Tileed Mint - instructions for use, doses, side effects, contraindications

Active substanceNedocromilNedocromil

Similar drugsTo uncover

Tyleed® Mint

aerosol d / inhal.

Aventis Pharma Co., Ltd. India

Dosage form: & nbspAerosol for inhalation dosed.

Composition:

Each dose of Tileed® Mint contains:

active substance: nedokromil sodium (micronized, dried, in terms of dry matter) - 2 mg;

Excipients: povidone K30 - 0.0355 mg, levomentol - 0.0710 mg, macrogol (polyethylene glycol) 600 - 0.4260 mg, hydrofluoroalkane (HFA-227) to 142.00 mg.

Description:Aluminum balloon with dosing outlet valve.

The contents of the balloon after evaporation of the propellant is a yellow powder.

Pharmacotherapeutic group:antiallergic agent - stabilizer of mast cell membranes

ATX: & nbsp

S.01.G.X Other antiallergic drugs

S.01.G.X.04 Nedocromil

Pharmacodynamics:

Tailed Mint refers to anti-allergic agents. The active substance in this preparation is undershot. When systematically applied, it reduces the symptoms of allergic inflammation in the respiratory system.

Nedocromil is a stabilizer of the membranes of mast cells, which inhibits both early and late stages of the allergic reaction, preventing the degranulation of mast cells and the release of inflammatory mediators (histamine, bradykinin, slowly reacting substance, leukotrienes,prostaglandin D 2, etc.) and prevents the release of eicosanoids from mast cells. Nedocromil suppresses the chemotactic activity of eosinophils and neutrophils and the release of cytokines from alveolar macrophages, bronchial epithelium and mast cells, and the activation of sensory nerves in the isolated bronchial muscle resulting in the development of bronchospasm.

In animal models undershot inhibited antigen-induced bronchospasm, edema of the respiratory tract, late stage of the allergic reaction, bronchial hyperreactivity caused by antigens, and cough caused by citric acid. In addition, he inhibited the bronchial hyperreactivity caused by exposure to nonspecific factors, such as cigarette smoke and sulfur dioxide. Also, when undershot was used after the development of early asthmatic reactions, he suppressed late asthmatic reactions and hyperreactivity of the bronchi.

In patients with bronchial asthma undershot also suppresses the antigen-induced intermediate and late allergic reactions and reduces the hyperreactivity of the bronchi, it is also able to suppress the late allergic reaction when it is taken after an early allergic reaction. Besides undershot sodium prevents the development of bronchospasm caused by nonspecific factors, such as physical stress, fog, cold air, adenosine and sulfur dioxide. The release of histamine into the lumen of the bronchi after provocation with antigen or a hyperosmotic sodium chloride solution in the treatment of nedocromil sodium is significantly reduced. The anti-inflammatory effects of the drug in patients with bronchial asthma are also associated with its ability to inhibit the antigen-induced intake of eosinophils into the bronchus lumen and reduce the number of activated eosinophils in the submucosal layer of the bronchi (after 16 weeks of treatment).

Due to these properties, Tileed® Mint prevents the development of bronchospasm caused by contact with an allergen or other provoking factor (cold air, physical stress, stress). When applied locally at the level of the bronchial tree, it has an anti-inflammatory effect. Long-term continuous use reduces the hyperreactivity of the bronchi, improves respiratory function, reduces the intensity and frequency of attacks of suffocation and the severity of cough.The drug is more effective in light and moderate forms of asthma. At admission, nighttime symptoms decrease and the need for a daily appointment of bronchodilators is reduced. The therapeutic effect develops by the end of the first week.

Pharmacokinetics:

After administration by inhalation, about 10% of the dose enters the respiratory tract, and the remainder settles in the oral cavity or nasopharynx and then swallowed. However, the absorption of nedocromil from the gastrointestinal tract is low (about 2%), so it is determined in the plasma after inhalation undershot mainly comes there as a result of absorption from the respiratory tract. The maximum plasma concentration of nedocromil is reached in about 60 minutes, and its half-life is 1-2 hours. Nedocromil moderately (up to 89%) and reversibly binds to plasma proteins in humans. Nedocromil not metabolized. It is excreted unchanged by the kidneys (approximately 70%) and through the intestine (approximately 30%).

The pharmacodynamic profile of nedocromil sodium in patients with bronchial asthma is similar to that of healthy volunteers.

