Description overdue on 09/16/2014

• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Foradil Combi, instructions for use (method and dosage)
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Analogs
• Reviews
• Price, where to buy

Composition

The drug Foradil Combi is available as a set of capsules formoterol   and budesonide .

The composition of one capsule formoterol   It included 12 ug of formoterol fumarate active ingredient, and as auxiliary agent acts lactose (25 mg). The composition of the capsule shell include gelatin, 100% (79 mg).

The composition of one capsule budesonide   It included 200 micrograms or 400 micrograms of the active substance budesonide, but as adjuvant serves lactose (25 mg). The composition of the capsule shell include iron oxide red (E172) and titanium dioxide (E171), water and gelatin.

Product form

The drug Foradil Combi is available as a set of capsules with powder for inhalation. Packaged Capsules 10 pcs. 1 blister. In a cardboard package may be from 4 to 18 blisters, t. E. 40 capsules (30 pcs. With formoterol and 10 pcs. Budesonide), 60 capsules (30 pcs. With formoterol and 30 pcs. Budesonide), 70 capsules (60 pcs. with formoterol and 10 pcs. budesonide), 90 capsules (30 pcs. with formoterol and 60 pcs. budesonide) 120 capsules (60 pcs. with formoterol and 60 pcs. budesonide) and 150 capsules (30 pcs. with formoterol and 120 pieces. budesonide) or 180 capsules (60 pcs. with formoterol and 120 pieces. budesonide).

In the sale of the drug Foradil Combi enters the complete with aerolayzerom   (device for inhalation).

Pharmacological action

The drug has anti-inflammatory and bronchodilator effects.

Pharmacodynamics and pharmacokinetics

Formoterol

Absorption

In single dose of the drug at a dose of 120 mg has been determined that formoterol is capable of rapidly absorbed into the plasma and Cmax of 266 pmol / l is reached after 5 minutes following inhalation.

Upon receipt of formoterol in a dose of 12 mg and 24 mg 2 times a day for 12 weeks in patients with COPD formoterol concentration in plasma is in the range 11.5-25.7 pmol / l.

Note that the amount of active compound in the systemic circulation is increased proportionally to the amount of inhaled dose.

Distribution of

Formoterol has a sufficiently strong connection to plasma proteins, which is about 60-64%.

Metabolism

The main route metabolism   direct conjugation of the active ingredient (with glucuronic acid). Seconded by metabolism is O-demethylation (with subsequent glucuronidation).

Withdrawal

In patients suffering from asthma   and COPD In urine is determined approximately 7 - 10% of unchanged formoterol.

Note that the active substance and metabolites   completely excreted via the kidneys (70%) and the intestines (30%). T1 / 2 of the drug is about 3 hours. Renal clearance of formoterol is 150 ml / min.

Budesonide

Absorption

This substance is completely and rapidly absorbed after administration. Its absolute bioavailability reaching 73%.

Distribution of

Vd budesonide is 3 l / kg, and the connection to plasma proteins up to about 88%. Systemic clearance of the drug was determined at the level of 0.5 l / min. Mostly accumulation of budesonide may be the spleen, lymph nodes, thymus, adrenal cortex, the reproductive organs and the bronchi, and in some cases, the placental barrier.

Metabolism

The process metabolism budesonide   It does not occur in the lungs. After taking the drug almost all (90%) metabolised in the liver and thus forms several inactive metabolites . Budesonide has a sufficiently a high systemic clearance - 84 l / h and a short enough T1 / 2 of - 2 hours.

Withdrawal

T1 / 2 of 2 or 2, 5 hours. Is displayed as the active agent through the gut as inactive metabolites (10%) and kidneys (70%).

Indications

It is recommended to use the drug Foradil Combi:

• at asthma   inadequately controlled using inhaled β₂-agonists and corticosteroids short period;
• at asthma   adequately controlled with inhaled β₂-agonists and corticosteroids prolonged period;
• at chronic obstructive pulmonary disease   (in the case of, if the efficiency of application of of GCS proved).

Contraindications

Not recommended to apply a preparation Foradil Combi:

• during Lactation   (when breast-feeding);
• with the active pulmonary tuberculosis ;
• when hereditary galactose intolerance, severe lactase deficiency syndrome and impaired glucose absorption process-galactose;
• in children under 6 years;
• hypersensitivity to budesonide . formoterol As well as any other components of the preparation.

With extreme caution should be used drug Foradil:

• at coronary heart disease ;
• at cardiac arrhythmias ;
• in severe Heart Failure ;
• at idiopathic subvalvular aortic stenosis ;
• at   hypertrophic obstructive cardiomyopathy ;
• at thyrotoxicosis ;
• when known or suspected prolongation of the interval QT;
• at diabetes .

Side effects

Formoterol

During treatment, patients may experience Foradilom enough discomfort from the following side effects:

• On the side   the immune system: of hypersensitivity reactions ( hypotension, urticaria, angioedema, pruritus, rash ).
• Mental disorders:   from agitation . anxiety, irritability, insomnia .
• On the side   Nervous system: from headache, tremor, dizziness, taste disorders .
• On the side   Cardiovascular system:   from palpitations, tachycardia, peripheral edema .
• On the side   respiratory system: from bronchospasm Including paradoxical.
• Local reactions: from irritation of the mucous membrane of larynx and pharynx .
• On the side   digestive system: from nausea .
• On the side   the musculoskeletal system:   from muscle spasms, myalgia .
• Other: from distorted sense of taste .

Note that when using this drug in clinical practice were observed quite serious changes results of these laboratory studies as hyperglycemia and hypokalemia, and prolongation of the interval QT.

During clinical trials when used in the treatment regimens of the drug Foradil Combi were identified and a slight increase in the incidence of worsening asthma compared with placebo.

