Instructions for Budenofalk (Budesonide)
Dosage form
enteric granules 9 mg: packets of 20 g or 50 g
Description Budenofalk:
The granules are enteric-soluble in the form of a mixture of powder and rounded granules or rounded granules from white to almost white, with a lemon smell.
1 pack.
budesonide 9 mg
Excipients:
- sugar grits - 900 mg,
- lactose monohydrate - 36 mg,
- povidone K25 - 2.7 mg.
Excipients (granule shell) Budenofalk:
methacrylic acid and methyl methacrylate copolymer 1:1
(Eudragite L 100) - 54.9 mg,
methacrylic acid and methyl methacrylate copolymer 1:2
(Eudragite S 100) - 54.9 mg,
methyl methacrylate,
trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer 2:0.1
(ammonio-methacrylate copolymer, type B, Eudragite RS) - 9 mg,
methyl methacrylate,
trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer 2:0.2:1
(ammonio-methacrylate copolymer,
type B, Eudragite RL) - 6.3 mg,
triethyl citrate - 12.6 mg,
talc - 134.1 mg.
English Product Name
Budenofalk
Dosage form
Caps. enteric 3 mg: 20, 50 or 100 pcs.
Description:
Enteric capsules hard gelatin, size No. 1, opaquent, white; the contents of the capsules are round pellets (granules) of white color.
1 caps.
budesonide 3 mg
Excipients:
granulated sugar - 300 mg,
lactose monohydrate - 12 mg,
povidone K25 - 0.9 mg,
copolymer of methacrylic acid and methyl methacrylate (1: 1) (eudragite L) - 18.3 mg,
copolymer of methacrylic acid and methyl methacrylate (1: 2) (eudragite S) - 18.3 mg,
copolymer of methyl methacrylate,
trimethylammonioethyl methacrylate chloride and ethyl acrylate [2: 0.1: 1]
(copolymer of ammoniomethacrylate (type B),
eudragite RS) - 3 mg,
copolymer of methyl methacrylate,
trimethylammonioethyl methacrylate chloride and ethyl acrylate [2: 0.2:1]
(ammoniomethacrylate copolymer (type A), eudragite RL) - 2.1 mg, triethyl citrate - 4.2 mg, talc - 44.7 mg.
ATX Codes
A07EA06 Budesonide
Clinical and pharmacological groups / Group affiliation
Corticosteroids for oral administration. The drug Budenofalk for the treatment of Crohn's disease
Active ingredient
budesonide
Pharmaco-therapeutic group
Glucocorticosteroid
Testimony Budenofalk:
For oral administration:
mild and moderate forms of Crohn's disease involving the ilium and / or ascending colon; collagenous (collagen) colitis; autoimmune hepatitis without histological signs of cirrhosis of the liver.
For rectal use:
exacerbation of distal forms of ulcerative colitis (with damage to the rectum and sigmoid colon).
Dosage, Course and Dosage:
When taken orally, the daily dose is six to nine mg. The frequency and duration of use depend on the treatment regimen.
Use in elderly patients
Use with caution in elderly patients to avoid exacerbation of chronic diseases.
Use in children
Contraindicated in children and adolescents under the age of 18 years.
- Nosology (ICD codes)
- K50
- Crohn's disease [regional enteritis]
- K51.2
- Ulcerative (chronic) proctitis
- K51.3
- Ulcerative (chronic) rectosigmoiditis
- K52.8
- Other refined non-infectious gastroenteritis and colitis
- K75.4
- Autoimmune hepatitis
Pharmachologic effect:
GCS for system applications. The exact mechanism of action of budesonide in inflammatory bowel diseases is not fully understood. The data of clinical-pharmacological and controlled clinical studies clearly indicate that the mechanism of action of budesonide is mainly based on local action in the intestine.
When taken orally in doses clinically equal to those of systemic action, budesonide causes significantly less inhibition of the hypothalamic-pituitary-adrenal system and has less effect on markers of inflammation. When used rectally at a dose of two mg, budesonide practically does not cause inhibition of the hypothalamic-pituitary-adrenal system.
