BUDENOFAL′K

Active material: Budesonide
When ATH: A07EA06
CCF: GCS for oral use. Crohn's disease drug
ICD-10 codes (testimony): K50
When CSF: 04.01
Manufacturer: Dr. FALK PHARMA GmbH (Germany)

Pharmaceutical form, composition and packaging

Capsules hard gelatin, size №1, of red color, opaque; contents of capsules – round pellets (granules) white.

Excipients: sugar pellets (sucrose 80%, corn starch 20%), lactose monohydrate, povidone K25, eudragit L, eudragit S, erudite RS, eudragit RL, talc, diʙutilftalat, gelatin, Titanium dioxide (E171), cochineal red A (crimson 4R, E124), iron oxide red (E172), sodium lauryl, Purified water.

10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (5) – packs cardboard.
10 PC. – blisters (10) – packs cardboard.

* international non-proprietary name, recommended by the WHO – ʙudezonid.

Pharmacological action

Crohn's disease drug. Budesonide is a non-halogen corticosteroids. Anti-inflammatory, antiallergic, anti-exudative and anti-edema effect. The effect of the drug is due to a decrease in the release of mediators from mast cells, basophils and macrophages, redistribution and suppression of migration of inflammatory cells, inhibition of inflammatory reactions and membrane stabilizing effect.

Induction of some proteins (eg, macrocortina) possibly one of the specific mechanisms of action of budesonide. By inhibiting phospholipase A₂, these proteins are involved in the metabolism of arachidonic acid and thus prevent the formation of inflammatory mediators leukotrienes and prostaglandins. Unnecessarily. the process of induction of protein synthesis takes a certain period of time, the full therapeutic effect of budesonide develops gradually.

Compared with classical corticosteroids, budesonide has a very high affinity for receptors. Due to these properties, Budenofalk has a targeted local action..

Pharmacokinetics

Absorption

Budesonide has pronounced lipophilic properties and is rapidly absorbed in the intestine due to good tissue permeability.

Metabolism

About 90% budesonide is metabolized in the liver when “first pass” and only about 10% has a systemic effect. Of this amount 90% budesonide is bound to albumin and, due to this, is in a biologically inactive form.

Testimony

- mild to moderate forms of Crohn's disease involving the ileum and / or ascending colon.

Dosage regimen

The recommended daily dose is 1 capsule (contains 3 mg budesonide) 3 times / day (morning, at noon and in the evening).

The capsules must be taken for approximately 30 minutes before eating, swallowing them whole and drinking plenty of fluids (eg, a glass of water). Patients with swallowing disorder can open the capsule and swallow its contents (microspheres) with enough liquid. The effectiveness of Budenofalk is not reduced in this case..

The course of treatment is usually 8 weeks. Usually, full effect comes through 2-4 of the week.

You can not abruptly stop taking Budenofalk, it is necessary to gradually reduce the dose.

Side effect

Sometimes side effects typical for systemic corticosteroids may occur. (Cushing's syndrome). These side effects are dose dependent, duration of treatment, concomitant or previous treatment with other corticosteroids and individual sensitivity.

Clinical trials have shown, what is the frequency of side effects, characteristic of the GCS, when using Budenofalk much less (about 2 times) compared with the incidence of adverse effects with oral administration of equivalent doses of prednisolone. Nonetheless, side effects cannot be completely ruled out, typical for GCS.

The following side effects may develop.

From the skin covers: allergic eczema, red striae, petechiae, ecchymosis, steroid acne, impaired wound healing, contact dermatitis.

On the part of the musculoskeletal system: muscular weakness, osteoporosis, aseptic necrosis of the femur and humerus head.

On the part of the organ of vision: glaucoma, Cataract.

CNS: depression, euphoria, irritability.

Cardio-vascular system: increased blood pressure, an increased risk of thrombosis, vasculitis (withdrawal after prolonged treatment).

On the part of the endocrine system: Cushing's syndrome (moon face, obese trunk, diabetes, reduced glucose tolerance, sodium retention with edema formation, kaliopenia, decrease in function or atrophy of the adrenal cortex, violation of secretion of sex hormones (amenorrhea, girsutizm, impotence).

On the part of the immune system: influence on the immune response (increased risk of infectious diseases).

When transferring patients from taking systemic corticosteroids to budesonide, extraintestinal symptoms may worsen or recur (especially damage to the skin and joints).

Contraindications

- infectious bowel diseases (Bacterial, Fungus, amoebic, viral infection);

- Severe liver;

- Children's age;

- hypersensitivity to budesonide or other components of the drug.

FROM caution the drug should be prescribed for tuberculosis, hypertension, diabetes, osteoporosis, peptic ulcer, glaucoma, Cataracts, a family history of diabetes or glaucoma.

Pregnancy and lactation

During pregnancy, the use of Budenofalk is possible only in those cases, the expected benefit to the mother outweighs the potential risk to the fetus.

In Women of childbearing age before starting therapy with Budenofalk, possible pregnancy should be excluded, and reliable contraceptive methods should be used during treatment.

Until now unknown, is budesonide able to pass into breast milk, therefore, during the period of treatment, it is necessary to stop breastfeeding.

Cautions

Budenofalk may suppress the function of the hypothalamic-pituitary-adrenal system.

Before surgery or exposure to another stress factor, additional prescription of systemic glucocorticosteroids is recommended.

Overdose

Data on overdose of the drug Budenofalk not provided.

Drug Interactions

When used simultaneously with Budenofalk, the effect of cardiac glycosides may be enhanced due to potassium deficiency.

With the simultaneous use of Budenofalk with saluretics, hypokalemia may increase.

Inhibitors of cytochrome P450 (ketonazole, troleandomiцin, Erythromycin, cyclosporine) can enhance the effect of Budenofalk.

Co-administration of cimetidine and budesonide may result in a slight increase in plasma levels of budesonide, however, this is not clinically relevant.

Concomitant administration of omeprazole does not affect the pharmacokinetics of budesonide.

In theory, interaction with resins cannot be ruled out, capable of binding steroids (eg, kolestiraminom), as well as antacids. With the simultaneous administration of these drugs with Budenofalk, as a result of interaction, the therapeutic effect of budesonide may decrease. In this regard, the above drugs should be taken with Budenofalk., at least, at intervals of 2 no.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.