Rx Item-Alvesco ciclesonide 80mcg Inhaler 6.1gm By Covis Pharma

Clinical Information
Gen. Code and Des.
58671 ciclesonide INHALATION HFA AER AD 80 MCG
GCN and Des.
24149 ciclesonide INHALATION HFA AER AD 80 MCG
Strength
80MCG
Dose Form
HFA AEROSOL WITH ADAPTER (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
48100808 ORALLY INHALED PREPARATIONS (STEROIDS)
68040000 ADRENALS
Active Ingredients
8829 ciclesonide 141845821
Inactive Ingredients
2464 alcohol 64175





ALVESCO- ciclesonide aerosol, metered
Sunovion Pharmaceuticals Inc.
The active component of ALVESCO 80 mcg Inhalation Aerosol, and ALVESCO 160 mcg Inhalation Aerosol is ciclesonide, 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)-,(11?,16?). The empirical formula is C32 H44 O7 and its molecular weight is 540.7
1 Mechanism of Action
Ciclesonide is prodrug that is enzymatically hydrolyzed to pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following oral inhalation. Des-ciclesonide has anti-inflammatory activity with affinity for glucocorticoid receptors that is 120 times greater than the parent compound and 12 times greater than dexamethasone. The clinical significance of these findings is unknown.

Treatment of Asthma
ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.
Important Limitations of Use:
ALVESCO is NOT indicated for the relief of acute bronchospasm.
ALVESCO is NOT indicated for children under 12 years of age.
2 DOSAGE AND ADMINISTRATION
ALVESCO should be administered by the orally inhaled route. Prime ALVESCO Inhalation Aerosol before using for the first time by actuating times prior to using the first dose from new canister or when the inhaler has not been used for more than 10 days. Individual patients will experience variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for four weeks or longer after initiation. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dose after weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ALVESCO when administered in excess of the highest recommended doses has not been established.

Recommended Dosages
The recommended starting dose and the highest recommended dose of ALVESCO Inhalation Aerosol are listed in the following table.
1 Prednisone should be reduced gradually, no faster than 2.5 mg/day on weekly basis, beginning after at least week of therapy with ALVESCO. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions ].
Previous Therapy
Recommended Starting Dose
Highest Recommended Dose
Patients 12 years who received bronchodilators alone
80 mcg twice daily
160 mcg twice daily
Patients 12 years who receivedinhaled corticosteroids
80 mcg twice daily
320 mcg twice daily
Patients 12 years who receivedoral corticosteroids1
320 mcg twice daily
320 mcg twice daily
DOSAGE FORMS AND STRENGTHS
ALVESCO Inhalation Aerosol is available in the following two strengths: 80 mcg/actuation, and 160 mcg/actuation. The 80 mcg/actuation strength contains 60 actuations fill/canister, and the 160 mcg/actuation strength contains 60 actuations fill/canister.
ALVESCO 80 mcg Inhalation Aerosol is supplied with brown plastic actuator with red dust cap.
ALVESCO 160 mcg Inhalation Aerosol is supplied with red plastic actuator with red dust cap.
4 CONTRAINDICATIONS
4.1 Status Asthmaticus
ALVESCO is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Rx Item-Alvesco 80mcg Inhaler 6.1gm By C
NDC No. New 70515-0711-01 70515-711-01 70515071101 7051571101 Old 63402-0711-01 UPC/GTIN No.3-70515-71101-3 MPN No. 71101 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.La

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Sunovion Pharmaceuticals Inc

CICLESONIDE INHALATION HF
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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