Nazoster nasal spray 0.05% Nasal Spray Santa treat allergic rhinitis (18g)

Dosage form Box x 18g
Specifications Mometason Furoat

Ingredient

Thành phần cho 100mg

Composition information	Content
Mometason Furoat	50mcg

Uses

Indications

Nazoster is indicated in the following cases:

Nazoster nasal spray 0.05% is indicated for use in adults and children 3 years and older to treat symptoms of seasonal allergic rhinitis or year -round rhinitis. Learning

Mometasone Furoate is an external glucocorticosteroid with local anti -inflammatory properties in the doses that have no body effect.

Perhaps, the mechanism of anti -allergic and anti -inflammatory effects of Mometasone Furoate based on inhibition of intermediate substances that cause allergic reactions.

Mometasone significantly inhibits Leucotrienes release from leukemia in allergies. In addition, it is a very powerful inhibitor the production of TH2 Cytokines, IL - 4 and IL - 5, from CD4+T cells in humans.

In cell trials, Mometasone Furoate is at least 10 times stronger than other steroids (Beclometasone dipropionate - BDP - Betametasone, Hydrocortisone and Dexametasone ) in Il - 1, 1, 6 and TNFα. In the inhibition of production IL - 5, Mometasone Furoate (ICM = 0.12Nm) at least 6 times stronger than BDP and Betametasone.

Moreover, Mometasone Furoate is considered a strong inhibitor than the synthesis of Leucotriene than BDP in white blood cells in patients with sensitive atopic.

In studies using nasal antigens, Mometasone Furoate shows anti -inflammatory effects in both allergies soon and later. This has been shown by the reduction of histamine and eosine -loving leukemia (compared to placebo), neutrophils and reduced epithelial adhesion protein (compared to the onset).

Clinical efficiency is clearly starting at the earliest 12 hours after the first dose.

pharmacokinetic

absorption

Mometasone Furoate is used in the form of nasal spray with insignificant bio -uses (≤ 0.1%). Mometasone Furoate phases are poorly absorbed in the digestive tract; A small amount can be swallowed and absorbed through a process of initial metabolism before being eliminated by urine and bile.

Distribution

In the laboratory test, the Mometasone Furoate bond protein has been reported 98 - 99% with a limited concentration of 5 - 500ng/ml.

Metabolism

Studies have shown swallowing and absorbing Mometasone Furoate to be widely metabolized and transformed into multiple metabolites. No main metabolites found in plasma.

One of the small metabolites converted into a laboratory is 6β - hydroxy - Mometasone Furoate. The metabolites formed in microsomes in the liver are controlled by Cytochrome P - 450 3A4 (CYP3A4).

Elimination

After intravenous injection, the effective plasma disposal time of Mometasone Furoate is 5.8 hours. Any drug is absorbed mainly eliminated in the form of metabolites through bile and limited ratio through urine.

Before taking Nazoster nasal spray 0.05% Nasal Spray Santa treat allergic rhinitis (18g)

How to use

Gently shake the jar and remove the protective lid.

Gently clean the nose.

cover one side of the nose, put the nozzle in the remaining nostrils. Keep the bottle straight while your head is slightly tilted.

Start breathing slowly and spray on the nose by pressing your fingers once and inhaling.

Breathe out by mouth: Repeat the process in step 4 again into the same nostrils.

Take the jar out of the nose and exhale through the mouth.

Repeat the process from step 3 - 6 for the remaining nostrils.

After use, wipe the spray with a clean towel or paper towel and close the lid.

Dosage

When used for the first time, or if the pump is not used for more than 14 days, should be sprayed for about 6 or 7 times until it is found that the pills are easy to spray, easy to adjust the pump.

Each spray contains about 100μg of Mometasone Furoate Mometasone Furoate Monohydrate, equivalent to 50 Microgram Mometasone Furoate.

Shake thoroughly before use.

Seasonal allergic rhinitis or year -round rhinitis

Adults (including elderly patients) and children over 12 years:

Normal recommendations are 2 sprays for preventive and normal treatment with a total daily dose of 200microgam divided into two 50micrograms into both nostrils once a day.

After the symptoms are controlled, the maintenance dose can be lowered to the total daily dose of 100micrograms divided into 1 spray on both nostrils.

If the symptoms are not fully controlled, the maximum daily dose can be increased to a total of 400micrograms like 4 sprays on both nostrils.

After the symptoms are controlled, the dose is recommended. Clinical effect quickly and clearly after 12 hours after taking the first dose.

Children from 3 to 11 years old:

Total daily dose recommended is 100microgram divided into a 50microgram spray into both nostrils once a day. Used for children should be done with the help of adults.

Treatment of nasal polyps

The usual recommendation for treating nasal polyps is 2 sprays (50 micrograms/spray) for a nostril, 1 time/day (total dose of 200 micrograms). If after 5 - 6 weeks of treatment, the symptoms are not fully controlled, the body increases the dose up to 2 sprays for each nose (50microgram/1 spray) x 2 times/day (total dose of 400 micrograms).

The dose should be titrated at the lowest dose at which the effectiveness of the symptoms is maintained. If there is no symptom improvement after 5-6 weeks, treatment with a procedure twice a day, it is advisable to re -evaluate the patient and review the treatment regimen.

