Foradil caps 12mcg #60

Foradil user manual

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See also - Foradil Combi

Composition

The composition of 1 capsule includes 12.5 mg of active substance formoterol fumarate.
Lactose (25 mg) acts as an auxiliary substance.

Form of issue

The drug Foradil is available in the form of capsules that contain a white free flowing powder for inhalation. On transparent colorless capsules of size # 3 there is a marking "CG" (on the lid) and "FXF" (on the body). The marking is applied to the capsule in black ink.
Capsules are packed in 10 pieces in blisters, which are placed together with an airlighter (device for inhalation) in cardboard packs.
Each cardboard bundle can have 3 or 6 blisters with capsules.

pharmachologic effect

Formoterol fumarate is a selective β 2 -adrenoreceptor agonist. Its pharmacological action is that it can be used as a bronchodilator as patients with reversible airway obstruction, as well as with irreversible.
The main advantages of Foradil over other drugs having a similar pharmacological effect is that formoterol fumarate acts quickly (within 3 minutes) and its action lasts about 12 hours after the inhalation procedure. Also, this drug, when taken at therapeutic doses, has practically no significant effect on the patient's cardiovascular system.

Pharmacodynamics and pharmacokinetics

Formoterol fumarate inhibits the release of both leukotrienes and histamine from mast cells. During the experiments on animals, strong enough anti-inflammatory abilities of formoterol were also detected. It is proved that this drug inhibits and blocks the development of edema and the accumulation of inflammatory cells.
As a result of experimental animal studies in vitro, it was also found that (R, R) - and (S, S) -enantiomers of racemic formoterol as well as he himself possess the properties of highly selective β2-receptor agonists. Note that the (S, S) -enantiomer was significantly less active than the (R, R) -enantiomer (800-1000 times), which confirms that it does not adversely affect the ability of (R, R ) -enantiomer with respect to smooth tracheal musculature. In the course of the experiments, and comparing these two enantiomers with the racemic mixture, no pharmacological evidence has been established by the experts on the advantages of using the (R, R) and (S, S) enantiomers.
During studies in which people participated, it was found that formoterol fumarate is very effective in preventing bronchospasm, which can be caused by both strong allergens, cold air and physical exertion, and by substances such as histamine and methacholine. Due to the fact that Foradil exerts a pronounced bronchodilating effect for 12 hours after the inhalation procedure, when taking this drug at the indicated doses 2 times a day it makes it possible in most cases to fully control bronchospasm both during the day and during the night.
In COPD (chronic obstructive pulmonary disease), the stable course of Foradil, which is used with an inhalation device (airlaser) 12 or 24 μg 2 times a day, promotes the rapid onset of the bronchodilator effect, which lasts a minimum of 12 hours.

Suction

During the experiment, it was determined that for a single inhalation with a dose of 120 μg, the drug was rapidly absorbed into the plasma and its plasma Cmax was reached within 10 minutes after the procedure and was 266 pmol / L. Using formoterol 12 or 24 μg twice daily for 10-12 weeks in patients with COPD (chronic obstructive pulmonary disease), the concentration of formoterol in plasma (measured at 15 minutes, 2 hours and 5 hours after the inhalation procedure) varied between 11.6 and 25.8 pmol / l, as well as 23.4 and 50.4 pmol / l.
In the course of the studies, the total excretion of both formoterol and its two enantiomers in urine was also studied. As a result, there was a proportional increase in the amount of formoterol in the systemic blood flow with increasing dose.
Note that with inhalation application of the drug with maintenance therapy, the excretion of the active substance by urine in patients suffering from bronchial asthma increases by 64-74%, and those who are diagnosed with COPD increase by 20-39%. This is an indication that formoterol is cumulated in plasma as a result of multiple procedures. But at the same time, after repeated inhalations, no more significant cumulation of enantiomers of formoterol was detected.
Since formoterol is used with an inhaler, the norm is that some of the active substance is swallowed and absorbed from the digestive tract.

Distribution

Foradil has a strong enough bond with plasma proteins, which reaches 61-64%.

Metabolism

The main way of metabolism of Foradil is direct glucuronization. Secondary pathway of metabolism is o-demethylation and subsequent glucuronization.
Also, metabolic pathways may include conjugation of the active ingredient with sulfate and subsequent deforming. The following isoenzymes participate in the process of glucuronization: 1A7, UGT1A1, 1A10, 1A3 and1A6, and also 1A8, 1A9, 2B7 and 2B15. And the 0-demethylation process involves isoenzymes: 2A6 and CYP2D6, as well as 2C9 and 2C19.

Excretion

In patients taking Foradil for 12 months and suffering from bronchial asthma in urine, 10% of formoterol was determined unchanged, and in patients with a COPD diagnosis of approximately 7%. The proportions of (R, R) - and (S, S) -enantiomers of formoterol are about 40% in urine (in patients with bronchial asthma) and 60% (in patients with COPD).
The active substance, as well as its metabolites are excreted from the body completely (1/3 of the total dose is excreted with feces, and 2/3 - with urine).
The renal clearance of the drug Foradil varies between 150 and 160 ml / min.
The final T1 / 2 drug from the plasma with a single dose of 120 μg is 10 hours; and the T1 / 2 enantiomers of formoterol were 13.8 and 12.2, respectively.
Pharmacokinetics in special clinical cases
When corrected for body weight pharmacokinetic characteristics of formoterol in both men and women remain the same.
Formoterol pharmacokinetics studies in elderly patients and people with impaired liver and / or kidney function were not performed.

