• Maintenance treatment of asthma as preventive therapy.
• Not for acute treatment of bronchospasm.

Contraindicated in:

• Hypersensitivity to ciclesonide or any other ingredients in the formulation
• Acute asthma/status asthmaticus.

Use Cautiously in:

• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Children <12 yr (safety and effectiveness not established).
• Geri: Consider age-related ↓ in cardiac, renal and hepatic function, concurrent disease state and drug therapy; consider lower initial dose.

EENT: nasal congestion, nasopharyngitis, ↑ intraocular pressure, candida infection of mouth and pharynx, cataracts, pharyngolaryngeal pain.

Endo: ↓growth (children), adrenal suppression (↑ dose, long term therapy).

MS: arthralgia, back pain, extremity pain, ↓ bone mineral density (↑ dose, long term therapy).

Neuro: headache.

Misc: worsening of infections.

Drug-Drug:

• None noted.

• Inhalation aerosol (contains HFA-134A as a propellant): 80 mcg/actuation in 6.1–g canisters of 60 actuations; 160 mcg/actuation in 6.1–g canisters of 60 actuations;

• Inhaln (Adults and Children 12 yr): Previous therapy with bronchodilators alone: 80 mcg twice daily, may be ↑ to 160 mcg twice daily; Previous therapy with inhaled corticosteroids: 80 mcg twice daily, may be ↑ to 320 mcg twice daily; Previous therapy with oral corticosteroids: 320 mcg twice daily.

Alvesco

• Potent, locally acting anti-inflammatory and immune modifier.

• ↓frequency and severity of asthma attacks; improved asthma symptoms.

Therapeutic Classification: antiasthmatics

Pharmacologic Classification: corticosteroids (inhalation)

Absorption: Negligible oral bioavailability, action is primarily local.

Distribution: Unknown.

Metabolism/Excretion: Converted by esterases to des-ciclesonide, the active drug, which is subsequently metabolized by the liver. Some further metabolites may be pharmacologically active. Mostly eliminated in feces via biliary excretion; <20% of des-ciclesonide is excreted in urine.

Half-life: Ciclesonide: 0.7 hr; Des-ciclesonide: 6–7 hr.

(improvement in symptoms)

† Improvement in pulmonary function, ↓ airway responsiveness may take longer.

• Instruct patient to use inhaler at regular intervals as directed. If a dose is missed, omit and take next regularly scheduled dose. Advise patient not to ↑ dose or discontinue medication, even if feeling better, without consulting health care professional; gradual ↓ is required. If asthma symptoms worsen, contact health care professional. Instruct patient to read Patient Leaflet before use.
• Advise patient to follow instructions supplied. Before first-time use or if inhaler has not been used for more than 10 days, prime unit by actuating 3 times prior to dose. Do not shake inhaler. When dose indicator display window shows a red zone, 20 inhalations are left and refill is required; discard when indicator shows zero. Do not use actuator with other medications. Clean mouthpiece weekly with a clean dry tissue; do not wash or put any part of the inhaler in water.
• Advise patients using inhalation corticosteroids and bronchodilator to use bronchodilator first and to allow 5 min to elapse before administering the corticosteroid, unless otherwise directed by health care professional.
• Advise patient that inhalation corticosteroids should not be used to treat an acute asthma attack but should be continued even if other inhalation agents are used.
• Instruct patient to notify health care professional if asthma worsens or if signs of adrenal insufficiency occur.
• Patients using inhalation corticosteroids to control asthma may require systemic corticosteroids for acute attacks. Advise patient to use regular peak flow monitoring to determine respiratory status.
• Advise patient to rinse mouth with water after treatment to ↓ risk of developing local candidiasis.
• Caution patient to avoid smoking, known allergens, and other respiratory irritants.
• Advise patient to notify health care professional if sore throat or mouth occurs or if exposed to anyone with chicken pox or measles.
• Instruct patient to consult health care professional before taking other Rx, OTC, or herbal products.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Instruct patient whose systemic corticosteroids have been recently reduced or withdrawn to carry a warning card indicating the need for supplemental systemic corticosteroids in the event of stress or severe asthma attack unresponsive to bronchodilators.

si-KLESS-o-nide

NDC Code^*

• 70515- Covis Pharma
  • 70515-701- Omnaris
    • 70515-701-01- 1 POUCH in 1 CARTON (70515-701-01) > 1 BOTTLE, GLASS in 1 POUCH > 120 SPRAY in 1 BOTTLE, GLASS

• 70515- Covis Pharma
  • 70515-711- Alvesco
    • 70515-711-01- 1 INHALER in 1 CARTON (70515-711-01) > 60 AEROSOL, METERED in 1 INHALER

• 70515- Covis Pharma
  • 70515-711- Alvesco
    • 70515-711-02- 1 INHALER in 1 CARTON (70515-711-02) > 60 AEROSOL, METERED in 1 INHALER

• 70515- Covis Pharma
  • 70515-712- Alvesco
    • 70515-712-01- 1 INHALER in 1 CARTON (70515-712-01) > 60 AEROSOL, METERED in 1 INHALER

• 70515- Covis Pharma
  • 70515-712- Alvesco
    • 70515-712-02- 1 INHALER in 1 CARTON (70515-712-02) > 60 AEROSOL, METERED in 1 INHALER

• 70515- Covis Pharma
  • 70515-737- Zetonna
    • 70515-737-60- 1 CANISTER in 1 CARTON (70515-737-60) > 60 AEROSOL, METERED in 1 CANISTER