Foradil Combi powder 12mcg/400mcg #120

Foradil Combi user manual

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Composition

The drug Foradil Combi is available as a set of capsules of formoterol and budesonide.
1 capsule of formoterol contains 12 μg of active substance formoterol fumarate, and as an auxiliary lactose (up to 25 mg). The capsule shell contains 100% gelatin (79 mg).
The composition of 1 capsule budesonide is 200 μg or 400 μg active substance budesonide, and as an auxiliary substance acts lactose (up to 25 mg). The structure of the capsule shell includes iron oxide red (E172), as well as titanium dioxide (E171), water and gelatin.

Form of issue

The drug Foradil Combi is available as a set of capsules with powder for inhalation. Packed capsules of 10 pcs. in 1 blister. One capsule can contain from 4 to 18 blisters, that is 40 capsules (30 pcs with formoterol and 10 pcs with budesonide), 60 capsules (30 pcs with formoterol and 30 pcs with budesonide), 70 capsules (60 pcs with formoterol and 10 pcs with budesonide), 90 capsules (30 pills with formoterol and 60 pcs with budesonide), 120 capsules (60 pills with formoterol and 60 pills with budesonide), and 150 capsules (30 pcs with formoterol and 120 pcs with budesonide), or 180 capsules (60 pcs with formoterol and 120 pcs with budesonide).
In the sale of the drug Foradil Combi comes complete with an airlighter (device for inhalation).

pharmachologic effect

The drug has anti-inflammatory and bronchodilator effect.

Pharmacodynamics and pharmacokinetics

Formoterol

Suction

With a single administration of the drug at a dose of 120 μg, it was determined that formoterol is rapidly absorbed into the plasma and its Cmax is 266 pmol / l and is reached only 5 minutes after the inhalation procedure.
When taking formoterol in a dose of 12 mcg and 24 mcg twice a day for 12 weeks in patients with COPD, the concentration of formoterol in the plasma is in the range of 11.5-25.7 pmol / l.
Please note that the amount of active substance in the systemic blood flow increases in proportion to the amount of inhalable dose.

Distribution

Formoterol has a strong enough bond with plasma proteins, which is about 60-64%.

Metabolism

The main pathway of metabolism of the active substance is direct conjugation (involving glucuronic acid). A secondary pathway of metabolism is O-demethylation (followed by glucuronization).

Excretion

In patients suffering from bronchial asthma and COPD, approximately 7-10% of unchanged formoterol is detected in the urine.
Please note that the active substance and its metabolites are excreted completely from the body with the help of the kidneys (70%) and the intestines (30%). T1 / 2 of the drug is about 3 hours. The renal clearance of formoterol reaches 150 ml / min.
Budesonide

Suction

This substance is completely and quickly absorbed after administration. Its absolute bioavailability reaches 73%.

Distribution

Vd budesonide is 3 l / kg, and the connection with plasma proteins reaches about 88%. Systemic clearance of the drug was determined at the level of 0.5 l / min. Places of accumulation of budesonide can include spleen, lymph nodes, thymus gland, adrenal cortex, reproductive organs and bronchi, and in some cases placental barrier.

Metabolism

The metabolism of budesonide does not occur in the lungs. After taking the drug, the whole (more than 90%) is metabolized in the liver and at the same time forms several inactive metabolites. Budesonide has a sufficiently high system clearance - 84 l / h and a short T1 / 2 - 2 hours.

Excretion

T1 / 2 is 2 or 2.5 hours. The active substance is released both through the intestine in the form of inactive metabolites (10%) and by the kidneys (70%).

Indications for use

It is recommended to apply the drug Foradil Combi:
    when bronchial asthma is not adequately controlled by the use of inhaled β-agonists and SCS of short duration of action;
    with bronchial asthma adequately controlled by inhaled β-agonists and SCS of a long period of action;
    with chronic obstructive pulmonary disease (in case the effectiveness of GCS is proven).

