Meseca Fort Merap nasal spray for allergic rhinitis (60 doses)

Dosage form Box
Specifications Azelastine, Fluticasone Propionate

Ingredient

Composition information	Content
Azelastine	0.137mg
Fluticasone Propionate	0.05mg

Uses

Indications

Meseca Fort is indicated to reduce the symptoms of seasonal allergic rhinitis and year -round rhinitis in adults and children aged 6 and older, subjects that need to be treated with both Azelastine hydrochloride and fluticasone propionate.

Pharmacology

Therapy pharmacological group

Pills of nose and other products used at the nose, combined with corticosteroids and fluticasone

ATC code: R01AD58.

Mechanism of action

Meseca Fort contains Azelastine Hydrocortisone and Fluticasone Propionate. Each ingredient has a different mechanism of action and creates a synergistic effect to improve the symptoms of rhinitis and allergic keratitis.

fluticasone propionate

Fluticasone Propionate is a trifluorinated corticosteroid derivative with very high affinity for glucocorticoid receptors and has strong anti -inflammatory effects. The stronger effect is 3-5 times dexamethasone in the test on the asexual glucocorticoid receptor of the person including the link and gene manifestation.

azelastine hydrochloride

Azelastine, a derivative of Phthalazinone, is classified as a prolonged anti -allergy compound, H1 selective antagonistic activity, mast cell stability and anti -inflammatory properties. Precision data and in vitro studies show that azelastine inhibits the synthesis or release of chemical intermediaries known to be involved in early and late allergic reactions, such as Leukotrienes, histamine, platelets activated (PAF) and serotonin.

After 15 minutes of medication, the results of reducing nasal allergies.

Azelastine Hydrochloride and Fluticasone Propionate

There are 4 clinical studies conducted in adults and adolescents with allergic rhinitis, using nasal spray mixture containing Azelastine Hydrochloride and Fluticasone Propionate with 1 dose of spray on the nose, 2 times/day. The results showed that the symptoms of rhinitis, (including: runny nose, stuffy nose, sneezing and itching) improved significantly compared to placebo, single therapy Azelastine hydrochloride or fluticasone propionate. The drug significantly improves eye symptoms (including itching, watery and red eyes) and the quality of life of patients in all 4 studies.

When compared to a Fluticasone Propionate nasal spray on the market, the nasal spray containing Azelastine Hydrochloride and Fluticasone Propionate improve symptoms significantly (50% decrease in severity of the nose), and achieve significant early results (at least 3 days earlier).

The outstanding effect of nasal spray chaos containing Azelastine Hydrochloride and Fluticasone Propionate compared to Fluticasone Propionate nasal spray is maintained throughout the study lasting a year in patients with chronic rhinitis, persistent allergies and vascular/non -allergic rhinitis.

Pharmacokinetics

Huan

After using a nasal spray mixture containing Azelastine Hydrochloride and Fluticasone Propionate 2 doses on each nose (total dose of 548 μg Azelastine hydrochloride and 200 μg fluticasone propionate), peak in plasma (cmax) of Azelastine is 194.5 ± 74.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4 ± 3.9 PG/ml; The area under the curve (AUC) average of Azelastine is 4217 ± 2618 PG.H.H.H. and 97.7 ± 43.1 PG.H.1 for Fluticasone. The average time to achieve the peak concentration (TMAX) from a single dose is 0.5 hours for Azelastine and 1.0 hours for Fluticasone.

Fluticasone's whole body bioavailability in a spray mixture (containing Azelastine Hydrochloride and Fluticasone Propionate) is about 50% higher than that of Fluticasone Propionate nasal spray. The whole body of Azelastine from the form of nasal spray (combination of Fluticasone Propionate and Azelastine Hydrochoride) is equivalent to the single therapy of Azelastine Hydrochloride. There is no evidence of pharmacokinetic interaction between Azelastine Hydrochloride and Fluticasone Propionate.

Distribution

Fluticasone Propionate has a large distribution, in a stable state (about 318 liters). Linking with an average plasma protein is about 91%.

Large distribution of azelastine, distributed mainly into peripherals. Linking with plasma proteins is about 80 - 90%. In addition, both Fluticasone Propionate and Azelastine Hydrochloride have wide treatment limits. Therefore, drug interactions are unlikely.

