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Omnaris
Overview
What is Omnaris?
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-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α)-.
Ciclesonide is delivered as the R-epimer. The empirical formula is CHO and its
molecular weight is 540.7. Its structural formula is as follows:
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, manual-pump 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. The contents of
one 12.5 gram bottle provide 120 actuations, after initial priming. Prior to
initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be
primed by actuating eight times. Once primed, each actuation of the pump
delivers 50 mcg ciclesonide in a volume of 70 microliters from the nasal
actuator. 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.
What does Omnaris look like?
What are the available doses of Omnaris?
Sorry No records found.
What should I talk to my health care provider before I take Omnaris?
Sorry No records found
How should I use Omnaris?
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.
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.
Seasonal Allergic Rhinitis
Adults and Children (6 Years of Age and Older):
Perennial Allergic Rhinitis
Adults and Adolescents (12 Years of Age and Older):
The maximum total daily dosage should not exceed 2 sprays in each nostril
(200 mcg/day).
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.
Directions for Use
Illustrated patient's instructions for proper use accompany each package of
OMNARIS Nasal Spray.
What interacts with Omnaris?
OMNARIS Nasal Spray is contraindicated in patients with a hypersensitivity to any of its ingredients.
What are the warnings of Omnaris?
(See , boxed ,
and ).
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.
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 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 exposed to chickenpox, prophylaxis with varicella zoster immune
globulin (VZIG) may be indicated. If 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.
What are the precautions of Omnaris?
Intranasal corticosteroids may cause a reduction in growth
velocity when administered to pediatric patients (see ). Rarely, immediate
hypersensitivity reactions or contact dermatitis may occur after the
administration of intranasal corticosteroids. Patients with a known
hypersensitivity reaction to other corticosteroid preparations should use
caution when using ciclesonide nasal spray since cross reactivity to other
corticosteroids including ciclesonide may also occur.
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.
In clinical studies with OMNARIS Nasal Spray, the development of localized
infections of the nose and pharynx with has rarely 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 infection or other signs of adverse effects on the
nasal mucosa. Intranasal 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.
If recommended doses of intranasal corticosteroids are exceeded or if
individuals are particularly sensitive or predisposed by virtue of recent
systemic steroid therapy, symptoms of hypercorticism may occur, including very
rare cases of menstrual irregularities, acneiform lesions, and cushingoid
features. If such changes occur, topical corticosteroids should be discontinued
slowly, consistent with accepted procedures for discontinuing oral steroid
therapy.
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 trials, no
significant differences in intraocular pressure changes were observed between
OMNARIS Nasal Spray 200 mcg and placebo-treated 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. Rare instances of wheezing,
nasal septum perforation, cataracts, glaucoma, and increased intraocular
pressure have been reported following the intranasal application of
corticosteroids. Close follow-up is warranted in patients with a change in
vision and with a history of glaucoma and/or cataracts.
Patients being treated with OMNARIS Nasal Spray should receive
the following information and instructions. This information is intended to aid
them in the safe and effective use of this medication. It is not a disclosure of
all possible adverse or intended effects.
Patients who are on immunosuppressive doses of corticosteroids should be
warned to avoid exposure to chickenpox or measles, and if exposed, to obtain
medical advice. Patients should use OMNARIS Nasal Spray at regular intervals
since its effectiveness depends on its regular use (See ).
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 timeframe and periodically until the
patients 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. For the proper use of
this unit and to attain maximum improvement, the patients should read and follow
the accompanying patient instructions carefully. Spraying OMNARIS Nasal Spray
directly into the eyes or onto the nasal septum should be avoided. 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.
Based on in vitro studies in human liver microsomes,
des-ciclesonide appears to have no inhibitory or induction potential on the
metabolism of other drugs metabolized by CYP 450 enzymes. The inhibitory
potential of ciclesonide on CYP450 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 erythromycin, an inhibitor of cytochrome P450 3A4, had no effect on the
pharmacokinetics of either des-ciclesonide or erythromycin. In another 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. Therefore, ketoconazole should be
administered with caution with intranasal ciclesonide.
