FLIXOTIDE 125MCG GSK Air Capacity (120 doses)

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Specifications Fluticasone Propionate

Ingredient

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Composition informationContent
Fluticasone Propionate125mcg

Uses

Indications

Flixotide 125MCG drugs are indicated in the following cases:

hen

Flixotide 125mcg has a clear anti -inflammatory effect in the lungs.

The drug reduces symptoms and asthma drama in patients treated earlier with just bronchodilators or other backup therapy.

Heavy asthma requires regular medical assessments because of death.

Severe asthma patients have constant persistent symptoms and regular plays, limited force and peak flow (PEF) value below 60% of the predictable value with the variation of the peak flow of over 30% and often do not return completely normal after using bronchodilators. These patients need high doses of corticosteroids inhaled (see the dose and how to use) or drink. Corticosteroid dose may be increased under emergency medical monitoring when symptoms suddenly get worse.

Adults

Preventive treatment in

Light bronchial asthma (the initial peak flow value is over 80% of the predictable value with the variation of the peak of less than 20%): Patients need to use bronchodilators to treat symptoms of asthma percentage rather than only bronchodilator when needed.

Moderate bronchial asthma (initial peak flow value from 60 - 80% of the predictable value with the variation of the peak flow from 20-30%): Patients need to use regular asthma medication and patients with unstable asthma or worsening asthma while using existing preventive drugs or taking only a simple bronchodilator.

Severe bronchial asthma (the initial peak flow value is below 60% of the predictable value with the variation of the peak flow greater than 30%): Patients with chronic severe severe asthma. When using Flixotide 125mcg inhaled, many patients are dependent on corticosteroids using systemic sugars to fully control asthma symptoms, can also reduce oral corticosteroid dose significantly or do not need to take corticosteroids.

Children

Any child who needs a backup asthma medication, including those who are not controlled by existing prophylaxis.

Pharmacokology

Flixotide 125mcg inhaled with recommended dose has a strong anti -inflammatory effect of glucocorticoid in the lungs, reducing symptoms and asthma play.

pharmacokinetic

absorption

Fluticasone Propionate's absolute bioavailability for each existing inhalation device is estimated from within and between comparisons of research on pharmacokinetic data of inhaled and intravenous form. In healthy adults, absolutely abused, the corresponding estimates for Fluticasone Propionate Accuhaler/Diskus (7.8%), Fluticasone Propionate Diskhaler (9.0%) and Fluticasone Propionate Evohaler (10.9%).

For patients with asthma or chronic obstructive pulmonary disease (COPD), observing the level of systemic exposure less with Fluticasone Propionate inhaled. The process of absorbing the whole client mainly through the lungs, initially absorbed quickly and then lasted. The rest of the inhaled dose may be swallowed but it affects the level of the whole body exposure due to the ability.

Distribution

Fluticasone Propionate has a large distribution in a stable stage (about 300 l). The cohesion with plasma protein is relatively high (91%).

Metabolism

Fluticasone Propionate is quickly eliminated from the circulatory system, mainly thanks to the conversion into carboxylic acid conversion in the inactive form of Cytochrome P450 enzyme CYP3A4. Should be cautious when used with the known agents as CYP3A4 inhibitors, due to the risk of increasing the absorption of Fluticasone Propionate.

Elimination

The elimination of Fluticasone Propionate is characterized by high plasma clearance (1150 ml/minute) and the final selling time is about 8 hours. The kidney clearance of Fluticasone Propionate is negligible (below 0.2%) and less than 5% in the form of metabolites.

Before taking FLIXOTIDE 125MCG GSK Air Capacity (120 doses)

How to use

Need to notify patients about the prophylactic nature of treatment therapy with Flixotide 125mcg inhaled and need regular use even without symptoms.

Flixotide 125mcg is only inhaled.

The drug is designed so that each prescription is at least 2 sprays.

If the patient finds it difficult to inhale from the spray bottle, the type of pressure should be used, Flixotide 125mcg inhaled through the buffer chamber.

