Meseca Advanced Merap nasal spray treats symptoms of runny nose, nasal congestion, itching (60 doses)

Dosage form Box
Specifications Fluticasone Furoate

Ingredient

Composition information	Content
Fluticasone Furoate	27.5mcg

Uses

Indications

Meseca Advanced nasal spray indications for treatment in the following cases:

adults and teenagers (12 years or older):

Treat the symptoms of the nose (runny nose, nasal congestion, itchy nose and sneezing) and symptoms of the eye (itchy/burning sensation of the eyes, watery and redness) of the seasonal allergic rhinitis. 11 years old):

Treatment of nasal symptoms (runny nose, nasal congestion, nose itching and sneezing) of both seasonal allergic and allergic rhinitis all year round. ATC code: R01AD12.

Mechanism of action

Fluticasone Furoate is a synthetic corticosteroid containing three fluores attached to the steroid frame, with a very high affinity with glucocorticoid receptor and strong anti -inflammatory effect.

Safe and clinical effectiveness

Seasonal allergic rhinitis in adults and teenagers:

Compared to the placebo group, Fluticasone Furoate Spray nasal 110 mcg once a day significantly improves symptoms in the nose (including runny nose, stuffy nose, sneezing and itchy nose) and symptoms in the eye (including itching/burning sensation, watery and red eyes) in all 4 studies. The effect is maintained more than 24 hours after using the drug once a day.

The drug tremens very early, only 8 hours after the starting dose, and the symptoms improving the symptoms continue to be observed after a few days of treatment. The quality of life of the patient (evaluating according to the set of questions about the quality of life in patients with rhinitis - conjunctivitis - RQLQ) has improved significantly compared to the original group using Fluticasone Furoate nasal spray in all 4 studies.

allergic rhinitis all year round in adults and teenagers:

Fluticasone Furoate 110 mcg nasal spray once a day significantly improves the symptoms in the nose as well as the patient's awareness of the general response to the treatment compared to the placebo group in all 3 studies.

Fluticasone Furoate 110 mcg nasal spray once a day significantly improves the symptoms of the eye as well as the quality of life of the patient (evaluated according to the set of questions about the quality of life in patients with rhinitis - Eye conjunctiva - RQLQ) compared to the placebo group in 1 study.

Effective is maintained more than 24 hours after taking the drug once a day.

In a 2 -year study to evaluate the safety of the eye of Fluticasone Furoate (nose spray 110 mcg once a day), the research object is adults and teenagers with allergic rhinitis all year round using Fluticasone Furoate (n = 367) or placebo (n = 181). Main criteria [Time to increase the turbidity below (≥ 0.3 compared to the original, according to the cataract classification system, version III (Opacities Classification System, Version III = LocS ILI Grade)) and time to increase internal pressure (IOP; ≥ 7 mmHg compared to the original)] is not different from the statistical significance between the two groups. The increased turbidity below (≥ 0.3 compared to the original) is more common in the subjects treated with Fluticasone Furoate 110 mcg [14 (4%)] compared to the placebo [4 (2%)] and this increase is in essence in 10 objects in the Fluticasone Furoate group and 2 objects in the placebo group. Interior pressure increased (≥ 7 mmHg compared to the original) is more common in Fluticasone Furoate 110 mcg treatment group: 7 (2%) for Fluticasone Furoate 110 mcg once a day and 1 ( 95%) have internal pressure value in ± 5 mmHg of the original value. Increasing turbidity below or increasing intraocular pressure does not accompany any unwanted effects of cataract or glaucoma.

Seasonal allergic rhinitis and allergic rhinitis all year round in children (from over 6 years old)

Determining the dose of drugs used in children based on evaluation of data on the effectiveness of drugs on children with allergic rhinitis.

In seasonal allergic rhinitis, Fluticasone Furoate nasal spray at a dose of 110 mcg once a day is effective, but does not observe the difference significantly between the Fluticasone Furoate nasal spray group at the dose of 55 mc once daily and the placebo group on any criteria.

In allergic rhinitis all year round, Fluticasone Furoate nasal spray at a dose of 55 mcg once a day shows a stronger effect than the 110 mcg dose once a day after 4 weeks of treatment. Post -hoc analysis (post -hooc analysis) data on drug efficiency after 6 and 12 weeks of this study, as well as a 6 -week study of safety for the hypothalamus axis - the adrenal (HPA) effectively supports Fluticasone Furoate nasal spray at a dose of 110 MCG once daily.

A 6 -week study has evaluated the effect of Fluticasone Furoate 110 mcg nasal spray once a day for adrenal gland function in children from 2 to 11 years old. The results showed that there was no significant impact on serum cortisol levels for 24 hours compared to the placebo group.

