Budesonide & Formoterol | BUDOWELL-F 0.5/20 RESPULES

₹1,200.00

Combination respule formulation containing budesonide and formoterol fumarate.

Product Specifications

Composition: Budesonide 0.5 mg + Formoterol Fumarate 20 mcg
Dosage Form: Respules
Therapeutic Categories: Anti-Asthmatic
SKU: BUDOWELL-F 0.5/20 RESPULES Category: Tags: , , , , Brand:

Description

BUDOWELL-F 0.5/20 RESPULES contains Budesonide 0.5 mg + Formoterol Fumarate 20 mcg in each 2mL respule. It is an inhaled combination of an anti-inflammatory corticosteroid and a long-acting bronchodilator used under medical supervision for obstructive airway conditions where both an inhaled corticosteroid and long-acting bronchodilator are clinically appropriate.

Budesonide helps reduce inflammatory activity in the airways, while formoterol fumarate provides prolonged relaxation of bronchial smooth muscle to support improved airflow. The combination therefore provides complementary anti-inflammatory and bronchodilator actions.

The supplied product information specifies Budesonide 0.5 mg + Formoterol Fumarate 20 mcg in each 2mL respule, with a pack size of 4 × 5 × 2mL. Because the stated budesonide strength differs substantially from commonly marketed budesonide nebulizer strengths, the product label and prescribed concentration should always be verified by the healthcare professional before administration.

BUDOWELL-F 0.5/20 RESPULES is part of the pharmaceutical product portfolio of Sarian Healthcare and may be relevant to healthcare professionals and pharmaceutical procurement channels seeking inhalation-based respiratory products.

Product use, dosage, nebulizer compatibility, and treatment duration should be determined by the prescribing physician according to the patient’s diagnosis and clinical requirements.

Composition

Budesonide 0.5 mg

Active Ingredient: Budesonide
Strength: 0.5 mg per 2mL respule, as supplied
Drug Class: Inhaled corticosteroid / glucocorticoid
Therapeutic Category: Respiratory anti-inflammatory medicine
Primary Function: Reduction of airway inflammation

Budesonide activates glucocorticoid receptors and influences inflammatory pathways involved in airway inflammation. It helps reduce the production and activity of multiple inflammatory mediators.

Formoterol Fumarate 20 mcg

Active Ingredient: Formoterol fumarate
Strength: 20mcg per 2mL respule, as supplied
Drug Class: Long-acting selective beta2-adrenergic receptor agonist (LABA)
Therapeutic Category: Long-acting bronchodilator
Primary Function: Prolonged relaxation of bronchial smooth muscle

Formoterol stimulates beta2-adrenergic receptors in airway smooth muscle, increasing intracellular cyclic AMP and producing bronchodilation.

What Is Budesonide + Formoterol Respules Used For?

Budesonide and formoterol combination therapy may be used under medical supervision for obstructive airway conditions where both anti-inflammatory corticosteroid therapy and long-acting bronchodilation are clinically appropriate.

The two ingredients address different components of respiratory disease:

  • Budesonide helps control airway inflammation.
  • Formoterol fumarate provides prolonged bronchodilation by relaxing bronchial smooth muscle.

The exact clinical indication depends on the patient’s diagnosis, disease severity, previous treatment, and physician’s treatment plan.

Budesonide-formoterol combination products are prescription therapies and should not be used for self-treatment or as a substitute for an individually prescribed rapid-relief strategy for sudden severe breathing symptoms.

Key Ingredients and Their Functions

Budesonide

Budesonide is an inhaled corticosteroid belonging to the glucocorticoid class. Its principal role is to suppress airway inflammatory activity.

It works through intracellular glucocorticoid receptors and influences gene transcription associated with inflammation, helping reduce inflammatory mediator activity and airway inflammatory responses.

Formoterol Fumarate

Formoterol is a long-acting selective beta2-adrenergic receptor agonist. It produces bronchodilation by acting on beta2 receptors in bronchial smooth muscle.

Its pharmacological action increases intracellular cyclic AMP, promoting smooth-muscle relaxation and supporting improved airway calibre and airflow.

Key Benefits of BUDOWELL-F 0.5/20 RESPULES

  • Dual pharmacological action: Combines an inhaled corticosteroid with a long-acting bronchodilator.
  • Helps control airway inflammation: Budesonide reduces inflammatory activity within the respiratory tract.
  • Provides bronchodilator activity: Formoterol supports prolonged relaxation of bronchial smooth muscle.
  • Supports airflow: Formoterol-mediated bronchodilation can help improve airway calibre and airflow.
  • Complementary respiratory therapy: The two ingredients work through different pharmacological pathways.
  • Nebulized dosage form: The respule presentation is designed for administration through an appropriate nebulization system when prescribed.
  • Consistent product presentation: Each supplied 2mL respule contains the specified Budesonide 0.5 mg + Formoterol Fumarate 20 mcg composition.

