Composition, form of production and packaging
Aerosol for inhalation dosage 1 dose
nedocromil sodium 2 mg
[PRING] povidone K30, levomenthol, macrogol (polyethylene glycol) 600, propellant HFA-227.
112 doses - aerosol aluminum cylinders with dosing device (1) - packs of cardboard (complete with synchronizer).
112 doses - aerosol aluminum cylinders with dosing device (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Tailed Mint refers to anti-allergic drugs. The active substance in this preparation is nedocromil. When systematically applied, it reduces the symptoms of allergic inflammation in the respiratory system. Nedocromil is a stabilizer of the membranes of mast cells, inhibits both early and late stages of the allergic reaction, preventing degranulacin from mast cells and secreting inflammatory mediators (histamine, bradiknin, slowly reacting substance, leukotrienes, prostaglandin D2) from them. Due to these properties, Tileed Mint warns of bronchospasm caused by contact with an allergen or other provoking factor (cold air, physical stress, stress). In patients with bronchial asthma, Nedocromilum suppresses antigen-induced allergic reactions of immediate and delayed types, and also reduces the hyperreactivity of the bronchi. With topical application at the level of the bronchial tree has anti-inflammatory effect. Prolonged 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. It 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%), therefore, nedocromil, which is determined in the plasma after inhalation, mainly enters there as a result of absorption from the respiratory tract. C max nedocromil is reached after about 60 min, and its half-life is 1-2 hours. Nedocromil is moderately (up to 89%) and reversibly binds to plasma proteins in humans. Nedocromyl is not metabolized. It is excreted unchanged in the urine (approximately 70%) and with feces (approximately 30%).
INDICATIONS
- treatment and prevention of bronchial asthma (of various origins, including asthma of physical effort);
- bronchospastic syndrome (caused by a number of stimuli: cold air, inhaled allergens, atmospheric pollution) in children older than 2 years and adults.
Tileed Mint can also be additionally assigned to all existing treatments for bronchial asthma.
DOSING MODE
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 / 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 / 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 / day. Additional intake of the drug in the form of two inhalations (4 mg) can be done once before physical exertion to prevent physical asthma or before contact with suspected allergens. Do not exceed the daily dose of the drug, which is 8 inhalations.
The therapeutic effect develops by the end of the first week.
In the event that the use of a bronchodilator is simultaneously prescribed, it is recommended that it be used before use by Thayled Mint.
The addition of Tileed Mint to the treatment of patients receiving SCS may allow a reduction in the maintenance dose of GCS or abolish them completely. When reducing the dose of steroids, strict observation of the patient is necessary; a weekly dose reduction of 10% is suggested. If a decrease in the dose of GCS is impossible, then you can not cancel Tileed Mint until the SCS cover is restored.
Use of the inhaler
At the first use, shake the inhaler and press 4 times on the dosing valve (idle). In case the inhaler has not been used for 7 days or more, it is necessary to bring it into working state by pressing twice on the dosing 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 far as possible.
The plastic body of the inhaler should be washed and thoroughly dried at least once every three days.
After inhalation, always cover the mouthpiece with a dust cap.
Care instructions
To prevent blockage of the mouthpiece mouthpiece with powder particles, the plastic body of the inhaler should be cleaned. At least every 3 days, it must be washed and left to dry for the night. The plastic housing is cleaned as follows:
1. Remove the plastic dust cap and pull out the metal can from the plastic device.
2. Thoroughly rinse the plastic device under a stream of hot, running water (+ 45 В° C) for 1 minute.
3. Turn the plastic device over and rinse it from the other end under a stream of hot running water for 1 minute.
4. Shake out the moisture from the plastic device, tapping it against a hard surface.
5. Leave the plastic device to dry for the night. If the package contains two devices, then to ensure their cleanliness and dryness, use them alternately.
6. Insert the metal can into the plastic case, making sure that it is completely dry, and the rubber ring is tightly wrapped around the metal can.
If the spray outlet from the inhaler is blocked, remove the dust cap, remove the metal canister (see step 1) and place the plastic housing in hot water for 20 minutes.Then perform the actions described in paragraphs 2-6 above.
Before using the inhaler, always make sure that the plastic housing is completely dry. Do not attempt to clean the inhaler outlet with a needle or a sharp object. this will lead to damage to the inhaler. Do not put a metal canister in the water and do not remove the rubber ring from it.
SIDE EFFECT
On the part of the respiratory system: irritation and possible infection of the upper respiratory tract, irritation of throat, pharyngitis, dry mouth, hoarseness, cough, short-term bronchospasm, rhinitis.
From the side of the central nervous system: headaches and dizziness.
On the part of the digestive system: unpleasant taste in the oral cavity, nausea, vomiting, pain in the epigastric region.
CONTRAINDICATIONS
- I trimester of pregnancy;
- 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
The drug can be given to pregnant women only in case of absolute necessity in the II and III trimesters of pregnancy.
Nedocromil in small amounts penetrates into breast milk, so it is recommended to stop breastfeeding when it is necessary to prescribe the drug.
Nedocromil can be prescribed by a doctor only when the expected benefit for a pregnant woman exceeds the possible risk to the fetus.
APPLICATION FOR CHILDREN
Contraindicated in children under 2 years.
SPECIAL INSTRUCTIONS
It is very important that patients, who are helped by Tileed Mint, apply it regularly, every day, even if they have no symptoms. Patients should also be warned that, due to the fact that several doses may be required to obtain a beneficial effect, relief may not occur immediately, and it may take several weeks to obtain the effect.
As with any inhalation therapy, immediately after inhalation, bronchospasm may suddenly develop. This condition requires immediate treatment with a short-acting inhaled bronchodilator and should immediately seek emergency medical attention. Therapy Tileed Mint should immediately stop and begin alternative treatment.
In the case of repetitive bronchospasm, the bronchodilator is pre-inhaled, and the cough is soothed by the intake of water immediately after inhalation.
If there is a need for drug cancellation, it should be done gradually, within one week, with the possible restoration of asthma symptoms.
For the relief of acute attacks of bronchial asthma, the drug is not intended.
Protect from direct sunlight. Do not store in the refrigerator and do not freeze.
OVERDOSE
Tailed Mint has low toxicity, so the risk of overdose and the development of any toxic phenomena is small. There were no cases of overdose.
DRUG INTERACTION
There were no interactions with Tileed Mint.
Tyled Mint can be used with many medications, including beta-adrenostimulators, glucocorticosteroids, theophylline and other methylxanthines, ipratropium bromide.
With concomitant therapy with bronchodilators, they must be taken before inhalation by Thayled Mint.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. At a temperature not higher than 30 В° C. Keep out of the reach of children. Shelf life - 2 years.