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 children, respectively, based on mcg/m) 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 children, respectively, based on mcg/m) 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/m).
Pregnancy Category C
Oral administration of ciclesonide in rats up to 900 mcg/kg (approximately 35
times the maximum human daily intranasal dose in adults based on mcg/m) produced no teratogenicity or other fetal effects. However,
subcutaneous administration of ciclesonide in rabbits at 5 mcg/kg (less than the
maximum human daily intranasal dose in adults based on mcg/m) 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 based on mcg/m).
There are no adequate and well-controlled studies in pregnant women. OMNARIS
Nasal Spray, like other corticosteroids, 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.
Hypoadrenalism may occur in infants born of mothers receiving
corticosteroids during pregnancy. Such infants should be carefully
monitored.
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.
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 is supported by evidence from four
adequate and well-controlled studies in adults and adolescents 12 years of age
and older with seasonal and perennial allergic rhinitis, and 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 perennial allergic
rhinitis in patient 6 to 11 years of age has not been established (see ).
The efficacy of OMNARIS Nasal Spray in children 2 to 5 years of age has not been
established. 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 studies in children less than two years of age have not been
conducted. Studies in children under 2 years of age are waived because of local
and systemic safety concerns.
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). 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.
Clinical studies of OMNARIS Nasal Spray did not include
sufficient numbers of subjects age 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.
What are the side effects of Omnaris?
Adult and Adolescent Patients Aged 12
Years and Older:
In controlled clinical studies conducted in the US and Canada, a total of
1524 patients ages 12 years and older received treatment with ciclesonide
administered intranasally. In studies of 2 to 6 weeks duration in patients 12
years and older, 546 patients were treated with OMNARIS Nasal Spray 200 mcg
daily, and in a study of up to one year in duration, 441 patients were treated
with OMNARIS Nasal Spray 200 mcg daily. The overall incidence of adverse events
for patients treated with OMNARIS Nasal Spray was comparable to that in patients
treated with placebo. Adverse events 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 events; this rate was
similar for patients treated with placebo. Table 4 displays adverse events,
irrespective of drug relationship, 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.
In a 52-week long-term safety trial that included 663 adults and adolescent
patients (441 treated with ciclesonide: 227 males and 436 females) with
perennial allergic rhinitis, the adverse event profile over the treatment period
was similar to the adverse event profile in trials of shorter duration. Adverse
events considered likely or definitely related to OMNARIS Nasal Spray that were
reported at an incidence of 1% or greater of patients and more commonly in
OMNARIS Nasal Spray versus placebo were epistaxis, nasal discomfort, and
headache. No patient experienced a nasal septal perforation or nasal ulcer
during long-term use of OMNARIS Nasal Spray. While primarily designed to assess
the long-term safety of OMNARIS Nasal Spray 200 mcg once daily, this 52-week
trial demonstrated greater decreases in total nasal symptom scores with OMNARIS
Nasal Spray versus placebo treated patients over the entire treatment
period.
Pediatric Patients Aged 6 to 11 Years:
Two controlled clinical studies 2 and 12 weeks in duration were conducted in
the US and Canada and included a total of 1282 patients with allergic rhinitis
ages 6 to 11 years, of which 913 were treated with OMNARIS (ciclesonide) Nasal
Spray 200 mcg, 100 mcg or 25 mcg daily. The overall incidence of adverse events
for patients treated with OMNARIS Nasal Spray was comparable to that in patients
treated with placebo. 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 events; these rates were lower than the rate in patients treated with
placebo (2.8%). Table 5 displays adverse events, 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.
Pediatric Patients Aged 2 to 5 Years:
Two controlled clinical studies 6 and 12 weeks in duration were conducted in
the US and included a total of 258 patients 2 to 5 years of age with perennial
allergic rhinitis, of which 183 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.
| 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 | 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 |
What should I look out for while using Omnaris?
OMNARIS Nasal Spray is contraindicated in patients with a hypersensitivity to
any of its ingredients.
