Alvesco aerosol 160mkg/dose 60dose 5ml

Composition

1 dose contains cycconid 160 mcg.

Release form

Aerosol for inhalation dosed.

Packaging

Cylinder 60 doses.

Mechanism of action

Alvesko - GCS for local use in the form of inhalation. Ciclesonide exhibits low affinity for glucocorticoid receptors. After inhalation with the participation of enzymes in the lungs is converted into the main metabolite (descyclesonide, C21-desmethylpropionylcyclosonide), which has a pronounced anti-inflammatory activity and therefore is considered an active metabolite. Cyclesonide suppresses inflammatory reactions in the respiratory tract and, thus, reduces the symptoms of bronchial asthma, improves lung function.

Indications

Bronchial asthma.

Contraindications

• hypersensitivity to the drug;
• age up to 6 years.

Carefully: patients with pulmonary tuberculosis in active or chronic form; patients with bacterial, viral, or fungal infections of the respiratory tract.

Use during pregnancy and lactation

Controlled studies in pregnant women have not been conducted. However, after inhalation of the drug, the concentration of ciclesonide in the 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 doctor, 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.

Special notes

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 taking SCS for a long period. If growth slows down, therapy should be reviewed to reduce the dose of inhaled corticosteroids. If possible, then to the lowest dose, with the help of which constant monitoring of asthma manifestations is maintained. The dose of Alvesco can be reduced in patients who need 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 response must always 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 decrease 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 over a weekly interval.

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. No data on the effect of the drug on the ability to drive vehicles and mechanisms.

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 can 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 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.

Case notes

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 bronchial asthma who depend on oral GCS therapy (for example, prednisone), Alvesco's dose 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.

Side effects

In most cases, the 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 mouth.
Inhaled GCS can cause systemic effects, especially with prolonged use in high doses.

Drug interaction

According to in vitro data, CYP3A4 is the main enzyme involved in the metabolism of the active metabolite of ciclesonide - M1 (descyclesonide) in humans.

In studies of drug interactions between ciclesonide and Ketoconazole , as a strong inhibitor of CYP3A4, the effect on the active metabolite of descyclesonide increased 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.

Overdose

Acute overdose

Symptoms: Inhalation administration of a single dose of 2880 µg 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 membranes of the mouth and pharynx, a feeling of irritation or irritation in the throat, dysphonia.

Treatment: after acute overdose, the need for specific treatment is absent.

Chronic overdose

Symptoms: After prolonged administration of 1280 µg of ciclesonide, no clinical signs of adrenal suppression were observed. However, if the excess of the recommended dose continues for a very 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.

Storage conditions

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C.

Pharmacy sales terms

Prescription doctor