Oxis Turbukhaler, 9 mcg/dose, 60 doses

Oxis Turbukhaler is a selective beta 2 -adrenomimetic.

It has a bronchodilator effect in patients with reversible airway obstruction.

Therapeutic effect is achieved quickly (in 1-3 minutes) and lasts on average 12 hours after administration of a single dose of the drug.

Indications

Oxis Turbukhaler is indicated in addition to corticosteroid therapy for regular maintenance therapy of bronchial asthma, for relief of bronchospasm attacks, for prevention of attacks caused by physical activity. In chronic obstructive pulmonary disease (COPD) for the prevention and treatment of broncho-obstructive symptoms.

Active ingredient

Composition

1 dose (delivered) of inhalation powder contains:

formoterol fumarate dihydrate 9 mcg

How to take, the dosage

– Adults take 1 inhalation 1-2 times a day (morning and/or evening). If necessary, 2 inhalations 1-2 times/day are prescribed. Daily dose of regular maintenance therapy is 4 inhalations.
– Children aged 6 years and older are prescribed 1 inhalation 1-2 times/day. The maximum daily dose is 2 inhalations.

If necessary, additional inhalations in adults over and above those recommended for regular maintenance therapy may be administered by the patient to relieve bronchospasm attacks up to a maximum daily dose of 6 inhalations (maintenance dose + doses taken as needed). It is not recommended to use more than 3 doses (inhalations) to relieve one attack. Frequent use of the drug (more than 2 times/day and/or 2 days/week), over and above that recommended for regular maintenance therapy, indicates insufficient disease control and the need to revise the treatment regimen.

In the presence of nocturnal attacks of bronchial asthma, the recommended dose of the drug can be taken once at night (duration of action of the drug is about 12 hours).

The lowest effective dose should be given when choosing a dose.

In chronic obstructive pulmonary disease: Prescribe 1 inhalation 1-2 times/day. Maximum daily dose for regular maintenance therapy is 2 inhalations. If necessary, additional inhalations (over and above those recommended for regular maintenance therapy) may be taken by the patient to relieve bronchoobstructive symptoms up to a maximum total daily dose of 4 inhalations (maintenance dose + doses taken as needed). It is not recommended to use more than 2 doses of the drug at once. Frequent use of the drug (more than 2 times/day and/or more than 2 days per week) above and beyond that recommended for regular maintenance therapy indicates insufficient disease control and the need to revise the treatment regimen.

For prevention of exercise-induced bronchial asthma attacks: Adults and children aged 6 years and older are prescribed 1 inhalation before physical activity. The maximum daily dose should not be exceeded.

Particular clinical use: No special dosage adjustment is required in elderly patients or patients with renal or hepatic impairment when prescribing the recommended doses of the drug.

Interaction

Special studies on the study of drug interactions of Oxis Turbukhaler with other drugs have not been conducted.

In concomitant use with other sympathomimetics (ephedrine) Oxys Turbukhaler may increase the side effects of the latter.

Concomitant use with xanthine derivatives, GCS or diuretics (thiazide and “loop” diuretics) may increase hypokalemia. Hypokalemia may increase the risk of arrhythmias in patients receiving cardiac glycosides.

The concomitant use of Oxis Turbukhaler with QTc prolonging drugs (including antihistamines: terfenadine, astemizole, misolastine; antiarrhythmic drugs: quinidine, disopyramide, procainamide ; erythromycin and tricyclic antidepressants) may increase the risk of ventricular arrhythmias.

There is a risk of arrhythmias in patients receiving Oxis Turbukhaler and concomitant anesthesia with halogenated hydrocarbons.

Beta-adrenoblockers may partially or completely block the action of the drug (especially when non-selective ?-adrenoreceptors are used). Therefore, Oxis Turbukhaler should not be administered together with beta-adrenoblockers (including eye drops) except in extreme cases of co-administration.

Special Instructions

The formoterol contained in the medication enters the patient’s airway with the air currents when actively inhaling through the Turbulator mouthpiece. It is important to clearly instruct the patient to take deep and strong breaths through the mouthpiece to ensure that the optimal dose of the medication reaches the airway.

The patient should also be instructed to never chew or chew on the mouthpiece, and not to use the Turbuhaler if the mouthpiece is damaged or if the mouthpiece becomes detached from the Turbuhaler body.

The patient may not taste or feel the medication after using the Oxis Turbukhaler due to the small amount delivered.