Your 125MCG Flixotide user guide

Check your spray bottle:

Before the first use or if your spray is not used for a week or longer, open the lid of the tube by gently squeezing the lid, shaking the drug bottle well, and spraying two fits into the air to make sure the drug bottle works.

Use your spray bottle:

1. Remove the cap by squeezing the sides of the lid.

2. Check the inner and outside spray, including the tube in the mouth to see if there is any place.

3. Shake the spray bottle carefully to make sure the objects have been removed and the drug ingredients in the spray are mixed.

4. Hold the vertical spray between the thumb and the other fingers, with the position of the thumb at the bottom of the jar, the bottom of the suck tube.

5. Breathing out as long as you feel comfortable and then put the tube into your mouth between your teeth and close your lips but do not bite your mouth.

6. Immediately after starting to breathe through the mouth, press down the top of the spray bottle to release Flixotide 125mcg while still inhaled and deep.

7. While holding your breath, remove the spray bottle from the mouth and relax but still hold the finger on the top of the spray bottle. Continue to hold your breath until you still feel comfortable.

8. If you continue to spray another dose, hold the vertical spray and wait about half a minute before repeating the steps from 3 to 7.

9. Then rinse your mouth with water and remove.

10. Close the tube lid to keep the lid tightly in the right position.

Important

Do not perform steps 5, 6 and 7 in a hurry. It is important that you start breathing as slow as possible right before operating the spray. Practice use in front of the mirror several times. If you see "dew" emitted from the top of the spray bottle or on both sides of your mouth, you should start again from step 2.

If your doctor offers other user instructions, follow those instructions carefully. Tell your doctor if you encounter any difficulty.

Spray cleaning:

Should wipe your spray at least once a week.

1. Remove the lid of the tube.

2. Do not remove the spray from the plastic shell.

3. Wipe off the inside and outside of the suck tube with a piece of cloth or dry tissue.

4. Reinstall the cap.

Do not put metal containers in water.

Dosage

hen

The starting time has the effect of 4 to 7 days, although some benefits can be clearly visible after 24 hours in patients who have not used inhaled steroids.

Should consult a doctor if the patient finds the effectiveness of bronchodilators, short -acting or needing more spray than usual.

Adults and children over 16 years old

100 to 1000mcg twice daily.

Patients should use the starting dose of Flixotide 125mcg inhalation appropriately depending on the severity of the disease:

  • Light asthma: 100 to 250mcg twice daily.
  • Moderate asthma: 250 to 500mcg twice daily.

    In other words, the starting dose of Fluticasone Propionate can be determined by half of the daily dose of Beclomethasone dipropionate or equivalent substance when used in a dose sprayer.

    Children 4 years of age and older

    50 to 200mcg twice daily

    Many cases of asthma in children are well controlled when using the dose of 50 to 100mcg twice a day. For children where this dose is not enough to control asthma, the effectiveness of treatment can be achieved when increasing the dose to 200mcg twice a day.

    Should use the starting dose of Flixotide 125mcg inhalation for children appropriately depending on the severity of the disease.

    Then can adjust the dose when the control is achieved or reduced to the lowest dose effectively depending on the response of each patient.

    It should be noted that only 50mcg spray bottle is suitable for this dose.

    This form of preparation of Flixotide 125MCG may not be able to respond to the necessary doses for children, in this case, consider using other cell formats of Flixotide 125MCG (such as dry powder inhaler).

    Children from 1 to 4 years old

    Flixotide 125mcg inhaled form works well with children in controlling regular and chewy asthma symptoms.

    Clinical trials in children from 1 to 4 years old show that at a dose of 100mcg twice daily use through children's buffer chamber along with masks (such as Babyhaler ™) achieved optimal control of symptoms of asthma.

    The diagnosis and treatment of asthma should be controlled regularly.

    Special patient group

    No dose adjustment for elderly patients or people with liver or kidney failure.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

    What to do when overdose? This case usually does not need emergency due to adrenal function, often recovering within a few days.