Indications:

Treatment and prevention of bronchial asthma (of various origins, including asthmatic bronchitis, asthma of physical effort); bronchospastic syndrome caused by a number of stimuli: cold air, inhaled allergens, atmospheric pollution or other irritants) in children older than 2 years and adults.

Tileed® Mint can also be used in addition to all existing treatments for bronchial asthma.

Contraindications:

Hypersensitivity to any of the components of the drug.

The drug should not be administered to children under 2 years of age.

Pregnancy and lactation:

Studies conducted with nedocromil of sodium in pregnant and lactating animals did not reveal an adverse effect on the course of pregnancy, the development of fetuses and calves. However, as with any medication, caution should be exercised when using the drug during pregnancy, especially during the first trimester. The drug can be used in pregnant women only in case of urgent need, when the expected benefit for a pregnant woman exceeds the possible risk to the fetus.

Nedokromil sodium in small amounts penetrates into breast milk. There is no evidence to support the fact that undershot Sodium has an adverse effect on the infant while taking the drug by his mother during the period of breastfeeding.

Dosing and Administration:

The drug is designed for regular daily use.

The drug is not intended for arresting an acute bronchospastic attack.

Adults (including the elderly) and children older than 2 years

The recommended dose of Tileed® Mint is 2 inhalations 2-4 times a day. When the control over the symptoms is achieved, the dose is gradually reduced to a supporting dose. The usual maintenance dose of the drug is 2 inhalations 2 times a day.

In severe cases, as well as with a high concentration of allergens, the dose of the drug can be increased to two inhalations 4 times a day.

Preparation Tileed Mint in the form of two inhalations (4 mg) once, held a few minutes before the impact of the triggering bronchospasm factors can provide within a few hours of protection from the development of bronchospasm,caused by physical exertion (with asthma physical effort), cold air, as well as inhaled allergens, atmospheric pollution and other irritants.

Do not exceed the daily dose of the drug, which is 8 inhalations. The therapeutic effect develops by the end of the first week.

Simultaneous bronchodilator therapy

In the event that the bronchodilator is used simultaneously, it is recommended to apply it before applying Tileed® Mint.

Simultaneous therapy with corticosteroids

The addition of Tileed® Mint to the treatment of patients receiving glucocorticosteroids may allow a reduction in the maintenance dose of glucocorticosteroids or completely eliminate them. When reducing the dose of glucocorticosteroids, strict observation of the patient is necessary; a weekly dose reduction of 10% is suggested. If a decrease in the dose of glucocorticosteroids is not possible, then you can not cancel Tileed® Mint until the "cover" of glucocorticosteroids is restored.

Use of the inhaler

At the first use, shake the inhaler and press 4 times on the dosing valve (idle).In the event that the inhaler has not been used for 3 days or more, it is necessary to bring it into operation by pressing twice on the metering valve (idling).

When inhaling, follow the instructions below.

Remove the dust cap. Inspect the inner and outer surfaces of the plastic housing of the inhaler to make sure they are clean. Vigorously shake the inhaler.

Hold the inhaler vertically, placing your thumb on the base of the can. Make the fullest exhalation, then insert the mouthpiece into the mouth between the teeth (without biting it) and tightly grasp your lips.

Starting to inhale air through the mouth, press the base of the canister so as to spray the dose of Tileed® Mint; simultaneously continue a calm and deep breath.

After holding your breath, take the inhaler out of your mouth. Continue to hold your breath as long as possible.

The plastic body of the inhaler should be washed and thoroughly dried at least once every three days (see the Instructions for cleaning the inhaler).

After inhalation, always cover the mouthpiece with a dust cap.

Children and patients with difficulty in coordinating the pressure on the dosing deviceand holding an inhalation to facilitate the use of the drug, it may be beneficial to use an aerosol-holding camera.

A standard mouthpiece (but not a synchromesh), suitable for use with a large number of aerosol holding chambers.

Instructions for cleaning the inhaler

It is very important to keep the plastic mouthpiece clean to prevent the accumulation of excess amount of the drug, which will then be difficult to remove and which can block the inhaler.

The plastic mouthpiece should be regularly cleaned and allowed to dry overnight every three days from the beginning of use of the inhaler.