Studies on the effectiveness and safety of the drug to treat nasal polyps are within 4 months.

Children

Seasonal allergic rhinitis or year round.

Safety and effectiveness of drugs in children under 3 years old.

nasal polyps.

Safety and effectiveness of nasal sprays in children and teenagers under 18 years of age have not been determined.

What to do when overdose?

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

Seasonal or year -round allergic rhinitis: In clinical studies, side effects related to the treatment in adults and adolescents are headaches (8%), nosebleeds (bleeding, bloody mucus and blood clotting) (8%), sore throat (4%), nasal burning (2%), nasal itching (2%), these effects are often found when using when using when using when using when using when using when using when using when using when using when using when using when using when using when using it is often seen when using it is often used when using it when using it when using it corticosteroid. Nosebleeds are usually mild and self -out. Although its percentage is higher than the placebo (5%), at an equivalent or lower ratio when compared to the study of nasal corticosteroids (up to 15%). The ratio of all other effects is compared to these placebo.

In pediatric patients, side effects such as headache (3%), nosebleeds (6%), nose itching (2%) and sneezing (2%) are compared with placebo.

Instant hypersensitivity reactions include bronchospasm and shortness of breath rarely occur after using Mometasone Furoate Monohydrate. It rarely occurs anaphylaxis and angioed.

Very rarely: taste disorders and sense of smell.

Nasal polyps: In patients with nasal polyps, the general ratios of the side effects compare with the placebo is similar to patients with allergic rhinitis.

Notify the doctor the side effects when taking the drug.

Warnings

Contraindicated

Do not use the product for the following cases:

Sensitive people with any ingredients of the drug;

Spraying should not be used in the case of local infection that is not treated related to the nasal mucosa;

Due to the inhibitory effect of corticosteroids on wound healing, nasal corticosteroids should not be used before healing wounds in patients with nose surgery or recent trauma;

People with fungal, viruses and tuberculosis.

Caution when taking drugs

Spraying should be used carefully in patients with hidden or active tuberculosis infections, non -treated fungal infections, bacteria or systemic infections, herpes Simplex infections in the eye.

After 12 months of treatment with Mometasone Furoate, there is no sign of atrophy in the nasal mucosa, and at the same time, Mometason Furoate tends to convert the nasal mucosa into a normal tissue phenomenon.

When long -term treatment, patients use a spray for months or longer, so they are tested for changes that may be in the nasal mucosa.

If localized fungal infections progress in the nose or pharyngeal, should stop treating with a spray form, or start appropriate treatment. If the stimulation lasts in the palate, it may require termination of treatment with Nazoster spray.

There is no evidence of hypothalamus pinching - yen - adrenal (HPA) when long -term use Nazoster. However, careful monitoring should be monitored from body corticosteroids for a long time to use 0.05% Nazoster. In these patients, when using corticosteroids can lead to signs of adrenal insufficiency for several months until the function of the HPA shaft improves. If these patients show signs of adrenal insufficiency, treatment with systemic corticosteroids should continue to be accompanied by other treatment methods and need to take measurement measures.

During the transition from corticosteroids to Nazoster 0.05% spray, some patients may complain about the recovery symptoms of systemic corticosteroids (e.g. joints/muscle pain, fatigue and depression), despite reducing nasal pain and needs advice to continue treating with Nazoster 0.05% spray. Such transformation can also cause allergies that exist when treated with systemic corticosteroids such as allergic conjunctivitis and Eczema.

In a placebo -controlled study in pediatric patients using 100micrograms/day Nazoster 0.05% spray in a year, observations do not see reduced growth rate.

The ability to reduce immunodeficiency in patients when using corticosteroids should be warned about the risk of some infections (for example: chickenpox, measles) and the importance of medical assistance in such situations should be emphasized.

Perforation of nasal septum or glaucoma due to the use of spray corticosteroids has been reported very rare.

The ability to drive and operate machinery

No report.

Pregnancy and lactation

Pregnancy

Mometasone safety when used for pregnant women has not been determined.

Mometasone's plasma concentration cannot be measured after the maximum recommended dose, so the fetus in contact with Mometasone is negligible and the toxic potential is expected to be very low.

Like other spray corticosteroid preparations, risks for mothers, fetuses and babies should be considered compared to the expected benefits when deciding to use Nazoster 0.05% nasal spray during pregnancy.

Long -term use and large amounts of use should be avoided during pregnancy. Babies of mothers are treating corticosteroids during pregnancy should be carefully observed about adrenal insufficiency syndrome.

Breastfeeding period

Like other spray corticosteroid preparations, risks for mothers and babies should be considered compared to the expected benefits when deciding to use 0.05% nazoster nasal spray during breastfeeding.

Drug interaction

Mometasone Furoate is a substrate of CYP3A4.

When Mometasone Furoate is used with Loratadine, it does not significantly affect the plasma concentration of Loratadine and its main metabolites.

The plasma concentration of Mometasone Furoate cannot be measured. Combining good intake treatment.

Storage

Keep pills out of reach of children and pets.

Expiry date: 24 months from the date of manufacture.

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