Budesonide (Budexa) 250mcg/ml 500mcg/2ml Suspension for Nebulization Corticosteroid Respules 20's

Here is the detailed information for Budesonide (Budexa) 250mcg/ml 500mcg/2ml Suspension for Nebulization Corticosteroid Respules 20's:

Product Description:

Budesonide (Budexa 250mcg/ml) is a corticosteroid used in the treatment of respiratory conditions like asthma and chronic obstructive pulmonary disease (COPD). The product is in the form of a suspension for nebulization, which means it is intended to be used via a nebulizer to deliver the medication directly into the lungs. This medication works by reducing inflammation in the airways, which helps to prevent and control symptoms of asthma and COPD.

Each respule contains 250 mcg of Budesonide per ml, and each vial contains 500 mcg per 2 ml. The package contains 20 respules for nebulization.

Indications:

Budesonide (Budexa 250mcg/ml) is indicated for the following conditions:

1. Asthma:

   • Budesonide is used for the maintenance treatment of asthma. It helps to reduce airway inflammation, preventing asthma attacks and improving breathing.

2. Chronic Obstructive Pulmonary Disease (COPD):

   • It is used as part of the treatment regimen for COPD to reduce inflammation and help manage symptoms such as wheezing, shortness of breath, and chronic cough.

3. Acute Exacerbation of Asthma or COPD:

   • In some cases, Budesonide may be used in the management of acute exacerbations or flare-ups of asthma or COPD, often in combination with other medications like bronchodilators.

Dosages:

The dosage of Budesonide (Budexa 250mcg/ml) varies depending on the patient's condition and the severity of symptoms. The usual dosages are as follows:

For Asthma:

• Adults and Children (≥12 years):

  • The usual dose is 500 mcg to 1 mg twice daily via nebulizer.

  • The maximum recommended dose is 2 mg twice daily.

• Children (6 to 12 years):

  • The usual dose is 250 mcg to 500 mcg twice daily via nebulizer.

  • The maximum recommended dose is 1 mg twice daily.

For Chronic Obstructive Pulmonary Disease (COPD):

• Adults:

  • The usual dose is 500 mcg twice daily via nebulizer.

  • The maximum dose is 1 mg twice daily.

For Acute Exacerbations:

• Higher doses may be used during acute exacerbations as determined by the healthcare provider, often in combination with other respiratory medications.

Side Effects:

Budesonide (Budexa 250mcg/ml) may cause the following side effects:

Common Side Effects:

1. Throat irritation or hoarseness.

2. Cough.

3. Headache.

4. Nausea.

5. Mouth or throat fungal infections (e.g., thrush).

6. Dry mouth.

7. Increased mucus production.

Less Common/Serious Side Effects:

1. Wheezing or shortness of breath (paradoxical bronchospasm).

2. Eye problems such as glaucoma or cataracts with long-term use.

3. Delayed growth in children (rare).

4. Suppressed immune system, increasing the risk of infections.

5. Bone thinning or osteoporosis with prolonged use.

6. Allergic reactions, including rash, swelling of the face or throat, and difficulty breathing (anaphylaxis).

7. Cushing's syndrome (characterized by weight gain, rounding of the face, etc.).

If any of the serious side effects occur, medical help should be sought immediately.

Contraindications:

Budesonide (Budexa 250mcg/ml) should not be used in the following conditions:

1. Hypersensitivity to Budesonide or any component of the formulation.

   • Patients with known allergies to Budesonide or other corticosteroids should not use this medication.

2. Acute Respiratory Infections:

   • Budesonide should not be used during acute infections like a severe bronchial infection unless prescribed by a healthcare professional, as corticosteroids may worsen the infection.

3. Untreated Fungal, Bacterial, or Viral Infections:

   • The use of Budesonide should be avoided in patients with active or untreated infections, especially those of the respiratory tract, as corticosteroids can suppress immune response and worsen infections.

4. Severe Liver Disease:

   • Budesonide should be used with caution in patients with severe liver disease, as the liver metabolizes this medication. The dosage may need to be adjusted based on liver function.

5. Pregnancy (Category C):

   • Budesonide should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider before using Budesonide during pregnancy.

6. Breastfeeding:

   • Budesonide is excreted in breast milk, so it should only be used during breastfeeding if absolutely necessary and if prescribed by a healthcare provider.

Precautions:

1. Inhaled Corticosteroid Use:

   • Inhaled corticosteroids like Budesonide may cause oral thrush (fungal infection of the mouth). It is important to rinse the mouth with water after each use to reduce this risk.

2. Growth in Children:

   • Prolonged use of Budesonide in children may affect growth. Regular monitoring of growth in pediatric patients is recommended.

3. Bone Health:

   • Long-term use of Budesonide may cause osteoporosis or bone thinning. Consider evaluating bone density in patients on prolonged therapy.

4. Immunosuppression:

   • Budesonide can suppress the immune system, increasing the risk of infections. Patients should avoid exposure to infections like chickenpox and measles.

5. Tapering Off:

   • If discontinuing Budesonide, it should be done gradually under the supervision of a healthcare provider to avoid adrenal insufficiency.

Summary:

Budesonide (Budexa 250mcg/ml) is a corticosteroid suspension used in the nebulization treatment of asthma and COPD. It works by reducing inflammation in the airways, helping to prevent symptoms and manage chronic respiratory conditions.

The typical dosage for asthma ranges from 250 mcg to 1 mg twice daily, while for COPD it is typically 500 mcg twice daily. The medication is generally well-tolerated, with common side effects such as throat irritation, cough, and headache. Serious side effects, though rare, may include cushing's syndrome, glaucoma, and bone thinning.

Budesonide is contraindicated in patients with hypersensitivity to the drug, active respiratory infections, or severe liver disease. Caution is advised for use in pregnant women and breastfeeding mothers. Regular monitoring is recommended for children and long-term users due to potential impacts on growth and bone health.

Please consult a healthcare professional before using this medication to ensure it is appropriate for your specific condition.