 immediately 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Omnaris (ciclesonide nasal spray) Side Effects Center for a complete guide to possible side effects

Learn More »

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. Therefore, 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 slow down a child's growth if used for a long time. The effect on final adult height is unknown. 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.

Consumer Overview Missed Dose

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 overdose is suspected, contact a poison control center or emergency room immediately. 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 and resume your usual dosing schedule. 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 March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Omnaris

Generic Name: ciclesonide nasal (Pronunciation: sik le SON ide)

  • What is ciclesonide (Omnaris)?
  • What are the possible side effects of ciclesonide nasal (Omnaris)?
  • What is the most important information I should know about ciclesonide (Omnaris)?
  • What should I discuss with my health care provider before using ciclesonide (Omnaris)?
  • How should I use ciclesonide nasal (Omnaris)?
  • What happens if I miss a dose (Omnaris)?
  • What happens if I overdose (Omnaris)?
  • What should I avoid while using ciclesonide nasal (Omnaris)?
  • What other drugs will affect ciclesonide nasal (Omnaris)?
  • Where can I get more information?

What is ciclesonide (Omnaris)?

Ciclesonide is a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Ciclesonide nasal is used to treat nasal symptoms (congestion, sneezing, runny nose) caused by seasonal allergies in adults and children as young as 6 years old. Ciclesonide nasal is also used to treat nasal symptoms caused by year-round allergies in adults and children who are at least 12 years old.

Ciclesonide may also be used for purposes not listed in this medication guide.

What are the possible side effects of ciclesonide nasal (Omnaris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nasal steroid medicine can be absorbed into your bloodstream, which may cause steroid side effects throughout the body. Although it is not likely that your body will absorb enough of this medication to cause serious side effects, tell your doctor if you have any of these steroid-related symptoms:

  • irregular menstrual periods;
  • acne or increased hair growth;
  • swelling, rapid weight gain, roundness of the face;
  • increased sweating; or
  • depression, anxiety, unusual thoughts or behavior.

Call your doctor at once if you have sores or white patches inside or around your nostrils, or if you have any vision problems, such as tunnel vision.

Less serious side effects may include:

  • headache;
  • nosebleed;
  • stuffy nose, sore throat; or
  • ear pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Omnaris (ciclesonide nasal spray) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about ciclesonide (Omnaris)?

You should not use this medication if you are allergic to ciclesonide.

Before using ciclesonide, tell your doctor if you have asthma, glaucoma, tuberculosis or other infection of the lungs, an open sore inside your nose, or a recent nose injury or surgery. Tell your doctor if you are or have been using any other steroid medications: oral, inhaled, or injected.

Ciclesonide nasal comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

It may take 1 to 2 days before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 2 to 5 weeks of treatment.

If you stopped using another steroid medication when you started using ciclesonide, you may have steroid withdrawal symptoms. These symptoms include joint or muscle pain, depression, and weakness. Do not stop using any steroid medication without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Although it is not likely that your body will absorb enough of this medication to cause serious side effects, tell your doctor if you have any steroid-related symptoms such as irregular menstrual periods, acne, increased hair growth, swelling, rapid weight gain, roundness of the face, increased sweating, depression, anxiety, or unusual thoughts or behavior.

Call your doctor at once if you have sores or white patches inside or around your nostrils, or if you have any vision problems, such as tunnel vision.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Side Effects Centers
  • Omnaris

Patient Detailed How Take

What should I discuss with my health care provider before using ciclesonide (Omnaris)?

You should not use this medication if you are allergic to ciclesonide.

To make sure you can safely use ciclesonide, tell your doctor if you have any of these other conditions:

  • asthma;
  • glaucoma or cataracts;
  • tuberculosis or other infection of the lungs;
  • a sore inside your nose that has not yet healed;
  • a recent nose injury or surgery; or
  • if you are or have been using an oral, inhaled, or injected steroid such as cortisone, methylprednisolone, prednisone, beclomethasone (Beclovent), flunisolide (AeroBid), fluticasone (Advair, Flovent), triamcinolone (Azmacort), and others.

FDA pregnancy category C. It is not known whether ciclesonide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ciclesonide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Long-term use of steroid medication can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

How should I use ciclesonide nasal (Omnaris)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

The usual dose of ciclesonide nasal spray is 2 sprays into each nostril once per day. Follow your doctor's instructions.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If needed, blow your nose to clear your nostrils just before using ciclesonide nasal.

Shake the medicine bottle well just before each use.

Before using the spray for the first time, you must prime the spray pump. Shake the medicine well and spray 8 test sprays into the air and away from your face. Prime the spray pump any time you have not used your nasal spray for longer than 4 days. Spray until a fine mist appears.

It may take 1 to 2 days before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 2 to 5 weeks of treatment.

If you stopped using another steroid medication when you started using ciclesonide, you may have steroid withdrawal symptoms. These symptoms include joint or muscle pain, depression, and weakness. Do not stop using any steroid medication without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Store in an upright position at room temperature, away from moisture and heat. Do not allow the medicine to freeze. Keep the spray bottle clean and dry.

Throw away the Omnaris nasal spray after you have used 120 sprays or 4 months after removing the bottle from the foil pouch, even if there is still medicine left in the bottle.

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  • Omnaris

Patient Detailed Avoid Taking

What happens if I miss a dose (Omnaris)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Omnaris)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of ciclesonide nasal is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using ciclesonide nasal (Omnaris)?

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Ciclesonide nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

What other drugs will affect ciclesonide nasal (Omnaris)?

Tell your doctor about all other medicines you use, especially ketoconazole (Nizoral).

There may be other drugs that can interact with ciclesonide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ciclesonide nasal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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