Indications for use

It is recommended to apply the drug Foradil:
    in the prevention and treatment of bronchospasm in patients with bronchial asthma (the drug Foradil is used as an additional means of therapy with inhaled glucocorticosteroids);
     in the prevention of bronchospasm, the causes of which are strong physical activity, cold air or inhaling allergens (Foradil is used as an additional means of therapy with inhaled glucocorticosteroids);
    in the prevention and treatment of symptoms caused by violations of bronchial patency in patients with chronic bronchitis, emphysema, and COPD (the drug Foradil is used in both reversible and irreversible bronchial obstruction).

Contraindications

Do not use Foradil:
    in children under 5 years;
    during lactation (breastfeeding);
    with increased sensitivity to the components of the drug.
With particular caution should be used drug Foradil:
    with ischemic heart disease;
    at disturbances of a warm rhythm;
    with severe heart failure;
    in idiopathic subclass aortic stenosis;
    with hypertrophic obstructive cardiomyopathy;
    with thyrotoxicosis;
    with known or suspected lengthening of the QT interval;
    at a diabetes.

Side effects

During treatment with Foradil, patients may experience quite strong discomfort from the following side effects:
    From the immune system: from reactions of hypersensitivity (arterial hypotension, hives, angioedema, itching, exanthema).
    Mental disorders: from agitation, feelings of anxiety, increased excitability, insomnia.
    From the nervous system: from headaches, tremors, dizziness, dysfunctions.
    From the cardiovascular system: from the palpitation, tachycardia, peripheral edema.
    From the respiratory system: from bronchospasm, including paradoxical.
    Local reactions: from irritation of the mucous membrane of the larynx and pharynx.
    From the digestive system: from nausea.
    From the musculoskeletal system: from muscle cramps, myalgia.
    Other: from distortion of gustatory sensations.
Please note that when using this drug in clinical practice, significant changes in the results of such laboratory tests as hyperglycemia and hypokalemia, as well as prolongation of the QT interval, were noted.
During clinical trials, the use of Foradil in the treatment regimens revealed a slight increase in the incidence of exacerbation of bronchial asthma compared with placebo.

Instruction for the use of Foradil (Method and dosage)

In accordance with the instructions for the use of Foradil, this drug is intended for inhalation use in treatment regimens for adults and children older than 5 years. This drug is available in the form of a powder for inhalation, which is used with an airlighter (a special device for inhalation).
Adults with bronchial asthma should take 12-24 mcg (1-2 capsules) 2 times a day. If necessary, you can increase the dose by 12-24 mcg per day. In case the use of additional Foradil dosages becomes permanent and not episodic (usually 2 days a week), the patient should consult a doctor in order to review the treatment regimen, as long as the dose is increased. frequent intake of additional doses can be an indicator of worsening of the course of the underlying disease.
In the prevention of bronchospasm, which occurs when strong physical exertion or the inevitable action of allergens, 15 μg before contact or load should take 12 μg (1 capsule). Patients with severe bronchial asthma can use a single dose of 24 mcg.
Patients suffering from chronic obstructive pulmonary disease with regular maintenance therapy should take 12 or 24 μg (1-2 capsules) 2 times a day.
Children aged 5 years and older should take 12 μg 2 times a day with maintenance therapy. If necessary, you can additionally take 12 or 24 μg of drug per day. If the use of additional Foradil dosages becomes permanent and not episodic (usually 2 days a week), the patient should seek medical advice in order to review the treatment regimen, since frequent intake of additional doses may be a measure of impairment course of the underlying disease.
For the prevention of bronchospasm in children, which can be caused by strong physical stress or the inevitable effects of a known allergen, 12 μg of Foradil (1 capsule) should be used 10-15 minutes before contact or load.

Overdose

When overdosed with Foradil, the patient may experience discomfort from severe nausea, vomiting, headaches, tremors, drowsiness, heart palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, and hypokalemia and hyperglycemia.
To remove symptoms of overdose, it is recommended to hold supportive and symptomatic therapy. In case of a serious overdose, hospitalization may be necessary.
Under the supervision of a doctor, beta-blockers can be used.

Interaction

Since Foradil is a beta2-adrenostimulator, it should be taken with extreme caution in patients who already use in their treatment regimens such drugs as procainamide, disopyramide, quinidine and phenothiazines. It is also not recommended to take Foradil together with antihistamines, MAO inhibitors, strong tricyclic antidepressants, as well as other drugs that contribute to the prolongation of the QT interval, as this can not only negatively affect the cardiovascular system, but also increase the risk of ventricular arrhythmias .
Note also that the simultaneous administration of Foradil with other sympathomimetic agents may trigger the occurrence of side effects of the drug.
Affect the potential hypokalemic effects of beta2-adrenomimetics can also be simultaneous reception with Foradil diuretics, xanthine and GCS.
Hypokalemia contributes to an increase in the patient's predisposition to the occurrence and development of cardiac arrhythmias if their medicine regimen contains digitalis preparations.
Significantly weaken the effect of Foradil beta-adrenoblockers.

Terms of sale

You don't need a prescription to buy Foradil online.

Storage conditions

The drug Foradil should be stored in a place protected from moisture at a temperature not exceeding 25 ° C.
Shelf life - 2 years.

Reviews of Foradil

The average score of Foradil on the forums is 4.8 on a 5-point scale.
The benefits of the drug forum visitors include:
    efficiency;
    reception 2 times a day.
Participants of medical forums and sites consider minuses of the drug:
    inconvenient air-conditioning;
    occurrence of side effects.
After analyzing the reviews about the Foradil of doctors, it can be concluded that many specialists actively use this drug in practice, but they advise to pay attention of their patients also to the preparation of Foradil Kombi, which also excellently gives itself excellent results in the removal of asthmatic attacks.
Information about the drug Foradil in Wikipedia is not.