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  • Flutixon, powder for inhalation hard capsules of 250 mcg 60 pcs, complete with an inhaler — Made in Poland by Adamed — Free Delivery

Flutixon, powder for inhalation hard capsules of 250 mcg 60 pcs, complete with an inhaler — Made in Poland by Adamed — Free Delivery

(Flutixon)
Flutixon, powder for inhalation hard capsules of 250 mcg 60 pcs, complete with an inhaler — Made in Poland by Adamed — Free Delivery
Flutixon, powder for inhalation hard capsules of 250 mcg 60 pcs, complete with an inhaler — Made in Poland by Adamed — Free Delivery
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Description Flutixon, powder for inhalation hard capsules of 250 mcg 60 pcs, complete with an inhaler — Made in Poland by Adamed — Free Delivery

Pharmacological properties

Pharmacodynamics. Fluticasone propionate - when inhaled in the form of a powder, it has a pronounced anti-inflammatory effect on the lungs and reduces the severity of symptoms and the frequency of BA attacks, significantly reduces the severity of symptoms of the hoble, which significantly affects the improvement of the quality of life of patients. the preparation normalizes lung function regardless of the age and gender of patients and the initial functional parameters, from the history of bad habits (cigarette smoking) or allergic status.
Pharmacokinetics. Systemic absorption of the preparation occurs through the respiratory system, at first the absorption is fast, then it slows down. The remainder of the dose is swallowed and enters the esophagus, with minimal effect due to the low solubility of fluticasone propionate in water and the first-pass metabolism of the preparation.
A linear increase in the severity of systemic action was noted with an increase in the inhalation dose of the preparation. Fluticasone propionate is characterized by a high plasma clearance (1150 ml / min), a large volume of distribution (≈300 l) and a final T½ ≈8 hours. The level of binding to blood plasma proteins is moderately high (91%).
Fluticasone propionate is rapidly excreted from the systemic circulation by metabolism into an inactive metabolite using the cytochrome P450 CYP 3A4 enzyme. The renal clearance of fluticasone propionate is insignificant (0.2%), of which 5% of the preparation is excreted in the form of metabolites. Caution should be exercised with the simultaneous administration of CYP 3A4 inhibitors due to the potential increase in the systemic effect of fluticasone propionate.
When fluticasone propionate is taken orally, 87-100% of the dose is excreted in the feces. Up to 75% - unchanged due to minimal systemic penetration. An inactive metabolite is also displayed. After intravenous administration, a rapid clearance was detected, which indicates an intensive metabolism in the liver.

Indications

Bah. adults and children over the age of 16
Preventive treatment:
  • mild asthma: patients who require periodic symptomatic treatment with bronchodilators;
  • moderate asthma: patients requiring regular anti-asthma treatment and patients with unstable asthma or worsening of their condition against the background of existing prophylactic therapy or therapy with only bronchodilators;
  • severe asthma: patients with severe chronic asthma. After starting the use of inhaled fluticasone propionate, patients with systemic steroid dependence may significantly reduce the dose of oral corticosteroids or refuse them altogether.
  • Symptomatic therapy for COPD.

Application

Flutixon is intended for inhalation use. there is no need to change the dose in elderly patients and with renal or hepatic insufficiency.
BA: the therapeutic effect becomes noticeable after 4–7 days from the start of treatment, although positive dynamics is noted after 24 hours, especially in patients who have not previously received inhaled steroids. The preparation Flutixon has a prophylactic effect, it must be taken regularly, even in the absence of asthma attacks. The dose of fluticasone propionate depends on the severity of the disease and the individual patient's response to treatment.
BA (adults and children over 16 years old)
Mild asthma: 125 mcg 2 times a day.
Moderate asthma: 125–250 mcg 2 times a day.
Severe asthma: 250–500 mcg 2 times a day.
The onset of therapeutic action is usually noted after 4-7 days. If asthma symptoms disappear, the dose should be reduced depending on the response to treatment in such a way as to obtain a state of optimal control of the disease, using the minimum daily dose of the preparation.
COPD. Adults: 250 mcg 2 times a day.
For optimal performance, the preparation  should be taken daily. Improvement of the condition is noted after about 3–6 months of treatment. In the absence of relief during this time, the patient must be clinically examined and the treatment regimen reviewed.