How Does Budesonide 0.5 mg + Formoterol Fumarate 20 mcg Work?

BUDOWELL-F 0.5/20 RESPULES works through two complementary mechanisms.

Action of Budesonide

Budesonide is a glucocorticoid corticosteroid. After reaching airway tissues, it interacts with intracellular glucocorticoid receptors and influences gene transcription involved in inflammatory processes.

This reduces the activity and production of inflammatory mediators and helps decrease airway inflammatory responses, mucosal swelling, and related inflammatory changes.

Action of Formoterol

Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist.

It binds to beta2 receptors on bronchial smooth muscle and activates adenylate cyclase, increasing intracellular cyclic AMP. This promotes smooth-muscle relaxation and produces bronchodilation, helping improve airway calibre and airflow.

Combined Action

The combination therefore addresses two important components of obstructive airway disease:

Airway inflammation → Budesonide

Bronchoconstriction → Formoterol

The precise clinical role of the combination depends on the patient’s diagnosis, disease severity, previous therapy, and physician-directed treatment plan.

Directions for Use

BUDOWELL-F 0.5/20 RESPULES should be used only as prescribed by a qualified healthcare professional.

  • The product is intended for inhalation through an appropriate nebulization system.
  • It is not intended for oral administration or injection.
  • The exact dose, frequency, nebulizer system, and treatment duration should be determined by the treating physician.
  • Do not change the prescribed dose or frequency independently.
  • Use the respule according to the product instructions and nebulizer manufacturer’s instructions.
  • Nebulizer devices may not provide equivalent drug delivery; healthcare professionals should verify device compatibility.
  • Rinse the mouth after inhalation, particularly because budesonide may increase the risk of oral candidiasis.
  • Do not use additional doses for sudden severe breathing symptoms unless specifically instructed by the treating physician.
  • Do not discontinue regular corticosteroid-containing therapy without medical advice.

Dosage and treatment duration should be determined according to the patient’s clinical condition and response to treatment.

Possible Side Effects

Possible side effects associated with Budesonide + Formoterol therapy may include:

  • Headache
  • Tremor or nervousness
  • Throat irritation
  • Hoarseness or voice changes
  • Cough
  • Dry mouth
  • Nausea
  • Muscle cramps
  • Palpitations or awareness of heartbeat
  • Oral or throat candidiasis (thrush)

Not every patient experiences these effects.

Important Adverse Reactions

Clinically important reactions may include:

  • Paradoxical bronchospasm or worsening wheezing immediately after inhalation
  • Hypersensitivity reactions, including rash, urticaria, angioedema, or bronchospasm
  • Significant cardiovascular effects such as tachycardia or rhythm disturbances
  • Hypokalemia or other metabolic effects associated with beta2-agonist therapy
  • Adrenal suppression or systemic corticosteroid effects with significant exposure
  • Effects on bone mineral density with prolonged corticosteroid exposure
  • Glaucoma or cataracts with long-term corticosteroid exposure

Severe breathing difficulty, facial or throat swelling, marked palpitations, or other serious symptoms require prompt medical evaluation.

Safety Information

Use BUDOWELL-F 0.5/20 RESPULES only according to the prescribing physician’s instructions.

  • Do not use in patients with known allergy to budesonide, formoterol, or any component of the product.
  • This combination should not automatically be considered a substitute for a prescribed rapid-relief medicine during an acute severe bronchospasm episode.
  • Rinse the mouth after inhalation to help reduce the risk of oral candidiasis.
  • Patients with significant heart disease, arrhythmias, hypertension, or other cardiovascular conditions should be assessed by a physician.
  • Beta2-agonists may affect blood glucose and potassium levels in susceptible patients.
  • Patients with hyperthyroidism or other thyroid conditions should inform their physician.
  • Patients with seizure disorders should inform their physician before treatment.
  • Dose and treatment decisions in kidney or liver impairment should be individualized according to the patient’s overall clinical status.
  • Use during pregnancy only when the expected clinical benefit justifies potential risks and under medical supervision.
  • Discuss treatment with the treating physician before use during breastfeeding.
  • Pediatric use should be based on the specific indication, formulation, strength, and physician’s assessment.
  • Prolonged therapy in children may require monitoring of growth and corticosteroid-related effects.
  • Elderly patients may require closer monitoring for cardiovascular, metabolic, and corticosteroid-related effects.
  • Inform the physician about beta-blockers, diuretics, other beta2-agonists, corticosteroids, medicines affecting potassium, strong CYP3A4 inhibitors, and other regular medicines.
  • If dizziness, tremor, palpitations, or other symptoms affect alertness or coordination, avoid driving or operating machinery until medically safe.

