The instruction for medical use
of Fliksotid medicine 50
name Flutikazon Lekarstvennaya a form
the Dosed aerosol for inhalations of 50 mkg / a dose, 125 mkg / a dose, or
250 mkg / a dose
One dose contains
active agent – a flutikazon mkg propionate 50, 125 or 250, auxiliary substances – GR106642X (1,1,1,2-tetrafluoretan, HFA 134a – does not contain freon)
the Metal inhaler with the concave basis and with the portioning device, supplied with the spray. Contents of an inhaler
the Pharmacotherapeutic group
Other drugs of inhalation use for treatment of bronchial asthma represents white or almost white suspension. Glucocorticoids.
The code of automatic telephone exchange R03BA05
Pharmacokinetics Later properties of inhalation introduction only of 10-30% of a flutikazon comes
directly to lungs. A part of a ngalyatsionny dose is swallowed, but its
systemic action is minimum owing to weak solubility
of drug in water and intensive metabolism at the first passing
through a liver.
The bioavailability at intake is less than 1%. Communication with
proteins of plasma makes 91%. Flutikazona propionate has the large
volume of distribution – about 300 l. Flutikazona propionate
is metabolized in a liver with the participation of CPY3A4 enzyme of a system
of P450 cytochrome, with formation of an inactive metabolite. Plasma
clearance of a flutikazon of propionate of 1150 ml/min. Time of semi-removal
is 8 h approximately. Renal clearance less than 0.2%.
Less than 5% are removed with urine in the form of a metabolite.
In the recommended doses Fliksotid has the significant anti-inflammatory and antiallergenic effect. Slows down processes of exudation and limits to it the swelling of mucous membranes which is quite often the main reason of obstruction of airways. Has permissive effect, i.e. restores reaction of beta adrenoceptors to catecholamines. Besides, Fliksotid interferes with interaction of immunoglobulin E with a Fc-receptor on a surface of mast cells and basophiles. Inhibits A2 phospholipase and by that reduces education and discharge of mediators of an anaphylaxis. At a syndrome of bronchial obstruction Fliksotid’s inhalation provides antiedematous effect, the bronchospasm warns, reduces products and improves evacuation of a dense, viscous phlegm.
Systemic action of drug is minimum. In therapeutic doses practically does not influence on gipotalamo – a hypophysial and adrenal system.
– basic anti-inflammatory therapy of bronchial asthma of adults and children of 1 year are also more senior (including patients with a severe disease who have a dependence on system glucocorticosteroids)
– a chronic obstructive pulmonary disease at adults.
The route of administration and doses
the Dosed Fliksotid aerosol is intended only for inhalation introduction. The drug needs to be taken regularly, even in the absence of disease symptoms. Depending on the individual answer of the patient, the initial dose of drug can be increased before emergence of clinical effect or to lower to minimum effective dose. With diseases of a liver or kidneys of special selection of a dose it is not required to elderly people and patients.
The therapeutic effect of Fliksotid in bronchial asthma occurs in 4-7 days after an initiation of treatment. At patients who did not accept inhalation glucocorticosteroids earlier the improvement can be noted in 24 hours after the beginning of use of drug.
Adults and teenagers are more senior than 16 years
the Recommended dose makes 100-1000 mkg 2 times a day.
The initial dose of drug depends on severity of a disease:
– bronchial asthma of light severity: 100-250 mkg 2 times a day,
– bronchial asthma of moderate severity: 250-500 mkg 2 times a day,
– bronchial asthma of heavy severity: 500-1000 mkg 2 times a day.
Children are more senior than 4 years
to Children Fliksotid containing 50 mkg of a flutikazon of propionate in one dose is recommended to apply an inhaler.
The recommended dose of 50-200 mkg 2 times a day.
The initial dose of drug depends on severity of a disease and makes 50-100 mkg 2 times a day.
The drug can be administered through a spacer a mask, for example, Volyumatik.
Children aged from 1 year up to 4 years
the Recommended dose makes 100 mkg 2 times a day. Higher doses of Fliksotid in comparison with children of advanced age owing to the complicated intake of drug at inhalation introduction are required for children of younger age. The drug is administered by means of an inhaler through a spacer with a front mask, for example, Bebikhaler
Dozirovanny Fliksotid aerosol is especially shown to children of younger age with a heavy course of bronchial asthma.
