Oxis Turbukhaler, 4.5 mcg/dose, 60 doses

Active ingredient

Formoterol

How to take, the dosage

Inhaled
4.5 mcg/dose

Adults:

Normal dosage: 1 or 2 inhalations once or twice daily. A dose of the drug may be inhaled in the morning and/or evening. Some patients may need 4 inhalations once or twice a day. The maximum daily dose for regular maintenance therapy is 8 inhalations.

If necessary, additional inhalations over and above those recommended for regular maintenance therapy may be taken by the patient to relieve bronchospasm attacks up to a maximum daily dose of 12 inhalations (maintenance dose plus doses taken as needed).

It is not recommended to take more than 6 doses (inhalations) of the drug to relieve one attack. The need to use the drug more than 2 times a day, and/or the use of doses exceeding the recommended as normal maintenance therapy more often than 2 days a week is a criterion for insufficient control of the disease, and the treatment regimen should be revised.

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

In selecting the dosage, one should aim to prescribe the minimum effective dose.

Chronic obstructive pulmonary disease:

Normal dosage: 2 inhalations once or twice a day. The maximum daily dose for regular maintenance therapy is 4 inhalations.

If necessary, additional inhalations over and above those recommended for regular maintenance therapy may be given by the patient to relieve broncho-obstructive symptoms, up to a maximum total daily dose of 8 inhalations (maintenance dose plus doses taken as needed).

It is not recommended to inhale more than 4 doses of the drug in one administration. The need to use the drug more than 2 times a day, and/or the use of doses exceeding the recommended as normal maintenance therapy more than 2 days a week is the criterion of insufficient disease control, and the treatment regimen should be reviewed.

Prevention of bronchial asthma attacks caused by physical activity: 2 inhalations before physical activity. The maximum daily dose should not be exceeded.

Children 6 years and older:

Normal dosage: 2 inhalations once or twice a day. It should not be more than 4 inhalations a day.
Prevention of bronchial asthma attacks caused by physical activity: 2 inhalations before physical activity. The maximum daily dose should not be exceeded.

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 speed of psychomotor reactions.

Contraindications

• High sensitivity to formoterol or lactose.
• Children under 6 years.

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

Frequent (>1/100)

Central nervous system: headache

Cardiovascular system: palpitations

Skeletal-muscular system: tremor

Rare (<1/100)

Central nervous system: agitation, restlessness, sleep disturbance

Skeletal-muscular system: muscle cramps

Cardiovascular system: tachycardia, changes in blood pressure

Very rare (<1/1000)

Skin: rash, urticaria, itching

Cardiovascular system: Atrial fibrillation, supraventricular tachycardia, extrasystoles

Metabolic disorders: hypokalemia/hyperkalemia

Respiratory system: bronchospasm

Tremors and palpitations are temporary and resolve during 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, changes in blood pressure, and hyperglycemia.

The use of β2-sympathomimetics may increase blood levels of insulin, free fatty acids, glycerol and ketone.

Overdose

There is no clinical experience of treatment in case of overdose. Overdose is most likely to produce symptoms typical of other β2-adrenomimetics: tremor, headache, palpitations.

Tachycardia, hyperglycemia, hypokalemia, QTc interval prolongation, arrhythmia, nausea and vomiting have been reported in individual cases. Symptomatic and supportive treatment is indicated.

Prescription of cardioselective β-blockers is possible, but it should be done with great caution, because the prescription of β-adrenergic receptor blockers may provoke bronchospasm. Serum potassium levels should be monitored.

Pregnancy use

Clinical experience with the drug in pregnant women is limited. Rejection of the implant was noted in experimental animals, as well as decreased life expectancy of the offspring in the early postnatal period and a decrease in body weight at birth.

These effects were observed at systemic exposures significantly greater than those achieved with clinical doses of the drug.

Bronchial asthma is a potentially dangerous disease, and therefore its symptoms should be controlled during pregnancy. If bronchial asthma needs to be controlled, Oxis Turbukhaler may be used at all stages of pregnancy (see section “Dosage and administration”).

However, as with any drug, the decision to prescribe the drug during pregnancy can only be made when the expected effect for the mother outweighs any possible risk to the fetus.

It is not known whether formoterol penetrates into 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.