Adacast Meraplion nasal spray treats allergic rhinitis, congestion and loss of smell, sinus rhinitis (60 doses)

Dosage form Nasal spray
Specifications Box
Ingredient Mometasone Furoate

Ingredient

Thành phần cho 0.1ml

Composition information	Content
Mometasone Furoate	50mcg

Uses

Indications

Adacast nasal spray are indicated in the following cases:

Treatment of seasonal or seasonal rhinitis symptoms for adults and children 2 years and older. In patients with a history of seasonal allergic rhinitis with average to severe symptoms, it is advisable to prevent Adacast from 2 to 4 weeks before starting the pollen season. Severe.

ATC code: RO1AD09.

Mechanism of action

Mometasone Furoate is corticosteroids with strong anti -inflammatory effects. The exact mechanism of corticosteroids for allergic rhinitis is unknown. Corticosteroid has been shown to have many effects on many types of cells (mast cells, eosinophilia, neutrophils, macrophages, lymphocytes) and intermediate substances (histamins, eicosanoids, leukotrienes, cytokine) related to inflammatory reactions.

In the study of the antigen stimulant, Mometasone Furoate shows anti -inflammatory effects in both early and late response stage. This is shown by the decrease phenomenon (compared to placebo) histamine and eosinophilia, reduced (compared to the original) eosinophilia, neutral leukocytes and epithelial adhesion proteins. The clinical significance of this phenomenon is unclear.

The effect of Mometasone Furoate nasal spray on the nasal mucosa after 12 months of treatment has been monitored in 46 patients with allergic rhinitis. There is no evidence of atrophy and significantly reduces the whole of eosinophilia in epithelium and inflammatory cell infection (eosinophilia, lymphocytic cells, single -type leukocytes, neutrophils and plasma cells).

Pharmacological properties

Adult adrenal gland function in adults: Four clinical studies have been conducted in adults to evaluate the effect of Mometasone Furoate 50 mcg nasal spray at different doses on adrenal gland function. In the first study, the use of Mometasone Furoate 50 mcg nasal spray 200 and 400 mcg daily and 10 mg Prednisone is compared with placebo in 64 patients (22 to 44 years old) with allergic rhinitis. The adrenal gland function before and after 36 consecutive treatments is evaluated by measuring cortisol levels in plasma after 6 hours of cortrosyn transmission and measuring cortisol levels in urine after 24 hours. The results showed that the Mometasone Furoate 50 mcg nasal spray at both the daily and 400 mcg dose daily reduces the average concentration of cortisol in plasma or the concentration of cortisol in the urine compared to the placebo is not statistically significant. Meanwhile, the significant reduction in cortisol concentration in plasma and urine has been discovered in the Prednison treatment group compared to the placebo group.

The second research has evaluated the adrenal response with Mometasone Furoate 50 mcg nasal spray (dose of 400 and 1600 mcg/day), Prednisone (10 mg/day) and fake over 48 male volunteers (21 to 42 years old). Area below the concentration curve - time for 24 hours (AUC0-24) of cortisol during and after the cortrosyn infusion 8 hours; Cortisol concentration in urine after 24 hours is determined before and after 29 days of treatment. The results showed that there was no significant difference in adrenal function after using Mometasone Furoate nasal spray compared to placebo.

The third research has evaluated the increase in the dose of use on Mometasone Furoate 50 mcg (1000, 2000 and 4000 mcg/day), Mometasone Furoate oral (2000, 4000 and 8000 mcg/day), Dexamethasone oral (200, 400 and 800 mcG/day) and placebo in 22 Volunteer Nam to 39 years old). The doses used at least 72 hours apart. Determine cortisol levels in sequential plasma at 8 am and within 24 hours each treatment to calculate AUC0-24 in addition to monitor cortisol concentration in urine after 24 hours before treatment and after each dose. The results showed that there was no significant decrease in cortisol's AUC0-24 statistics in plasma and cortisol levels in urine after 24 hours in volunteers using Mometasone Furoate oral and nasal spray compared to placebo. In contrast, almost all volunteers using dexamethasone appeared abnormalities in cortisol levels at 8 am (cortisol level The fourth research has evaluated the function of the adrenal gland in 213 patients (from 18 to 81 years old) with a nasal polyp before and after 4 months of treatment with Mometasone Furoate 50 mcg nasal spray (dose of 200 mc x 1 time or 2 times/day) and placebo by measuring cortisol levels in urine 24 hours. The results showed that Mometasone Furoate 50 mcg nasal spray at both doses (200 and 400 mcg/day) reduced the level of cortisol in urine 24 hours compared to placebo, which is not statistically significant.The three clinical studies have been conducted in pediatric patients to evaluate the effects of Mometasone Furoate nasal spray for adrenal gland function at daily dose of 50, 100 and 200 mcg compared to placebo. In the first study, the adrenal gland function before and after 7 consecutive treatments was assessed on 48 patients with allergic rhinitis (from 6 to 11 years old) by measuring cortisol levels in morning plasma and cortisol levels in urine 24 hours. The results showed that Mometasone Furoate nasal spray at all three doses did not significantly reduce cortisol concentration statistics in plasma or 24 -hour urine compared to placebo. In the second study, the adrenal gland function before and after 14 consecutive treatments is evaluated on 48 children (from 3 to 5 years old) with allergic rhinitis by measuring cortisol levels in plasma after 30 -minute cortrosyn infusion. The results showed that Mometasone Furoate 50 mcg nasal spray at all three doses (50, 100 and 200 mcg/day), did not significantly reduce cortisol concentration in plasma after cortrosyn infusion compared to placebo. All patients react normally with cortrosyn. In the third study, the adrenal gland function before and after 42 days of continuous treatment was assessed in 52 patients with allergic rhinitis (aged 2 to 5 years old), 28 of them used Mometasone Furoate 50 mcg nasal spray on each nose (total dose of 100 mc/day), by measuring plasma cortisol levels in the morning and cortisol concentration in urine 24 hours. The results showed that Mometasone Furoate nasal spray does not significantly reduce plasma cortisol concentration statistics or 24 hours in placebo.