    If continuing to use the dose higher than the approved dose for a long time, it may cause significant adrenal inhibition. It is rare for reports on acute adrenal insufficiency in children when the dose is higher than the approved dose (typically 1000mcg per day or more), prolonged treatment (several months or year); Observations include hypoglycemia and sequelae of consciousness and/or convulsions. Cases that are likely to cause an outbreak of acute adrenal insufficiency include: trauma, surgery, bacterial infection or any sudden decrease in the dose.

    Patients with higher doses than the approved dose should be closely monitored and reduced the dose slowly.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

  • Side Effects

    When using Flixotide 125mcg, you may experience unwanted effects (ADR).

    Infections and parasites

  • Very common: mouth and throat candidiasis. In these patients, it is necessary to gargle with water after spraying. Symptomic candidiasis can be treated with antifungal drugs while continuing to use Flixotide 125MCG.
  • Immune disorders

    The hypersensitivity reaction to the following manifestations has been reported:

  • Unsatibly: Hypersensitivity reactions on the skin.
  • Endocrine disorders

    Systemic effects may include (see caution when using):

  • Very rare: Cushing syndrome, cushing syndrome, adrenal inhibition, developmental retardation in children, reducing bone mineral density, cataracts, glaucoma.
  • Very rare: anxiety, sleep disorders and behavioral changes, including excessive hyperactivity and irritability (mainly in children). Can cause hoarseness. Rinse your mouth with water immediately after spraying can be helpful.

    As well as other inhaled therapy, paradoxical bronchospasm can occur with an increase in wheezing right after the medication. Should be treated immediately with bronchodilators inhaled quickly. Stop using Flixotide 125MCG immediately, re -evaluate the patient's condition and if necessary, use another replacement treatment.

    Skin and tissue disorders

  • Popular: bruises.
  • Notify the doctor with unwanted effects when taking the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Flixotide 125mcg drug contraindicated in the following cases:

  • Hypersensitivity to any ingredients of the drug.
  • Precautions when using

    Hen control should follow the steps and response programs of patients should be clinically monitored and through lung function tests.

    Increase the use of beta -shipping substances; Short -acting inhalation to control asthma symptoms shows that the control of asthma is poor. In these cases, the patient's treatment regimen should be re -evaluated.

    Sudden and worse developments in controlling asthma are at risk of life -threatening patients, so they should consider increasing the dose of corticosteroids. In patients who are considered to be at risk, should monitor the daily peak flow.

    Flixotide 125MCG is not used in acute asthma attacks but only used for long -term control of the routine. Patients will need to use bronchodilators inhaled quickly and short to reduce acute asthma symptoms.

    When not responding to treatment or severe dramatic drama of bronchial asthma, the Flixotide dose of 125mcg should be increased in the inhaled form and if necessary, use systemic steroids and/or use antibiotics if there is infection.

    Systemic effects can occur with any inhaled corticosteroids, especially when using high and long -term doses, these effects are much less likely to occur than when using oral corticosteroids. Systemic effects can be encountered including cushing syndrome, manifestation of cushing, adrenal inhibition, slow growth in children and adolescents, reducing bone mineral density, cataracts and glaucoma. Therefore, it is important to adjust the inhaled corticosteroid dose to the lowest content while maintaining effective asthma control (see side effects).

    Should regularly check the height of children with corticosteroids for long -term inhalation in children.

    Some patients may have a more sensitive manifestation of the effect of inhaled corticosteroids than most other patients.

    Due to the ability to decrease in the adrenal response, patients need special care when changing from oral steroid therapy to Flixotide 125mg inhaled Flixotide therapy and need to regularly monitor the adrenal function regularly.

    After using Flixotide 125mcg inhaled, should stop treating systemic steroids slowly and should recommend that patients always carry a warning card about steroids indicating situations that need additional treatments in emergency cases.

    Similarly, the replacement of systemic steroid therapy with inhaled steroids can reveal other allergic diseases such as allergic rhinitis or eczema that has been previously controlled with systemic steroids. Symptoms should be treated with these allergies with antihistamine and/or topical medications, including topical steroids.

