si-KLESS-o-nide

• Maintenance treatment of asthma as preventive therapy in patients 12 yr.
• Not for acute treatment of bronchospasm.

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

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

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;.

Contraindicated in:

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

Use Cautiously in:

• Geri: Consider age-related ↓ in cardiac, renal and hepatic function, concurrent disease state and drug therapy; consider lower initial dose
• OB: ↓dose may be sufficient
• Lactation: Many corticosteroids enter breast milk, hypercorticism may be seen with ↑ maternal doses
• Pedi: Safety and effectiveness in children <12 has not been established.

CNS: headache.

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

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

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

Misc: worsening of infections.

Drug-Drug:

• None noted.

• Inhaln (Adults 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.

• When changing from oral to inhaled corticosteroids, taper oral dose slowly, no faster than prednisone 2.5 mg/day on a weekly basis, beginning after at least 1 wk of ciclesonide inhalation therapy.
• After the desired clinical effect has been obtained, attempts should be made to ↓ dose to lowest amount required to control symptoms. Gradually ↓ as long as desired effect is maintained. If symptoms return, dose may briefly return to starting dose.
• Inhaln: Allow at least 1 min between inhalations. Do not shake inhaler or use with spacer (See Appendix F).
  • If bronchospasm occurs right after ciclesonide dose, discontinue and administer short acting bronchodilator; notify health care professional.

Alvesco

Therapeutic Classification: antiasthmatics

Pharmacologic Classification: corticosteroids (inhalation)

• Aerosol inhalation (contains HFA-134A as a propellant): 80 mcg/actuation in 6.1 g cannisters of 60 actuations; 160 mcg/actuation in 6.1 and 9.6 g cannisters of 60 and 120 actuations;

(improvement in symptoms)

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

• Monitor respiratory status and lung sounds. Pulmonary function tests may be assessed periodically during and for several mo following a transfer from systemic to inhalation corticosteroids.
• Assess patients changing from systemic corticosteroids to inhalation corticosteroids for signs of adrenal insufficiency (anorexia, nausea, weakness, fatigue, hypotension, hypoglycemia) during initial therapy and periods of stress. If these signs appear, notify health care professional immediately; condition may be life-threatening.
• Monitor for withdrawal symptoms (fatigue, weakness, nausea, vomiting, hypotension, joint or muscular pain, lassitude, depression) during withdrawal from oral corticosteroids.
• Monitor growth rates in children receiving chronic therapy; lowest possible dose should be used.
• Monitor patients with a change in vision or with a history of ↑ intraocular pressure, glaucoma, or cataracts closely.

• Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic therapy. Children and patients using higher than recommended doses are at highest risk for HPA suppression.

• Ineffective airway clearance (Indications).
• Risk for infection (Side Effects).

• 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 female patients 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.

• Management of the symptoms of chronic asthma.
• Improvement in asthma symptoms. Maximum benefit may take 4 wks or longer.

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