Dynamic pharmacokinetics

absorption

Mometasone Furoate is used in the form of a nasal spray with a very low systemic bio -used ( distribution

On Vitro, protein - Mometasone bonding is reported 98% - 99% in the concentration range of 5 - 500 ng/ml.

transformation

Studies have shown that all the amounts of mometasone are swallowed and absorbed through strong metabolism initially creating many metabolites. No main metabolites are detected in plasma. According to In vitro, one of the metabolites formed is 6ß-Hydroxymetasone Furoate. In human liver microsome, the formation of metabolites is regulated by CYP3A4.

excretion

Mometasone Furoate is excreted mainly through bile and partly limited through urine in the form of metabolites.

Before taking Adacast Meraplion nasal spray treats allergic rhinitis, congestion and loss of smell, sinus rhinitis (60 doses)

How to use

only use nasal spray.

Before using, proceed to pump the pump by directing the nozzle away and spray until the mist is uniform (about 8-10 sprays). Shake the spray bottle carefully before each use.

clean the nose, shake the bottle, open the protective lid. Inhale gently through the nose, while inhaling, spray the dosage according to the prescribed dose. Breathe out through the mouth.
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. Let completely dry in the air before reinstalling.
Dosage

Seasonal or year -round allergic rhinitis
Adults and teenagers ≥ 12 years: The usual proposal for prophylaxis and treatment is 2 sprays for each nose, 1 time/day. Once the symptoms have been controlled, the dose reduced to 1 spray for each nose can be effectively maintained. If the symptoms are not controlled, the maximum dose should be increased by 4 sprays for each nose/day, so the dose should be reduced after control of symptoms. Clinical significant effects appear early after 12 hours of first dose.
Children from 2 to 11 years old: The normal proposal is 1 spray for each nose, 1 time/day. Adults should help children when taking medicine.
Nose polyps
Adults ≥ 18 years old: The normal dose is 2 sprays for each side of the nose 2 times/day. If the symptoms have been controlled well, the dose should be reduced to 2 sprays for each side of the nose, 1 time/day.
Sinusitis
Adults and teenagers ≥ 12 years: The normal dose is 2 spray for each side x 2 times/day. Ask your doctor if the symptom becomes worse during treatment.
Support treatment in acute sinusitis
Adults and teenagers ≥ 12 years: The proposal is usually 2 sprays on the side of the nose 2 times/day. Without good symptoms can increase up to 4 sprays for each side x 2 times/day.
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? Due to the body's bioavailability of Mometasone Furoate when using nasal spray In case of 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 doses to compensate for missed dose.

Side Effects

When using the drug often has unwanted effects (ADR) such as:

Summary of data on safety

Nosebleeds often go away on its own and at a mild level, which occurs at a higher frequency than a placebo (5%), but with the equivalent or lower ratio when compared to corticosteroids using nasal sugars (nearly 15%), which has been reported in clinical research in patients with allergic rhinitis. The incidence of all other side effects can be comparable to placebo. In patients treated with nasal polyps, the incidence of side effects is similar to patients with allergic rhinitis. The systemic effect of corticosteroids can occur especially when prescribed at high doses in a long time.

Summary of unwanted effects

The adverse reactions related to treatment (≥ 1%) are reported in clinical trials in patients with allergic rhinitis or nasal polyps and after -sales studies presented below. Unwanted effects are listed according to the Meddra system. For each agency, unwanted effects are ranked by frequency. The frequency is classified as follows: Very common (≥ 1/10); Common (≥ 1/100 to Very common

Respiratory disorders, chest and mediastinum: Nosebleeds (recorded at a dose 2 times daily for nasal polyps).