Metabolism

Fluticasone propionate quickly transformed from the circulatory system, mainly through the liver transformation path by the Cytochrome P450 enzyme CYP3A4 enzyme produces inactive carboxylic acid metabolites. The Fluticasone Propionate part is swallowed as an extended step object. Azelastine is converted into N-Desmethylazelastine through different isenzymes CYP, mainly CYP3A4, CYP2D6 and CYP2C19.

Elimination

Fluticasone propionate's excretion rate after intravenous injection is linearly between the dose of 250 - 1000 μg and is characterized by high plasma clearance (Cl = 1.1 l/min). The peak concentration of plasma decreased by about 98% within 3-4 hours and the sale time was 7.8 hours. The kidney clearance of fluticasone propionate is negligible ( After using a single dose of Azelastine Hydrochloride, Azelastine's waste sale time and N -Desmethyl Azelastine metabolites are about 20-25 hours and 45 hours, respectively. Azelastine Hydrochloride is excreted mainly in feces. The excretion of a small amount of drugs found in the feces shows that the diverges can occur.

Before taking Meseca Fort Merap nasal spray for allergic rhinitis (60 doses)

How to use

only use nasal spray. Do not spray into the eyes or mouth.

Shake thoroughly before use.

Before using for the first time, spray must be removed until the fog appears uniformly. When not using more than 14 days from the previous use, you should remove 1 dose of spray or until the fog is collected homogeneous.

Avoid spraying your eyes. If sprayed in the eyes, wash your eyes with water for at least 10 minutes.

Nasal spray process includes the following steps:

Clean nose.

Open the protective lid. Place the top of the spray of the vial in the nostrils, press the head in the direction of the arrow and pump according to the specified dose. Similarly to the other nose. Rinse the spray head and protective lid with warm water. Let completely dry in the air before reinstalling.

Dosage

1 dose of spray on the nose, 2 times/day, in the morning and evening

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? There is no data from patients available in terms of overdose or chronic with fluticasone propionate nasal spray.

The use of doses higher than the dose for a long time can lead to temporary inhibition of adrenal function. In these patients, Meseca Fort should be treated with sufficient doses to control the symptoms of adrenal function to recover for a few days and can be verified by measuring plasma cortisol.

Handling

There may be central neurological disorders (including drowsiness, confusion, coma, tachycardia and hypotension) caused by Azelastine Hydrochloride when the patient takes the wrong drug.

Treatment of these disorders must treat symptoms. Depending on the amount of swallow, it is recommended to wash the stomach. There is no specific antidote.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Meseca Fort often has unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache, unpleasant taste.

Respiratory, chest, mediastinum: nosebleeds.

Uncommon, 1/1000

Respiratory, chest, mediastinum: uncomfortable in the nose (including stimulating nose, aches, itching), sneezing, dry nose, cough, dry throat, sore throat.

Rare, 1/10,000

Digestive: dry mouth.

Very rare, ADR

Neurological: dizziness, drowsiness.

immunity: Hypersensitivity includes anaphylactic reaction, angioedema (face or tongue and skin rash), bronchospasm.

Eye: glaucoma, cataract.

Respiratory, chest, mediastinum: Perforation of the nasal septum, ulcerative nasal mucosa.

digestive: nausea.

tissue and subcutaneous tissues: rash, itching, urticaria.

Systemic and at the position of use: fatigue, exhaustion.

Instructions on how to handle ADR

If the mucosa is irritated, the nasal mucosa is dry, or the mucosal congestion reaction, it should stop using the drug or reduce the number of use and notify the doctor.

In the case of candidiasis infection in the nose and/or throat (a white coating appears on the tongue, inside the nose, blisters, ulcers or smelled breaths ..) when using Meseca Fort for a few months or longer: Stop drugs, consult a doctor for appropriate treatment. Using Meseca Fort for a long time, there should be periodic testing of fungal infection or other signs of unwanted effects on the nasal mucosa.

Go to the medical facility immediately if there is any of the following symptoms: swelling of the face, lips, tongue or throat that can make it difficult to swallow, wheeze and suddenly have a skin rash. This may be a sign of a serious allergic reaction. Please note: This is a very rare symptom.

If drowsiness occurs, dizziness, must stop using the drug when driving, operating machinery

Warnings

Contraindicated

contraindicated drugs for patients with a history of allergies to Azelastine Hydrochloride, Fluticasone Propionate or any ingredient of the drug.