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.
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 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 exposed to chickenpox, prophylaxis with varicella zoster immune
globulin (VZIG) may be indicated. If 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.
What might happen if I take too much Omnaris?
There are no data available on the effects of acute or chronic overdosage with
OMNARIS Nasal Spray. Because of low systemic bioavailability, acute overdosage
is unlikely to require any therapy other than observation. A single oral dose of
up to 10 mg of ciclesonide in healthy volunteers was well tolerated and serum
cortisol levels were virtually unchanged in comparison with placebo treatment.
Chronic overdosage with any corticosteroid may result in signs or symptoms of
hypercorticism (See ).
How should I store and handle Omnaris?
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). PROTECT FROM LIGHT. KEEP TIGHTLY CLOSED. Sarafem is a registered trademark of Eli Lilly and Company. 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 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. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. 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.OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. ()Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Do not spray in eyes. Manufactured for: Sepracor Inc.Marlborough, MA 01752 USAMade in GermanyFor customer service, call 1-888-394-7377To report adverse events, call 1-877-737-7226For medical information, call 1-800-739-0565November 2007USA F.1/1207/3.5472.73Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
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 (des-ciclesonide) 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.
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.
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
Intranasal ciclesonide is hydrolyzed to a biologically active metabolite,
des-ciclesonide, by esterases in the nasal mucosa. 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 C-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). C-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. 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 1280 mcg ex-actuator ciclesonide by oral inhalation and
dose adjustment in liver impairment is not necessary. Studies in renal impaired
patients were not conducted.
In a 12-week study in children 6-11 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 ciclesonide-treated 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 ).
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 ciclesonide-treated 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 ).
There are no adequately conducted studies in adults and adolescents that
assess the effect of OMNARIS Nasal Spray on adrenal function.
Non-Clinical Toxicology
OMNARIS Nasal Spray is contraindicated in patients with a hypersensitivity to any of its ingredients.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.
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 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 exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If 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.
If diazepam is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of diazepam, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines, narcotics, barbiturates, MAO inhibitors and other antidepressants.
Concomitant use with alcohol is not recommended due to enhancement of the sedative effect.
Diazepam peak concentrations are 30% lower when antacids are administered concurrently. However, there is no effect on the extent of absorption. The lower peak concentrations appear due to a slower rate of absorption, with the time required to achieve peak concentrations on average 20–25 minutes greater in the presence of antacids. However, this difference was not statistically significant.
There is a potentially relevant interaction between diazepam and compounds which inhibit certain hepatic enzymes (particularly cytochrome P450 3A and 2C19). Data indicate that these compounds influence the pharmacokinetics of diazepam and may lead to increased and prolonged sedation. At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole.
There have also been reports that the metabolic elimination of phenytoin is decreased by diazepam.
Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see ). Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of intranasal corticosteroids. Patients with a known hypersensitivity reaction to other corticosteroid preparations should use caution when using ciclesonide nasal spray since cross reactivity to other corticosteroids including ciclesonide may also occur.
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. In clinical studies with OMNARIS Nasal Spray, the development of localized infections of the nose and pharynx with has rarely 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 infection or other signs of adverse effects on the nasal mucosa. Intranasal 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.
If recommended doses of intranasal corticosteroids are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapy, symptoms of hypercorticism may occur, including very rare cases of menstrual irregularities, acneiform lesions, and cushingoid features. If such changes occur, topical corticosteroids should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.
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 trials, no significant differences in intraocular pressure changes were observed between OMNARIS Nasal Spray 200 mcg and placebo-treated 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. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids. Close follow-up is warranted in patients with a change in vision and with a history of glaucoma and/or cataracts.
Patients being treated with OMNARIS Nasal Spray should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Patients who are on immunosuppressive doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and if exposed, to obtain medical advice. Patients should use OMNARIS Nasal Spray at regular intervals since its effectiveness depends on its regular use (See ).
