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  • Budenofalk 3mg, 50 capsules— Made in Germany — Free Delivery

Budenofalk 3mg, 50 capsules— Made in Germany — Free Delivery

(Budenofalk )
Budenofalk 3mg, 50 capsules— Made in Germany — Free Delivery
Budenofalk 3mg, 50 capsules— Made in Germany — Free Delivery
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Dr. Falk Pharma GmbH Brand: Dr. Falk Pharma GmbH
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Description Budenofalk 3mg, 50 capsules— Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. The exact mechanism of action of budesonide (inn - budesonidum) in the treatment of Crohn's disease has not been elucidated. the data of clinical and pharmacological studies and other controlled clinical studies clearly indicate that the mechanism of influence of budesonide is based mainly on local action in the intestine. budesonide is a GCS with a high local anti-inflammatory effect. at doses clinically equivalent to doses of systemic corticosteroids, budesonide causes significantly less suppression of the hypothalamic-pituitary-adrenal system and has less effect on markers of inflammation.
Budenofalk exhibits a dose-dependent effect on the level of cortisol in the blood plasma, which, at the recommended dose of 3 mg of budesonide 3 times a day, is probably lower than the equally effective doses of systemic corticosteroids.
Clinical efficacy and safety
Adults. Clinical study in patients with Crohn's disease. In a randomized, double-blind, double-sham study in individuals with mild to moderate Crohn's disease (200 CDAI 400), involving the ileum and / or ascending intestine, the efficacy of 9 mg budesonide as a single daily dose (9 mg OD) was compared with the use of 3 mg budesonide 3 times a day (3 mg TID).
The primary efficacy endpoint was the proportion of patients in remission (CDAI 150) at 8 weeks.
A total of 471 patients were included in the study (complete assay set, FAS), 439 patients were in accordance with the protocol (RR) of the assay set. There were no significant differences in baseline characteristics of both treatment groups. In support of the analysis, 71.3% of patients were in remission in the 9 mg OD group and 75.1% in the 3 mg TID group (P: 0.01975), which demonstrated no less efficacy of 9 mg OD budesonide to 3 mg TID budesonide.
No serious preparation-related side effects have been reported.
Children. Clinical studies of autoimmune hepatitis. The safety and efficacy of budesonide was studied for 6 months in 46 pediatric patients aged 9 to 18 years. In order to induce remission, 19 participants took budesonide (9 mg) and 27 patients - prednisone (starting dose - 40 mg). The patients then changed their therapy to open budesonide for 6 months.
The proportion of patients with a complete response (namely, normalization of AST and ALT levels without steroid-specific adverse events) was significantly lower in the group of patients ≤18 years old compared to the group of adults. However, after further 6 months of treatment with budesonide, the differences between the age groups became significantly smaller. There was no significant difference between the patients initially taking prednisone and budesonide regarding the proportion of patients who achieved a complete response.

Pharmacokinetics

General properties of budesonide
Suction. Oral bioavailability in both volunteers and patients with Crohn's disease on an empty stomach is about 9-13%.
Distribution. Budesonide has a high volume of distribution (about 3 L / kg body weight). Plasma protein binding is 85–90%.
Biotransformation. Budesonide undergoes intensive biotransformation in the liver (≈90%) to metabolites with low glucocorticoid activity. The GCS activity of the main metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, which are formed due to CYP 3A, is 1% of that of budesonide.
Excretion. The average T½ after oral administration is about 3-4 hours. The average clearance is about 10 l / min.
Specific patient groups (patients with impaired liver function). Depending on the type and severity of the disease, the metabolism of budesonide due to CYP 3A may be reduced in these patients.
Features of budesonide
Absorption. Due to the special enteric-soluble coating of the granules contained in the hard capsules of Budenofalk 3 mg, absorption occurs with a delay of 2-3 hours. In healthy volunteers, as in persons with Crohn's disease, Cmax of budesonide in blood plasma, which is 1-2 ng / ml, on average, it is noted 5 hours after taking 1 capsule of Budenofalk 3 mg before meals. The maximum release occurs in the terminal ileum and cecum, the main sites of inflammation in Crohn's disease.
The release of budesonide from Budenofalk in patients with ileostomy is the same as in healthy volunteers or patients with Crohn's disease, and accounts for 30-40% of the released budesonide, which is in the ileostomy sac. This indicates that a significant amount of budesonide from Budenofalk is normally transported to the colon.
Simultaneous food intake can delay the passage through the gastrointestinal tract by about 2-3 hours. In such cases, the lag phase is about 6-8 hours, but this does not change the rate of absorption.
Specific patient groups (patients with impaired liver function)
As shown for patients with autoimmune hepatitis, the systemic availability of budesonide may increase in patients with impaired liver function. As soon as liver function improves, the metabolism of budesonide is normalized.
The systemic bioavailability of budesonide is significantly higher in patients with the last stage of primary biliary cirrhosis (stage IV) than in the early stages of this disease (stage I / II), AUC was on average 3 times higher after repeated administration of 3 mg of budesonide 3 times a day.

