the Trade name
Mezhdunarodnoye the unlicensed
name Budesonid Lekarstvennaya a form
of the Capsule, 3 mg
One capsule contains
active agent – budesonid 3 mg,
excipients: sugar pellets (sucrose of 80% + starch of corn 20%), lactoses monohydrate, K25 povidone, Eudragit of L, Eudragit of S, Eudragit of RS, Eudragit of RL, talc, gelatin, water purified the titan dioxide (E171), the cochineal insect red And (crimson color 4R, E124), iron oxide red (E172), sodium lauryl sulfate.
the Solid gelatin opaque capsules of darkly pink color containing large pellets (granules) of white color
Corticosteroids for system use. Glucocorticoids.
The code of automatic telephone exchange HO2AB16
Budesonid Pharmacokinetics properties has the significant lipophilic properties and is quickly absorbed in intestines owing to strong fabric permeability. Budesonid has very high degree of affinity to receptors. Thanks to these properties budenofalk possesses purposeful local action. About 90% of a budesonid are metabolized in a liver at the first passing and only about 10% make system impact. From this number of 90% of a budesonid it is connected with albumine and at the expense of it is in biologically inactive form. Elimination half-life (T1/2) – 2.8 hours, is removed mainly by kidneys.
Budenofalk is not halogen glucocorticosteroid with anti-inflammatory, antiallergic, anti-exudative and antiedematous properties. These properties are based on:
– reduction of discharge of mediators from mast cells, basophiles and
– redistribution and suppression of migration of inflammatory cells
– inhibition of inflammatory reactions
– membrane stabilizing action
Induction of some proteins (for example, macrocortinum) perhaps is one of specific mechanisms of action of a budenofalk. Inhibiting A2 phospholipase, these proteins participate in metabolism of arachidonic acid and, thus, prevent formation of mediators of inflammation of leukotrienes and prostaglandins. As process of induction of synthesis of proteins demands some period, the full therapeutic effect of a budenofalk develops gradually.
– Crohn’s disease with involvement of the ileal and/or ascending colon (as a part of complex therapy).
A route of administration and doses
Before Budenofalk’s use consult with your attending physician.
The recommended daily dose – on 1 capsule 3 times a day.
Capsules need to be accepted in 30 min. prior to food, swallowing them entirely and washing down with enough liquid (150-200 ml).
Patients with the complicated act of swallowing of the encapsulated form of drug can open the capsule and accept its contents with enough liquid (the efficiency of drug at the same time does not decrease).
The course of treatment makes 8 weeks. As a rule, the effect occurs in 2-4 weeks. It is impossible to stop administration of drug sharply. It is necessary to reduce doses gradually.
– allergic eczema, pink striya, petechias, an ecchymoma, steroid
eels, deterioration healing of wounds, contact dermatitis
– muscle weakness, osteoporosis, aseptic necrosis of a head humeral and
– glaucoma, a cataract
– a depression, euphoria, irritability
– Itsenko’s syndrome – Cushing (a crescent-shaped face, trunk obesity,
a sodium delay in an organism with forming of hypostases, a hypopotassemia)
– an amenorrhea, a hirsutism, impotence
– diabetes, decrease in tolerance to glucose
– increase in arterial blood pressure, the increased risk of a thrombogenesis,
– a withdrawal after long-term treatment
– the increased risk of developing of infectious diseases
– exacerbation of a peptic ulcer of a stomach and 12 items to., a perforation of the ulcer,
– hypersensitivity to a budenosid or other components of drug
– infectious diseases of intestines (bacterial, fungal, amoebic,
– heavy abnormal liver functions
– children’s age up to 6 years
– pregnancy and the period of a lactation
At simultaneous use of Budenofalk with:
– cardiac glycosides action of the last because of deficiency of potassium can amplify
– the hypopotassemia can be aggravated with saluretics
– P450 cytochrome inhibitors (ketonazoly, troleandomitsiny, erythromycin, cyclosporines) the glucocorticosteroid effect amplifies
– Cimetidinum the level of a budesonid in blood plasma can slightly increase, however it has no clinical value
– omeprazolum the pharmacokinetics of a budenofalk does not change.
Theoretically it is impossible to exclude interaction with the pitches capable to connect steroids (for example, holestiraminy) and also antacids. In this regard, the above-mentioned drugs have to be taken with budenofalky, at least, at an interval of the 2nd hour.
It is necessary to appoint special instructions with care budenofalk in tuberculosis, arterial hypertension, diabetes, osteoporosis, a round ulcer,
glaucoma, a cataract, at the burdened family anamnesis on diabetes or glaucoma.
Budenofalk can suppress function gipotalamo – a hypophysial and adrenal system. Before surgery or influence of other stressful factor the additional purpose of system glucocorticosteroids is recommended.
Pregnancy and a lactation
At women of childbearing age prior to therapy by Budenofalk has to be excluded possible pregnancy, and during treatment reliable methods of contraception have to be applied.
Use in pediatrics
This dosage form is not applied at children up to 6 years.
Features of influence of medicine on ability to run
transport and other mechanisms
Considering side effects of drug it is necessary to be careful
during the driving of transport and control of mechanisms.
So far cases of overdose and intoxication
were not noted.
Symptoms: strengthening of side effects.
A form of release and packing
On 10 capsules in the blister.
In cardboard packing on 20 capsules (2 blisters), 50 capsules (5 blisters), 100 capsules (10 blisters) with the instruction for use
to Store at a temperature not above +25os
to Store out of children’s reach!
not to apply a period of storage on expiry date, specified on packing.
According to the prescription
of Proizvoditel Dr. Falk Pharm GmbH
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