Chronic obstructive pulmonary disease.
The adult the recommended dose makes 500 mkg 2 times a day.
IInstruktsiya on use of an inhaler
Check of serviceability of an inhaler
If an inhaler new or was not used within a week or it is longer necessary to uncover carefully a mouthpiece, to vigorously stir up an inhaler and to spray one dose of drug in air to be convinced of serviceability.
Use of an inhaler
1. It is careful to uncover a mouthpiece. To be convinced that outside and inside a mouthpiece clean.
2. To vigorously stir up an inhaler.
3. To place an inhaler vertically between big and index fingers, having arranged a thumb on the basis of, below a mouthpiece.
4. To make a deep, as far as possible, exhalation. To place a mouthpiece between teeth, without biting it and to clasp densely with lips.
5. To make a deep breath through a mouth. Continuing to take a deep breath, to press an upper part of an inhaler to carry out spraying of medicinal substance.
6. To hold the breath, to take out an inhaler from a mouth and to take away a forefinger from an upper part of an inhaler. To continue to constrain breath so long as far as it is possible.
7. If it is necessary to continue inhalations, it is necessary to wait about half-minute, holding an inhaler vertically, and then to repeat stages from the 2nd for the 6th.
After inhalation to put on a cap a mouthpiece.
not to hurry when performing the actions specified in Paragraph 4, 5 and 6. It is important that pressing of an inhaler came at the beginning of a quiet, deep breath. To be sure that inhalation is executed correctly, it is necessary to control for a start a way of drug intake in front of the mirror. Appearing during inhalation from an inhaler, lips or a nose of a smoke points to the wrong technology of inhalation and it is necessary again, to practice starting with Paragraph 2 in use of an inhaler.
Cleaning of an inhaler
it is necessary to clean the Inhaler not less once a week.
1. To take a metal container from the plastic body of an inhaler and to uncover a mouthpiece,
2. To wash the spray with warm flowing water,
3. To carefully dry the spray from within and outside,
4. To place back into place a container and a cover of a mouthpiece.
NOT to LOWER the METAL CONTAINER IN WATER.
– candidiasis of a mucous membrane of a mouth and throat, hoarseness of a voice
– skin rash, a Quincke’s disease, anaphylactic reactions,
dispny and a bronchospasm
– depression of function of bark of adrenal glands, osteoporosis, a growth inhibition at
children, a cataract, glaucoma, an Icenco-Cushing syndrome at prolonged
use of drug in high doses
– a hyperglycemia
– concern, sleep disorders, changes in behavior, including
hyperactivity and irritability (generally at children).
– hypersensitivity to any component of drug
– a sharp bronchospasm
– children’s age (till 1 year).
At an inhalation way of introduction of Fliksotid of its concentration in blood plasma very low therefore adverse interactions with other medicines are improbable. At co-administration of Fliksotid and inhibitors of CYP3A4 enzyme (for example, a ketokonazola, a ritonavira), systemic action of Fliksotid can increase.
instructions Fliksotid it is intended for long-term treatment of bronchial asthma, but not for stopping of attacks.
Drug is used with care in cirrhosis, glaucoma, a hypothyroidism, system infections (bacterial, fungal, parasitic, virus), osteoporosis, a pulmonary tuberculosis.
The patient has to obtain information on the correct use of an inhaler, and also about need of the immediate address to the doctor if decrease in efficiency of bronchodilators of short action is noted or it is required to apply inhalers more often than usually. Increase in need for use of inhalation agonists 2 of adrenoceptors of short action demonstrates deterioration in a disease. In such cases it is recommended to revise the treatment plan. The sudden and progressing deterioration in bronchial asthma can pose a threat for the patient’s life therefore in similar situations it is necessary to resolve urgently an issue of increase in a dose of glucocorticosteroids.
Sharply it is not recommended to stop treatment by Fliksotid.
In case of a paradoxical bronchospasm it is necessary to stop at once use of drug and to immediately stop an attack by means of high-speed inhalation bronchodilator.