Indications

Crohn's disease of mild to moderate severity localized in the ileum (part of the small intestine) and / or ascending colon (part of the large intestine); collagenous colitis; autoimmune hepatitis.
Treatment with Budenofalk is ineffective in patients with Crohn's disease, which spreads to the upper gastrointestinal tract.
Given the local action of the preparation, Budenofalk is unlikely to be effective for extraintestinal symptoms of the disease, for example, manifested on the skin, eyes or joints.

Application

Crohn's disease
Adults (over 18 years old): the recommended daily dose is 3 capsules 1 time in the morning or 1 capsule (containing 3 mg of budesonide) 3 times a day (morning, afternoon and evening), if it is more convenient for the patient.
Collagenous colitis
Adults (over 18 years old): The recommended daily dose is 3 capsules 1 time in the morning before breakfast (corresponds to a daily dose of 9 mg of budesonide).
Autoimmune hepatitis
Adults
Induction of remission. For the induction of remission (that is, to normalize the increased level of liver enzymes), the recommended daily dose is 1 hard capsule 3 times a day (morning, afternoon and evening, which is equivalent to a total daily dose of 9 mg of budesonide).
Maintenance of remission. After achieving remission, the recommended daily dose is 1 hard capsule 2 times a day (morning and evening, which is equivalent to a total daily dose of 6 mg of budesonide). If, against the background of this treatment, there is an increase in the level of transaminases ALT and / or AST, the dose should be increased to 3 capsules per day, as for the induction of remission (equivalent to a total daily dose of 9 mg of budesonide).
In patients who tolerate azathioprine, budesonide should be combined with this preparation to maintain remission.
Patients with impaired renal function. There are no specific dosage recommendations for those with renal impairment.
Patients with impaired liver function. Caution should be exercised in persons with mild to moderate hepatic impairment.
The capsules should be taken before meals, swallowed whole with a sufficient amount of liquid (for example, a glass of water).
Patients who have difficulty swallowing the capsules can open them and take only enteric granules with sufficient liquid. This will not affect the effectiveness of Budenofalk.
The duration of treatment is usually 8 weeks.
As a rule, the desired effect is achieved in 2-4 weeks.
Reception of Budenofalk 3 mg should not be stopped immediately, but only gradually reducing the dose. During the first week, the dose should be reduced to 2 capsules per day (morning and evening). For the second week, only 1 capsule should be taken in the morning. After that, the treatment can be stopped.
Duration of use. Crohn's disease and collagenous colitis. The typical duration of treatment is 8 weeks. The full effect is usually achieved after 2–4 weeks of administration.
Autoimmune hepatitis. Once remission is achieved, treatment for autoimmune hepatitis should be continued for at least 24 months. If biochemical remission is stable and there is no evidence of acute inflammation on the liver biopsy, treatment may be completed.
Do not stop taking Budenofalk 3 mg suddenly. The preparation must be withdrawn gradually (by slowly reducing the dose). During the first week, the dose should be reduced to 2 hard capsules per day (1 hard capsule in the morning and in the evening). During the second week, the patient should take 1 hard capsule per day, only in the morning. Then the treatment can be stopped.

Contraindications

Hypersensitivity to budesonide or other components of the preparation, local intestinal infections (bacterial, fungal, amoebic, viral), liver cirrhosis and signs of portal hypertension, for example, in the late stage of primary biliary cirrhosis.

