Expiration date: 09/2025
The composition and form of issue:
Powder for inhalations dosed. 1 dose contains
active substance:
formoterol fumarate dihydrate 4,5 or 9 micrograms
excipients: lactose monohydrate
in Turbuhaler inhaler 60 doses (consists of a metering device, a reservoir for storing powder, the container dessicant, mouthpiece, screw cover, lower rotating coloured disc) in the paper cartons 1 PC.
Description pharmaceutical form:
Plastic inhaler. The color of the rotating disk for the dosage of 4.5 µg/dose of bright greenish blue, for the dose of 9 µg/dose of dark greenish blue.
The contents of the inhaler — rounded granules from white to almost white, disintegrating into fine powder at low pressure. Perhaps the content of the powdery fraction.
Indications:
- In addition to corticosteroid therapy:
- for regular maintenance therapy of bronchial asthma
- cupping bronchospasm
- to prevent attacks caused by exercise.
In chronic obstructive pulmonary disease (COPD) for the prevention and treatment of broncho-obstructive symptoms.
Contraindications:
hypersensitivity to formoterol or to lactose
children up to 6 years.
Caution: to be prescribed to patients with thyrotoxicosis, pheochromocytoma, diabetes, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular diseases (e.g. ischemic heart disease, tachyarrhythmia or severe heart failure).
Care is needed not to prescribe the drug to patients, which is determined by the lengthening of the QTc interval, and patients taking the drug can affect the duration of the QTc-interval.
You should be very careful when exacerbation of severe asthma as the risk of development of hypokalemia may worsen hypoxia.
Application of pregnancy and breast-feeding:
Clinical experience with the drug in pregnant women is limited. In the experimental animals marked rejection of the implant, and reducing the lifespan of the offspring in the early postnatal period and decreased body weight at birth. These effects were observed at systemic exposures significantly in excess of the exposure achieved when using clinical doses of the drug.
Bronchial asthma is a potentially dangerous disease, therefore, during pregnancy should be control its symptoms. If necessary, provide control over bronchial asthma Oxis Turbuhaler can be applied at all stages of pregnancy (see section "Method of application and dosage"). However, just like any other drugs, the decision on the appointment of the drug during pregnancy can only be made in the case when the expected benefits to the mother outweighs any potential risk to the fetus.
It is not known whether formoterol penetrates the breast milk of women.
In experiments on laboratory animals (rats) have shown the presence of small amounts of formoterol in human milk.
The decision on the appointment of the Oxis Turbuhaler women during breast-feeding is accepted in the case when expected benefit for mother exceeds any possible risk to the child.
Side effects:
Common (>1/100)
CNS: headache.
From the CCC: palpitations.
From the musculoskeletal: tremor.
Rare (<1/100)
CNS: agitation, anxiety, sleep disturbance.
From the side of musculoskeletal system: muscle cramps.
From the CCC: palpitations, change in blood pressure.
Very rare (<1/1000)
The skin: rash, hives, itching.
From the CCC: atrial fibrillation, supraventricular tachycardia, arrythmia.
Metabolic disorders: hypokalemia/hyperkalemia.
From the respiratory: bronchospasm.
Tremor and palpitations are temporary and are in the process of treatment. As with any inhaled therapy in very rare cases may develop paradoxical bronchospasm.
Described isolated cases of the following side effects: nausea, taste disturbance, dizziness, angina pectoris, prolongation of QTc interval, hypersensitivity reactions, changes blood pressure and hyperglycemia.
Application &beta2 - sympathomimetics may result in increased blood levels of insulin, free fatty acids, glycerol and ketone.
Method of application and dose:
Inhalation
4,5 µg/dose
Adults.
The normal dosage is 1 or 2 inhalations of 1 or 2 times a day. The dose can ingalirovti in the morning and/or evening. Some patients may need 4 inhalations 1 or 2 times a day. The maximum daily dose for regular maintenance therapy is 8 inhalations. If necessary, additional inhalations, more than recommended for the regular maintenance therapy may be taken by a patient for relief of attacks of bronchial spasm up to maximum daily dose, which is 12 inhalations (maintenance dose plus the dose taken as needed). It is not recommended to take more than 6 doses (inhalation) drug for the relief of one attack. Need to use a drug more than 2 times a day, and/or use of doses higher than recommended as normal maintenance therapy more often than 2 days a week, is the criterion of insufficient control of the disease and the treatment regimen should be revised.
