Alvesko

Alvesko – an inhalation glucocorticosteroid (GKS) for treatment of bronchial asthma.

Form of release and structure

Dosage form – an aerosol for inhalations dosed: transparent colourless solution (in aluminum barrels with the dosing valve and the mouthpiece closed by a protective cover on 5 and 8 ml (60 or 120 sprayings respectively), 1 barrel in a pack cardboard).

Active agent: циклесонид, its content is to 1 dose (1 spraying) – 40, 80 or 160 mkg.

Auxiliary components: ethanol and норфлуран (HFA-134a).

Indications to use

Alvesko – means for therapy of bronchial asthma.

Contraindications

• Children's age up to 6 years;
• Individual hypersensitivity to drug.

With care:

• Active or chronic form of pulmonary tuberculosis;
• Virus, fungal or bacterial respiratory infections.

Route of administration and dosage

Alvesko is intended for peroral inhalation. It is necessary to use drug daily, prolonged treatment.

The initial dose is selected by the doctor depending on weight of a course of a disease. After achievement of necessary clinical effect the dose is reduced to the minimum, allowing to control manifestations disease.

To teenagers 12 years and to adult, including elderly people are more senior, at bronchial asthma easy and moderate severity appoint 160-640 mkg a day, divide the highest daily dose into 2 uses. At a severe disease increase in a dose up to 640 mkg 2 times a day daily is possible.

Improvement of a state is noted within 24 hours after Alvesko's inhalation. The maximum effect has to be reached in 2-3 months of therapy.

To children 6 years are more senior appoint 80-160 mkg of 1 times a day or on 80 mkg 2 times a day.

Important condition of effective treatment is continuousness of use of drug, even in case of lack of symptoms of bronchial asthma.

Alvesko can be applied as independently, and with a spacer. In the latter case it is recommended to choose AeroChamber Plus spacer.

At the heavy course of bronchial asthma at the adults and teenagers who are constantly receiving peroral GKS (for example, Prednisolonum), Alvesko's dose makes 640 mkg 2 times a day. Treatment duration – 10 days then the daily dose gradually (no more than on 2,5 mg every week) is reduced to achievement of the minimum effective.

In a stage of remission of a disease transfer of patients from peroral GKS on Alvesko is possible.

Instruction for use of an inhaler:

1. To remove a protective cap from a spray, to check a mouthpiece outside and inside and to be convinced that it dry and pure;
2. To turn an inhaler upside down, to arrange an index finger at the bottom of a barrel, a thumb – under a mouthpiece;
3. If the inhaler new or was not used more than 1 week, to execute the first 3 pressing of the valve in air;
4. To make aside (not in an inhaler) the maximum exhalation as far as it is possible;
5. To place a mouthpiece in a mouth and to close around it lips;
6. To begin a slow and deep breath and to press an index finger an inhaler top. To take care that drug could not pass through space between a mouthpiece and lips;
7. To hold the breath, to take out a mouthpiece from a mouth, to remove a finger from an inhaler top. The breath should be held at least for 10 seconds, whenever possible – longer;
8. To exhale slowly through a mouth (not through a mouthpiece);
9. In need of acceptance of one more dose it is necessary to wait 30 seconds then to repeat points 4-8;
10. To put on a protective cap a barrel, to densely close and record it on site.

The barrel does not need to be stirred up since the aerosol dissolved.

For hygiene:

• It is regularly necessary to clear a mouthpiece a dry napkin outside and inside;
• To wipe a surface with a small opening from where there is medicine, using the dry put napkin;
• Not to use water or other liquids for cleaning.

