Alvesco inhaler (Tentavir inhaler) contains ciclesonide, a prodrug that is activated in the body. It is a potent steroid used for maintenance and prophylactic therapy via the inhalational route in patients with Asthma. It should not be advised to patients with acute severe asthma.

Ciclesonide (oral inhalation) Dose in Adults

Note: Titrate to the lowest effective dose once asthma stability is achieved.

Alvesco inhaler (Tentavir inhaler) dose in Asthma:

Note: Dosing based on previous asthma therapy and asthma severity. May increase the dose after 4 weeks of therapy in patients who are not adequately controlled.

• Prior therapy with bronchodilators alone:

  • 80 mcg twice daily to a maximum dose of 160 mcg twice daily

• Prior therapy with inhaled corticosteroids:

  • 80 mcg twice daily to a maximum dose of 320 mcg twice daily

• Prior therapy with oral corticosteroids:

  • 320 mcg twice daily to a maximum dose of 320 mcg twice daily.

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Asthma guidelines: Global Initiative for Asthma guidelines (HFA inhaler):

Metered dose Alvesco (Tentavir) inhaler:

• Low-dose therapy:

  • 80 to 160 mcg/day in divided doses twice daily

• Medium-dose therapy:

  • greater than 160 to 320 mcg/day in divided doses twice daily

• High-dose therapy:

  • greater than 320 mcg/day in divided doses twice daily

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Conversion from oral to orally-inhaled steroid:

• A gradual dose reduction of oral corticosteroids should begin at least 1 week after starting inhaled therapy.
• The dose of oral corticosteroids should not be reduced more rapidly than 2.5 mg per week.

Ciclesonide (oral inhalation) Dose in Childrens

Ciclesonide (Alvesco, Tentavir) use in maintenance therapy of Asthma:

• Alvesco inhaler comes in two dosages:

  • 80 mcg/inhalation and
  • 160 mcg/inhalation:

• Children 2 to 11 years:

  • Metered-dose inhaler:
    •  40, 80, or 160 mcg once daily.

• Children older than 12 years and Adolescents:

  • Prior therapy with bronchodilators alone:

    • 80 mcg twice daily. Increase the dose after 4 weeks of therapy if the response is inadequate. The maximum daily dose is 320 mcg/day

  • Prior therapy with inhaled corticosteroids:

    • 80 mcg twice daily. Increase the dose after 4 weeks of therapy if response inadequate to a maximum daily dose of 640 mcg/day.

  • Prior therapy with oral corticosteroids:

    • 320 mcg twice daily to a maximum daily dose of 640 mcg/day

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• Children 6 to 11 years:

  • "Low" dose: 80 mcg/day
  • "Medium" dose: greater than 80 to 160 mcg/day
  • "High" dose: greater than 160 mcg/day

• Children ≥12 years and Adolescents:

  • "Low" dose: 80 to 160 mcg/day
  • "Medium" dose: greater than 160 to 320 mcg/day
  • "High" dose: greater than 320 mcg/day

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• Children 6 to 11 years (Canadian labeling)

  • 100 to 200 mcg once daily
  • The maintenance dose is 100 to 200 mcg/day

• Children older than 12 years and Adolescents:

  • 400 mcg once daily
  • Maintenance dose: 100 to 800 mcg/day

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Conversion: Conversion from oral to orally-inhaled steroid:

• Children older than 12 years and Adolescents:
  • A gradual dose reduction of oral corticosteroids should begin at least 1 week after starting inhaled therapy.
  • The dose of oral corticosteroids should not be reduced more rapidly than 2.5 mg per week.

Pregnancy Risk Factor C

• Uncontrolled asthma can lead to adverse pregnancy events such as preterm births, perinatal mortality, pre-eclampsia and preterm births.
• Pregnant women may be given inhaled corticosteroids. Inhalational steroids may cause more severe asthma symptoms than those that are controlled.

Use of clesonide during breastfeeding

• Breastfeeding should be encouraged for people with asthma.
• Breastfeeding is safe with the use of inhalational steroids.
• But, it is important to be cautious and monitor the infant for signs of hypercortisolism.

Ciclesonide (oral inhalation) Dose in Kidney Disease:

• Ciclesonide use has not been studied in patients with renal disease.
• However, dose adjustment may not be necessary since only 20% of the drug is excreted via the Renal system.

Ciclesonide (oral inhalation) dose in Liver Disease:

No dose adjustment required in patients with liver disease.