In the presence of nocturnal symptoms of asthma, the recommended dose of the drug can be taken 1 time at night. The duration of action of the drug is about 12 hours
The selection of dosage it is necessary to aspire to appointment of the minimum effective dose.
COPD. The normal dosage is 2 inhalations of 1 or 2 times a day. The maximum daily dose for regular maintenance therapy is 4 inhalations.
If necessary, additional inhalations, more than recommended for the regular maintenance therapy may be made by the patient for the relief of broncho-obstructive symptoms, up to a maximum total daily dose, which is 8 inhalations (maintenance dose plus the dose taken as needed). It is not recommended to vaporize more than 4 doses in one go. Need to use a drug more than 2 times a day, and/or use of doses higher than recommended as normal maintenance therapy more often than 2 days a week, is the criterion of insufficient control of the disease and the treatment regimen should be revised.
Prevention of asthma attacks caused by exercise. 2 inhalations before exercise. Do not exceed the maximum daily dose.
Children 6 years and older.
The normal dosage is 2 inhalations of 1 or 2 times a day. Should not be more than 4 inhalations a day.
Prevention of asthma attacks caused by exercise. 2 inhalations before exercise. Do not exceed the maximum daily dose.
9 µg/dose
Adults.
The normal dosage is 1 inhalation 1 or 2 times a day. Dose (inhalation) drug can be taken in the morning or evening. Some patients may need 2 inhalations of 1 or 2 times a day. The daily dose for regular maintenance therapy is 4 inhalations. If necessary, additional inhalations, more than recommended for the regular maintenance therapy may be made by a patient for relief of attacks of bronchial spasm up to maximum daily dose, which is 6 inhalations (maintenance dose plus the dose taken as needed). It is not recommended to take more than 3 doses (inhalation) drug for the relief of one attack. Need to use a drug more than 2 times a day, and/or use of doses higher than recommended as normal maintenance therapy more often than 2 days a week, is the criterion of insufficient control of the disease and the treatment regimen should be revised.
In the presence of nocturnal symptoms of asthma the dose of the drug can be taken at a time at night. The duration of action of the drug is about 12 hours
The selection of dosage it is necessary to aspire to appointment of the minimum effective dose.
COPD. The normal dosage is 1 inhalation 1 or 2 times a day. The maximum daily dose for regular maintenance therapy is 2 inhalations. If necessary, additional inhalations, more than recommended for the regular maintenance therapy may be taken by a patient for relief of broncho-obstructive symptoms, up to a maximum total daily dose which is 4 inhalations (dose plus maintenance dose taken as needed). Not recommended to be inhaled more than 2 doses at one time. Frequent use of the drug (more than 2 times per day and/or more often 2 days a week), over recommended for regular maintenance therapy, indicates insufficient control of the disease and the need for revision of treatment regimens.
Prevention of asthma attacks caused by exercise. 1 inhalation before exercise. Do not exceed the maximum daily dose.
Children 6 years and older.
The normal dosage is 1 inhalation 1 or 2 times a day. Should not more 2 inhalations per day.
Prevention of asthma attacks caused by exercise. 1 inhalation before exercise. Do not exceed the maximum daily dose.
Special groups of patients. Does not require special dose adjustment in elderly patients and in patients with impaired renal function or liver the appointment of the recommended normal doses of the drug (see "Special instructions").
Overdose:
Clinical experience of treatment in case of overdose is absent. It is most likely that the overdose would show symptoms typical of other &beta2-agonists: tremor, headache, palpitations. In some cases, reported on the development of tachycardia, hyperglycemia, hypokalemia, prolongation of QTc interval, arrhythmia, nausea and vomiting. Symptomatic and supportive treatment.
Perhaps the appointment of cardioselective &beta-blockers, but it must be done with great caution, because the appointment blockers &beta-adrenergic receptors may precipitate bronchospasm. In this case it is necessary to control the level of potassium in the blood serum.
Special instructions:
The formoterol contained in the drug gets into the patient's airway with the flow of air when performing active breath through the mouthpiece Turbuhaler.
It is important to instruct the patient to hold a strong and deep breath through the mouthpiece Turbuhalera to guarantee getting the optimal dose of the drug in the respiratory tract.