Method of using the inhaler

1. Remove the nozzle cover from the inhaler.
2. Holding the lower part of the inhaler, open it by turning the tip (body) in the direction of the arrow.
3. Place the capsule in the capsule-shaped chamber located at the bottom of the inhaler. The capsule should be removed from the packaging immediately before use.
4. Return the tip to the closed position.
5. Simultaneously press the button at the bottom of the inhaler to the end (once!), Keeping the inhaler in an upright position.
ATTENTION! At this point, the capsule may disintegrate and small pieces of it may fall into the mouth or throat. It doesn't hurt. The likelihood of capsule disintegration will be minimal if it is pierced once, if the storage conditions are observed and when the capsule is unpacked immediately before use.
6. Take a deep breath.
7. Take the tip in your mouth and tilt your head back a little, clamp it with your lips and take one quick and even breath. At this moment, the capsule begins to rotate in the inhaler chamber, and the powder scatters, accompanied by a characteristic sound. If this sound does not appear, then the capsule is stuck in the chamber. In this case, you should open the inhaler and release the capsule. Do not try to release the capsule by repeatedly pressing the buttons.
8. Hearing a characteristic sound (buzzing), you must hold your breath as much as possible without feeling discomfort, and pull the inhaler out of your mouth. Exhale. Then open the inhaler and check if there is any powder left in the capsule. If the powder remains, it is necessary to repeat the steps specified in points 6-8.
9. Open the inhaler, remove the empty used capsule, return the tip to its original position and put on the cap-nozzle.
Nebulizer cleaning: To remove powder residues, wipe the tip and capsule chamber with a dry cloth or clean soft brush.
Any remaining unused product or waste should be disposed of in accordance with local regulations.

Contraindications

Hypersensitivity to any component of the preparation.

Side effects

The frequency of detection is defined as follows: very often (? 1/10), often (? 1/100 to 1/10), infrequently (? 1/1000 to 1/100), rarely (? 1/10 000 to 1/1000) , very rarely (1/10 000), including isolated cases.
Information about side effects, which appear very often, often and infrequently, obtained in the course of clinical studies. Side effects that are rare and very rare - evidence from episodic reports.
From the immune system: infrequently - hypersensitivity skin reactions; very rarely - angioedema (face, mouth and throat), respiratory symptoms (shortness of breath and / or bronchospasm), anaphylactic reactions.
From the endocrine system: very rarely - Cushing's syndrome, cushingoid symptoms, suppression of adrenal function, growth retardation in children, decreased bone mineralization, cataracts and glaucoma.
Infections and invasions: very often, candidiasis of the oral cavity and pharynx (in order to prevent candidiasis, rinsing the mouth is indicated immediately after inhalation). If necessary, an antifungal preparation is prescribed, while the preparation is continued.
From the side of the central nervous system: very rarely - anxiety, sleep disturbances, changes in behavior, including hyperactivity and irritability (mainly in children).
Metabolic disorders: very rarely - hyperglycemia.
Respiratory, thoracic and mediastinal disorders: often - hoarseness (in order to prevent it, rinsing the throat with water immediately after inhalation is indicated); very rarely - paradoxical bronchospasm (in this case, inhalation of the preparation immediately stops, fast-acting inhaled bronchodilators are used). The patient is examined and, if necessary, alternative therapy is prescribed.
From the gastrointestinal tract: very rarely - dyspepsia.
From the musculoskeletal system: very rarely - joint pain.
On the part of the skin: often - slight bruising.

