Fortix, powder for inhalation hard capsules, 12 mcg 60 pcs — Made in Spain — Free Delivery

(Fortix)
Fortix, powder for inhalation hard capsules, 12 mcg 60 pcs — Made in Spain — Free Delivery
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Laboratorios Liconsa, S.A. Brand: Laboratorios Liconsa, S.A.
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Description Fortix, powder for inhalation hard capsules, 12 mcg 60 pcs — Made in Spain — Free Delivery

Pharmacological properties

Pharmacodynamics. Formoterol fumarate is a selective β2-adrenergic receptor agonist. in patients with reversible airway obstruction, it has a rapid bronchodilating effect (within 1-3 minutes), which persists for 12 hours after inhalation at a high level. in therapeutic doses, the effect on the cardiovascular system is minimal and occurs only in isolated cases.
Formoterol inhibits the release of histamine and leukotrienes from the passively sensitized human lung. Some anti-inflammatory effects have been noted, such as a decrease in the severity of edema and inflammatory cell accumulation.
Pharmacokinetics. As with other inhaled preparations, about 90% of formoterol, when used with an inhaler, is swallowed and absorbed in the gastrointestinal tract. Therefore, the pharmacokinetic characteristics of formoterol for oral administration can be largely applied to powder for inhalation.
Oral doses of formoterol fumarate up to 300 mcg are rapidly absorbed in the gastrointestinal tract. Cmax of unchanged substance in blood plasma is achieved after 0.5-1 hours. The degree of absorption of 80 μg of the preparation taken orally is ≥65%.
The pharmacokinetics of formoterol is linear within the studied doses of 20–300 mcg orally. Repeated oral administration of a daily dose of 40–160 mcg does not lead to significant accumulation of the preparation in the body. After inhalation administration at therapeutic doses, formoterol cannot be determined in blood plasma using the analytical methods available today. However, the rate of excretion in urine indicates rapid absorption after inhalation. The maximum elimination rate after administration at a dose of 12–96 μg was achieved in most cases after 1–2 hours.
Cumulative excretion of formoterol in the urine after inhalation of powder (12–24 μg) and two aerosol preparations (12–96 μg) proves that the amount of formoterol in blood plasma increases in proportion to the dose taken.
Binding to blood plasma proteins is 61–64% (of which 34% is with albumin), therefore, at concentrations achieved when taken in therapeutic doses, saturation of the binding sites does not occur.
Formoterol is excreted by metabolism, mainly by direct glucuronidation of the molecule. Another route of elimination is O-demethylation followed by glucuronidation.
Formoterol can be excreted in several steps, the actual T½ depends on the interval between doses. Considering the concentration in the blood plasma 6, 8 or 12 hours after oral administration, the T½ was determined to be 2–3 hours. The T½, established by the rate of excretion in the urine 3–16 hours after inhalation, was about 5 hours.
The active substance and metabolites are completely eliminated from the body; about 2/3 of the dose taken orally was detected in urine and 1/3 in feces. After inhalation, on average, about 6–9% of the dose was excreted unchanged in the urine.
The renal clearance of formoterol is 150 ml / min.

Indications

Prevention and treatment of bronchoconstriction in patients with reversible bronchial obstruction, BA and chronic bronchitis, with or without emphysema.
Prevention of bronchospasm caused by inhalation of allergens, cold air or exercise.

Application

Fortix is ​​intended for adults, including elderly patients, and children over the age of 6 years.
Since the bronchodilating effect of formoterol is largely retained after 12 hours, in most cases, supportive treatment using two inhalations per day makes it possible to control bronchoconstriction associated with chronic conditions both during the day and at night.
Supportive therapy
Adults and children over 6 years old: 1 capsule for inhalation (12 mcg) 2 times a day. In severe cases, you can prescribe 2 capsules 2 times a day. If necessary, to reduce the severity of symptoms, in addition to the maintenance dose, 1 or 2 capsules per day can be used. However, if the use of the preparation in high doses is necessary more often than usual (that is, more than 2 times a week), the dose should be revised, since this may indicate a worsening of the underlying disease.
Prevention of bronchospasm caused by exercise or exposure to known allergens, which cannot be avoided
Adults: 1 capsule for inhalation (12 mcg) approximately 15 minutes before exercise or contact with an allergen. Patients with severe asthma may need 2 inhalation capsules (24 μg).
Children aged 6 years: 1 capsule for inhalation (12 mcg) approximately 15 minutes before exercise or contact with an allergen.
Application
The doctor or other healthcare professional should explain to the patient how to use the inhaler.
The capsules are removed from the blister only immediately before use.
1. Remove the protective cap.
2. To open the inhaler, you need to take its base and turn the mouthpiece counterclockwise.
3. Place the capsule in the chamber at the base of the inhaler. It is important to remove the capsule from the blister pack just before use.
4. Return the mouthpiece to the closed position.
5. Press the red buttons while holding the inhaler upright. Release the buttons.
6. Exhale completely.
7. Place the mouthpiece in your mouth and tilt your head back slightly. They grip the mouthpiece with their lips and inhale quickly and continuously as deeply as possible.
8. Hold the breath for as long as possible, without creating discomfort, while removing the inhaler from the mouth. Then exhale. Open the inhaler to check if any powder remains in the capsule. If remaining, repeat steps 6-8.
9. After use, remove the empty capsule, close the mouthpiece and re-cap the inhaler.
To remove powder residues, clean the mouthpiece and capsule chamber with a dry cloth or use a soft brush for cleaning.

