Budenofalk - instructions for use, dose, side effects, contraindications

Excipients: sugar crockery (sucrose, molasses starch) 300 mg,lactose monohydrate 12 mg, povidone-K25 0.9 mg; methacrylic acid and methyl methacrylate copolymer (1: 1) (Eudragit L) 18.3 mg; methacrylic acid and methyl methacrylate copolymer (1: 2) (Eudragit S) 18.3 mg; methyl methacrylate, trimethylammonioethyl methacrylate chloride, and ethyl acrylate copolymer [2: 0.1: 1] (Ammonio methacrylate copolymer (type B), Eudragit RS) 3.0 mg; methyl methacrylate, trimethylammonioethyl methacrylate chloride, and ethyl acrylate copolymer [2: 0.2: 1] (Ammonio methacrylate copolymer (type A), Eudragit RL) 2.1 mg; triethyl citrate 4.2 mg; talcum 44.7 mg.

Capsule shell (body): gelatin 38.0760 mg, water 6.6120 mg, titanium dioxide 0.9120 mg,

Capsule shell (lid): gelatin 25.3840 mg, water 4.4080 mg, titanium dioxide 0.6080 mg.

Description:Hard gelatin capsules number 1; the case and the lid are opaque, white. Contents of capsules: round pellets (granules) of white color.

Pharmacotherapeutic group:Glucocorticosteroid

ATX: & nbsp

R.03.B.A.02 Budesonide

Pharmacodynamics:

Budesonide is a non-halogen glucocorticosteroid with anti-inflammatory, anti-allergic, anti-exudative and anti-edematous properties.

These properties are based on:

- 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;

membrane-stabilizing action.

Induction of certain proteins (eg, macrocortin) is one of the specific mechanisms of action of budesonide. Inhibiting phospholipase A2, these proteins are involved in the metabolism of arachidonic acid and thus prevent the formation of mediators of inflammation of leukotrienes and prostaglandins. Since the process of induction of protein synthesis requires a certain period of 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 with classic glucocorticosteroids budesonide has a very high affinity for receptors. Thanks to these properties, Budenofalk has a purposeful local action.

Approximately 90% of budesonide is metabolized in the liver at the "first pass" 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:

- LEasy and medium-heavy forms of Crohn's disease involving the ileum and / or ascending colon;

- collagen (collagen) colitis autoimmune hepatitis without histological signs of liver cirrhosis.

Contraindications:

Hypersensitivity to budesonide or other components of the drug, cirrhosis, infectious diseases of the intestine (bacterial, fungal, amoebic, viral infections), lactation (breastfeeding), lactose intolerance, fructose, galactose, lactase deficiency, sugarase / isomaltase deficiency, glucose-galactose malabsorption, children under 3 years old.

Carefully:It should be used for tuberculosis, arterial hypertension, diabetes, osteoporosis, peptic ulcer, glaucoma, cataract, a family history of diabetes with a history of diabetes or glaucoma, pregnancy.

Pregnancy and lactation:

During pregnancy, the use of Budenofalk is only possible if the expected benefit to the mother exceeds the potential risk to the fetus.In women of childbearing age, prior to initiation of therapy with Budenofacom, a possible pregnancy should be excluded, and during the treatment reliable methods of contraception should be used.

Until now, it is not known whether budesonide penetrate into breast milk, so during the period of treatment it is necessary to refuse breastfeeding.

Dosing and Administration:

Crohn's disease

Adults ( over 18 years of age)

The recommended daily dose is three capsules once a day in the morning or one capsule (containing 3 mg budesonide) 3 times a day (morning, afternoon and evening).

Collagen (collagen) colitis

Adults (over 18 years)

The recommended daily dose is three capsules once in the morning before breakfast (corresponding to a daily dose of 9 mg budesonide).

The course of treatment for Crohn's disease and Collagen (collagen) Colitis is usually 8 weeks.

As a rule, the full effect comes in 2-4 weeks.

Autoimmune Hepatitis

Adults (over 18 years)

Treatment of active hepatitis

The recommended daily dose is 1 capsule 3 times a day (morning, afternoon and evening).

Supportive treatment

1 capsule twice a day (morning and evening).

The course of treatment is long and can be up to 6-12 months with active hepatitis (exacerbation) and up to 24 months with maintenance therapy.

Duration and frequency of taking the drug is determined by the attending physician.

Capsules should be taken about 30 minutes before meals, swallowing them whole with a sufficient amount of liquid.

If the patient has swallowing problems, he can open hard capsules and take the granules that are resistant to the action of gastric juice without chewing them and squeezed with enough liquid that will not affect the effectiveness of the drug.

Do not abruptly stop taking the drug. The drug should be canceled gradually (slowly lowering the dosage). During the first week, the dosage should be reduced to 2 capsules per day (1 capsule in the morning and in the evening). During the second week, the patient should take 1 capsule per day, only in the morning. The treatment can then be discontinued.

