Description
Release form
Powder for inhalation.
Packaging
Bottle 60 doses.
Pharmacological action
Oksis Turbuhaler – selective beta 2 -adrenomimetic. It has a bronchodilator effect in patients with reversible airway obstruction. After using the drug in a single dose, the therapeutic effect is achieved quickly (after 1-3 minutes) and lasts an average of 12 hours.
Indications
Oxis Turbuhaler is indicated in addition to corticosteroid therapy for regular maintenance treatment of bronchial asthma, for stopping bronchospasm attacks, and for preventing attacks caused by physical exertion. In chronic obstructive pulmonary disease (COPD) for the prevention and treatment of broncho-obstructive symptoms.
Contraindications
Hypersensitivity to formoterol or lactose.
Children under 6 years.
Caution: prescribe the drug to patients with thyrotoxicosis, pheochromocytoma, diabetes, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular diseases, such as coronary heart disease or tachyaritis.
Use in pregnancy and lactation
Clinical experience with the drug in pregnant women is limited. In experimental animals, rejection of the implant was noted, as well as a decrease in the life expectancy of the offspring in the early postnatal period and a decrease in body weight at birth. These effects were observed with systemic exposures significantly higher than those achieved with clinical doses of the drug.
Bronchial asthma is a potentially dangerous disease, and therefore, all symptoms should be controlled during pregnancy. If it is necessary to ensure control of bronchial asthma, Oxis Turbuhaler can be used at all stages of pregnancy (see section “Dosage and administration”). However, as with any other drug, the decision to prescribe the drug during pregnancy can only be made if the expected effect for the mother outweighs any possible risk to the fetus.
It is not known whether formoterol passes into breast milk of women.
In experiments on laboratory animals (rats), the presence of small amounts of formoterol in breast milk has been shown. The decision on the appointment of Oxis Turbuhaler to women during breastfeeding is also made when the expected benefit to the mother outweighs any possible risk to the baby.
Special instructions
Formoterol contained in the preparation enters the patient’s airways along with airflows when an active breath is taken through the mouthpiece of the Turbuhaler. It is important to clearly instruct the patient to take a deep and strong breath through the mouthpiece to ensure that the optimal dose of the drug enters the respiratory tract.
Also, the patient should be instructed never to chew or chew on the mouthpiece, do not use the Turbuhaler if the mouthpiece is damaged or the mouthpiece is disconnected from the Turbuhaler case.
The patient may not feel the taste or feel the drug after using Oksis Turbuhaler, due to the small amount of delivered substance.
It should be borne in mind that patients with bronchial asthma who regularly take beta 2 -adrenomimetics should receive optimal anti-inflammatory therapy with corticosteroids. Patients should be advised to continue anti-inflammatory therapy even in cases when after taking Oksis Turbuhaler improvement occurs. The persistence of symptoms or the need to increase the dose of beta 2 -adrenomimetics is a sign of a deterioration in the patient’s condition and requires a review of anti-asthma therapy.
Do not start treatment with Oksis Turbuhaler and increase its dose in case of exacerbation of the disease.
Do not exceed the maximum daily dose of the drug. There is no safety data for long-term continuous use of the drug at higher doses, such as 36 Ñg / day in adults and 18 Ñg / day in children with bronchial asthma, and 18 Ñg / day in patients with COPD.
Frequent use of the drug for the prevention of symptoms of bronchial asthma caused by physical exertion, may indicate inadequate control over the course of the disease and cause a review of the treatment regimen used, as well as an assessment of the patient’s adherence to compliance with the applicable treatment regimen. If the need for the prevention of symptoms of bronchial asthma caused by physical exertion occurs several times within one week against the background of adequate supportive therapy (GCS, beta 2 -adrenergic agonists, long-term action), then it is necessary to review the current treatment regimen by a specialist.
In diabetes mellitus, the concentration of glucose in the blood should be monitored at the beginning of treatment, since beta 2 -adrenomimetics have a hyperglycemic effect.
As a result of beta 2 -adrenomimetics, severe hypokalemia can potentially develop. Particular care should be taken when exacerbating severe bronchial asthma, because the risk of hypokalemia may increase with hypoxia. Hypokalemia can be aggravated with concomitant therapy with xanthine derivatives, steroids, diuretics. In such cases, it is necessary to control the level of potassium in the blood serum.
As well as when using other inhalation therapy, it is necessary to consider the possibility of developing paradoxical bronchospasm.
The delivered dose of the drug contains 450 mcg of lactose (corresponding to 600 mcg in the measured dose). This amount, as a rule, does not cause problems in people with lactose intolerance.
Application for impaired liver function: No special dose selection is required for patients with impaired liver function when prescribing recommended doses of the drug.
Use for impaired renal function: No special dose selection is required for patients with impaired renal function when prescribing recommended doses of the drug.
Use in pediatrics: Children under 6 years of age should not be prescribed the drug, since there is not enough information for this age group.