Standard inhaler

Cleaning the mouthpiece

1. Remove the plastic cap to protect it from dust and remove the metal can from the mouthpiece before cleaning it.

2. Rinse the plastic mouthpiece through the top for 1 minute with hot tap water (about 45 ° C).

3. Rinse the plastic mouthpiece on the other side for one minute with hot tap water (about 45 ° C).

4. Shake out the remaining water from the inside of the mouthpiece, touching the mouthpiece against a hard surface from the side where it attaches to the outlet of the metal can.

5. Leave the plastic balloon dry for the whole night.

6. Make sure that the plastic mouthpiece is completely dry before connecting it to the metal can and that the white rubber coating is pressed tightly to the metal can.

IMPORTANT: If the inhaler is clogged, remove the plastic cap that protects against dust, disconnect (as in step 1) and soak the plastic mouthpiece in hot water for 20 minutes. Then repeat steps 2-6. Always check that the mouthpiece has been completely dried.

Never attempt to unlock the mouthpiece with a needle or sharp object. This will lead to a breakdown in the inhaler. Do not put a metal can in the water.

Do not remove the white rubber coating from the metal can.

Inhaler with Synchronizer

Cleaning the mouthpiece

1. Remove the plastic cap to protect it from dust and remove the metal can from the mouthpiece before cleaning it.

2. Rinse the plastic nozzle casing through the top for 1 minute with hot tap water (approx. 45 ° C).

3. Rinse the plastic mouthpiece on the other side for one minute with hot tap water (about 45 ° C).

4.Shake out the remaining water from the inside of the mouthpiece, touching the mouthpiece against a hard surface from the side where it attaches to the outlet of the metal can.

5. Leave the plastic can to dry for the whole night.

IMPORTANT: If the inhaler is clogged, remove the plastic cap that protects against dust and disconnect (as in step 1) and soak the plastic mouthpiece in hot water for 20 minutes. Then repeat steps 2-5. Always check that the mouthpiece has been completely dried. Never attempt to unlock the mouthpiece with a needle or sharp object. This will lead to a breakdown in the inhaler. Do not put a metal can in the water.

Side effects:

Several side effects have been reported, mainly headache and symptoms from the upper gastrointestinal tract (nausea, vomiting, dyspepsia and abdominal pain). They were usually mild and transitory.

Like other inhalants, Tileed® Mint can cause a cough or bronchospasm.

Perhaps the appearance of unusual or unpleasant taste in the mouth.

Overdose:Studies carried out on animals did not show the presence of toxic effects in nedocromil sodium, even when administered in high doses. A lot of studies conducted in humans have not revealed any adverse effects of the drug. Thus, it is unlikely that an overdose of the drug will cause problems. However, if there is a suspicion of an overdose, treatment should be supportive and aimed at eliminating the emerging symptoms.

Interaction:

Nedocromil sodium was used in combination with a large number of drugs in humans, including oral beta-adrenostimulators, inhalation and oral glucocorticosteroids, theophylline and other methylxanthines, as well as ipaptropium bromide. There were no adverse interactions with Tileed® Mint in either humans or animals.

Special instructions:

The drug is not intended for relief of acute attacks of bronchial asthma. It is very important that patients who are helped with Tileed® Mint use it regularly, every day, even if they do not have symptoms.

Patients should also be warned that, due to the fact that several doses may be required to obtain a favorable effect, relief may not come immediately, and that it may take several weeks to develop the full effect.

As with any inhalation therapy, immediately after inhalation, bronchospasm may suddenly develop. This condition requires immediate treatment with short-acting inhaled bronchodilators. In this case, immediate medical attention should be sought immediately, and Tileed® Mint therapy should be immediately discontinued and alternative treatment initiated.

In the case of recurrent bronchospasm, the bronchodilator is pre-inhaled, and the cough is soothed by the intake of water immediately after inhalation.

Abolition of Tylede therapy® Mint

If there is a need to cancel the drug, it should be done gradually, within one week, with the possible restoration of asthma symptoms.

The drug should be protected from direct sunlight. Do not store in the refrigerator and do not freeze.

Form release / dosage:

Aerosol for inhalation dosed, 2 mg / dose.

Packaging:

The amount of the drug, equal to 112 doses, in an aerosol aluminum canister placed in a dispensing plastic device with a synchronizer or without a synchronizer and a dust cap.

1 bottle with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N 015676/01

Date of registration:27.04.2009 / 02.12.2009

Expiration Date:Unlimited

The owner of the registration certificate:Aventis Pharma Co., Ltd.Aventis Pharma Co., Ltd. India