Flusort 50mcg nose spray/Glenmark dose for seasonal allergic rhinitis, year round (120 doses)

Dosage form Bottle x 50mcg
Specifications Fluticasone Propionate

Ingredient

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Composition information	Content
Fluticasone Propionate	50mcg

Uses

indications

Flusort drugs are indicated in the following cases:

Treatment of seasonal allergic rhinitis (including hay sauce (or fever) and rhinitis all year round.

Fluticason Propionate is strong anti -inflammatory but when used on the spot nasal mucosa does not show the anti -inflammatory effect.

Pharmacokology

Fluticason Propionate has anti -congestion and other cell formations of corticosteroids in place. Fluticason propionat causes little or does not affect the axis of the pituitary - the adrenal gland when using the nose.

Pharmacokinetics

absorption

When using Fluticason propionat nose with a dose of 200mcg/day, the maximum concentration in a stable state in plasma is not quantified in most objects (

Distribution

large amounts of Fluticason propionat pharmaceutical distributed in a stable state (approximately 318L). Relatively strong plasma protein bonds (91%).

Metabolism

Fluticason Propionat disappears quickly from the circulatory system, mainly due to the metabolism through the liver into the form of metabolic carboxylic acid, because the cytochrom P450 enzyme CYP3A4. The amount of fluticason propionate swallowed is also strongly metabolized through the liver. Be careful when combining CYP3A4 inhibitors such as ketoconazole and ritonavir due to the risk of increasing fluticason levels in the blood.

Elimination

Fluticason propionat intravenously is linearly in the dose of 250 - 1000mcg and is characterized by high plasma clearance (Cl = 1.1 l/min). Peak plasma concentration decreased by approximately 98% within 34 hours and only low concentrations in plasma combined with the final semi -exhaust time of 7.8 hours.

Fluticason propionat's renal elimination is negligible ( The main excretion path of Fluticason Propionate and its metabolites are biliary tract.

Before taking Flusort 50mcg nose spray/Glenmark dose for seasonal allergic rhinitis, year round (120 doses)

How to use

Fluticason nasal spray only uses sugar in the nose.

Avoid direct contact with the eyes.

Dosage

Adults and children over 12 years old

Used to prevent and treat seasonal allergic and rhinitis all year round. Twice for each nose, once a day, should be used in the morning.

In some cases, it may be required to use twice for each nose, twice daily. Once the symptoms are controlled, the dose can be maintained at one spray for each nose, once a day.

If the symptoms recur, the dose may need to be increased accordingly. The minimum dosage is required to effectively control symptoms. Do not exceed the maximum daily dose is four spray for each nose.

Children under 12 years old

Use and treat and treat year -round allergic rhinitis and rhinitis all year round in children from 4 to 11 years old with a one -time -spraying dose for each nose, once a day and should be used in the morning.

In some cases, one spray can be used for each nose, twice daily. The maximum daily dose is not allowed to exceed twice for each nose, it is necessary to maintain the minimum dosage effectively control the symptoms.

Older people

Can take the usual dosage for adults.

Regular use to achieve the optimal effect is very important. Due to the maximum reduction of symptoms that can reach after 3 to 4 days of treatment, it is necessary to explain to the patient if it is not effective instantaneously.

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? The use of the nose line at the dose of 2mg Fluticason Propionat twice a day for seven days on healthy volunteers does not show the impact on the function of the hill -pituitary -adrenal gland (HPA).

The use of inhaled or oral lines of high doses of corticosteroids during a long time can cause impaired axial function under the hypothalamus - pituitary - adrenal.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

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

Common, ADR> 1/100

Nervous system: headache, unpleasant taste.

Respiratory system: Nosebleeds, dry nose, nose irritation, dry throat, throat irritation.

Uncommon, 1/1000

Not recorded.

The immune system: The hypersensitivity reaction to the following manifestations: sensitive reaction on the skin. Evaluation (mainly on the face and edema of the throat). Respiratory symptoms (bronchial spasms). Anaphylactic reactions.

Eye: glaucoma, increased pressure in the eyes, cataracts.

Respiratory system: Perforation of the nasal septum.

Instructions on how to handle ADR

When experiencing side effects of the drug, 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

Flusort drugs are contraindicated in case of hypersensitivity to the active ingredient or any excipient of the drug.

Be cautious when used

Infacement: Air sugar infections should be treated appropriately but does not lead to contraindications for treatment with Fluticason nasal spray.

The optimal treatment effect of Fluticason nasal spray can only be achieved after long -term use. Be careful when transferring medication for patients from steroid effects to use Fluticason nasal spray if there is any sign that the patient has adrenal insufficiency.