Be cautious when using

should avoid simultaneous use of Meseca Fort nasal spray with alcoholic beverages or other central nervous system inhibitors such as colds, allergies or sedatives, analgesics with anesthesia, sleeping pills, muscle relaxants, epilepsy drugs, depression, anxiety. Because this can reduce alertness and further decrease in the activity of the central nervous system.

Concentrated with oral antihistamine is likely to lead to serious harmful effects in children. The drug should be out of reach of children.

When clinical trials for 2 - 52 weeks, nosebleeds appear more often in patients treating drug chaos compared to placebo users. Cases of nasal ulcers and nasal septum have been reported in patients when using nasal spray preparations containing corticosteroids.

However, there are no cases of nasal ulcers or puncture nasal walls reported in clinical trials with drugs containing azelastine hydrochloride and fluticasone propionate. Because corticosteroid inhibits wound healing, people who have just had nose ulcer, nose surgery or nose injury should not use Meseca Fort until healing.

In clinical trials with Fluticasone Propionate using nasal sugar, the development of Candida Albicans infection at the nose and throat has occurred. When an infection is developed, it is necessary to apply appropriate local treatment and stop treatment with Meseca Fort. Patients using Meseca Fort for several months or longer should have periodic examination of candidiasis or other signs of unwanted effects on the nasal mucosa.

Corticosteroids and inhalation can lead to the growth of glaucoma and/or cataracts. Therefore, it is necessary to closely monitor in patients with vision changes or a history of glaucoma, glaucoma, and/or cataracts.

Be cautious when using corticosteroids for hidden tuberculosis or respiratory activity. No treatment when infections of fungal or bacteria in place or whole body; Virus infections or systemic parasites, herpes Simplex infection because of the worsening risks of infections.

When steroid sprays are used at a higher dosage than the recommended dose or in people who are sensitive to recommended doses, body corticosteroid effects such as adrenal energy and adrenal inhibition may appear. If such a case occurs, the dosage of Meseca Fort should be slowly reduced, suitable for the process of stopping oral corticosteroid. The simultaneous use of nasal corticosteroids with other inhaled corticosteroids may increase the risk of signs or symptoms of adrenal energy and/or inhibit the pituitary-rooting axis.

The replacement of a whole corticosteroid with a local corticosteroid may be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms, such as joint pain and/or muscle pain, fatigue and depression. The previous patient has been treated for a long time with systemic corticosteroids and switched to local corticosteroids, so they should be carefully monitored in acute adrenal failure in the reaction with stress. In patients with asthma or patients who need long -term corticosteroid treatment, reducing the body corticosteroids too quickly can cause serious symptoms of acute adrenal failure.

Meseca Fort contains benzalkonium chloride: can irritate the nasal mucosa and bronchospasm. Notify your doctor if you feel uncomfortable when using the drug.

The ability to drive and operate machinery

In clinical trials, drowsiness is reported in some patients treated with drug chaos. Therefore, you should use Meseca Fort carefully when driving or operating machinery.

Pregnancy

There is no adequate and well -controlled clinical research of nasal spray combined with Azelastine Hydrochloride and Fluticasone Propionate, Fluticasone Propionate or Azelastine Hydrochloride in pregnant women. Meseca Fort nasal spray is only used during pregnancy if the benefits are superior to the risk of the fetus.

The period of breastfeeding

is not sure whether Meseca Fort is excreted in breast milk or not. Because many drugs can be through breast milk, it is cautious when using Meseca Fort for breastfeeding women.

Medicinal interaction

simultaneous use of Meseca Fort with alcoholic beverages or with other central economic inhibitors that can reduce alertness and increase inhibition of the activity of the central nervous system.

ritonavir: simultaneously use Fluticasone Propionate with a powerful CYP3A4 inhibitor like Ritonavir is not recommended.

Be careful when using Meseca Fort with other powerful CYP3A4 inhibitors. In drug interaction study, shared Fluticasone Propionate by inhaling line (1000 PG) and ketoconazole (200 mg, 1 time/day), increasing the contact of Fluticasone Propionate with plasma, reducing the area under the curve (AUC) plasma cortisol, but no influence on urine excretion.

Storage

Store in dry places, under 30 ° C, avoid direct light. Not frozen.

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