special instructions

The physician should periodically monitor the patient's ability to use the inhaler.
The preparation Flutixon is not intended for the relief of acute attacks of asthma; it is prescribed for long-term preventive treatment. In order to stop an acute attack of asthma, inhalation of preparations that rapidly expand the bronchi should be used, so the patient should always have such preparations with him.
Severe asthma requires regular monitoring of lung function, as there is a risk of severe attacks and potential life-threatening.
If the patient uses fast-acting bronchodilators more often, this indicates a complicated course of asthma. In such cases, the patient's treatment regimen should be reviewed, given that a sudden and severe increase in the severity of asthma symptoms can pose a threat to life. Then the dose of corticosteroids should be increased. Patients at risk of this course of the disease should measure the maximum volume of air exhaled during forced expiration daily.
As with other inhaled preparations, paradoxical bronchospasm may occur. Then you should immediately stop taking Flutixon, urgently apply a quick-acting inhaled bronchodilator, assess the patient's condition and, if necessary, apply another treatment.
In the absence of a response to treatment or severe exacerbation of asthma, the dose of fluticasone propionate should be increased and, if necessary, oral steroids should be prescribed and / or an antibiotic should be used in case of infection.
Systemic effects can occur with all inhaled steroids, for example, when used in high doses with prolonged therapy. Systemic effects are less likely to occur with inhaled steroids than with oral steroids. Possible systemic effects: Cushing's syndrome, cushingoid symptoms, suppression of adrenal cortex function, growth retardation in children, decreased bone mineralization, glaucoma and cataracts. It is important to carry out treatment with the lowest possible dose of the preparation, which ensures effective control of the manifestations of the disease.
It is recommended to regularly measure the height in children during long-term therapy with Flutixon. If the growth of children is slowed down, the dose of fluticasone propionate should be reduced so that treatment is carried out with the preparation in the minimum effective dose, ensuring effective control of the manifestations of the disease.
When using the preparation in recommended doses, the function and reserve of the adrenal glands remain within normal limits. The effect of the use of inhaled Flutixon allows you to minimize the need for oral steroids. But the possibility of side effects in patients who have previously taken oral steroids persists for some time. The degree of adrenal dysfunction in certain situations may require a specialist assessment.
Long-term use of inhaled corticosteroids in high doses can lead to suppression of adrenal cortex function and acute adrenal crisis. Very rarely, cases of suppression of the function of the adrenal cortex and acute adrenal crisis have been noted when used in doses of 250-500 μg of fluticasone propionate. Sudden situations (trauma, surgery, infection, or sudden dose reduction) can cause an acute adrenal crisis. Then the patients develop such uncharacteristic symptoms as fatigue, loss of appetite, nausea, vomiting, weight loss, abdominal pain, headache, hypoglycemia, epileptic seizures, loss of consciousness, decreased blood pressure, confusion. During a period of threat of stress or before a planned surgical operation, the possibility of adrenal dysfunction should be taken into account and appropriate GCS therapy should be carried out.
Replacing oral steroids with inhaled steroids can cause allergic manifestations, such as allergic inflammation of the nasal mucosa or rashes, which were previously treated with general steroids. In this case, allergy manifestations should be treated symptomatically with antihistamines or topical preparations, including topical steroids.
Patients with COPD should be closely monitored for pneumonia or other lower respiratory tract infections, as the clinical manifestations of these infections and exacerbations of COPD are often similar.
There are very rare cases of an increase in the concentration of glucose in the blood plasma. When prescribing Flutixon to patients with a history of diabetes mellitus, it should be noted that the dose of Flutixon contains ≈25 mg of lactose. In patients with lactose intolerance, this amount does not cause any problems.
You should not suddenly stop treatment with Flutixon.
It is recommended to be especially careful when treating patients with active or passive form of pulmonary tuberculosis.
There is an individual hypersensitivity to inhaled corticosteroids.
Replacement of oral steroid treatment with inhaled fluticasone propionate. Given the possibility of impaired adrenal cortex function, patients in whom oral steroid hormones are replaced with inhaled fluticasone propionate should remain under observation, with adrenal cortex function being monitored. After the introduction of fluticasone propionate into the treatment regimen, the dose of oral steroids acting systemically should be gradually reduced, and patients should have a steroid card with them, which informs about the need to prescribe additional steroids that have a general effect in a stressful situation.
Tapering of the oral steroid dose should be started after a week of concomitant use of fluticasone propionate. Dose reduction should be carried out no more than 1 time per week. Maintenance doses of 10 mg / day or less in terms of prednisone should be reduced no faster than 1 mg once a week. For maintenance doses of prednisolone 10 mg / day, a dose reduction of more than 1 mg / day once a week can be allowed.
Some patients experience atypical symptoms of unwell during the period of reduced doses of oral steroids, even though the function of the respiratory system improves. These patients should continue treatment with Flutixon and reduce the dose of oral steroids if there are no objective symptoms of adrenal insufficiency.
Patients who, after stopping taking oral steroids, persist symptoms of dysfunction of the adrenal cortex, should have a document informing about the need for additional intake of general steroids in case of stress, for example, increased asthma attacks, the occurrence of respiratory, thoracic and mediastinal infections, severe concomitant diseases , surgical interventions, injuries, etc.
Use during pregnancy and lactation. There are no data on the use of fluticasone propionate during pregnancy. Prescribing the preparation  to pregnant women is possible only if the expected therapeutic effect for the mother outweighs the potential risk to the fetus. There is no data on the penetration of fluticasone propionate and its metabolites into breast milk. In humans, after inhalation of the recommended doses of the preparation, its concentration in the blood plasma will be low.
Children. Not intended for use in children under the age of 16.
The ability to influence the reaction rate when driving or operating machinery. The use of the preparation has no effect.

