Budenofalk

General characteristics. Structure:

Active agent: будесонид - 3 mg.

Excipients: sugar pellets (sucrose of 80% + starch of corn 20%) — 300 mg (240 mg + 60 mg); lactoses monohydrate — 12 mg; K25 povidone — 0,9 mg;

pellet covering: Eudrazhit L (copolymer of methacrylic acid, type A) — 18,3 mg; Eudrazhit S (copolymer of methacrylic acid, type B) — 18,3 mg; Eudrazhit RS (methacrylate ammonium copolymer, type A) — 3 mg; Eudrazhit RL (methacrylate ammonium copolymer, type B) — 2,1 mg; dibutyl phthalate — 4,2 mg; talc — 44,7 mg;

structure of a wall of the capsule: gelatin — 61,4004 mg; the water purified — 10,8680 mg; titanium dioxide (E171) — 1,9 mg; the cochineal insect red And (crimson 4R, E124) — 1,0336 mg; iron oxide red (E172) — 0,646 mg; sodium lauryl sulfate — 0,152 mg.

Pharmacological properties:

Pharmacokinetics.

It is quickly soaked up in intestines. Cmax is reached in 90 min. after intake. About 90% of a budesonid are metabolized in a liver already at "the first passing". From the remained quantity (i.e. from 10%) to 90% it is connected with albumine and is in an inactive state. It is removed with urine, partially – with bile in the form of inactive metabolites.

Pharmacodynamics.

In comparison with traditional glucocorticosteroids (GKS) of systemic action (a hydrocortisone, Prednisolonum) possesses very high degree of affinity to specific receptors of GKS thanks to what has purposeful local effect. Possesses antiinflammatory, antiallergenic, anti-exudative and antiedematous action. The mechanism of action is based on reduction of allocation of mediators of an inflammation from mast cells, basophiles and macrophages, redistribution and suppression of migration of inflammatory cells and membrane stabilizing action. Specificity of the mechanism of action is connected with induction of a number of proteins (for example, macrocortinum) which influence metabolism of arachidonic acid (inhibiting A phospholipase) and prevent in such a way formation of mediators of an inflammation (leukotrienes and prostaglandins).

Indications to use:

Disease Krone with involvement of the ileal and/or ascending colon (for induction of remission at easy and medium-weight forms), ulcer colitis, kollagenozny colitis, autoimmune hepatitis.

Route of administration and doses:

Inside, without chewing (at disturbance of the act of swallowing it is possible to open the capsule and to swallow all microspheres), washing down with enough liquid (a full glass of water), in 30 min. prior to food 3 mg 3 times a day (in the morning, at noon and in the evening). A course – 2-8 weeks.

Features of use:

With extra care appoint to patients with arterial hypertension, a diabetes mellitus, osteoporosis, tuberculosis, a round ulcer, glaucoma, a cataract (special medical observation is necessary). In a case of chicken pox and measles it is necessary to carry out treatment by the corresponding immunoglobulins and to appoint antiviral drugs. Can suppress function гипоталамо - pituitary and adrenal system and to reduce response to a stress. 

Side effects:

From a nervous system and sense bodys: depression, euphoria, irritability, glaucoma, cataract.

From cardiovascular system and system of blood (a hemopoiesis, a hemostasis): arterial hypertension, the increased risk of a thrombogenesis, a vasculitis.

From bodies of a GIT: gastric discomfort, duodenal ulcers, pancreatitis.

From endocrine organs: Cushing's syndrome, depression of function or atrophy of bark of adrenal glands.

From a musculoskeletal system: muscular weakness, osteoporosis, aseptic necrosis of bones.

From integuments: allergic dieback, red striya, petechias, ecchymoma, steroid acnes, deterioration in healing of wounds.

Others: the increased risk of developing of infectious diseases.

Interaction with other medicines:

P450 cytochrome inhibitors (кетоконазол, тролеандомицин, erythromycin, cyclosporine) strengthen effect. Increases effect of cardiac glycosides (owing to deficit of potassium); saluretics increase potassium excretion.

Contraindications:

Hypersensitivity, GIT infections (bacterial, fungal, amoebic, virus), heavy abnormal liver functions, feeding by a breast, children's age.

Overdose:

Cases are not described.

Storage conditions:

At a temperature not above 25 °C.

To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Capsules, 3 mg. On 10 капс. in aluminum / PVC the blister, on 2, 5 or 10 blisters in a cardboard pack.