Budenofalk, 3 mg capsules 20 pcs

Budesofalc has a topical anti-inflammatory effect.

Pharmacodynamics

Budesonide is a non-halogenated GKS with anti-inflammatory, anti-allergic, anti-exudative and anti-edema properties.

These properties are based on:

• reduction of mediator release from mast cells, basophils and macrophages;
• redistribution and suppression of inflammatory cell migration, inhibiting inflammatory reactions;
• membrane-stabilizing action.

The induction of some proteins (e.g., macrocortin) may be one specific mechanism of action of budesonide. By inhibiting phospholipase A2, these proteins are involved in the metabolism of arachidonic acid and thus prevent the formation of the inflammatory mediators leukotrienes and PGs. Because the process of induction of protein synthesis requires some time, the full therapeutic effect of budesonide develops gradually.

Pharmacokinetics

Budesonide has pronounced lipophilic properties and is rapidly absorbed in the intestine due to good tissue permeability. Compared to classical GCS, budesonide has a very high affinity for receptors. Due to these properties budesofalc has a targeted local action.

Approximately 90% of budesonide is metabolized in the liver during first passage and only about 10% has systemic effects. Of this amount, 90% of budesonide is bound to albumin and due to this is in a biologically inactive form.

Indications

Mild to moderate forms of Crohn’s disease with involvement of the ileum and/or ascending colon.

Active ingredient

Composition

1 capsule contains:

the active ingredient:

budesonide 3 mg,

excipients:

sugar pellets (sucrose 80% + corn starch 20%) 300 mg (240 mg + 60 mg);

Lactose monohydrate – 12 mg;

Povidone K25 – 0.9 mg,

Pellet coating:

Eudrajit L (methacrylic acid copolymer, type A) – 18.3 mg;

Eudrajit S (methacrylic acid copolymer, type B) – 18.3 mg;

Eudrajit RS (ammonium methacrylate copolymer, type A) – 3 mg;

Eudrajit RL (ammonium methacrylate copolymer, type B) – 2.1 mg;

dibutyl phthalate – 4.2 mg;

Talc – 44.7 mg,

The composition of the capsule wall:

gelatin – 61.4004 mg;

purified water – 10.8680 mg;

titanium dioxide (E171) – 1.9 mg;

cochineal red A (crimson 4R, E124) – 1.0336 mg;

Red iron oxide (E172) – 0.646 mg;

sodium lauryl sulfate – 0.152 mg

How to take, the dosage

Inhaled approximately 30 minutes before a meal, swallowing the capsule whole with enough fluid (e.g. a glass of water).

The recommended daily dose is 1 capsule containing 3 mg budesonide, 3 times daily (morning, noon, and evening).

Patients with impaired swallowing can open the capsules and swallow all the microspheres directly with enough fluid. The efficacy of Budenofalc is not reduced.

The course of treatment is usually 8 weeks. As a rule, the full effect comes after 2-4 weeks.

Budenofalc should not be stopped abruptly; the doses should be gradually reduced.

Special Instructions

Budenofalc may inhibit hypothalamic-pituitary-adrenal function.

Additional prescribing of systemic GCS is recommended before surgical intervention or exposure to another stressor.

Contraindications

With caution: tuberculosis, arterial hypertension, diabetes, osteoporosis, peptic ulcer, glaucoma, cataracts, and a history of diabetes or glaucoma in the family.

Side effects

Sometimes side effects typical of systemic GCS can occur (Cushing’s syndrome). These side effects depend on the dose, duration of treatment, concomitant or prior treatment with other GKS, and individual sensitivity.

Clinical trials have shown that the incidence of GCS-specific side effects with Budenofolk is significantly lower (approximately 2-fold) compared to the incidence of adverse effects with oral administration of equivalent doses of prednisolone. However, side effects typical of GCS cannot be completely excluded.

The following side effects may occur

Skin side effects: allergic eczema, red stricture, petechiae, ecchymosis, steroid acne, impaired wound healing, contact dermatitis.

Musculoskeletal system: muscle weakness, osteoporosis, aseptic necrosis of bones (femur and humeral head).

Sensory organs: glaucoma, cataract.

Mental disorders: depression, euphoria, irritability.

Endocrine system disorders: Cushing’s syndrome (moon-shaped face, obesity, diabetes, decreased glucose tolerance, sodium retention with the formation of edema, hypokalemia, decreased function or atrophy of the adrenal cortex, disorders of sex hormone secretion (amenorrhea, hirsutism, impotence).

Cardiovascular system disorders: increase in BP, increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term treatment).

The immune system: effect on the immune response (increased risk of infectious diseases).

If patients are switched from systemic GCS to budesonide, extraintestinal symptoms (especially skin and joint involvement) may worsen or reoccur.

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Pregnancy use

During pregnancy, Budenofalc may be used only when the expected benefit to the mother exceeds the potential risk to the fetus.

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

To date, it is unknown whether budesonide is able to penetrate into breast milk, so breastfeeding should be avoided during treatment.

Similarities