Contraindications

Hypersensitivity to formoterol, other components of the preparation, or other β2-adrenergic receptor agonists.
Tachyarrhythmia, 3rd degree atrioventricular block, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, thyrotoxicosis.
Patients with suspected or established prolongation of the QT interval (QTc 0.44 s).
Children under 6 years of age.

Side effects

From the musculoskeletal system: tremor, muscle spasms, myalgia.
From the side of the cardiovascular system: increased heart rate, tachycardia.
From the nervous system: headache, agitation, dizziness, anxiety, nervousness, insomnia, anxiety.
From the respiratory system: worsening clinical condition, dry mouth.
Others: Irritation of the mucous membrane of the mouth and throat.
Special cases: hypersensitivity reactions, such as severe arterial hypotension, rashes, angioedema, itching, peripheral edema, changes in taste, nausea, irritation of the mucous membrane of the eyes, edema of the eyelids.

special instructions

The preparation should not be used in patients with hereditary galactose intolerance, lactase deficiency or impaired absorption of glucose or galactose.
Long-acting β2-adrenergic receptor agonists are not intended (and insufficient) for the basic therapy of AD. Along with regular treatment with β2-adrenergic receptor agonists in patients with AD, it is necessary to use regular concomitant treatment with inhaled anti-inflammatory preparations (for example, corticosteroids and / or sodium cromoglycate in children) or oral corticosteroids. Before prescribing formoterol, the patient should be assessed to determine whether he is receiving sufficient anti-inflammatory treatment. When control over asthma symptoms is achieved, it is necessary to gradually reduce the dose of formoterol. During the period of dose reduction, the patient's condition should be monitored regularly. The lowest effective dose of formoterol should be used.
Although formoterol can be included in the treatment regimen if inhaled corticosteroids do not provide sufficient control over the symptoms of asthma, treatment with formoterol should not be started during severe exacerbation of asthma or in the event of a significant or acute deterioration of its course.
At the beginning of treatment with formoterol, there is a risk of developing side effects associated with asthma, as well as a worsening of its course. If BA symptoms remain uncontrollable or if the patient becomes worse after inhalation of formoterol, it is necessary to consult a doctor regarding the advisability of continuing treatment.
Anti-inflammatory treatment should not be discontinued after starting therapy with formoterol, even if the severity of the symptoms of the disease decreases. Persistence of symptoms or the need to increase the dose of formoterol to control them usually indicates a worsening of the underlying disease and the need to correct treatment.
Deaths have been reported with excessive use of preparations containing β2-adrenergic receptor agonists, although the exact cause of death is unknown. In several cases, cardiac arrest was the cause of death. Patients should be warned about the importance of strict adherence to dosage recommendations and the inadmissibility of exceeding the maximum dose.
When using β2-adrenergic receptor agonists at doses higher than recommended, an increase in the QT interval on the ECG was noted, which increased the risk of changes in ventricular rhythm.
Dosage limits for patients using formoterol should be carefully evaluated in such cases:
- ischemic heart disease;
- myocardial infarction;
- severe hypertension;
- Heart arythmy;
- severe heart failure.
Treatment with β2-adrenergic agonists can cause potentially severe hypokalemia. Particular care is required in severe asthma, since this effect can be enhanced by concomitant treatment and hypoxia. In this case, it is necessary to control the level of potassium in the blood plasma.
As with other inhaled preparations, the possibility of paradoxical bronchospasm must be considered; in this case, the preparation should be discontinued and an alternative treatment should be prescribed.
Due to the hyperglycemic effect of β2-adrenergic receptor agonists, it is necessary to control the blood glucose level in patients with diabetes mellitus.
Children. Formoterol is not used in children under 6 years of age.
During pregnancy and breastfeeding. The safety of using formoterol during pregnancy and lactation has not been established. The preparation should not be used during pregnancy unless there is another safe alternative. Like other β2-adrenergic receptor agonists, formoterol can delay labor due to its relaxing effect on uterine smooth muscle.
It is not known whether formoterol passes into breast milk. Therefore, in each case, it is necessary to carefully assess the benefits and risks.
The ability to influence the reaction rate when driving and operating other mechanisms. The patient should be warned about the likelihood of deterioration in the ability to drive vehicles and complex mechanisms due to the development of side effects such as tremors or agitation.

Interactions

The use of preparations such as quinidine, disopyramide, procainamide, phenothiazine, antihistamines and tricyclic antidepressants may be associated with a prolongation of the q-t interval and an increased risk of ventricular arrhythmia.
Additional use of sympathomimetic agents can increase the severity of reactions from the cardiovascular system.
Formoterol should be used with caution in patients using MAO inhibitors or tricyclic antidepressants, since they can increase the effect of β2-adrenergic receptor agonists on the cardiovascular system.
Concomitant treatment with xanthine derivatives, steroids or diuretics may enhance the possible hypokalemic effect of β2-agonists. Hypokalemia can increase the tendency to cardiac arrhythmias in patients taking digitalis preparations. Β-adrenergic receptor blockers can weaken or neutralize the effect of formoterol, therefore β-adrenergic receptor blockers (including eye drops) should not be used concomitantly with formoterol, unless there is an alternative.

Overdose

Symptoms: nausea, vomiting, headache, tremors, dizziness, increased heart rate, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalemia, hyperglycemia.
In case of overdose of formoterol, treatment should be stopped immediately and supportive and symptomatic therapy should be started. In case of severe overdose, the patient must be hospitalized.

Storage conditions

In its original packaging at temperatures up to 25 ° C.

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