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 timeframe and periodically until the patients 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. For the proper use of this unit and to attain maximum improvement, the patients should read and follow the accompanying patient instructions carefully. Spraying OMNARIS Nasal Spray directly into the eyes or onto the nasal septum should be avoided. 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.
Based on in vitro studies in human liver microsomes, des-ciclesonide appears to have no inhibitory or induction potential on the metabolism of other drugs metabolized by CYP 450 enzymes. The inhibitory potential of ciclesonide on CYP450 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 erythromycin, an inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin. In another 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. Therefore, ketoconazole should be administered with caution with intranasal ciclesonide.
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 children, respectively, based on mcg/m) 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 children, respectively, based on mcg/m) 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/m).
Pregnancy Category C
Oral administration of ciclesonide in rats up to 900 mcg/kg (approximately 35 times the maximum human daily intranasal dose in adults based on mcg/m) produced no teratogenicity or other fetal effects. However, subcutaneous administration of ciclesonide in rabbits at 5 mcg/kg (less than the maximum human daily intranasal dose in adults based on mcg/m) 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 based on mcg/m).
There are no adequate and well-controlled studies in pregnant women. OMNARIS Nasal Spray, like other corticosteroids, 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.
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
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.
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 is supported by evidence from four adequate and well-controlled studies in adults and adolescents 12 years of age and older with seasonal and perennial allergic rhinitis, and 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 perennial allergic rhinitis in patient 6 to 11 years of age has not been established (see ). The efficacy of OMNARIS Nasal Spray in children 2 to 5 years of age has not been established. 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 studies in children less than two years of age have not been conducted. Studies in children under 2 years of age are waived because of local and systemic safety concerns.
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). 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.
Clinical studies of OMNARIS Nasal Spray did not include sufficient numbers of subjects age 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.
Adult and Adolescent Patients Aged 12 Years and Older:
In controlled clinical studies conducted in the US and Canada, a total of 1524 patients ages 12 years and older received treatment with ciclesonide administered intranasally. In studies of 2 to 6 weeks duration in patients 12 years and older, 546 patients were treated with OMNARIS Nasal Spray 200 mcg daily, and in a study of up to one year in duration, 441 patients were treated with OMNARIS Nasal Spray 200 mcg daily. The overall incidence of adverse events for patients treated with OMNARIS Nasal Spray was comparable to that in patients treated with placebo. Adverse events 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 events; this rate was similar for patients treated with placebo. Table 4 displays adverse events, irrespective of drug relationship, 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.
In a 52-week long-term safety trial that included 663 adults and adolescent patients (441 treated with ciclesonide: 227 males and 436 females) with perennial allergic rhinitis, the adverse event profile over the treatment period was similar to the adverse event profile in trials of shorter duration. Adverse events considered likely or definitely related to OMNARIS Nasal Spray that were reported at an incidence of 1% or greater of patients and more commonly in OMNARIS Nasal Spray versus placebo were epistaxis, nasal discomfort, and headache. No patient experienced a nasal septal perforation or nasal ulcer during long-term use of OMNARIS Nasal Spray. While primarily designed to assess the long-term safety of OMNARIS Nasal Spray 200 mcg once daily, this 52-week trial demonstrated greater decreases in total nasal symptom scores with OMNARIS Nasal Spray versus placebo treated patients over the entire treatment period.
Pediatric Patients Aged 6 to 11 Years:
Two controlled clinical studies 2 and 12 weeks in duration were conducted in the US and Canada and included a total of 1282 patients with allergic rhinitis ages 6 to 11 years, of which 913 were treated with OMNARIS (ciclesonide) Nasal Spray 200 mcg, 100 mcg or 25 mcg daily. The overall incidence of adverse events for patients treated with OMNARIS Nasal Spray was comparable to that in patients treated with placebo. 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 events; these rates were lower than the rate in patients treated with placebo (2.8%). Table 5 displays adverse events, 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.
Pediatric Patients Aged 2 to 5 Years:
Two controlled clinical studies 6 and 12 weeks in duration were conducted in the US and included a total of 258 patients 2 to 5 years of age with perennial allergic rhinitis, of which 183 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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