A random study, double blindness, parallel group, multicolor, control with placebo, lasting 1 year on clinical growth has assessed the effect of Fluticasone Furoate 110 mcg nasal spray/day on growth rate at 474 children before puberty (5 to 7.5 years old with girls and 5 to 8.5 years old with boys), using height measurement equipment. The average growth rate during the 52 -week treatment period in Fluticasone Furoate patients (5.19 cm/year) is lower than the place of placebo patients using placebo (5.46 cm/year). The average treatment difference is -0.27 cm/year [95% CI -0.48 to -0.06] Seasonal allergic rhinitis and allergic rhinitis all year round in children (under 6 years old).

Studies on safety and effectiveness have been conducted on a total of 271 children from 2 to 5 years old for both seasonal allergic and allergic rhinitis all year round, including 176 children using Fluticasone Furoate.

Safety and efficiency on this group of objects have not been well established.

Pharmacokinetics

absorption

Fluticasone Furoate is incomplete and initially metabolized in the liver and intestines, leading to insignificant system exposure. When using 110 mcg nasal spray a day, the drug concentration in plasma is usually below the quantitative level (less than 10 PG/ml). The absolute bioavailability of Fluticasone Furoate nasal spray is 0.5%, so there is less than 1 mcg Fluticasone Furoate at the common circulation after using the 110 mcg dose.

Distribution

The ratio of cohesion to the plasma protein of Fluticasone Furoate is greater than 99%. Fluticasone Furoate is widely distributed with an integral distribution in an average equilibrium of 608 l.

Metabolism

Fluticasone Furoate is rapidly eliminated (total plasma clearance is 58.7 liters/hour) from the completely client week mainly due to the metabolism in the liver into an inactive metabolic 17 beta-carboxylic (GW694301X), by Cytochrome P450 enzyme CYP3A4. The main metabolic path is S - Fluoromethyl Carbothioate to form a metabolism of 17 beta -carboxylic acid. In-Vivo studies do not show evidence of Furoate separation to form fluticasone.

Elimination

The main elimination of the feces after oral medication and venous sugar shows that Fluticasone Furoate and its metabolites are excreted in bile. After using drugs by intravenously, the average disposal time is 15.1 hours. About 1% of oral dosage and 2% of the venous dosage are excreted in the urine.

Special subjects

Children

In most patients, Fluticasone Furoate (

Elderly

Dynamic dynamic data is provided only based on a few of the elderly patients (≥ 65 years old, n = 23/872; 2.6%). There is no evidence that the percentage of objects with Fluticasone Furoate concentration can be quantified in the elderly group higher than the younger object group.

Patients with renal failure

No Fluticasone Furoate is not detected in urine of healthy volunteers after using nasal sprays. Under 1% of the active ingredient is excreted in the urine, so the kidney failure is not considered a factor that affects the pharmacokinetics of Fluticasone Furoate.

Patients with liver failure

There is no data on the use of Fluticasone Furoate nasal spray in patients with hepatic impairment. The following data is available by Fluticasone Furoate (Fluticasone Furoate or Fluticasone Furoate/ Vilanterol) Using the mouth line in the mouth in patients with liver failure can also be applied to the form of nasal sprays. In a study of a single dose of 400 mcg fluticasone Furoate inhaled in the mouth in patients with medium-level liver impairment (Child-Pugh B), the results showed an increase in CMAX (42%) and the area under the AUC curve (0-CO) (172%) and moderate decrease (average 23%) of cortisol levels compared to healthy subjects. After repeating the dose of Fluticasone Furoate/Vilanterol inhales the mouth for 7 days, in patients with moderate or severe liver impairment (Child Pugh B or C) has an increase in the body exposure to Fluticasone Furoate (an average of twice - measured by the area under the AUC curve (0-24) compared to healthy subjects.

Increasing body exposure to Fluticasone Furoate (Fluticasone Furoate/Vilanterol 200/25 MCG) in patients with liver failure level is both related to an average reduction of 34% serum cortisol concentration compared to healthy objects. There is no effect on serum cortisol levels in patients with severe liver failure (when using Fluticasone Furoate/ Vilanterol 100/ 12.5 mcg). Based on these results, the average exposure is predicted when using 110 McG Fluticasone Furoate nasal spray in patients with liver failure is not considered to lead to cortisol inhibition.

Before taking Meseca Advanced Merap nasal spray treats symptoms of runny nose, nasal congestion, itching (60 doses)

How to use

only use the drug through the spray in the nose.