Patients with bronchial asthma who regularly take beta 2 -adrenomimetics should be considered for optimal anti-inflammatory therapy with corticosteroids. Patients should be advised to continue anti-inflammatory therapy even when improvement occurs after taking Oxis Turbukhaler. Persistence of symptoms or the need to increase the dose of beta 2-adrenomimetics is an indication that the patient’s condition is worsening and requires a review of anti-asthmatic therapy.

Do not initiate treatment with Oxis Turbukhaler or increase its dose if the condition worsens.

The maximum daily dose of the drug should not be exceeded. There are no safety data on long-term continuous use of the drug at higher doses, such as 36 mcg/day in adults and 18 mcg/day in children with bronchial asthma, and 18 mcg/day in patients with COPD.

The frequent use of the drug for prophylaxis of exercise-induced bronchial asthma symptoms may indicate insufficient control of the course of the disease and may warrant a review of the treatment regimen used, as well as an evaluation of the patient’s adherence to the applicable therapy regimen. If the need for prevention of exercise-induced bronchial asthma symptoms occurs multiple times in one week with adequate supportive therapy (GCS, long-acting beta 2-adrenomimetics), a review of the current treatment regimen by the specialist is necessary.

In diabetes mellitus, blood glucose concentrations should be monitored at the start of treatment, since beta 2-adrenomimetics have a hyperglycemic effect.

The use of beta 2 -adrenomimetics can potentially lead to severe hypokalemia. Particular caution should be exercised during exacerbations of severe bronchial asthma because the risk of hypokalemia may increase with hypoxia . Hypokalemia may be aggravated in concomitant therapy with xanthine derivatives, steroids, diuretics. In such cases it is necessary to monitor serum potassium level.

As with other inhalation therapy, the possibility of paradoxical bronchospasm should be considered.

The delivered dose of the drug contains 450 mcg of lactose per (corresponding to 600 mcg in the measured dose). This amount usually does not cause problems in people with lactose intolerance .

Perhaps for use in patients with hepatic impairment: No special dosing is necessary for patients with hepatic impairment when the recommended doses of the drug are administered.

Application for renal impairment: Patients with renal impairment do not require special dose selection when prescribing the recommended doses of the drug.

Pediatric use: The drug should not be administered to children under 6 years of age because there is insufficient information for this age group.

Impact on driving and operating ability: Oxis Turbukhaler does not affect the ability to concentrate and the speed of psychomotor reactions.

Contraindications

With caution: Prescribe the drug in patients with thyrotoxicosis, pheochromocytoma, diabetes, hypertrophic obstructive cardiomyopathy, idiopathic subclavian aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disease, such as coronary artery disease, tachyarrhythmias or severe heart failure.

Side effects

Tremors and palpitations are temporary and subside with treatment. As with any inhalation therapy, paradoxical bronchospasm may develop in very rare cases.

I have described single cases of the following side effects: nausea, taste disorders, dizziness, angina pectoris, prolongation of the QTc interval, hypersensitivity reactions, BP changes, and hyperglycemia. The use of ? 2 -sympathomimetics may increase blood levels of insulin, free fatty acids, glycerol and ketone.

CNS disorders: Frequent (> 1/100) – headache; rare (< 1/100) – agitation, restlessness, sleep disturbance.

Cardiovascular system: Frequent (> 1/100) – palpitations; rare (< 1/100) – tachycardia, BP changes; very rare (< 1/1000) – atrial fibrillation, supraventricular tachycardia, extrasystole .

Muscular system: Often (> 1/100) – tremor ; rarely (< 1/100) – muscle cramps.

Dermatological reactions: Very rare (< 1/1000) – rash, urticaria, itching.

Metabolic disorders: Very rare (< 1/1000) – hypokalemia, hyperkalemia.

Respiratory system disorders: Very rare (< 1/1000) – bronchospasm.

Pregnancy use

Clinical experience with the drug in pregnant women is limited. Rejection of the implant was observed in experimental animals, as well as decreased life expectancy of the offspring in the early postnatal period and decreased body weight at birth. These effects were observed at systemic exposures significantly higher than those achieved with clinical doses of the drug.

Bronchial asthma is a potentially dangerous condition, and as such, its symptoms should be controlled during pregnancy. If bronchial asthma needs to be controlled, Oxis Turbukhaler can be used at all stages of pregnancy (see section “Dosage and administration”). However, as with any other medication, the decision to prescribe the drug during pregnancy can only be made when the expected effect on the mother outweighs any possible risk to the fetus.

It is not known whether formoterol penetrates women’s breast milk.

In experiments on laboratory animals (rats), small amounts of formoterol have been shown to be present in maternal milk. The decision to prescribe Oxis Turbukhaler to women during breastfeeding is made when the expected benefit to the mother exceeds any possible risk to the baby.