Side effects:With the use of budesonide, the following side effects were observed, systematized by the system of organs and frequency of occurrence:

Organs and Systems	Frequency, according to MedDRA classification
Organs and Systems	frequent (from ≥ 1/100 to <1/10)	very rare (<1 / 10,000)
Disorders from the metabolism and nutrition	Cushing's syndrome: for example, lunar face, abdominal obesity, decreased glucose tolerance, diabetes mellitus, hypertension, sodium retention and edema formation, hypokalemia, decreased function or atrophy of the adrenal cortex, red striae, steroid acne, steroid hormone secretion disorder (eg, amenorrhea , hirsutism, impotence)	Growth retardation in children
Disturbances on the part of the organ of sight		Glaucoma, cataract
Disorders from the gastrointestinal tract		Complaints from the stomach, gastroduodenal ulcers, pancreatitis, constipation
Immune system disorders	Increased risk of infectious diseases
Disturbances from musculoskeletal and connective tissue	Muscle and joint pain, muscle weakness and twitching, osteoporosis	Aseptic necrosis of bone (thigh and head of humerus)
Disturbances from the nervous system	Headache	Idiopathic intracranial hypertension, including edema of the optic nerve disc in adolescents
Disorders of the psyche	Depression, irritability, euphoria	Various psychiatric effects or behavioral disorders
Disorders from the skin and subcutaneous tissues	Allergic eczema, petechiae, ecchymosis, deterioration of wound healing, contact dermatitis
Vascular disorders		Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)
Common disorders and disorders together		Weakness, malaise

Sometimes, undesirable phenomena typical for systemic glucocorticosteroids may occur. These side effects depend on the dose, duration of treatment, concomitant or prior treatment with other glucocorticosteroids, and individual sensitivity.

In clinical trials, it has been shown that the incidence of glucocorticosteroid-associated adverse events with 3 mg of Budenofalk was less (approximately one-half) compared to oral therapy with equivalent dosages of prednisolone.

When transferring patients from receiving systemic glucocorticosteroids to budesonide, extraintestinal symptoms may increase or re-emerge (especially skin and joint damage).

Overdose:

Cases of an overdose have not been revealed.

In case of an overdose, symptomatic treatment is performed.

Interaction:

Cardiac glycosides:

The action of cardiac glycosides can be intensified because of potassium deficiency.

Saluretics:

Hypokalemia may increase.

Inhibitors of cytochrome P450 (ketaconazole, itraconazole, ritonavir, clarithromycin, troleandomycin, erythromycin, ciclosporin):

Glucocorticosteroid effect may be intensified.

During treatment with this drug, you can not drink grapefruit juice, since it can affect the effectiveness of the drug.

There is evidence of elevated estrogen concentrations in plasma and an increase in the effects of corticosteroids in women taking estrogen or oral contraceptives in combination with budesonide. However, this effect was not observed in the case of low-dose oral contraceptives.

Simultaneous administration of cimetidine and budesonide may lead to a slight increase in the level of budesonide in plasma, but this has no clinical significance. The simultaneous administration of omeprazole does not affect the pharmacokinetics of budesonide.

Theoretically, it is impossible to exclude the interaction with resins that can bind steroids (for example, cholestyramine), as well as antacids.With the simultaneous administration of these drugs with Budenofalk as a result of the interaction, the therapeutic effect of budesonide may decrease. In this regard, the above drugs should be taken with Budenofalk at least with an interval of 2 hours.

Special instructions:

Budenofalk can suppress the function of the hypothalamic-pituitary-adrenal system. Before the surgery or exposure to another stress factor, additional administration of systemic glucocorticosteroids is recommended.

Budenofalk 3 mg contains lactose and sucrose. The drug should not be taken to patients with rare hereditary conditions of intolerance to galactose or fructose, malnutrition of isomaltase sucrose or malabsorption of glucose-galactose, as well as lactase deficiency or congenital insufficiency of lactase.

In patients with autoimmune hepatitis, the level of transaminases (ALT, ACT) in the serum should be monitored regularly (every 2 weeks during the first month of treatment and at least every 3 months thereafter), with a view to possible correction of the dosage of budesonide.

Effect on the ability to drive transp. cf. and fur:

Care must be taken when driving vehicles and engaging in potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, as the drug can cause headache, weakness, visual impairment, and other side effects that may affect these abilities.

Form release / dosage:Capsules enteric, 3 mg.

Packaging:

10 capsules per blister of PVC / PVDC / aluminum foil.

For 2, 5 or 10 blisters together with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015022 / 01

Date of registration:22.07.2008 / 19.08.2014

Expiration Date:Unlimited

The owner of the registration certificate: Dr. Falk Farma GmbH Dr. Falk Farma GmbH Germany

Manufacturer: & nbsp

Dr. FALK PHARMA, GmbH Germany

Representation: & nbspDOCTOR FALK PHARMA GmbH DOCTOR FALK PHARMA GmbH Germany

Information update date: & nbsp19.04.2017

Illustrated instructions

Instructions

Budenofalk (Budenofalk®)