Contraindications

Do not use Foradil Combi:
    during lactation (when breastfeeding);
    with active pulmonary tuberculosis;
    with hereditary intolerance to galactose, severe lactase deficiency, and the syndrome of impaired glucose-galactose absorption;
    in children up to 6 years;
    with hypersensitivity to budesonide, formoterol, as well as any other 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

Formoterol
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, when using the drug Foradil Combi in the treatment regimens, there was a slight increase in the incidence of exacerbation of bronchial asthma in comparison with placebo.
Budesonide
Since Foradil Combi is a combined drug and contains budesonide, patients can also experience discomfort from the following side effects:
    On the part of the endocrine system: from suppression of the functions of the adrenal cortex, Cushing's syndrome, hypercorticism, growth retardation in childhood.
    From the side of the organs of vision: from cataracts, glaucoma.
    From the immune system: from the reactions of hypersensitivity, rash, urticaria, angioedema, itching, contact dermatitis.
    Disorders of the psyche: from psychomotor hyperactivity, sleep disorders, anxiety, depression, aggressive behavior, behavioral disorders.
    From the musculoskeletal and connective tissue: from the reduction in density (mineral) bone tissue.
    From the respiratory system, chest and mediastinum: from cough, paradoxical bronchospasm, candidiasis of the mucous membrane of the larynx and oral cavity, irritation of the pharynx, dysphonia.

Foradil Combi, Instructions for Use (Method and Dosage)

Formoterol and budesonide are available in the form of capsules with a special powder for inhalations, which must be used exclusively with the help of a special device-inhaler that comes with the package.

Instruction for the Foradil Combi 12 μg + 400 μg

When taking Foradil Combi, the following recommendations should be considered:
With regular maintenance therapy, the dose of formoterol varies between 12 and 24 μg (1 or 2 capsules) 2 times a day. Given that the maximum daily dose of the active ingredient should not exceed 48 mcg, with acute need it is permissible to additionally take 12-24 mcg per day in order to alleviate the symptoms of bronchial asthma.
The minimum dose of the drug in 1 capsule is 200 μg. Foradil Combi is not prescribed if the dose should be less than 200 μg in the treatment regimen.
The maintenance dose of budesonide for adults can vary from 400 to 800 μg per day in 2 divided doses.
With a severe exacerbation of bronchial asthma, budesonide can be prescribed at a dose of 1600 mcg per day in 2-4 doses.

Overdose

Formoterol
Symptoms of overdose with formoterol can be expressed as: nausea, severe vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, as well as metabolic acidosis, hypokalemia, hyperglycemia and hypertension.
In order to remove the symptoms, it is necessary to hold supportive and symptomatic therapy. In cases of severe overdose, hospitalization is necessary.
Budesonide
Budesonide has a low acute toxicity. With a single inhalation of a large amount of the drug may cause a temporary suppression of the hypothalamic-pituitary-adrenal system and this does not require emergency care.

Interaction

Formoterol
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, tricyclic antidepressants, and other drugs that promote QT interval prolongation, as this can not only negatively affect the cardiovascular system, but also increase the risk of serious 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 severe cardiac arrhythmias if their medicine regimen contains digitalis preparations.
Significantly weaken the effect of Foradil beta-adrenoblockers.
Budesonide
In order to avoid a decrease in budesonide metabolism and increase in its systemic concentration, Foradil Combi and CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, nelfinavir, amiodarone, clarithromycin) should not be taken together. In the event that the joint administration of these active substances and budesonide is not possible, it is not only necessary to constantly dose budesonide, but also closely monitor the function of the adrenal cortex. The common use of budesonide and drugs inducing CYP3A4 (rifampicin, phenobarbital, phenytoin) may also become a reason for increasing the metabolism of budesonide and reducing its systemic concentration.
Significantly enhance the action of budesonide can methandrostenolone and estrogens.

Storage conditions

Medicinal preparation Foradil Combi is not recommended to be stored in an unprotected place at a temperature that exceeds 25 ° C.

Shelf life

Shelf life of the drug Foradil Combi is 2 years, subject to storage conditions.

Reviews of Foradil Combi

Evaluation of Foradil Combi at the forums is 4.9 on a 5-point scale. To the merits of the drug forum visitors include:
    high efficiency;
    convenient to use inhaler;
    affordable price.
After analyzing the reviews about the Foradil Combi at the forums, it was found that some participants in the discussion had side effects in the form of severe nausea and headache, but during treatment these symptoms completely disappeared.
One of the most frequently asked questions to specialists is the question: "Hormonal or not?" Doctors honestly answer that this drug is hormonal and advise everyone before consulting this doctor to consult with your doctor.