Budesonide Nebuliser Suspension BP 0.5mg/2ml Technical Specification:
Product Name: | Budesonide Nebuliser Suspension BP |
Brand Name: | Asthacort |
Strength: | 0.5mg/2ml, 1mg/2ml |
Dosage Form: | Nebuliser / Respules for inhalation Only **Preservative Free |
Route of Administration: | Via Inhalation Route Only |
Packing: | 2ml Respules |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Anti-asthmatic |
Indication: | Budesonide Nebuliser Suspension is used to prevent asthma attacks. |
Storage: | Store below 25°C. Protect from light. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Budesonide Nebuliser Suspension BP 0.5mg/2ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Budesonide Nebuliser Suspension BP 0.5mg/2ml
Each 2ml contains:
Budesonide BP………….0.5mg
THERAPEUTIC INDICATIONS:
Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma.
Direction Of Use:
The product should be used with a nebuliser only, under the direction of a physician. It is not to be injected or administered orally. Remove a pouch of combipack respule from the carton. Use a fresh respule for each dose.
- Open the sealed aluminum foil envelope and remove one ampoule from the plastic strip. Record the space provided.
- Gently shake the ampoule using a circular motion. Before if use.
- Hold the ampoule upright without squeezing and open by twisting off the top.
- Place the open end of the ampoule into the nebulizer cup, and slowly squeeze out all of the contents. Discard the respules after use.
CAUTION & WARNING:
CAUTION: Even invisible damage to respule caused during storage or transit may result in contamination. Do not use, and return for replacement if the solution is discoloured, leak found on squeezing or contains visible black particles.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
shake well before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store the respules in foil pouch at all times. Once the foil pouch is opened the respules should be used within one month.
Store below 25°C.
Protect from light.
Do not freeze.
Dosage: As directed by the Physician
Why Taj Pharmaceuticals?
Taj Pharmaceuticals is a reputable pharmaceutical company known for its unwavering commitment to delivering high-quality healthcare solutions, making it a preferred choice for healthcare providers and patients seeking Budesonide inhalation powder. This commitment to quality assurance is foundational, assuring both healthcare professionals and patients of the efficacy and safety of the medication. With extensive expertise in the pharmaceutical industry, Taj Pharmaceuticals brings a wealth of experience to the production and distribution of a wide range of pharmaceutical products. This expertise not only enhances the reliability of their offerings but also positions them as a trusted and dependable supplier. Healthcare providers and patients can rely on the consistency and excellence that Taj Pharmaceuticals brings to the table. Furthermore, Taj Pharmaceuticals places paramount importance on regulatory compliance, strictly adhering to industry standards and implementing robust quality control procedures. This commitment ensures that Budesonide inhalation powder complies with essential quality and safety requirements mandated by regulatory authorities. The focus on regulatory compliance further reinforces patient safety, a critical aspect of pharmaceutical products.
Taj Pharmaceuticals’ global presence and well-established distribution network are instrumental in ensuring the widespread availability of Budesonide inhalation powder and other pharmaceuticals. Their international reach guarantees that essential medications are accessible to healthcare providers and patients in diverse regions, elevating patient care to a global level. Investment in research and development (R&D) is another distinguishing feature of Taj Pharmaceuticals. This commitment to innovation may lead to the development of more effective and advanced formulations of Budesonide inhalation powder, potentially enhancing its therapeutic benefits for patients. The reliability of the pharmaceutical supply chain is of paramount importance, and Taj Pharmaceuticals excels in this regard. Their dedication to supply chain management ensures a consistent and dependable supply of medications, ensuring that healthcare institutions and patients have uninterrupted access to vital treatments.
Affordability is another key consideration, and Taj Pharmaceuticals may offer competitive pricing options, making Budesonide inhalation powder more accessible to healthcare providers and patients. This commitment to affordability aligns with the goal of ensuring that essential medications are accessible to all without imposing financial barriers. Lastly, Taj Pharmaceuticals places a strong emphasis on patient-centric care, emphasizing patient well-being and safety. This focus aligns seamlessly with the importance of respiratory treatments, as Budesonide inhalation powder is used to manage respiratory conditions. Taj Pharmaceuticals’ commitment to patient safety reinforces the trust placed in their products by healthcare providers and patients, ultimately contributing to improved patient care and outcomes on a global scale. Taj Pharmaceuticals’ dedication to quality, compliance, research, affordability, and patient support positions them as a preferred choice for healthcare providers seeking a reliable supplier for Budesonide inhalation powder and other pharmaceutical needs. Their unwavering commitment to patient safety further enhances the value they bring to the healthcare community, ultimately benefiting patient care and outcomes worldwide.
What is Budesonide inhalation powder and its uses:
Budesonide inhalation powder is a medication used to treat various respiratory conditions. It belongs to a class of drugs known as corticosteroids, which have anti-inflammatory properties. Budesonide is typically administered through inhalation, where it is delivered directly to the lungs. Here are its uses:
- Asthma: Budesonide inhalation powder is commonly prescribed as a maintenance therapy for asthma. It helps reduce inflammation in the airways, making it easier for individuals with asthma to breathe. It is often used in combination with bronchodilators, such as beta-agonists, to control and prevent asthma symptoms.
- Chronic Obstructive Pulmonary Disease (COPD): Budesonide inhalation powder may be used as part of the treatment plan for individuals with COPD, a progressive lung condition that includes chronic bronchitis and emphysema. It can help reduce airway inflammation and improve lung function.
- Allergic Rhinitis: In some cases, Budesonide inhalation powder may be used to manage symptoms of allergic rhinitis (hay fever) when other treatments have not been effective. By reducing inflammation in the nasal passages, it can alleviate symptoms like nasal congestion, sneezing, and runny nose.
