Flixonase nasal spray 0.05% GSK treat allergic rhinitis (60 doses)

Dosage form Box x 6g
Specifications Fluticason Propionat

Ingredient

Composition information	Content
Fluticason Propionat	0.05% W/W

Uses

indications

Flixonase drugs are indicated in the following cases:

Preventing and treating seasonal allergic rhinitis, including allergic rhinitis caused by pollen (hay sauce) and allergic rhinitis all year round. In patients with allergic rhinitis, Flixonase nasal spray is also indicated to control the symptoms of pain and severe sinus area. Fluticason propionat has strong anti -inflammatory activity but when used on the spot on the nasal mucosa, it does not observe the whole body effect.

Pharmacology

Fluticason Propionate has a strong anti -inflammatory effect, but when used on the spot on the nasal mucosa does not see the whole body effect.

Fluticason propionat is small or does not inhibit the hypothalamus - pituitary - adrenal gland when used in a nasal spray line.

After spraying Fluticason Propionate (200 micrograms/day), there is no significant change in serum AUC Cortisol 24 hours compared to placebo (ratio 1.01; 90% trust (CI) 0.9 to 1.14).

Fluticason Propionate is a synthetic corticosteroid with fluor atom attached to the steroid frame. The mechanism of action of topical corticosteroids is a combination of three important properties against inflammation, anti -itching and vasoconstrictor effect. The effect of the drug is partially linked to the steroid receptor. Corticosteroids reduce inflammation by stabilizing the lysosom membrane of leukemia, inhibiting the concentration of macrophages in inflamed areas, reducing the adhesion of leukocytes with capillary endothelium, reducing capillary permeability, reducing complementary components, antagonists of histamine and releasing kinine from substrates that reduce fiber proliferation, reducing collagen and then reducing tissue into scars.

Corticosteroids, especially fluoride corticosteroids, have anti -cell fertilizer effects in skin and epidermal cells.

Fluticason Propionate is a topical corticosteroid corticosteroids with very large initial liver clearance, resulting in very low body bioavailability. That reduces the risk of the whole body side effects after taking the drug in the inhalation line, even when inhaling at very high doses.

Treatment of allergic rhinitis all year round or seasonal:

The effect of Fluticason Propionate in the treatment of allergic rhinitis is caused by a decrease in the release of intermediate substances that cause inflammation, which produces symptoms such as itching, sneezing, runny nose and edema.

Patients must use Flixonase medication according to regular distance as instructed because the effectiveness of treatment depends on the use of the drug regularly.

Symptoms are usually mild within 12-48 hours after starting to take the drug, but in some patients, it takes 2-4 days to achieve maximum treatment effect.

may need additional treatment with antihistamines and/or use nasal stuffy drugs until clinical response. In some people with allergic rhinitis all year round or seasonal, especially those with attached asthma, may need to be treated simultaneously with corticosteroids by oral or inhaling through the mouth, bronchodilator, antihistamine, anti -stuffy nose to reduce maximum symptoms.

There may be rapid decrease in anti -inflammatory effects of corticosteroids when used repeated although it is not known for the clinical importance.

Dynamic pharmacokinetics

Absorption: After spraying with nose with fluticason propionat (200 micrograms/day), in most patients with maximum plasma concentrations in a stable state is not quantified (less than 0.01 nanogram/ml). The highest CMAX observed is 0.017 Nanogram/ml. Absorption directly from the nose is negligible due to low water solubility and most of the drugs are often swallowed. Absolutely oral bioavailability is negligible (less than 1%) due to a combination of incomplete absorption through the digestive tract and the first metabolism. The whole body absorption obtained from the absorption at the nose and the oral absorption of the amount of pills swallowed so is not significant.

Distribution: Fluticason propionat has a large distribution in a stable state (approximately 318 l). Links to plasma proteins at a medium high level (91%).

Metabolism: Fluticason propionat is quickly removed from the completely body week, mainly through metabolism in the liver into metabolites without carboxylic acid activity and through CYP3A4 - an enamel of the Cytochrom P450 system. The amount of fluticason propionat swallowed is also strongly transformed. Pay attention to simultaneous use of strong CYP3A4 inhibitors such as ketoconazole and ritonavir due to the ability to increase the body exposure to Fluticason Propionate.

Elimination: Fluticason propionat's excretion rate when used in intravenous lines is linearly between the dose from 250 to 1000 micrograms and characterized by high plasma clearance (Cl = 1.1 l/min). The peak of plasma peaks decreased by about 98% after 3 to 4 hours and after 7.8 hours of sale, the plasma concentration was only low. The kidney removal of Fluticason Propionate is negligible (less than 0.2%) and less than 5% in the form of carboxylic acid metabolites. The main excretion line is the excretion of Fluticason propionat and its metabolites in biliary tract.

Before taking Flixonase nasal spray 0.05% GSK treat allergic rhinitis (60 doses)

How to use

use only through the nose. Flixonase medication is needed to get the effectiveness of treatment. Patients should be explained that the effect of the drug does not appear immediately due to the most powerful effect that can only be achieved after 3 to 4 days of treatment.

Spray has 1 dust -proof lid to protect the spray and keep the spray clean. Remember to remove this dust lid before using the spray bottle. The new sprayer (or the sprayer is not used for a few days) may not work for the first time, so you need to prepare the sprayer according to the instructions in the "Prepare the spray bottle".

Prepare spray bottle:

You have to prepare a spray bottle:

Before you use a spray bottle for the first time

If you do not use a spray bottle for a few days

If you have just cleaned the spray bottle according to the instructions in the "Spray cleaning". Follow the following steps:

Shake the spray bottle and remove the dust -proof lid.

