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Alvesko - GCS for topical inhalation. Ciclesonide exhibits low affinity for glucocorticoid receptors. After inhalation with the participation of enzymes in the lungs is converted into the main metabolite (desCiclesonide, C21-desmethylpropionylcyclosonide), which has a pronounced anti-inflammatory activity and therefore is considered an active metabolite. Ciclesonide suppresses inflammatory reactions in the respiratory tract and, thus, reduces the symptoms of bronchial asthma, improves lung function.
1 dose contains cycconid 160 mcg.
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Dosage and Administration
For oral inhalation.
Alvesco must be taken for a long period of time daily. The drug is dosed individually. The initial dose should be adjusted depending on the severity of the condition. When the desired clinical effect is achieved, the dose should be reduced to the minimum necessary to control the manifestations of the disease.
Adults, elderly patients and adolescents over 12 years old
Mild to moderate asthma: The recommended daily dose ranges from 160 to 640 mcg; The dose of 640 mcg should be divided into 2 doses per day.
Severe asthma: The dose may be increased to a maximum of 2 × 640 mcg daily.
Improvement of the manifestations of the disease occurs within 24 hours after taking Alvesco. It is assumed that the maximum effect of the treatment - as with other inhaled GCS - is achieved after 2-3 months of use of the drug.
Patients should not stop treatment, even in the absence of asthma symptoms.
Children over 6 years old
The recommended daily dose is 80–160 mcg once or 80 mcg twice a day.
Alvesco can be used with or without spacer. If spacer use is necessary, a spacer is recommended.AeroChamberPlus.
There is no need to adjust the dose for elderly patients or patients with hepatic or renal insufficiency.
Adults and adolescents who constantly take oral GCS
In patients with severe asthma who depend on oral therapy of GCS (for example, prednisone), the dose of Alvesco is 640 mcg twice a day. To transfer patients from oral GCS to Alvesco - patients must be in remission. The dose of Alvesco (640 mcg twice a day) should be applied for 10 days in combination with oral GCS. The dose of oral GCS should then be gradually reduced every week to the lowest possible level, with a decrease in the daily dose of no more than 2.5 mg each time.
In most cases, side effects were mild and did not require discontinuation of the drug Alvesco.
- On the part of the digestive system: sometimes (> 1/1000, <1/100) - nausea, vomiting, unpleasant taste; rarely (> 1/10 000, <1/1000) - abdominal pain, dyspepsia.
- On the part of the respiratory system: sometimes - dyspnea, cough after inhalation, paradoxical bronchospasm.
- From the side of the central nervous system: sometimes - a headache.
- From the side of the cardiovascular system: rarely - heartbeat, arterial hypertension.
- Dermatological reactions: sometimes - eczema and skin rash.
- Allergic reactions: rarely - angioedema, hypersensitivity reactions.
- Local reactions: sometimes - reactions at the site of application, dryness at the site of application.
Other: sometimes - fungal infections of the oral cavity.
Inhaled GCS can cause systemic effects, especially with long-term use in high doses.
Carefully: patients with pulmonary tuberculosis in active or chronic form; patients with bacterial, viral, or fungal infections of the respiratory tract.
According to in vitro data, CYP3A4 is the main enzyme involved in the metabolism of the active metabolite of ciclesonide - M1 (desCiclesonide) in humans.
In studies of drug interactions between ciclesonide and ketoconazole, as a strong inhibitor of CYP3A4, the effect on the active metabolite of desCiclesonide increased by about 3.5 times, whereas no effect on ciclesonide was noted. On this basis, the simultaneous use of potential inhibitors of CYP3A4 and ciclesonide should be avoided.
A study of the interaction of ciclesonide and the substrate CYP3A4 erythromycin showed no interaction between them.
Pregnancy and Lactation
Controlled studies in pregnant women have not been conducted. However, after inhalation of the drug, the concentration of ciclesonide in the blood serum is very low, hence the effect on the embryo and the potential toxicity affecting reproductive function are insignificant. The isolation of ciclesonide or its metabolites through breast milk has not been studied.
Like other inhaled corticosteroids, ciclesonide can be used during pregnancy and lactation as prescribed by a physician, if the expected therapeutic effect exceeds the risk of possible side effects. Newborns from mothers treated with GCS should be monitored by a physician to rule out adrenal hypofunction.
Alvesco is not indicated for the treatment of asthmatic status or other acute episodes of asthma requiring intensive therapeutic measures.
The effect of inhaled corticosteroids with long-term use in children is not fully understood. The physician must constantly monitor the growth of children receiving SCS for a long period. If growth slows down, therapy should be revised to reduce the dose of inhaled corticosteroids. If possible, then to the lowest dose, which is used to maintain constant monitoring of asthma manifestations. Alvesco's dose may be reduced in patients requiring oral GCS.
For patients transferred from oral GCS to Alvesco's inhalation treatment, there may be a decrease in the function of the adrenal cortex for a considerable period of time after the transfer. The possibility of the development of undesirable effects from the use of oral corticosteroids may persist for some time after their cancellation. In such cases it is recommended to monitor the reserve function of the adrenal cortex. The possibility of a residual deterioration of the adrenocortical response in a critical situation (therapeutic or surgical) and in other individual cases that may be caused by a stress reaction, should therefore be taken into account, and therefore the appropriate GCS treatment should be initiated.