Budesonide

Since Foradil Combi is a combined preparation, and it includes budesonide , The patients also may experience discomfort and side effects from the following:

• On the side   Endocrine system: from suppression of the adrenal cortex, Cushing's syndrome, Cushing's, stunting in children .
• On the side   of organs of vision: from Cataract . Glaucoma .
• On the side   the immune system: by reactions hypersensitivity, rash, urticaria, angioedema, pruritus, contact dermatitis .
• Mental Disorders: from psychomotor hyperactivity, sleep disorders, anxiety, depression, aggressive behavior, behavioral disorders .
• On the side   musculoskeletal and connective tissue disorders: from reduce the density of (mineral) bone .
• On the side   respiratory system, organs, thoracic and mediastinal disorders: from cough, paradoxical bronchospasm, laryngeal mucosa candidiasis   and mouth, throat irritation, dysphonia .

Foradil Combi, instructions for use (method and dosage)

Formoterol   and budesonide   issued in the form of capsules with a special powder for inhalation to be used exclusively with a special inhaler device that comes in the package.

Instructions on Foradil Combi 12 mg + 400 mg

When taking the drug Foradil Combi should consider the following recommendations:

With regular maintenance therapy dose formoterol   It varies between 12 and 24 mg (contents of 1 or 2 capsules) two times a day. Considering that the maximum daily dose of the active ingredient should not exceed 48 mg in acute need further allowed to take 12-24 mg per day to alleviate symptoms asthma .

The minimum dose of the drug in one capsule is 200 mg. Foradil Combi not prescribed in the case when the treatment regimen is necessary to use a dose of less than 200 micrograms.

Maintenance dose budesonide for adults can vary from 400 to 800 mg per day in 2 divided doses.

With strong exacerbation asthma budesonide It may be appointed in a dose 1.6 thousand mcg per day in 2-4 reception.

Overdose

Formoterol

Symptoms of overdose formoterol   can be expressed as: nausea, violent vomiting, headache, tremor, somnolence, palpitations, tachycardia, ventricular arrhythmias , and metabolic acidosis, hypokalemia, hyperglycemia   and hypertension .

To relieve the symptoms you need to spend a supportive and symptomatic therapy. In cases of severe overdose requiring hospitalization.

Budesonide

Budesonide   It has low acute toxicity. When a single inhalation of large amounts of the drug may cause temporary suppression of the hypothalamic-pituitary-adrenal system and it does not require emergency assistance.

Cooperation

Formoterol

Since Foradil is a beta2-agonists, it is necessary to take extreme caution to patients who have been using in their treatment regimens drugs such as procainamide, disopyramide, quinidine   and phenothiazines .

It is also not recommended to take Foradil in conjunction with antihistamines, MAO inhibitors, tricyclic antidepressants, and other drugs that contribute to lengthening the interval QT, as it may not only adversely affect the cardiovascular system, but also increase the risk of serious   ventricular arrhythmias .

Note also that the simultaneous reception of Foradil with other sympathomimetic agents may provoke side effects of the drug.

Reflect on the potential gipokaliemicheskoe effect of beta2-agonists may also be simultaneous with Foradilom diuretics, xanthine derivatives and corticosteroids. Hypokalemia promotes increase of predisposition the patient's to the emergence and the development of strong cardiac arrhythmias If their treatment regimen contains digitalis preparations.

Significantly weaken the effect of Foradil able to beta-blockers.

Budesonide

In order to avoid a decrease in metabolism budesonide   and increasing its systemic concentration should not be taken together Foradil Combi and inhibitors of CYP3A4 ( itraconazole, ketokonazol, ritonavir, nelfinavir, amiodarone, clarithromycin ). If you reject co-administration of these active substances and budesonide not possible, but it is necessary not only to continuously dose of budesonide, but also closely monitor the function of the adrenal cortex. Cause increased metabolism of budesonide and reduce its systemic concentration can also be combined use of budesonide and drugs that induce CYP3A4 ( rifampicin, phenobarbital, phenytoin ).

Significantly enhance the action of budesonide may   methandrostenolone   and Estrogens .

Terms of sale

Foradil Combi can be purchased at the pharmacy by prescription only.

Storage conditions

The drug Foradil Combi should not be stored unprotected from moisture at a temperature higher than 25 ° C.

Shelf life

Term of life of the drug Foradil Combi is 2 years at observance of storage conditions.

Analogs

To date, Foradil Combi has about 10 analogues on pharmacological action among of medicinal funds domestic and foreign production.

The main counterparts of the drug Foradil Combi on the market are: Atmadisk Forte . Biasten . Seretide   and Seretid Multidisk . Also popular are analogues Tevakomb   and Foster .

Reviews Foradile Combi

Evaluation Foradil Combi forums is 4, 9 to 5-point scale. The advantages of the drug Visitors forums include:

• high efficiency;
• convenient in use the inhaler;
• affordable price.

After analyzing the responses about Foradil Combi on the forums, it was revealed that some participants in discussions of the drug caused side effects such as severe   nausea   and headache But in the course of treatment, these symptoms completely disappeared.

One of the most frequently asked questions to experts is the question: "Hormonal or not? "Doctors honest answer is that the drug is a hormone and advise all before application of this product consult with your physician.

Information about the drug Foradil in Wikipedia is not.

Price Foradil Combi, where to buy

The average price of the drug Foradil Combi in Ukraine is 1050 UAH. (200mkg / 12mkg) №60) and 1300 UAH (400mkg / 12mkg) №60).

In Moscow, the price of 12 mcg Foradil Combi + 200 mcg of 1060 rubles. and 1400 rubles. (400mkg / 12mkg) №60).