Influence on the ability to drive vehicles and control mechanisms: Oksis Turbuhaler does not affect the ability to concentrate and the speed of psychomotor reactions.
Composition
1 dose (delivered) : formoterol fumarate dihydrate 9 mcg
Dosage and administration of
– Adults are prescribed 1 inhalation 1-2 times / day (morning and / or evening). If necessary, appoint 2 inhalations 1-2 times / day. The daily dose of regular maintenance therapy is 4 inhalations.
– Children aged 6 years and over are prescribed 1 inhalation 1-2 times / day. The maximum daily dose is 2 inhalations.
If necessary, additional inhalations in adults, more than recommended for regular maintenance therapy, can be carried out by the patient to stop bronchospasm attacks up to a maximum daily dose of 6 inhalations (maintenance dose + doses taken as needed). The use of more than 3 doses (inhalations) for stopping one attack is not recommended. Frequent use of the drug (more than 2 times / day and / or 2 days a week), more than recommended for regular maintenance therapy, indicates insufficient control of the disease and the need to review the treatment regimen.
If there are nocturnal attacks of bronchial asthma, the recommended dose of the drug can be taken 1 time at night (the duration of the drug is about 12 hours).
When selecting a dose, it is necessary to prescribe the minimum effective dose.
In chronic obstructive pulmonary disease: Prescribe 1 inhalation 1-2 times / day. The maximum daily dose for regular maintenance therapy is 2 inhalations. If necessary, additional inhalations (more than recommended for regular maintenance therapy) can be taken by the patient to relieve bronchial obstructive symptoms up to a maximum total daily dose of 4 inhalations (maintenance dose + doses taken as needed). The use of more than 2 doses of the drug in 1 dose is not recommended. Frequent use of the drug (more than 2 times / day and / or more often 2 days a week), more than recommended for regular maintenance therapy, indicates insufficient control of the disease and the need to review the treatment regimen.
For the prevention of asthma attacks caused by physical exertion: Adults and children 6 years of age and over are prescribed 1 inhalation before physical exertion. Do not exceed the maximum daily dose.
Use in special clinical cases: No special dose selection is required for elderly patients, as well as patients with impaired renal or hepatic function when prescribing recommended doses of the drug.
Side effects
Tremor and heart palpitations are temporary and go away during treatment. As with any inhalation therapy, in very rare cases, the development of paradoxical bronchospasm is possible.
Isolated cases of the following side effects are described: nausea, taste disturbance, dizziness, angina pectoris, prolongation of the QTc interval, hypersensitivity reactions, changes in blood pressure and hyperglycemia. Application? 2 -sympathomimetics can lead to an increase in blood levels of insulin, free fatty acids, glycerol and ketone.
From the side of the central nervous system: Often (> 1/100) – rarely a headache (<1/100) - agitation, anxiety, sleep disturbance. From the cardiovascular system: Often (> 1/100) – heart palpitations rarely (<1/100) - tachycardia, change in blood pressure is very rare (<1/1000) - atrial fibrillation, supraventricular tachycardia, extrasystole. From the musculoskeletal system: Often (> 1/100) – rarely tremors (<1/100) - muscle cramps. Dermatological reactions: Very rarely (<1/1000) - rash, urticaria, itching. Metabolic disorders: Very rarely (<1/1000) - hypokalemia, hyperkalemia. From the respiratory system: Very rarely (<1/1000) - bronchospasm. Drug Interactions No specific studies have been conducted on the drug interaction of Oxis Turbuhaler with other drugs. With simultaneous use with other sympathomimetics (ephedrine) Oksis Turbuhalera, side effects of the latter may be enhanced. With simultaneous use with xanthine derivatives, corticosteroids, or diuretics (thiazide and loop diuretics), hypokalemia may be enhanced. Hypokalemia may increase the risk of arrhythmias in patients receiving cardiac glycosides. With the simultaneous use of Oxis Turbuhaler with drugs that extend the QTc interval (including antihistamines: terfenadine, astemizole, misolastine with antiarrhythmics: quinidine, disopyramide, procainamide erythromycin and tricyclic antidepressants), the risk of developing may increase. There is a risk of developing arrhythmias in patients receiving Oxis Turbuhaler and concomitant anesthesia with halogenated hydrocarbons. Beta-blockers can partially or completely block the effect of the drug (especially in cases where non-selective -adrenoreceptors are used). In this connection, Oxis Turbuhaler should not be prescribed together with beta-blockers (including eye drops), except for the urgent need for joint use. Storage Conditions The product should be stored at a temperature not exceeding 30 ° C. Expiration 2 years. active substance Formoterol Terms leave through pharmacies recipe lekarstvennaja form powder ynhalyatsyy Prescription Adults as prescribed by a doctor, For children prescribed by a doctor Indications Indications Bronchial asthma, Bronchitis, Low learning, Bronchospasis AstraZeneca, United Kingdom