Side effects

Estimation of the frequency of adverse reactions is based on the following parameters: very often (≥1 / 10); often (≥1 / 100, 1/10); infrequently (≥1 / 1000, 1/100); rarely (≥1 / 10,000, 1/1000); very rarely (1/10 000), including isolated messages.
There were spontaneous reports of the following adverse reactions of Budenofalk at a dose of 3 mg.
Very rare, including isolated reports (1/10 000):
metabolic disorders: leg edema, Cushing's syndrome;
from the side of the central nervous system and peripheral nervous system: pseudotumor of the brain, sometimes with edema of the optical disc in adolescents;
violation of the musculoskeletal system: diffuse muscle pain and weakness, osteoporosis.
Some of these adverse reactions have been noted after long-term use.
Side effects typical of systemic corticosteroids are rarely possible. These adverse reactions depend on the dose, duration of treatment, combined or previous treatment with other corticosteroids, and on individual sensitivity.
Clinical studies conducted with the participation of patients with Crohn's disease have shown that the frequency of GCS-associated side effects of Budenofalk 3 mg is almost half that observed with oral administration of equally effective doses of prednisolone.
Skin and subcutaneous tissue disorders: allergic rash, red striae, petechiae, ecchymosis, steroid acne, delayed wound healing, contact dermatitis.
From the musculoskeletal system, connective tissue and bones: aseptic necrosis of bones (femur and humerus head).
Visual impairment: glaucoma, cataracts.
Mental disorders: depression, irritability, euphoria, fatigue, weakness, dizziness.
Gastrointestinal disorders: stomach discomfort, stomach and duodenal ulcers, pancreatitis, constipation, nausea, vomiting.
Metabolic disorders: Cushing's syndrome, moon face, obesity, decreased glucose tolerance, diabetes mellitus, sodium retention due to edema, increased potassium excretion, inactivity and / or atrophy of the adrenal cortex, growth retardation in children, impaired secretion of sex hormones (e.g. amenorrhea, hirsutism, impotence).
Vascular disorders: hypertension, increased risk of thrombosis, vasculitis (withdrawal syndrome after prolonged therapy), headache.
Immune system disorders: Interaction with the immune response (for example, increasing the risk of infections).
Adverse reactions in clinical trials in patients with autoimmune hepatitis. In clinical trials involving patients with autoimmune hepatitis, adverse events were reported in 57% of 102 patients treated with budesonide (compared with 79% of 105 patients treated with prednisone). The most common side effects that were observed in patients taking budesonide were skin changes (in particular acne) [23% of those receiving treatment], endocrine disorders such as Cushing's syndrome [16% of those receiving treatment], gastrointestinal disorders [14% of those receiving treatment], mental disorders (mainly mood swings) [14% of those receiving treatment] and pain [12% of those receiving treatment]. With the exception of headache, these adverse events were less common with budesonide than with prednisone.
The type and frequency of side effects in the subgroup of pediatric patients were comparable to those in adult patients.