    Do not stop the Flixotide 125mcg therapy suddenly.

    Very rare reports on hyperglycemia (see side effects) and should consider when prescribing patients with a history of diabetes.

    Like other inhaled corticosteroids, especially cautious in patients with pulmonary tuberculosis or silence.

    During after -sales use, there was a clinical drug interaction report in patients using Fluticasone Propionate and Ritonavir leading to the systemic effects of corticosteroids including Cushing syndrome and adrenal inhibitors. Therefore, avoid combining Fluticasone and Ritonavir unless the benefits for patients are superior to the risk of corticosteroid side effects (see drug interaction).

    should always pay attention to the ability to decline adrenal response in emergency cases including surgery and in certain cases that are likely to cause stress and then consider appropriate treatment with corticosteroids.

    adrenal function and adrenal reserve are often maintained within normal limits when using Flixotide 125mcg at the recommended dose. The benefit of Flixotide 125MCG treatment is to minimize the need for oral steroids. However, the unwanted effects of oral steroids have previously used or interrupted may continue to last for a while. The degree of adrenal insufficiency may need experts' opinions before urgent procedures.

    Should check the technique of the patient's spray to ensure the synchronization between the spray and inhalation movements to bring the drug to the lungs optimally.

    Powering and operating machinery

    Flixotide 125MCG usually does not affect these possibilities.

    Pregnancy

    There is no complete evidence of the safety of Fluticasone Propionate during pregnancy in humans. Research on animal fertility has shown only the typical effects of glucocorticosteroid at the level of systemic exposure much greater than the level of exposure to observe in the recommended dose of the inhaled medication. There is no ability to cause mutations in gene toxic tests.

    However, like other drugs, it is advisable to consider using Fluticasone Propionate during pregnancy if the expected benefits for the mother outperform all the risks that can cause the embryo.

    Breastfeeding period

    Not surveyed on the excretion of Fluticasone Propionate into human milk. When injecting subcutaneous skin for nursing mouse culverts to breastfeed so that it is possible to measure the concentration of drugs in plasma, it has noticed that there is evidence of Fluticasone Propionate in milk. However, the concentration of Fluticasone Propionate in plasma in patients with inhaled drugs with recommended dose may be low.

    Medicinal interaction

    under normal conditions, the low concentration of Fluticasone Propionate in plasma is often achieved after inhalation, because the body clearance is high and the first metabolism is strong by Cytochrome P450 3A4 in the intestine and liver. Therefore, it is unlikely to interact with clinical significance through Fluticasone Propionate.

    A study of drug interactions in healthy objects shows that Ritonavir (strong inhibitor of Cytochrome P450 3A4) can increase the concentration of fluticasone propionate in plasma, resulting in a significant reduction in serum cortisol levels.

    During the after -sales drug, there was a significant report on clinical drug interaction occurred in patients using Fluticasone Propionate combining effect on the nasal mucosa or inhalation with Ritonavir, resulting in corticosteroid effects including curry syndrome and adrenal inhibition. Therefore, it is advisable to avoid using Fluticasone Propionate and Ritonavir simultaneously, except for benefits for patients who are outstanding risks of unwanted effects of systemic corticosteroids.

    Studies show that other Cytochrome P450 3A4 inhibitors increase negligible (such as erythromycin) and slightly increased (such as ketoconazole) to expose the body with fluticasone propionate without significantly reducing cortisol levels in serum. However, be careful when using a combination of strong Cytochrome P450 3A4 (e.g. ketoconazole) because it can increase the body exposure to Fluticasone Propionate.

    Storage

    Close the lid of the tube definitely and close it in the right position.

    Do not store Flixotide 125mcg at temperatures above 30 ° C.

    Avoid frost and direct sunlight.

    Like most inhalers in the pressure bottle, the effectiveness of the drug can be reduced when the spray is cooled.

    Do not puncture, break or burn the spray even when the bottle is completely out of the drug.

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