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BUDESONE 1OO INHALATION

BUDOSONIDE

FDA/SD.253-010099 100MG

What it does

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

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

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

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Registration & product details

Registration no.
FDA/SD.253-010099
Registration date
2025-01-21
Expiry date
2028-02-01
Status
Valid
Active ingredient
BUDOSONIDE
Dosage form
-
Strength
100MG
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Midos Care Pharmaceuticals
Country of origin
-
Manufacturer location
Midas Care Pharmaceuticals Pvt. Ltd, 3B, Lotus Corporate Park,, Gram Path, Goregaon East, Western Express Highway., Geetanjali Railway Colony, Laxmi Nagar, Jogeshwari East, Mumbai, Maharashtra 400060, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:45:56 · updated 2026-10-20 04:00:14

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

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

What it treats

  • asthma
  • chronic obstructive pulmonary disease (COPD)
  • inflammatory bowel disease
  • allergic rhinitis

How it works

Budesonide works by calming down the immune system's response, which helps to decrease swelling and irritation in the airways and intestines.

Who it's for

Budesonide is for people suffering from conditions like asthma, COPD, or inflammation in the gut.

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

Clinical monograph: budosonide

Budesonide is a synthetic corticosteroid that exhibits anti-inflammatory effects. It is primarily used in the management of asthma and chronic obstructive pulmonary disease (COPD), as well as allergic rhinitis and other conditions requiring anti-inflammatory treatment. Budesonide works by reducing inflammation in the airways, leading to improved respiratory function and reduced symptoms.

Indications

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Allergic rhinitis
  • Eosinophilic esophagitis
  • Inflammatory bowel disease (IBD)

Dosage

Children: Refer to the BNF for Children for appropriate dosing.

Adults: Refer to the specific product information and local guidelines for appropriate dosing.

Mechanism of action

Budesonide binds to glucocorticoid receptors, which, upon activation, translocate to the nucleus and regulate the expression of anti-inflammatory proteins while inhibiting pro-inflammatory cytokines. This results in decreased inflammation and modulation of immune responses. Budesonide also inhibits the migration of leukocytes to sites of inflammation.

Pharmacodynamics

Budesonide has potent anti-inflammatory properties that help to control inflammation in the respiratory tract. The onset of action for budesonide is relatively quick, leading to symptomatic relief in asthma and COPD. Its effects can be long-lasting, allowing for improved lung function and reduced frequency of exacerbations.

Pharmacokinetics

Budesonide is administered via inhalation, allowing for direct delivery to the lungs. It undergoes extensive first-pass metabolism in the liver, which results in a low systemic bioavailability (approximately 10-15%). The drug is primarily metabolized by CYP3A4 enzymes, and its elimination half-life ranges from 2 to 3 hours. Budesonide is excreted mainly via urine as metabolites, with less than 1% excreted unchanged.

Contra-indications

  • Hypersensitivity to budesonide or any of its components
  • Untreated systemic infections

Adverse effects

  • Headache
  • Nausea
  • Vomiting
  • Dizziness
  • Cough
  • Throat irritation
  • Oral candidiasis
  • Adrenal suppression
  • Growth retardation in children

Interactions

  • CYP3A4 inhibitors may increase systemic exposure to budesonide
  • Strong CYP3A4 inducers may decrease the efficacy of budesonide

Precautions

  • Use with caution in patients with active or latent tuberculosis
  • Monitor for signs of adrenal suppression, especially during stress
  • Consider alternative treatments in patients with severe liver disease

Pregnancy

Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Budesonide is excreted in breast milk; use caution and consider benefits versus risks.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Inhalation aerosol
  • Nebulizer solution
  • Nasal spray
  • Oral extended-release capsule

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