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Budenofalk application instructions

Release form

The drug is available in the form of hard gelatin capsules of red color. The contents of the capsules are opaque granules (pellets) of a round shape, having a white color. Capsules are packaged in blisters of 10 pcs. in each and then in cardboard boxes. Each box may contain 1 pc., 5 pcs. or 10 pcs. blisters.

Composition

In one capsule of Budenofalk contains budesonide in the amount of 3 g.

Excipients:

  • sodium lauryl sulfate;
  • red iron oxide;
  • red cochineal A;
  • titanium dioxide;
  • purified water;
  • gelatin;
  • dibutyl phthalate;
  • talc;
  • eudrozhit (RL, RS, S, L);
  • pavidone K25;
  • lactose monohydrate;
  • sugar granules, 20% composed of corn starch and 80% sucrose.

pharmachologic effect

This drug is taken by mouth for the treatment of Crohn's disease. Budenofalk has the following effects on the body:

  • decongestant;
  • antiexudative;
  • antiallergic;
  • anti-inflammatory.

The mechanism of action of the drug is due to:

  • suppression and redistribution of inflammatory cells that migrate;
  • a decrease in the number produced by mast cells mediators;
  • inhibition of inflammatory processes.

One of the specific mechanisms of action of the main active ingredient of the drug (budesonide) is the induction of proteins (some). These proteins inhibit phospholipase A2. At the same time, they take part in arachidonic acid metabolic processes. It provides prevention of the development of foci of inflammation in prostaglandins and leukotrienes.

Due to the fact that the process of induction of protein synthesis will take some time, and the therapeutic effect of the drug will be manifested gradually. The maximum degree of therapeutic effect is observed 10-15 days after the start of the drug. Due to the great similarity of budesonide with receptors, Budenofalk is able to have a targeted local action.

Inhalation use of Budenofalk allows to relieve bronchial obstruction. During the reception of Budenofalk, the respiratory functions are improved, and the frequency and degree of intensity is also reduced:

  • cough;
  • asthma attacks;
  • shortness of breath.

Indications

Crohn's disease, occurring in moderate or mild form with involvement in the pathological process of the ascending colon and / or ileum.


Contraindications

  1. Childhood.
  2. Functional disorders of the liver.
  3. Infectious bowel disease of bacterial, fungal, viral or amoebic etiology.
  4. Individual intolerance to the body of budesonide or other ingredients that make up Budenofalk.

Table of possible side effects

From the side Symptomatic manifestations
Immune system The risk of developing infectious diseases (the effect of the immune response)
Of cardio-vascular system Vasculitis

Thrombophlebitis

Blood pressure increase

Endocrine system Imbalance of sex hormones (impotence, hirsutism, amenorrhea )

Atrophy or impaired function of the adrenal cortex

Hypokalemia

Puffiness due to sodium retention in the body

Decreased glucose tolerance

Diabetes

Obesity

Cushing's syndrome

Organs of vision Cataract

Glaucoma

Musculoskeletal System Aseptic necrosis of the femoral and humerus (head)

Osteoporosis

Muscle weakness

Skin integument Contact dermatitis

Decreased rate and quality of wound healing

Steroid acne

Ecchymosis

Petechiae

Pink Striae

Allergic Eczema

CNS Irritability

Feeling of euphoria

Depressed state

It is also worth noting that the occurrence of adverse events depends on the individual sensitivity of the body to the components of the drug, the administration of other GCS (previous and concomitant), the duration of therapy and the doses taken.

Overdose

Cases of overdose are not recorded. Considering the properties possessed by the main active ingredient of the drug (budesonide), an overdose with the development of toxic manifestations is unlikely.


Doses and method of use

The drug is taken in 3 capsules (3 g each) per day - in the morning, afternoon and evening. The maximum daily dose is 9 g. It is advisable to take the drug 15-20 minutes before meals, drinking plenty of water. If it is difficult to swallow the capsule, it is allowed to open it and take the contents (granular powder), also drinking water. The method of administration does not affect the effect of the drug. The course of treatment in most cases is 2 months. Reception Budenofalk can not be canceled abruptly, you need to gradually reduce the dose.

special instructions

With special attention, when prescribing the drug, you need to treat patients suffering from such pathologies:

If a patient has measles or chickenpox, taking Budenofalk may complicate the course of these diseases. And if a patient is infected with these diseases during the treatment with Budenofalk, it is necessary to undergo a course of therapy with appropriate immunoglobulins. As for chickenpox disease, antiviral drugs may be needed.

If the patient is prepared for surgery or any other stressful procedure for the body, systemic use of the SCS is necessary.

During pregnancy (especially in the first trimester), when prescribing Budenofalk, the doctor should take into account the possible risk of complications, comparing it with the effect of drug therapy. That is, the ratio of these two aspects must be taken into account.

If the drug is prescribed to women in reproductive age, the doctor is obliged to exclude pregnancy. And women, during the period of treatment with Budenofalk, should take contraceptives.

During lactation, the intake of the drug is unacceptable, as it is unclear whether it can penetrate into breast milk and influence its composition.

The use of the drug is contraindicated in the presence of functional disorders of the liver.

If you take Budenofalk and Zimetidine at the same time, the level of budesonide (the main active ingredient of Budenofalk) in the liquid component of blood may increase slightly. However, this process will not have significant clinical significance.

The following drugs that are in the group of cytochrome P450 inhibitors can enhance the effect of Budenofalk:

  • Cyclosporine;
  • Erythromycin;
  • Troleandomycin;
  • Ketonazole.

Hypokalemia may increase with simultaneous administration of budenofalk and saluretics.

Cardiac glycosides, while taking with Budenofalk, may enhance their action due to the lack of an insufficient amount of potassium.

As for antacids and resins (for example, Kolestiramine), which have the ability to bind steroids, their combination with Budenofalk can weaken the effect of budesonide. Because of this, the interval between taking Bidenofalk and the above remedies should be at least 2 hours.

Vacation conditions

The drug is sold in pharmacies only upon presentation of a prescription.

Term and storage conditions

Budenofalk should be stored at a temperature not exceeding 25 ° C and in a place that is inaccessible to children. Shelf life - 3 years.

Budenofalk price

Budenofalk capsules 3mg, 20 pieces - 2500-3400 rubles.

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