Interactions

Under normal conditions, after inhalation of fluticasone, propionate reaches a low concentration in the blood plasma due to the extensive metabolism of the primary passage, as well as high clearance, depending on the activity of cytochrome p450 3a4 in the intestine and liver. therefore, significant clinical interactions of fluticasone propionate with other preparations are unlikely. studies show that the simultaneous administration of inhibitors of cytochrome p450 3a4 (for example, erythromycin or terfenadine) causes a slight increase in the systemic concentration of fluticasone propionate without a significant decrease in the concentration of cortisol in the blood plasma.
The concomitant administration of strong inhibitors of cytochrome P450 3A4 (for example ritonavir), as well as fluticasone propionate, including nasally, significantly increases the concentration of fluticasone propionate in the blood plasma, and decreases the concentration of cortisol in the blood plasma. According to a post-marketing study of a clinically significant preparation interaction in patients taking fluticasone propionate and ritonavir, which led to systemic effects of corticosteroids, including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided unless the benefits of such use outweigh the risk of systemic effects of corticosteroids. This interaction was not observed with inhalation of fluticasone propionate, but its appearance cannot be ruled out.
According to studies with other inhibitors of cytochrome P450 3A4, it was found that they have an insignificant (erythromycin) effect on increasing the systemic concentration of fluticasone propionate in blood plasma without a significant decrease in the concentration of cortisol. Ketoconazole, an inhibitor of CYP 3A isoenzymes, increases the concentration of fluticasone propionate after a single dose to 150%. This causes a significant decrease in the concentration of cortisol in the blood plasma. It cannot be ruled out that fluticasone propionate interacts with other inhibitors of CYP 3A (for example, itraconazole). However, special care should be taken and, if possible, avoid long-term use of fluticasone propionate with strong inhibitors of cytochrome P450 3A4 (for example ketoconazole), given the possibility of increasing the systemic concentration of fluticasone and the risk of developing undesirable systemic manifestations.

Overdose

A single use of the preparation flutixon in doses exceeding the recommended ones can cause acute poisoning, which manifests itself in the temporary suppression of the hypothalamic-pituitary-adrenal system. this does not require special measures, and the function of the adrenal cortex returns to normal in a few days. when using the preparation flutixon in doses exceeding the recommended ones, for a long time, a significant suppression of the function of the adrenal cortex is possible. factors that can provoke an acute adrenal crisis can be trauma, surgery, infection, or a sharp dose reduction. Patients taking Flutixone doses higher than recommended should be monitored closely and the dose should be reduced gradually. in such cases, control of the adrenal reserve may be required. in cases of overdose, treatment with the preparation  should be continued in doses that ensure effective control of ba.

Storage conditions

Store at temperatures below 30 ° c.

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