Common Side Effects of ciclesonide (Alvesco, tentavir inhaler):

• Central nervous system:

  • Headache

• Respiratory:

  • Nasopharyngitis

Less Common Side Effects of Alvesco inhaler (ciclesonide, tentavir 160):

• Cardiovascular:

  • Facial edema

• Central nervous system:

  • Dizziness
  • Fatigue
  • Voice disorder

• Dermatologic:

  • Urticaria

• Gastrointestinal:

  • Gastroenteritis
  • Oral candidiasis

• Infection:

  • Influenza

• Neuromuscular & skeletal:

  • Arthralgia
  • Back pain
  • Limb pain
  • musculoskeletal chest pain

• Ophthalmic:

  • Conjunctivitis

• Otic:

  • Otalgia

• Respiratory:

  • Upper respiratory tract infection
  • Nasal congestion
  • Pharyngolaryngeal pain
  • Hoarseness
  • Pneumonia
  • Sinusitis
  • Paradoxical
  • Bronchospasm

Contraindication to Ciclesonide include:

• Allergy or sensitivity to ciclesonide, any component of the formulation
• Acute asthma episodes or status asthmaticus require intensive treatment
• Untreated fungal, bacterial, or tuberculosis infections of the respiratory tract
• Moderate to severe bronchiectasis

Warnings and Precautions

• Suppression of the adrenals:
  • Hypercortisolism, or suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur in children younger than 5 years old or patients who have been taking high doses for long periods.
  • If the drug is suddenly stopped, HPA axis suppression could cause adrenal crises.
  • It is important to withdraw and stop using a corticosteroid slowly and carefully.
  • Patients who have an acute illness or during the perioperative period should receive intravenous hydrocortisone stress doses.
• Bronchospasm
  • Paradoxical bronchospasm is a condition that has been reported. It can be hard to distinguish from worsening asthmatic symptoms. It is important to get treatment as soon as possible.​​​​​​​
• Immunosuppression:
  • Corticosteroids can cause immunosuppression, which may increase the risk of infection, especially tuberculosis, fungal and rare viral infections.
  • Steroids can make vaccines less effective.
  • Avoid measles and chickenpox exposure. It is important to get timely immunoglobulins. Antiviral agents may be required if chickenpox is developed.​​​​​​​
• Oral candidiasis:
  • To avoid any oral candidiasis, patients should rinse their mouth with water after using an inhaler.​​​​​​​
• Vasculitis:
  • If symptoms of asthma persist, you should seek treatment for the churgh–Strauss syndrome.​​​​​​​​​​​​​​
• Bone mineral density:
  • Patients on long-term steroids should monitor their bone mineral density regularly.​​​​​​​
• Ocular disease:
  • Regularly monitor your visual acuity, and check for glaucoma or cataracts.

Ciclesonide (oral inhalation): Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters while using ciclesonide (Tentavir/ alvesco) inhaler:

• Forced expiratory volume
• peak flow rate, and other pulmonary function tests;
• bone mineral density
• growth velocity (adolescents and children via stadiometry);
• Observe for signs & symptoms of HPA axis suppression & adrenal insufficiency
• observe for oral candidiasis
• Monitor for symptoms and improvement/ deterioration of asthma
• Monitor for visual problems, glaucoma & cataracts

How to use Ciclesonide metered-dose inhaler (Tentavir 160, Alvesco)?

• Prime inhaler by actuating 3 times before the first use or when the inhaler has not been used for more than 10 consecutive days. (do not shake before use)
• Rinse mouth with water (and spit out) after inhalation or use it before meals.
• Do not wash or place the inhaler in water.
• Clean mouthpiece using a dry cloth or tissue once weekly.
• Discard after the "discard by" date or when dose indicator display window reads "0", even if canister is not completely empty.

Mechanism of action of Alvesco inhaler (Ciclesonide):

After being administered, Ciclesonide, a glucocorticoid drug, is hydrolyzed to become its active metabolite desciclesonide. Des-ciclesonide is highly attracted to the glucocorticoid hormone receptor. The mechanism of action for corticosteroids is believed to be a combination of three important properties:

• Anti-inflammatory activity
• Immunosuppressive properties and
• Antiproliferative measures

The drug must be taken orally.Maximum benefit can be achieved for up to 4 weeks. Nearly half of the drug is absorbed through the lungs, and 99% is bound to proteins. Hydrolysis of Ciclesonide to des-ciclesonide, its active metabolite via esterases within the nasal mucosa or lungs is how it is metabolized. Further hepatic metabolism occurs via CYP3A4 (and to a lesser degree via CYP2D6). Following are the bioavailabilities of the active drugInhalation is 63%, while oral intake is negligible. Eliminating half-lifeCiclesonide takes 0.7 hours, and des-ciclesonide takes 6 to 7 hours The time it takes for the active drug to reach its peak plasma concentration is1 hour 66% of the drug can be excreted via feces

Ciclesonide inhaler international brands:

• Alvesco
• Cesonide
• Cicletex
• Ciclocip
• Ciclohale
• Ciclotis
• Disbronc
• Osonide
• Tentavir

Ciclesonide (oral inhalation) Brands in Pakistan:

No brands of ciclesonide inhaler are available in Pakistan