budesonide reference
Reference image
(budesonide · DailyMed)
Registered Zambia · ZAMRA

Budecort 0.5mg Respules

Budesonide 0.5 mg

ZAMRA-HM-22-68 Inhalation aerosol 0.5 mg alimentary tract and metabolism INN generic

What it does

Budesonide is a corticosteroid used to reduce inflammation in the body.

Commonly used for: asthma, chronic obstructive pulmonary disease (COPD), inflammatory bowel disease (IBD)

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
ZAMRA-HM-22-68
Registration date
2022-09-21
Expiry date
2027-09-20
Status
Registered/Compliant
Active ingredient
Budesonide 0.5 mg
Dosage form
Inhalation aerosol
Strength
0.5 mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
A07EA - Corticosteroids acting locally
RxNorm RxCUI
19831
Manufacturer / MAH
Cipla Ltd
Applicant / LTR
Cipla Ltd
Country of origin
India
Manufacturer location
Peninsula Business Park, Ganapatrao Kadam Marg, Lower Parel West, Lower Parel, Mumbai, Maharashtra 400013, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:06:05 · updated 2026-09-14 03:33:08

Drug Interactions

43
Check interactions

Pharmacodynamic Warnings

Budesonide appears in TABLE 17: Drugs that reduce serum potassium

Severe (2)

Budesonide - increases exposure

Grapefruit juice moderately increases the exposure to oral corticosteroids (budesonide). Avoid.

Severe Study

Mifamurtide - decreases efficacy

Corticosteroidsarepredictedtodecreasetheefficacyof mifamurtide.Avoid.rTheoretical

Severe Theoretical

Moderate (21)

Budesonide - decreases exposure

Cenobamate is predicted to decrease the exposure to oral corticosteroids (budesonide). Adjust dose.

Moderate Theoretical

Budesonide - decreases exposure

Mitotane is predicted to decrease the exposure to corticosteroids (budesonide, deflazacort, dexamethasone, fludrocortisone, hydrocortisone, methylprednisolone, prednisolone, triamcinolone). Monitor an

Moderate Study

Budesonide - decreases exposure

Rifampicin is predicted to decrease the exposure to corticosteroids (budesonide, deflazacort, dexamethasone, fludrocortisone, hydrocortisone, methylprednisolone, prednisolone, triamcinolone). Monitor

Moderate Study

Corticosteroids - increases exposure

Dronedarone is predicted to increase the exposure to corticosteroids (methylprednisolone). Monitor and adjust dose.

Moderate Study

Corticosteroids - increases concentration

Miconazole is predicted to increase the concentration of corticosteroids (methylprednisolone). Monitor and adjust dose.

Moderate Theoretical

Unknown (20)

Aspirin - decreases concentration

Corticosteroids are predicted to decrease the concentration of aspirin (high-dose) and aspirin (high-dose) increases the risk of gastrointestinal bleeding when given with corticosteroids.

Unknown Study

Budesonide - increases exposure

Cobicistat is predicted to increase the exposure to corticosteroids (betamethasone, budesonide, ciclesonide, deflazacort, dexamethasone, fludrocortisone, fluticasone, hydrocortisone, methylprednisolon

Unknown Study

Budesonide - increases exposure

Idelalisib is predicted to increase the exposure to corticosteroids (betamethasone, budesonide, ciclesonide, deflazacort, dexamethasone, fludrocortisone, fluticasone, hydrocortisone, methylprednisolon

Unknown Study

Budesonide - increases exposure

Clarithromycin is predicted to increase the exposure to corticosteroids (betamethasone, budesonide, ciclesonide, deflazacort, dexamethasone, fludrocortisone, fluticasone, hydrocortisone, methylprednis

Unknown Study

Choline Salicylate - decreases concentration

Corticosteroids are predicted to decrease the concentration of cholinesalicylate. Ciclesonide → see corticosteroids Ciclosporin → see TABLE 2 p. 1517 (nephrotoxicity), TABLE 16 p. 1521 (increased seru

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About this medicine

Budesonide is a corticosteroid used to reduce inflammation in the body.

What it treats

  • asthma
  • chronic obstructive pulmonary disease (COPD)
  • inflammatory bowel disease (IBD)

How it works

It works by calming down the immune response and reducing swelling and irritation in the airways or intestines.

Who it's for

It is for people with conditions like asthma, COPD, or certain bowel diseases.

Drug class

Corticosteroids

Cautions

  • • Be careful if you are taking other medications that lower potassium levels.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Budesonide

BNF-referenced

Budesonide is a glucocorticoid corticosteroid used primarily for its anti-inflammatory effects in various chronic bowel disorders, such as Crohn's disease and ulcerative colitis. It is also utilized in asthma management and can be administered via oral, rectal, or inhalation routes.

Indications

  • Chronic bowel disorders
  • Crohn's disease affecting the ileum or ascending colon
  • Ulcerative colitis
  • Asthma management

Dosage

Children: For children 1-17 years: 3 mg three times a day for up to 8 weeks for Crohn's disease; 1 enema daily for 4 weeks for ulcerative colitis in children 12-17 years.

Adults: For Crohn's disease: 9 mg once daily for up to 8 weeks; for ulcerative colitis: 1 enema daily for 4 weeks. Dosage may vary, so refer to specific guidelines.

Mechanism of action

Budesonide exerts its effects by binding to corticosteroid receptors, modulating the expression of genes involved in inflammatory processes. This action leads to a significant reduction in inflammation and immune response.