Storage Instructions

Store BUDOWELL-F 0.5/20 RESPULES in a cool, dry place away from direct sunlight and moisture.

Keep out of reach of children and follow the storage instructions printed on the product packaging.

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BUDOWELL-F 0.5/20 RESPULES – Product Summary

BUDOWELL-F 0.5/20 RESPULES contains Budesonide 0.5 mg + Formoterol Fumarate 20 mcg per 2mL respule, as specified in the supplied product information.

Budesonide provides anti-inflammatory corticosteroid activity, while formoterol provides long-acting bronchodilator activity. The combination is intended for physician-directed nebulized respiratory treatment where both pharmacological actions are clinically appropriate.

Product: BUDOWELL-F 0.5/20 RESPULES
Composition: Budesonide 0.5 mg + Formoterol Fumarate 20 mcg
Dosage Form: 2mL Respule
Pack Size: 4 × 5 × 2mL
Manufacturer: Sarian Healthcare

Additional information

Product Name

BUDOWELL-F 0.5/20 RESPULES

Generic Name

Budesonide + Formoterol Fumarate

Composition

Budesonide 0.5 mg + Formoterol Fumarate 20 mcg

Dosage Form

Therapeutic Categories

Drug Class

Inhaled Corticosteroid & Long-Acting Beta-2 Agonist

Indication

Maintenance treatment of asthma and chronic obstructive airway disease

Target Infections - Conditions

Asthma & COPD

Strength

Budesonide 0.5 mg + Formoterol Fumarate 20 mcg / 2 mL

Pack Size

4X5X2 ml

Packaging Type

Respule

Storage Conditions

Store in a cool and dry place below 25?C. Protect from moisture and direct sunlight.

Prescription Status

Rx (To be taken under medical supervision)

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Product FAQ

Q1. What is Budesonide 0.5 mg + Formoterol Fumarate 20 mcg used for?
Budesonide 0.5 mg + Formoterol Fumarate 20 mcg is an inhaled corticosteroid-LABA combination used under medical supervision for appropriate obstructive airway conditions where both anti-inflammatory and long-acting bronchodilator therapy are indicated.

Q2. What is Budesonide and which drug class does it belong to?
Budesonide is a synthetic glucocorticoid corticosteroid. In inhaled therapy, it primarily reduces airway inflammation by activating glucocorticoid receptors and modifying inflammatory gene activity.

Q3. What is Formoterol Fumarate and how does it work?
Formoterol Fumarate is a long-acting selective beta2-adrenergic receptor agonist. It stimulates beta2 receptors in bronchial smooth muscle, increases cyclic AMP, and produces prolonged bronchodilation.

Q4. What are the benefits of Budesonide 0.5 mg + Formoterol Fumarate 20 mcg?
The combination provides complementary anti-inflammatory and bronchodilator actions. Budesonide targets airway inflammation, while Formoterol promotes sustained relaxation of bronchial smooth muscle.

Q5. What is BUDOWELL-F 0.5/20 RESPULES?
BUDOWELL-F 0.5/20 RESPULES is a Sarian Healthcare respiratory product supplied as 2 mL respules containing the stated Budesonide 0.5 mg + Formoterol Fumarate 20 mcg composition.

Q6. How should Budesonide + Formoterol respules be taken?
Budesonide 0.5 mg + Formoterol Fumarate 20 mcg respules should be administered by inhalation using the appropriate nebulization system as prescribed. The physician should determine the dosage, frequency, device requirements, and treatment duration.

Q7. What are the common side effects of Budesonide + Formoterol?
Possible adverse effects include headache, tremor, throat irritation, hoarseness, cough, oral candidiasis, nausea, muscle cramps, and palpitations. The occurrence and severity vary between patients.

Q8. Who should use caution with Budesonide + Formoterol?
Patients with cardiovascular disease, arrhythmias, hypertension, diabetes, thyroid disorders, seizure disorders, osteoporosis risk, glaucoma, cataracts, or recurrent infections should inform their physician before treatment.

Q9. Should the mouth be rinsed after Budesonide + Formoterol nebulization?
Yes. Rinsing the mouth after inhaled Budesonide therapy can help reduce residual corticosteroid exposure in the mouth and lower the risk of oral candidiasis.

Q10. Where can healthcare professionals or pharmaceutical distributors source Budesonide + Formoterol products from Sarian Healthcare?
Healthcare professionals, distributors, stockists, and procurement teams can contact Sarian Healthcare for product availability, commercial requirements, and pharmaceutical sourcing information for BUDOWELL-F 0.5/20 RESPULES.