Shake thoroughly before use. Before using, proceed to pump by directing the spray and spray until the mist is uniform (about 8-10 sprays). If after 24 hours to use the next dose, the bottle must be reloaded. This time just spraying once into the air is enough.

clean the nose, shake the bottle, open the protective lid. Inhale gently through the nose, while inhaling, spray the prescribed dose.
Similarly, spray the other nose.
Remove the protective lid and the spray head by drawing straight (do not try to open the spray bottle by using sharp objects because it may damage the spray bottle, resulting in the absence of an accurate dose). Rinse the spray head and protective lid with warm water then rinse under the tap. To completely dry in the air before reinstalling
Dosage

should recommend that patients use the drug regularly to get adequate treatment effect. The drug acts early about 8 hours after the starting dose. May need medication for a few days to achieve maximum benefits. It is necessary to explain to the patient that the treatment effect of the drug does not appear immediately.
Adults and teenagers (12 years or older)
The initial starting dose is 2 sprays (27.5 mcg/dose) on each side x 1 time/day (total daily dose is 110 mcg) once the symptoms are fully controlled, the reduction of the dose to 1 spray on each side x 1 time/day (total daily dose is 55 mcg) can be effective for maintenance treatment.
Children (from 2 to 11 years old)
The initial starting dose is 1 spray (27.5 mcg/dose) on each side x 1 time/day (total daily dose is 55 mcg).
Can use 2 sprays on each side of the nose x 1 time/day (total daily dose is 110 mcg) when the patient does not respond fully with 1 spray on each side of the nose x 1 time/day (total daily dose is 55 mcg). Once the symptoms have been fully controlled, the dose should be reduced to 1 spray on each side of the nose x 1 time/day (the total daily dose is 55 mcg).
Children (under 2 years old)
There is no data to recommend the use of drugs in the treatment of seasonal allergic rhinitis or allergic rhinitis year -round in children under 2 years old.
Special subject group:
Elderly: No need to adjust the dose. 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?

Symptoms of overdose:
In a biochemical student, there is no observation of unwanted effects when using a nasal spray up to 2640 mcg/day (24 times higher than the daily dose of the nasal spray is recommended for adults) for more than 3 days.
Overdose:
Excavity overdose may not need any treatment but follow -up.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
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

The most unwanted effects in the Fluticasone Furoate treatment process are nosebleeds, nose ulcers and headaches. The most serious unwanted effects are cases of rare reports on hypersensitivity reactions, including anaphylaxis (less than 1 case on 1,000 patients).

List of unwanted effects

There are over 2700 patients treated with Fluticasone Furoate in studies on safety and effectiveness in the treatment of seasonal allergic rhinitis and allergic rhinitis all year round. The group of children exposed to Fluticasone Furoate in these studies includes 243 patients from 12 to under 18 years old, 790 patients from 6 to under 12 years old and 241 patients from 2 to under 6 years old.

Data from large clinical trials is used to estimate the frequency of unwanted effects of the drug.

Unwanted effects are classified by organ systems and frequency encountered with the following convention: Very common (≥ 1/10), common (≥ 1/100 and

immune system disorders

Rare: Hypersensitivity reactions include anaphylaxis, angioedema, rash and urticaria.

Nervous system disorders

Common: headache.

Eye disorders

Unknown: transient vision changes, blurred vision.

Very common: nosebleeds. Bone muscles and connective tissue in children

Not known: Growth. ***

Describe some unwanted effects

Systemic effects: The systemic effects of corticosteroids using nasal sugar can occur, especially when using high doses for a long time. Growth has been reported in children with corticosteroids for nasal use.

*Nosebleeds: Overall, nosebleeds have mild to moderate intensity. In adults and teenagers, the rate of nosebleeds when using the drug for a long time (> 6 weeks) is higher than when using the drug for a short time (≤ 6 weeks).

** Difficulty: Cases of shortness of breath has been reported in more than 1% of patients in Fluticasone Furoate clinical trials; The same ratio is also observed in the placebo group.

Children

Safety in children under 6 years old has not been well set. Frequency, classification and severity of unwanted effects are observed in children are similar to adults.

*Nosebleeds: In children's clinical studies lasting up to 12 weeks, the rate of nosebleeds is similar between the group using Fluticasone Furoate and the placebo group.

*** Growth: In a 1 -year clinical study, assessing growth in children before puberty using 110 mcg Fluticasone Furoate 1 time/day, observing the average treatment difference -0.27 cm per year in the growth rate compared to the placebo group.

Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.

Warnings

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

Contraindicated

Meseca Advanced nasal spray is contraindicated in the following cases:

Hypersensitivity to Fluticasone Furoate or any ingredients of the drug.

Be cautious when using

only use sprays on the nose. Do not spray into the eyes or mouth.