Special instructions

Treatment with budenofalk results in a more significant decrease in systemic steroid levels than conventional oral steroid therapy. switching from therapy with other steroids may cause symptoms associated with changes in systemic steroid levels.
Patients with one or more of the following diseases require especially careful medical supervision: tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer (stomach or duodenal ulcer), glaucoma, cataracts, cases of diabetes or glaucoma in a family history.
Systemic effects of corticosteroids may occur, especially when the preparation is used in high doses and over a long period. Similar effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataracts, glaucoma, and, very rarely, a wide range of mental / behavioral disorders.
Infections. Inhibition of the response to inflammation and the immune system increases the susceptibility to infection and the severity of its course. The risk of complications of bacterial, fungal, amoebic and viral infections during treatment with glucocorticoids should be carefully evaluated. Clinical manifestations may be atypical, and serious infections such as sepsis and tuberculosis may be masked and developed before they are recognized.
Chickenpox. Chickenpox deserves special attention, as the disease can be severe and sometimes fatal in immunocompromised patients. Patients who have not had this disease should avoid close personal contact with patients with chickenpox or shingles (herpes zoster). If the patient is sick with chickenpox, you should immediately consult a doctor. Similar recommendations are required to be provided to the parents of the child patient. Non-immunized patients using systemic corticosteroids or taking them within the last 3 months should receive passive immunization with herpes zoster immunoglobulin (VZIG) after contact with a patient with herpes zoster. Passive immunization should be given within 10 days of exposure to chickenpox. If chickenpox is confirmed, immediate special treatment is required.
Corticosteroids should not be discontinued and may even need to be increased.
Measles. In the case of exposure to a patient with measles, immunocompromised patients should, if possible, receive an injection of normal immunoglobulin as soon as possible after exposure.
Live vaccines. Patients taking long-term corticosteroids should not receive live vaccines. Antibody production in response to other vaccines may be reduced.
Patients with impaired liver function. Based on the experience obtained in patients with late stage primary biliary cirrhosis, with liver cirrhosis, an increased systemic bioavailability of budesonide should be expected in all patients with severely impaired liver function. However, in individuals with liver disease without cirrhosis, budesonide at a daily dose of 9 mg was safe and well tolerated. There is no evidence of the need for specific dosage recommendations for patients with non-cirrhotic liver disease or mild liver dysfunction.
Others. GCS can suppress the reaction of the hypothalamic-pituitary-adrenal system to stress. For this reason, patients who have had surgery or other stresses should be additionally prescribed systemic glucocorticosteroids.
Concomitant use of ketoconazole or other CYP 3A inhibitors should be avoided.
The preparation should not be taken in patients with rare hereditary diseases of galactose or fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption, as well as Lapp-lactase deficiency or congenital lactase deficiency.
Patients with autoimmune hepatitis should regularly monitor the level of transaminases (ALT, ASAT) in the blood plasma (every 2 weeks during the first month of treatment and at least every 3 months thereafter) in order to possibly adjust the dose of budesonide.
Taking the preparation Budenofalk 3 mg can lead to positive results of doping tests.
Application during pregnancy or lactation. There is no experience of using Budenofalk during pregnancy. Animal studies have demonstrated reproductive toxicity. The preparation should not be used during pregnancy, unless absolutely necessary. In women of reproductive age, pregnancy should be excluded before starting treatment and appropriate contraceptives should be used during treatment.
It is not known whether budesonide, like other corticosteroids, penetrates into breast milk. Therefore, during treatment with Budenofalk 3 mg, breastfeeding should be discontinued.
Children. Due to the current lack of sufficient experience with the use of Budenofalk in pediatrics, the preparation should not be used in children under the age of 12 years. The safety and efficacy of Budenofalk 3 mg in adolescents aged 12 to 18 years have not been established. The currently available data from adolescents (age 12-18) with autoimmune hepatitis are described in the SIDE EFFECTS and PHARMACOLOGICAL PROPERTIES sections. However, there are no dosage recommendations.
The ability to influence the reaction rate when driving or working with other mechanisms. Budenofalk does not affect the ability to drive vehicles and operate machinery. But since some side effects may occur, you should be careful and assess your condition before driving or operating machinery.

Interactions

Pharmacodynamic interactions
Cardiac glycosides. The action of glycosides can be potentiated by potassium deficiency.
Saluretics. Potassium excretion may increase.
Pharmacokinetic interactions
Cytochrome P450 3A (CYP 3A)
CYP 3A inhibitors such as ketoconazole, ritonavir, troleandomycin, erythromycin, cyclosporine, grapefruit juice. The action of GCS can be enhanced.
CYP 3A inducers, such as carbamazepine and rifampicin, can reduce the severity of both systemic and local effects of budesonide on the intestinal mucosa. The dose of budesonide must be adjusted.
CYP 3A substrates such as ethinyl estradiol compete with budesonide for metabolism. If the relationship of the competing compound for CYP 3A is higher, it can cause an increase in the concentration of budesonide in the blood plasma. If budesonide has a high binding capacity for CYP 3A, plasma levels of competing compounds may increase. In such cases, the dose of budesonide or a competitor will need to be adjusted.
In women taking estrogens or oral contraceptives, an increase in plasma concentration and an increase in the action of GCS were reported. These interactions were not observed with the use of combined low-dose oral contraceptives.
The simultaneous use of cimetidine and budesonide can cause some, but clinically insignificant, increase in the level of budesonide in the blood plasma. The use of omeprazole does not affect the pharmacokinetics of budesonide.
Potential interactions with steroid binding resins such as cholestyramine and antacids cannot be ruled out. When taken simultaneously with Budenofalk, such interactions can lead to a decrease in the severity of the effect of budesonide. Therefore, these preparations must be taken separately at intervals of at least 2 hours.

Overdose

To date, overdose cases have not been described. given the properties of budesonide, an overdose with the development of toxic manifestations is unlikely.

Storage conditions

At temperatures up to 25 ° c.

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