Hold the spray bottle upwards and directed the nozzle away from you.

while holding the thumb, using the index finger and the middle finger to press down to release a dose of spray containing super fine particles into the air.

spray bottle is now ready to use.

Shake the spray bottle and remove the dust -proof lid. Tilting your head slightly and holding the spray bottle upwards.
When inhaled with the nose, use the fingers to press the spray.
Breathe out through the mouth.
Repeat steps 3 and 4 with the other nostrils.
After using a spray bottle, use a dry paper towel or a handkerchief to wipe the spray tap.
Close the dust -proof lid.
You have to clean Flixonase spray at least once a week to prevent the nozzle from being clogged. Follow the following steps:
Remove the dust -proof lid.
Remove the spray nozzle by pulling the spray nozzle.
then wash under the flowing faucet. Around:
Adults and children over 12 years: Spray 2 times on each side of the nose, 1 time a day, preferably in the morning. In some necessary cases, you can spray 2 times on each side of the nose, 2 times daily if needed. The maximum daily dose should not exceed 4 sprays for each nose.
Children from 4 to 11 years old: spray 1 shot on each side of the nose, 1 time a day, preferably in the morning. In some necessary cases, you can spray one by each side of the nose, 2 times daily. The maximum daily dose should not exceed 2 sprays for each nose.
Elderly: Using normal doses like adults.
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 do
do when overdose? On healthy volunteers, there has not been an effect on the hypothalamus function - the pituitary gland - the kidney when using 2 mg of fluticason propionate nasal spray, 2 times a day for 7 days. Using higher doses than the recommended dose for a long time can lead to temporary inhibition of adrenal function. For these patients, Fluticason Propionate should be used at the effective dose to control symptoms, adrenal function will recover for a few days and can be monitored by quantifying plasma cortisol.
What to do when forgetting 1 dose?

Not recorded.

Side Effects

When using Flixonase, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous system: headache, smell and annoying taste.

When experiencing side effects of Flixonase, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Flixonase medicine is contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Be cautious when using

Local infections: Nasal tract infections should be appropriate, but it is not specific contraindications for treatment with Fluticason Propionate nasal spray.

Be careful for cases of stopping steroidal treatment and switch to Fluticason propionate nasal spray, especially if there is a reason to doubt the adrenal function is impaired.

There has been a report on the body effect when using corticosteroids sprayed through the nasal line, especially when taking high doses for a long time. These effects are much less occurs than when using oral corticosteroids and may vary in patients and corticosteroids.

Observed the reduction of growth in children treated with nasal corticosteroids. Therefore, the lowest dose should be maintained for children while controlling adequate symptoms.

During the use of drugs on the market, there was a report on clinical drug interactions in patients using Fluticason propionat and ritonavir leading to the systemic effect of corticosteroids including cushing syndrome and adrenal insufficiency. Therefore, avoid simultaneous use of Fluticason propionat and ritonavir unless the benefits are superior to the risk of corticosteroid side effects.

There have been reports on visual disorders in patients using systemic corticosteroids and/or local. If the patient has a blurred vision or other visual disorders, considering assessing the possible causes including cataracts, glaucoma or central retinopathy.

The maximum efficiency of Flixonase nasal spray can be achieved after many days of treatment.

Although Flixonase nasal spray can control most cases of seasonal allergic rhinitis, exposure to summer allergens in large quantities, abnormalities sometimes need appropriate additional treatments.

The ability to drive and operate machinery

Fluticason Propionat almost does not affect the ability to drive and operate the machine.

Pregnancy

is like other drugs, only use Fluticason propionate nasal spray in pregnancy and during breastfeeding when benefits are superior to the risks that may be related to drugs or any replacement treatment.

There is not enough evidence of safety when used for pregnant women. In animal reproductive studies, the typical unwanted effect of strong corticosteroids only observed that at high levels of exposure, when used directly through the nose, it will ensure the minimum body exposure.

The period of breastfeeding

The excretion of Fluticason Propionate into the mother's milk has not been studied. After the subcutaneous injection, the experimental mouse is breastfeeding, when the concentration is measured in plasma, there is evidence that Fluticason Propionate is present in breast milk. However, plasma concentrations are low in patients using Fluticason Propionate nasal spray with recommended dose.

drug interaction

under normal conditions, the level of Futicason propionat in plasma is very low after taking the drug through the nose, due to the first metabolism and the body clearance through the cytochrom P450 3A4 in the intestine and the liver. The drug interaction is so it is difficult to have clinical significance between Futicason Propionat and other drugs.

A study of drug interaction in healthy objects shows that Ritonavir (a very strong Cytochrom P450 3A4 inhibitor) can increase the concentration of fluticason propionat in plasma, leading to a significant reduction in serum cortisol levels. In the process of using drugs on the market, there was a report on clinical drug interaction in patients using Fluticason Propionate in a nasal spray or inhaled form with ritonavir, leading to corticosteroid -body effects including cushing syndrome and adrenal insufficiency. Therefore, it is advisable to avoid using Fluticason Propionat and Ritonavir and unless the benefits are superior to the risk of corticosteroid side effects.

Studies show that other Cytochrom P450 3A4 inhibitors increase body exposure with negligible fluticason (such as erythromycin) and light (like ketoconazole) without significantly reducing serum cortisol levels. However, it is necessary to be cautious when using a combination of strong Cytochrom P450 3A4 (eg ketoconazole) because it has the ability to increase the body exposure to Fluticason Propionate.

Storage

Store under 30 ° C.

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