OMNARIS- ciclesonide spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CICLESONIDE (UNII: S59502J185) (CICLESONIDE - UNII:S59502J185)

Available from:

Physicians Total Care, Inc.

INN (International Name):

CICLESONIDE

Composition:

CICLESONIDE 50 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. OMNARIS Nasal Spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

Product summary:

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. (NDC 54868-6020-0 ) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Shake gently before use. Do not spray in eyes. Keep out of reach of children. Manufactured for: Sepracor Inc. Marlborough, MA 01752 USA Made in Germany For customer service, call 1-888-394-7377 To report adverse events, call 1-877-737-7226 For medical information, call 1-800-739-0565 November 2007 USA F.1/1207/3.5472.73 Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

New Drug Application

Summary of Product characteristics

OMNARIS - CICLESONIDE SPRAY
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
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 C
H O 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.
CLINICAL PHARMACOLOGY
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,
eico