Although Fluticason nasal spray will control most cases of seasonal allergic rhinitis, the patient's exposure abnormally with summer allergens in some cases may require additional treatment.

The systemic effect of corticosteroids can occur especially when taking high doses for a long time. These effects are less likely than when using oral corticosteroids and may vary among patients and between different forms of dosage of corticosteriod.

The risk of systemic impact may include Cushing syndrome, the characteristics of Cushing syndrome, adrenal inhibition, slow development in children and adolescents, cataracts, glaucoma and rarity rarely rarely a variety of psychological symptoms or act on behavior including excessive hyperactive state, sleep disorders, anxiety, depression or aggression (especially in children).

Development retardation has been reported in children using some nasal corticosteroids at a licensed dosage. The regular height control is recommended in children with long -term treatment with nasal corticosteroids.

If the child's growth is slowed down, the treatment should be reconsidered to reduce the dose of corticosteroids, if possible, down to the lowest doses, to control the symptoms. In addition, it is necessary to consider consulting patients to see a pediatrician.

Treatment with higher dose than the recommended doses of corticosteroids can cause significant adrenal inhibition in clinical inhibition. If there is a basis for the use of doses higher than the recommended dose, it is necessary to consider adding systemic corticosteroids in stress stages or selection surgery?

The optimal effect of Fluticason Propionate nasal spray may be achieved after a few days of drug use.

Ritonavir may significantly increase the concentration of Fluticason Propionate in plasma. Therefore, it is necessary to avoid using these two medications at the same time, unless the benefits can be achieved for patients than the risk of side effects of systemic corticosteroid drugs. There is also the risk of increasing unwanted effects when combining Fluticason Propionate with other CYP3A inhibitors.

Fluticason nasal spray contains benzalkonium chloride is a substance that can cause bronchospasm.

The ability to drive and operate machinery

Not recorded.

Pregnancy

There is no complete evidence of safety in pregnant women. The use of corticosteroids on pregnant animals can cause defects to the development of the fetus, including causing cleft palate and slowing the development of the fetus in the uterus so the above effects are very small at a fetus in humans.

However, it should be noted that the transformation of animal fetus occurs after using the systemic doses at a high level; Using the nose directly can ensure the lowest blood concentration in the blood.

Similar to other drugs, the use of Fluticason nasal spray on pregnant women requires the consideration between the possible benefits of the drug compared to the risk of unwanted effects that may occur.

The period of breastfeeding

The excretion of Fluticason Propionate into milk on breastfeeding women has not been surveyed. The use of Fluticason propionat under the skin on pregnant mice allows measurement of drug concentration in plasma and seeing the presence of Fluticason propionate in milk.

However, when using nasal sprays on the primates, there is no presence of the drug in plasma, and therefore not sure that the drug can be detected in milk. When using Fluticason nasal spray on nursing mothers, it is necessary to compare the benefits of treatment and the risk of harm on the mother and the baby.

Interactive drug

In normal cases, the concentration of Fluticason Propionate in plasma is low after the patient inhales the drug, due to strong hepatoma metabolism and strong excretion of the body through Cytochrom P450 3A4 in the intestine and liver.

Therefore, it is unlikely that Fluticason Proonate can be an intermediary that causes a significant medication interaction. In a study of drug interactions on healthy objects using Fluticason Propionate nose and Ritonavir (a powerful inhibitor of Cytochrom P450 3A4) at a dose of 100 mg twice a day, increasing the level of fluticason propionate with plenus several hundred times, causing a significant reduction in serum cortisol levels.

Cases of patients with Cushing syndrome and adrenal insufficiency have been reported. It is necessary to avoid combining the above two drugs unless the benefits are out of the increased risk of the system of systemic side effects of Glucocorticoid.

In a small study using Fluticason propionat inhalation on healthy volunteers, Ketoconazole is a weaker CYP3A4 inhibitor that increases the concentration of Fluticason propionat after a single inhalation to 150%.

This leads to a significant reduction in plasma cortisol levels compared to the single fluticason propionat. Combining treatment with other strong CYP3A inhibitors, for example, iTraconazole, may also increase the level of fluticason propionat body and increase the risk of systemic side effects, need to be cautious and avoid long -term treatment with these drugs if possible.

Studies have shown that other Cytochrom P450 3A4 inhibitors cause negligible increase (erythromycin) and slight increase (ketoconazol) fluticason propionate levels in the blood without significantly reducing serum cortisol levels. However, be careful when combining the use of Cytochrom P450 3A4 inhibitors (such as ketoconazole), due to the risk of increasing the concentration of fluticason propionate in the blood.

Storage

Store at temperatures below 30 ° C. Do not freeze.

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