Pharmacodynamics

As a potent anti-inflammatory agent, budesonide reduces the activity of inflammatory mediators and inhibits the recruitment of inflammatory cells to sites of inflammation, thus alleviating symptoms associated with conditions like asthma and inflammatory bowel disease.

Pharmacokinetics

Budesonide is rapidly absorbed after administration, with a significant first-pass metabolism resulting in a lower systemic exposure. It has a half-life of approximately 2-3 hours, and its effects can be prolonged due to its local action in the gut when used for bowel disorders.

Adverse effects

  • Insomnia
  • Stomatitis
  • Taste disorders
  • Diarrhoea
  • Muscle twitching
  • Oedema
  • Anaemia
  • Decreased appetite
  • Ataxia
  • Lymphadenopathy
  • Macrocytosis
  • Aseptic meningitis
  • Severe cutaneous adverse reactions (SCARs)
  • Parotitis
  • Nephrotic syndrome
  • Pseudomembranous enterocolitis
  • Blood disorders

Interactions

  • Grapefruit juice (severe - increases exposure)
  • Cenobamate (moderate - decreases exposure)
  • Mitotane (moderate - decreases exposure)
  • Rifampicin (moderate - decreases exposure)
  • Cobicistat (unknown - increases exposure)
  • Idelalisib (unknown - increases exposure)
  • Clarithromycin (unknown - increases exposure)

Precautions

  • Caution in hepatic impairment
  • Caution in renal impairment
  • Monitor blood counts and liver function tests

Pregnancy

Theoretical risk of neonatal haemolysis; adequate folate supplements advised.

Breast-feeding

Small amounts may appear in milk; theoretical risk of neonatal haemolysis, especially in G6PD-deficient infants.

Storage

Store in a cool, dry place, protected from light.

Formulations

  • Budenofalk® Capsules
  • Entocort® Capsules
  • Entocort® Enema
  • Oral suspension
BNF for Children 2019-2020 p.56 BNF for Children 2019-2020 p.185 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Budesonide

PubChem CID 5281004

Molecular formula: C25H34O6

Mechanism of action

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels. To investigate the roles of signal transduction and activator of transcription 6 (STAT6) and orosomucoid 1-like 3 (ORMDL3) in airway remodeling among asthmatic mice and to observe the effects of budesonide (BUD) on their expression, thirty mice were randomly divided into control, asthma, and BUD intervention group. The mice were sensitized and challenged with ovalbumin (OVA) to establish a mouse model of asthma. The BUD intervention group received aerosol inhalation of BUD dissolved in normal saline 30 minutes before each OVA challenge, while normal saline was used instead of OVA solution in the control group. The pathological changes in the airway were observed by hematoxylin-eosin staining and Masson staining. The interleukin-13 (IL-13) level in lung homogenate was measured by enzyme-linked immunosorbent assay. The mRNA expression of STAT6 and ORMDL3 was measured by RT-PCR. The asthma group showed more pathological changes in the airway than the control and BUD intervention groups, and the BUD intervention group had reduced pathological changes in the airway compared with the asthma group. The asthma and BUD intervention groups had significantly higher IL-13 levels and mRNA expression of STAT6 and ORMDL3 than the control group (P<0.05), and these indices were significantly higher in the asthma group than in the BUD intervention group (P<0.05). The Pearson correlation analysis showed that STAT6 mRNA expression was positively correlated with ORMDL3 mRNA expression (r=0.676, P=0.032). STAT6 and ORMDL3 may be involved in the airway remodeling of mice, and BUD can reduce airway remodeling in asthmatic mice, possibly by down-regulating mRNA expression of STAT6 and ORMDL3. Mucus hypersecretion from airway epithelium is a characteristic feature of severe asthma. Glucocorticoids (GCs) may suppress mucus production and diminish the harmful airway obstruction. We investigated the ability of GCs to suppress mRNA expression and protein synthesis of a gene encoding mucin, MUC5AC, induced by transforming growth factor (TGF)-alpha in human mucoepidermoid carcinoma (NCI-H292) cells and the molecular mechanisms underlying the suppression. We determined if GCs such as dexamethasone (DEX), budesonide (BUD), and fluticasone (FP) could suppress MUC5AC production induced by a combination of TGF-alpha and double-strand RNA, polyinosinic-polycytidylic acid (polyI:C). MUC5AC mRNA expression and MUC5AC protein production were evaluated. The signaling pathways activated by TGF-alpha and their inhibition by GCs were tested using a phosphoprotein assay and MUC5AC promoter assay. DEX significantly suppressed the expression of MUC5AC mRNA and MUC5AC protein induced by TGF-alpha. The activation of the MUC5AC promoter by TGF-alpha was significantly inhibited by DEX. DEX did not affect activation of downstream pathways of the EGF receptor or mRNA stability of MUC5AC transcripts. DEX, BUD, and FP suppressed MUC5AC protein expression induced by a combination of TGF-alpha and polyI:C in a dose-dependent manner. GCs inhibited MUC5AC production induced by TGF-alpha alone or a combination of TGF-alpha and polyI

Pharmacodynamics

Budesonide is a glucocorticoid used to treat respiratory and digestive conditions by reducing inflammation. It has a wide therapeutic index, as dosing varies highly from patient to patient. Patients should be counselled regarding the risk of hypercorticism and adrenal axis suppression.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.