It is also important to instruct the patient never to chew and not to chew on the mouthpiece, do not use Turbuhaler in the event of damage to the mouthpiece or disconnection of the mouthpiece from the body Turbuhalera.
The patient may not taste or feel the medication after using the Oxis Turbuhalera that due to the small number of the delivered material.
Patients suffering from bronchial asthma and regularly taking &beta2-agonists, should receive optimal anti-inflammatory therapy with corticosteroids. Should encourage patients to continue anti-inflammatory therapy even in cases where after the application of Oxis Turbuhaler comes improvement. Preservation of symptoms or the occurrence of the need to increase the dosage &beta2-agonists is a sign of deterioration in the patient's condition and requires a revision of anti-asthma treatment. You should not start treatment with the drug and increase its dose in case of severe exacerbation of the disease.
Do not exceed the maximum daily dose. There are no data on safety during prolonged constant use of the drug in higher doses, such as 36 micrograms per day in adults and 18 micrograms per day in children with asthma and 18 micrograms per day in patients with COPD.
Frequent use of the drug to prevent symptoms of asthma caused by physical activity, may indicate inadequate control of the disease and could lead to a revision of the used treatment regimens, and to evaluate the level of commitment of the patient to compliance with applicable regimens. If the need for prevention of symptoms of bronchial asthma, caused by physical activity, occurs several times in one week on the background of adequate maintenance therapy (corticosteroids and beta2-agonists long-acting), it is necessary to revise the current scheme of treatment specialist.
In patients with diabetes, early treatment should be to control the blood glucose level, as &beta2-agonists have hypoglycemic effect.
As a result of applying &beta2-agonists may potentially develop severe hypokalemia. You should be very careful when exacerbation of severe asthma as the risk of development of hypokalemia may worsen hypoxia. Hypokalemia may be exacerbated by concomitant therapy xantinove derivatives, steroids and diuretics. In these cases, it is necessary to control the level of potassium in the blood serum.
Also as with other inhalation therapy, it is necessary to consider the possibility of paradoxical bronchospasm.
Children under 6 years should not receive the drug treatment, because little information is available for this age group.
The liver and kidneys. Effect on the pharmacokinetics of formoterol reduced kidney function or liver, and pharmacokinetics in elderly patients is not described. Because formoterol is excreted from the body as a result of metabolism, in patients with severe cirrhosis of the liver, one should expect a slower elimination of the drug.
Delivered dose contains lactose 450 micrograms (corresponding to 600 micrograms per measured dose). This amount usually does not cause problems in people with lactose intolerance.
How to use Oxis Turbuhaler
Turbuhaler is a multidose inhaler, allow the mixture and inhale the drug in very small doses. When the patient inhales, the powder of Turbuhaler is delivered to the lungs. It is therefore important that the patient strongly and deeply inhaled through the mouthpiece.
Turbuhaler very easy to use. Just follow the instructions below:
1. Unscrew and remove the cap.
2. Keep the inhaler upright with the spout down. To load in inhaler dose by rotating the dispenser until it stops, and then returning it to its original position.
3. Exhale. Do not exhale through the mouthpiece. Before you exhale, remove inhaler from the mouth.
4. Gently squeeze the mouthpiece with your teeth, compressed lips and breathe deeply and strongly through the mouth. The mouthpiece should not be chewed and strong gripping teeth.
5. If you want to inhalation of more than one dose, repeat steps 2-5.
6. Close the inhaler cap.
7. Rinse your mouth with water.
IMPORTANT!
Never exhale through the mouthpiece. Always close the inhaler cap after use.
Since the amount of the inhaled powder is very small, the patient may not taste the powder after inhalation. However, if he followed the instructions, you can be sure that inhaled the dose of the drug.
Cleaning
Regularly (once a week) you should clean the mouthpiece on the outside with a dry cloth.
Do not use water or other liquids to clean the mouthpiece.
How to know inhaler empty?
The appearance in the window of the dose indicator red mark means that the inhaler is approximately 20 doses. The inhaler is empty when the red mark reaches the lower edge of the window of the dose indicator.
The sound that you hear when shaking the inhaler is drying agent, not a cure.
Effects on ability to drive or other mechanisms. Oxis Turbuhaler does not affect the ability to drive and operate machinery.
Incompatibility. Missing.
Review:
Before using the drug you must read the instructions for use.
Storage conditions:
Turbuhaler after applying to store with tightly closed cap.
