Registered Rwanda · Rwanda FDA

BUDECOT 0.5MG

BUDESONIDEINHALATION SUSPENTION 0.5MG/2ML

Rwanda FDA-HMP-MA-1893 TABLETS 0.5MG

What it does

Budesonide inhalation is a medication used to manage and prevent symptoms of asthma and chronic obstructive pulmonary disease (COPD).

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

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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.
Rwanda FDA-HMP-MA-1893
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
BUDESONIDEINHALATION SUSPENTION 0.5MG/2ML
Dosage form
TABLETS
Strength
0.5MG
Pack size
Carton containing 4 combipack pouch having 5 respules of 2 ml each
Therapeutic class
-
Manufacturer / MAH
Cipla Ltd
Applicant / LTR
-
Country of origin
India
Manufacturer location
Lal Bahadur Shastri Marg, Chandan Nagar, Vikhroli West, Mumbai, Maharashtra 400083, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:09 · updated 2026-09-21 02:30:19

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

About budesonideinhalation

Budesonide inhalation is a medication used to manage and prevent symptoms of asthma and chronic obstructive pulmonary disease (COPD).

What it treats

  • asthma
  • chronic obstructive pulmonary disease (COPD)

How it works

Budesonide works by reducing inflammation in the airways, making it easier to breathe.

Who it's for

This medication is for people with asthma or COPD who need help controlling their breathing.

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

About suspention

Suspension is a liquid form of medication that contains tiny particles of a drug mixed in a liquid. It is often used for easier swallowing, especially in children.

What it treats

  • treating infections
  • managing pain
  • reducing inflammation

How it works

Suspensions work by delivering medication directly into the body, where the active ingredients can take effect quickly.

Who it's for

Suspensions are suitable for people of all ages, including children and those who have difficulty swallowing pills.

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

Clinical monograph: budesonideinhalation

Budesonide is a potent corticosteroid used primarily in the management of asthma and chronic obstructive pulmonary disease (COPD) through inhalation. It functions as an anti-inflammatory agent, reducing airway inflammation and hyper-responsiveness, thus improving respiratory function and decreasing the frequency of exacerbations. Budesonide is also utilized in the treatment of allergic rhinitis and certain gastrointestinal conditions when given in other formulations.

Indications

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

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing recommendations.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Budesonide exerts its effects by binding to glucocorticoid receptors within the cytoplasm of target cells. This binding leads to the regulation of gene expression and subsequent synthesis of anti-inflammatory proteins, while inhibiting the expression of pro-inflammatory genes. The net effect is a reduction in inflammation and immune response in the airways, enhancing airway patency and reducing symptoms associated with asthma and COPD.

Pharmacodynamics

The pharmacodynamic effects of budesonide include decreased synthesis and release of inflammatory mediators such as cytokines and leukotrienes. It also inhibits the migration of inflammatory cells to the airways and decreases mucus production. These actions contribute to improved lung function and reduced symptoms of respiratory conditions.

Pharmacokinetics

Budesonide is rapidly absorbed following inhalation, with peak plasma concentrations occurring within 30 minutes to 2 hours. It has a high first-pass metabolism in the liver, resulting in a bioavailability of approximately 15-20% when inhaled. The elimination half-life is about 2 to 3 hours. The drug is primarily metabolized by the cytochrome P450 system, specifically CYP3A4, and is excreted mainly in the urine as metabolites, with less than 1% excreted unchanged.

Contra-indications

  • Hypersensitivity to budesonide or any other component of the formulation
  • Untreated systemic fungal infections

Adverse effects

  • Oral thrush
  • Hoarseness
  • Cough
  • Headache
  • Nausea
  • Respiratory infection
  • Pneumonia
  • Adrenal suppression
  • Growth retardation in children

Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase the plasma concentration of budesonide
  • CYP3A4 inducers (e.g., rifampicin, phenytoin) may decrease the effectiveness of budesonide

Precautions

  • Use with caution in patients with active or quiescent pulmonary tuberculosis
  • Monitor for signs of adrenal insufficiency
  • Consider potential effects on growth in children
  • Patients with hepatic impairment may require dose adjustment

Pregnancy

Budesonide is classified as category B. Animal studies have not shown teratogenic effects, but use should be limited to necessary cases during pregnancy.

Breast-feeding

Budesonide is excreted in breast milk, but is generally considered safe for use during breastfeeding as systemic absorption is low.

Storage

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

Formulations

  • Inhalation aerosol
  • Dry powder inhaler

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

Clinical monograph: suspention

Suspension refers to a liquid formulation containing solid particles dispersed throughout a liquid medium. These formulations are commonly used for drugs that are insoluble or poorly soluble in their intended solvent, allowing for easier administration and absorption. Suspensions can be utilized in various therapeutic areas, including antibiotics, antipyretics, and anti-inflammatory medications.

Indications

  • Antibiotic therapy
  • Pain relief
  • Reduction of fever
  • Treatment of inflammation
  • Nutritional supplementation

Dosage

Children: Refer to specific drug formulations and their respective guidelines for dosing.

Adults: Refer to specific drug formulations and their respective guidelines for dosing.

Mechanism of action

The mechanism of action for drugs in suspension varies depending on the active ingredient. For example, antibiotics in suspension may inhibit bacterial cell wall synthesis or protein synthesis, leading to bacterial cell death. The dispersed solid particles allow for a controlled release of the active drug once ingested, enhancing bioavailability and therapeutic effects.

Pharmacodynamics

Suspensions provide an alternative route for drug delivery, particularly for patients who have difficulty swallowing pills. The pharmacodynamic effects depend on the active ingredient; for instance, anti-inflammatory agents reduce inflammation by inhibiting cyclooxygenase enzymes, while antipyretics work by acting on the hypothalamus to lower fever.

Pharmacokinetics

The pharmacokinetics of a drug in suspension is influenced by the particle size of the suspended solids, the viscosity of the medium, and the solubility of the active ingredient. Generally, after administration, the active drug is released from the suspension and absorbed through the gastrointestinal tract, reaching peak plasma concentrations within a specific time frame, which varies by formulation and drug properties.

Pregnancy

Consult healthcare professionals before use, as safety may vary depending on the specific active ingredient in the suspension.

Breast-feeding

Consult healthcare professionals before use, as safety may vary depending on the specific active ingredient in the suspension.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

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

This drug in other countries

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