At prolonged use of drug, especially in high doses, system effects can be noted, however the probability of their development is much lower, than at reception of GKS inside. Therefore at achievement of therapeutic effect Fliksotid’s dose has to be reduced to minimum effective dose controlling a course of the disease.
It is recommended to watch dynamics of growth of the children receiving inhalation GKS for a long time regularly.
The translation of the patients having hormonedependent bronchial asthma from system GKS on Fliksotid’s inhalation requires special attention as restoration of function of adrenal glands takes long times. It is regularly necessary to control function of bark of adrenal glands and to be careful at a dose decline of system GKS.
In the period of a dose decline of system GKS perhaps general malaise against the background of stabilization or even improvement of indicators of function of external respiration. If at the same time there are no objective signs of adrenal insufficiency, patients have to continue transition to inhalation GKS with gradual cancellation of system GKS. Cancellation of system GKS against the background of inhalation Fliksotid should be carried out gradually, and patients have to carry with themselves the card specifying that additional reception of GKS in the period of a stress can be required by them.
At certain patients the individual high sensitivity to inhalation GKS can be noted. Function of bark of adrenal glands when assigning a flutikazon of propionate in the recommended doses, as a rule, remains within norm. Advantages of inhalation introduction of a flutikazon of propionate minimize need for purpose of system GKS. However the likelihood of development of side effects at the patients who were earlier receiving or periodically accepting GKS inside can remain. When holding resuscitation actions or surgical interventions the consultation of the expert for definition of degree of adrenal insufficiency can be required. In similar stressful situations it is always necessary to consider possible adrenal insufficiency and if necessary in addition to appoint GKS.
In rare instances when translating patients from reception of system GKS on inhalation therapy the states which are followed by a hypereosinophilia can be shown (for example, Churg-Strauss syndrome). As a rule, it occurs during a dose decline or cancellation of system GKS. Also the accompanying allergic diseases (for example, allergic rhinitis, eczema) which were suppressed with system drugs earlier can become aggravated. In similar situations it is recommended to carry out symptomatic treatment by antihistaminic drugs and/or drugs of local action, including GKS for topical administration.
For prevention of hoarseness of a voice and development of candidiasis it is necessary to rinse a mouth and a throat after inhalations. If necessary throughout the entire period of treatment it is possible to appoint local antifungal therapy.
There are very rare messages about increase in level of glucose in blood, and it is necessary to remember it, appointing a flutikazon propionate by sick diabetes.
The effect of administration of drug decreases when cooling a barrel.
Pregnancy and a lactation
Drug is appointed only when the expected advantage for mother exceeds possible risk for a fruit or the child.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
It is improbable.
Acute overdose of drug can lead to temporary depression of function of bark of adrenal glands that does not demand the emergency therapy. At chronic overdose the suppression of function of bark of adrenal glands can be noted. In similar cases it is recommended to carry out monitoring of reserve function of bark of adrenal glands. Treatment by Fliksotid can be continued in the doses sufficient for maintenance of therapeutic effect.
A form of release and packing
the Dosed aerosol for inhalations the 50th mkg/dose of 120 doses, 125 mkg / a dose
and 250 mkg / a dose on 60 or 120 doses in an inhaler.
The inhaler equipped with the plastic portioning device with a protective cap. Cardboard box with an inhaler and instruction for use.
To Store storage conditions at a temperature below + 30C
not to allow freezing of an inhaler and impact of direct sunshine on it.
To store out of children’s reach!
A period of storage
not to take the drug after the expiry date specified on packing.
According to the prescription
it is made by S.A. Glakso Vellk, Spain,
packed S.A. GlaksoSmitKlyayn Pharmasyyutikalz, Poland
(Avda producer. Extremadura, 3, 09400 ARANDA DE DUERO, Burgos,
the packer – Grunwaldzka 189, 60-322 Poznań).
On all questions to address to representative office of GlaksoSmit Klein Export Ltd in Kazakhstan: 050059, Almaty, Furmanov St., 273, ph. 8-3272-590996, 590997 fax: 8-3272-582890.