In case of insufficiency of adrenocortical response or serious exacerbations, the dose of Alvesco should be increased; if necessary, oral GCS should be used. In case of infection, antibiotics should be used. Paradoxical bronchospasm with increased wheezing and other symptoms of bronchoconstriction that appeared immediately after inhalation should be treated with a fast-acting bronchodilator, which usually leads to quick relief. The patient should be examined, and Alvesco's therapy should be continued only if, after a balanced examination, the expected effect is higher than the possible risk. The relationship between the severity of asthma and the general predisposition to acute bronchial reactions should be taken into account.
Transfer of patients taking oral GCS to Alvesco.
The transfer of patients receiving treatment with oral corticosteroids to Alvesco and their subsequent management needs attention, since recovery of reduced adrenal function caused by prolonged systematic GCS therapy may take some time.
Patients taking systemic corticosteroids for a long period of time or at a high dose may experience suppression of adrenal function. The adrenal function in these patients should be monitored regularly, and the dose of systemic corticosteroids should be reduced gradually. After approximately one week, gradual elimination of systemic corticosteroids with a reduction in their daily dose of 1 mg of prednisolone or its equivalent can be started. For a maintenance dose of prednisone over 10 mg daily, it may be prudent to take larger dose reductions during weekly intervals.
Some patients may feel unwell during drug withdrawal, despite maintaining or even improving respiratory function. They must be examined for adrenocortical insufficiency.
When transferring patients from taking systemic corticosteroids to inhalation therapy, allergic reactions may occur (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs.These allergies should be treated symptomatically with antihistamines and / or topical agents, including topical GCS.
Influence on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. There is no data on the effect of the drug on the ability to drive vehicles and mechanisms.
Symptoms: Inhalation use of a single dose of 2880 mcg of ciclesonide in healthy volunteers was well tolerated. The possibility of acute toxic effects following an overdose of inhaled ciclesonide is low. May increase the dryness of the mucous membrane of the mouth and pharynx, sensations of irritation or sore throat, dysphonia.
Treatment: after acute overdose, the need for specific treatment is absent.
Symptoms: After prolonged administration of 1280 mcg of ciclesonide, no clinical signs of adrenal suppression were observed. However, if the excess of the recommended dose continues for an extremely long period of time, some degree of suppression of the adrenal glands cannot be excluded.
Treatment: It is recommended to control the function of the adrenal glands.
- Brand name: Alvesco
- Active ingredient: Ciclesonide
- Dosage form: Aerosol for inhalation dosed.
- Manufacturer: Takeda GmbH
- Country of Origin: Japan
- Physicochemical, crystallographic, thermal, and spectroscopic behavior of crystalline and X-ray amorphous ciclesonide
- Sensitive simultaneous determination of ciclesonide, ciclesonide-M1-metabolite and fluticasone propionate in human serum by HPLC–MS/MS with APPI
- Simultaneous determination of ciclesonide and its active metabolite desisobutyryl-ciclesonide in human plasma by LC–APCI-MS/MS: Application to pharmacokinetic study in healthy Chinese volunteers
- Effect of ciclesonide on allergen challenge in subjects with bronchial asthma
- Ciclesonide uptake and metabolism in human alveolar type II epithelial cells (A549)
- Uptake and metabolism of ciclesonide and retention of desisobutyryl-ciclesonide for up to 24 hours in rabbit nasal mucosa
- Inhaled ciclesonide versus inhaled budesonide or inhaled beclomethasone or inhaled fluticasone for chronic asthma in adults: a systematic review
- A comparative study of inhaled ciclesonide 160 µg/day and fluticasone propionate 176 µg/day in children with asthma
- Identification of enzymes involved in Phase I metabolism of ciclesonide by human liver microsomes
- Lower oropharyngeal deposition of inhaled ciclesonide via hydrofluoroalkane metered-dose inhaler compared with budesonide via chlorofluorocarbon metered-dose inhaler in healthy subjects
- Effects of hydrofluoroalkane formulations of ciclesonide 400 µg once daily vs fluticasone 250 µg twice daily on methacholine hyper-responsiveness in mild-to-moderate persistent asthma
- Effects of inhaled ciclesonide on circulating T-helper type 1/T-helper type 2 cells in atopic asthmatics after allergen challenge
- Maintenance of asthma control by once-daily inhaled ciclesonide in adults with persistent asthma
- Anti-inflammatory effects of once daily low dose inhaled ciclesonide in mild to moderate asthmatic patients
- Comparison of the efficacy and safety of ciclesonide 160 μg once daily vs. budesonide 400 μg once daily in children with asthma
- Lower-leg growth rates in children with asthma during treatment with ciclesonide and fluticasone propionate
- Efficacy and safety of once-daily inhaled ciclesonide in adults with mild to moderate asthma: A double-blind, placebo-controlled study
- Efficacy and safety of inhaled ciclesonide compared with chlorofluorocarbon beclomethasone dipropionate in adults with moderate to severe persistent asthma
- Pharmacokinetic and Pharmacodynamic Properties of Inhaled Ciclesonide
- The role of esterases in the metabolism of ciclesonide to desisobutyryl-ciclesonide in human tissue
- Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: An open-label, single-dose, three-period crossover study in healthy volunteers