Systemic corticosteroid effect

The whole body effect when using corticosteroids through nasal spray can occur, especially when used in high doses for a long time. These effects are much less occur than when corticosteroids use oral and may vary in each patient or difference between corticosteroid preparations. The hidden systemic effects may include Cushing syndrome, the characteristics of Cushing syndrome, adrenal inhibitors, slow growth in children and teenagers, cataracts, glaucoma and rarely rarely a variety of psychological or behavioral effects including mental hyperactivity, sleep disorders, anxiety, depression or aggression (especially in children).

Corticosteroid treatment with higher doses is recommended, which can lead to clinical adrenal inhibition of clinical implications. If there is evidence of the higher dosage use, it is necessary to consider using more body corticosteroids during the time the patient has stress or surgical surgery. Fluticasone Furoate 110 mcg x 1 time/day does not inhibit the hypothalamus - pituitary - adrenal (HPA) in adults, teenagers or children. However, the dose of Fluticasone Furoate nasal spray should be reduced to the lowest doses that can maintain the effective control of the symptoms of rhinitis. Similar to all corticosteroids using nasal sugar, it is necessary to consider the total burden of the body with corticosteroids whenever other forms of corticosteroid treatment are indicated simultaneously.

If there is any reason that the adrenal gland function is impaired, be cautious when switching from systemic steroid treatment to Fluticasone Furoate.

visual disorders

visual disorders can be reported when using systemic and local corticosteroids. If the patient appears symptoms such as blurred vision or other visual disorders, it is necessary to consider transferring the patient to an ophthalmologist to evaluate the possible causes of this condition, including cataracts, glaucoma or rare diseases such as the central retinopathy (CSCR) that has been reported after the use of body corticosteroids.

growth slowly

Growth has been reported in children with corticosteroids using nasal sugars with licensed dose. The deceleration of growth has been reported in children with Fluticasone Furoate 110 mcg/day for 1 year (see unwanted effects). Therefore, the lowest dose should be maintained enough to effectively control symptoms for children. Regular monitoring of children's growth for long periods of treatment with corticosteroids use nasal sugar. If the growth is slow, it is advisable to reconsider the treatment with the goal of reducing the dose if possible, proceeding to maintain the lowest dose enough to effectively control symptoms. In addition, it is necessary to consider transferring children to pediatricians.

Patients who are being treated with Ritonavir

It is not recommended to use simultaneously with Ritonavir due to the risk of increased body exposure to Fluticasone Furoate.

excipients

The drug contains benzalkonium chloride can cause irritation or edema of the nasal mucosa, especially when taking the drug for a long time.

Use drugs for women during pregnancy and lactation

Pregnant women

There is no sufficient data on the use of Fluticasone Furoate in pregnant women. Animal studies show that glucocorticoids cause defects including cleft palate and slow growth in the uterus. This is not likely to occur in humans when using the recommended nasal spray because when using glucocorticoid through the nasal spray, creating minimum systemic exposure. Fluticasone Furoate nasal spray should only be used during pregnancy if the desired benefits for mothers are superior to the potential risk to the fetus.

breastfeeding women

It is unknown whether Fluticasone Furoate uses nasal sugar to excrete in breast milk.

The use of Fluticasone Furoate in breastfeeding women should only be considered if the desired benefits for mothers are superior to potential risks for breastfed babies.

The effect of the drug on the ability to drive and operate machinery

does not affect or negatively affect the ability to drive, operate machinery

Drug interaction

Interact with CYP3A4 inhibitors

Fluticasone Furoate is excreted quickly by initial transformation quite a lot through intermediaries Cytochrome P450 3A4.

Based on the data of Fluticasone Propionate, a glucocorticoid metabolized by CYP3A4, does not recommend simultaneous use of Fluticasone Furoate with Ritonavir due to the risk of increased body exposure.

Be careful when using Fluticasone Furoate simultaneously with strong CYP3A inhibitors, including products containing COBICISTAT, due to the risk of unwanted body effects. Evangled to avoid unless the benefits are superior to the risk of increased unwanted effects of corticosteroids, and in this case, the patient needs to be monitored unwanted effects of corticosteroids. In a study of drug interaction between Fluticasone Furoate nasal spray with strong CYP3A4 inhibitor is Ketoconazole, the number of patients with Fluticasone Furoate levels can be measured in plasma in the group using ketoconazole (6 out of 20 patients) higher than the placebo group (1 of 20 patients). The slight increase of this concentration does not lead to statistical differences in serum cortisol levels in 24 hours between the two groups.

Data on enzyme inhibition and enzyme indications suggest that there is no theoretical basis to predict metabolic interaction between Fluticasone Furoate and the metabolism through the cytochrome P450 intermediate of other compounds in clinical doses of nasal sprays. Therefore, clinical research has not been conducted to survey drug interactions between Fluticasone Furoate and other drugs.

Storage

Store at a temperature not exceeding 30 ° C in the original packaging, avoid moisture and avoid light.

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