Commonly encountered

Infection and parasitic infection: Sore throat, upper respiratory infection (recorded with a rarely frequency at a dose 2 times daily for nasal polyps). for nasal polyps).

Not known

The immune system disorder: Hypersensitivity including anaphylactic reaction, angioedema, bronchospasm and shortness of breath. > Children

For children, the rate of unwanted effects is recorded in clinical studies, for example, nosebleeds (6%), headache (3%), nose irritation (2%) and sneezing (2%) compared to placebo.

Report unexpected effects

Reporting unwanted effects after the drug is licensed is very important. This allows to continue controlling the balance of benefits/risks of drug products. Health workers need to report any unwanted effects through the national ADR reporting system.

Instructions on how to handle ADR

Notify the physician with unwanted effects when using the drug.

Warnings

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

Contraindicated

Adacast nasal spray is contraindicated in the following cases:

Patients with hypersensitivity to Mometasone Furoate or any ingredient of the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

influence at the nose

Nosebleeds: In clinical studies, nosebleeds occur in patients with allergic rhinitis using Mometasone Furoate with higher frequency than placebo.

Candida infection: In clinical studies conducted on Mometasone Furoate nasal spray, there is a localized Candida albicans infection in the nose and pharyngeal. When infected with fungal infections, Mometasone Furoate should be stopped and used on -site or body treatment if necessary.

Perforation of the nasal septum: Very rare cases of nasal septum has been reported when using nasal corticosteroids. As well as the long -term treatment in the nasal cavity, the patient uses Mometasone Furoate 50 mcg nasal spray for a few months or longer, so it is checked periodically to determine the changes that may appear in the nasal mucosa.

Slow healing of wounds: Due to the inhibitory effect of corticosteroids in healing wounds, patients with nasal septal ulcer, nose surgery or nasal trauma should not use nasal corticosteroids until the wound heals.

glaucoma and cataracts

Tabula and cataract disease are reported when using systemic and topical corticosteroids (including sugar in the nose, inhalation, in the eyes). Consider the patient examination of ophthalmic examination in the case of abnormal symptoms in the eye when using adacast drugs.

Hypersensitivity reaction

Hypersensitivity reactions include wheezing cases that may occur after using Mometasone Furoate. Stop using the drug if such reactions occur.

immunosuppressive inhibitors

Should be used carefully in patients with tuberculosis or respiratory tract, or fungal infection, bacterial infection, systemic virus infection that has not been treated or herpes simplex herpes in the eye. Patients who are using strong corticosteroids inhibit immunodeficiency should be warned about the risk of exposure to some infections (such as chickenpox, measles) and the importance of doctor's advice if exposed to infection.

affect HPA axis

When using corticosteroid nasal spray at a dose higher than the recommended dose or in people who are sensitive to the recommended dose, there may be systemic corticosteroid effects such as hypertension and adrenal inhibition. If these changes occur, the Adacast nasal spray should be stopped slowly, in accordance with the instructions that are applied for stopping oral corticosteroids.

affects the development of children

corticosteroid may slow down the growth rate when used for pediatric patients. Monitor the regular development of pediatric patients when using Mometasone Furoate 50 mcg nasal spray. To minimize the systemic effect of corticosteroids using nasal sugar, including Adacast nasal spray, it is advisable to start treating patients with the lowest doses to control symptoms effectively.

Pills containing benzalkonium chloride can cause nose irritation.

affects the ability to drive and operate machinery

There is no evidence of the effect of the drug on the ability to drive and operate machinery.

Use drugs for women during pregnancy and lactation

Pregnant women

Consult your doctor about the risks and benefits when using the drug. There is no data on drug use in pregnant women, should only be used if the benefits are superior to the risk.

breastfeeding women

It is not known whether the drug is excreted in breast milk or not. Consult your doctor before use in nursing women.

Drug interaction

No official drug interaction studies have been done with Mometasone Furoate 50 mcg nasal spray.

Studies have shown that Mometasone Furoate is metabolized mainly in the liver to form many metabolites. In vitro studies have identified the main role of Cytochrom P450 3A4 during the metabolism of Mometasone Furoate. Simultaneous use of CYP3A4 inhibitors can inhibit metabolism and increase body exposure to Mometasone Furoate and have the ability to increase the risk of corticosteroid side effects. Caution should be careful when considering the sharing of the Adacast nasal spray with strong CYP3A4 inhibitors (for example, ketoconazole, ritonavir, products containing cobicistat, Atazanavir, Clarithromycin, indinavir, iTraconazole, Nefazodone, Nelfinavir, SaQuavir, Saquinavir, Saquinavi telithromycin).

Consider the benefits of using the drug simultaneously compared to the risk of corticosteroid. In that case the patient should be monitored the whole body effect of corticosteroids.

Storage

Leave a dry place, avoid direct light, temperatures below 30⁰C, not frozen.

To be out of reach of children, read the instructions carefully before use.

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