Side effects

• From the alimentary system: infrequently (> 1/1000, <1/100) – unpleasant smack in a mouth, nausea, vomiting; seldom (> 1/10 000, <1/1000) – dyspepsia, an abdominal pain;
• From cardiovascular system: seldom – increase in arterial pressure, and also the strengthened heartbeat (at simultaneous use of drugs which can have side effect on a cordial rhythm, for example, of theophylline or salbutamol);
• From respiratory system: infrequently – cough after inhalation, a dysphonia, a paradoxical bronchospasm;
• Infectious and parasitic diseases: infrequently – fungal infections of an oral cavity;
• From a nervous system: infrequently – a headache;
• From integuments: infrequently – skin rash, eczema;
• Allergic reactions: seldom – a Quincke's disease, hypersensitivity reactions;
• Local reactions: infrequently – dryness of a mucous membrane of an oral cavity and throat, feeling of irritation and irritation in a throat;
• System side effects: at use of drug in high doses for a long time – Cushing's syndrome and kushingopodobny symptoms, such as reduction of density of a bone, glaucoma, a cataract, delay of growth at children and teenagers, suppression of adrenal glands.

Directly after inhalation the paradoxical bronchospasm is possible. It is acute nonspecific reaction on any inhalation drugs and can be connected with active agent, auxiliary components or cooling owing to evaporation of propellant at use of the dosed inhalers. In most cases the bronchospasm is adverse reaction which takes place independently and does not demand the treatment termination.

Special instructions

On doctor's orders Alvesko can be applied at pregnancy and a lactation if the expected effect surpasses potential risks. Newborns, whose mothers during pregnancy received GKS, have to be under careful medical observation to exclude a hypoadrenalism.

Alvesko is not intended for treatment of the asthmatic status and other bad attacks of bronchial asthma which stopping requires carrying out intensive therapeutic measures.

The dose of drug should be reduced to patients who need peroral GKS.

The paradoxical bronchospasm and other symptoms of narrowing of bronchial tubes which developed right after inhalations stop high-speed bronchodilatory means. After that the doctor has to examine the patient and resolve an issue of expediency of continuation of therapy of Alvesko. It is possible only if the expected effect considerably surpasses risks. At the same time it is necessary to consider interrelation between severity of bronchial asthma and the general predisposition of the patient to acute bronchial reactions.

In case of development of an infection it is necessary to appoint antibiotics.

At the patients transferred from peroral GKS on Alvesko depression of function of bark of adrenal glands is possible for a long time, and also there is a risk of development of side effects of peroral GKS after their cancellation for some time. In this case it is recommended to control reserve function of bark of adrenal glands. At the same time it is necessary to consider probability of residual deterioration in function of bark of adrenal glands in critical situation (surgical or therapeutic) and in other individual cases caused by a stressful situation. Thereof it is necessary to begin the corresponding treatment of GKS.

At serious aggravations and in case of insufficiency of function of bark of adrenal glands it is necessary to increase Alvesko's dose, if necessary – to appoint peroral GKS.

At the patients receiving system GKS (Prednisolonum or its equivalent) in a high dose or for a long time suppression of function of adrenal glands therefore it is regularly necessary to control it is possible and to gradually reduce a dose of system GKS. Approximately after 1 week it is possible to exclude gradually this drug, daily lowering its dose by 1 mg. At reception of a daily maintenance dose more than 10 mg it is necessary to observe extra care and to consider that reasonable can be more considerable dose decline during week intervals.

Cases when after drug withdrawal patients badly felt, despite preservation or even improvement of respiratory function are known. Such patients need to be inspected on existence of adrenocortical insufficiency.

At transfer of patients from system GKS on Alvesko there is a probability of development of allergic reactions (for example, allergic rhinitis, eczema) which were suppressed by system drug earlier. In these cases performing symptomatic therapy by antihistamines, including for topical and external use, the containing GKS is shown.

As action of inhalation GKS on children at prolonged use is up to the end not established, during treatment it is necessary to watch development of growth of children constantly. If it is slowed down, it is necessary to reconsider therapy and to lower a drug dose to the minimum effective, allowing to control symptoms bronchial asthma.

Information on Alvesko's influence on the speed of reactions and ability to concentration there is no attention.

Medicinal interaction

It is not recommended to apply along with Alvesko CYP3A4 inhibitors, including potential.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C. Not to open a cylinder and not to subject it to heating higher than 50 ºС.

Period of validity – 3 years.