- Nasal Polyps: Budesonide nasal spray, a different formulation of the medication, is used to treat nasal polyps. Nasal polyps are noncancerous growths in the nasal passages that can cause congestion and breathing difficulties. Budesonide helps shrink these polyps and reduce associated symptoms.
- Inflammatory Bowel Disease: While Budesonide inhalation powder is primarily used for respiratory conditions, another formulation of the drug, Budesonide capsules or tablets, may be used to treat inflammatory bowel diseases like Crohn’s disease and ulcerative colitis. These conditions involve inflammation of the gastrointestinal tract, and Budesonide helps reduce inflammation and relieve symptoms.
It’s important to note that the specific use and dosage of Budesonide inhalation powder will be determined by a healthcare provider based on the individual’s medical condition, the severity of symptoms, and other factors. This medication is typically prescribed for the long-term management of chronic respiratory conditions and should be used regularly as directed by a healthcare professional. It is not intended for the relief of acute asthma attacks or sudden worsening of COPD symptoms; rescue inhalers are used for such situations.
How does Budesonide inhalation powder work?
Budesonide inhalation powder works by reducing inflammation and suppressing the immune response in the airways of the lungs. It is classified as a corticosteroid medication, and its mechanism of action is as follows:
- Anti-Inflammatory Effect: Budesonide is a potent anti-inflammatory medication. In respiratory conditions like asthma and chronic obstructive pulmonary disease (COPD), inflammation in the airways is a major contributor to symptoms such as wheezing, shortness of breath, and coughing. Budesonide works by inhibiting the production and release of inflammatory mediators, such as histamines and leukotrienes, which cause swelling and constriction of the airways. By reducing inflammation, it helps to open up the airways and improve airflow.
- Immune System Suppression: Budesonide also has immunosuppressive properties. In conditions like asthma, the immune system can overreact to triggers like allergens or irritants, leading to inflammation and bronchoconstriction. Budesonide helps modulate the immune response by suppressing the activity of immune cells, such as T-lymphocytes and eosinophils, which are involved in the inflammatory process.
- Prevention of Exacerbations: Budesonide inhalation powder is primarily used as a maintenance therapy to prevent and control symptoms in chronic respiratory conditions. By keeping inflammation in check, it reduces the frequency and severity of exacerbations, or flare-ups, that can occur in conditions like asthma and COPD.
- Long-Term Control: It is important to note that Budesonide inhalation powder is not a quick-relief medication for acute symptoms or sudden attacks. Instead, it is used on a regular basis to provide long-term control and stability in managing chronic respiratory conditions. Individuals with asthma or COPD should have a separate rescue inhaler for immediate relief during acute episodes.
- Targeted Delivery: Budesonide inhalation powder is administered through an inhaler device, allowing the medication to be delivered directly to the lungs. This targeted delivery minimizes systemic absorption, reducing the risk of systemic side effects commonly associated with oral corticosteroids.
Overall, Budesonide inhalation powder plays a critical role in managing chronic respiratory conditions by addressing the underlying inflammation and immune system responses that contribute to symptoms. It helps improve lung function, reduce the frequency of exacerbations, and enhance the overall quality of life for individuals with conditions like asthma and COPD.
Benefits of Budesonide Inhalation Powder:
- Effective Symptom Control: Budesonide inhalation powder is highly effective in controlling and managing chronic respiratory conditions like asthma and COPD. It helps reduce inflammation in the airways, leading to improved lung function and better symptom control.
- Prevention of Exacerbations: One of the key benefits is its ability to prevent exacerbations or flare-ups of respiratory conditions. By reducing airway inflammation, it lowers the risk of sudden worsening of symptoms, hospitalizations, and emergency room visits.
- Improved Quality of Life: Many individuals with asthma or COPD experience a significant improvement in their quality of life when using Budesonide inhalation powder regularly. Controlled symptoms mean better daily functioning and a reduced impact on daily activities.
- Targeted Delivery: Budesonide inhalation powder is delivered directly to the lungs via an inhaler, allowing for targeted and efficient delivery of the medication to the affected airways while minimizing systemic side effects.
- Suitable for Long-Term Use: It is designed for long-term use as a maintenance medication, allowing individuals to manage their chronic respiratory conditions over an extended period with consistent symptom control.
- Reduced Reliance on Rescue Medications: When used as prescribed, Budesonide inhalation powder can reduce the need for rescue inhalers or short-acting bronchodilators, which are typically used for acute symptom relief.
Common Side Effects of Budesonide Inhalation Powder:
- Sore Throat: Some individuals may experience a mild sore throat or irritation in the throat after using Budesonide inhalation powder. Gargling with water after inhalation may help alleviate this side effect.
- Coughing: Coughing is a potential side effect, especially when initiating treatment. This is often temporary and may subside as the body adjusts to the medication.
- Oral Thrush: In some cases, the use of Budesonide inhalation powder can lead to oral thrush, a fungal infection in the mouth. To minimize the risk, it’s important to rinse the mouth with water and spit it out after each use of the inhaler. Maintaining good oral hygiene is also crucial.
- Hoarseness: Hoarseness or changes in voice quality can occur, although this side effect is generally mild and reversible.
- Nasal Congestion: Budesonide inhalation powder is designed for the lungs, but some individuals may experience nasal congestion as a side effect. This can be managed by using a nasal rinse or saline spray if needed.
- Systemic Side Effects: Compared to oral corticosteroids, the risk of systemic side effects with Budesonide inhalation powder is relatively low. However, long-term use of high doses may still carry a slight risk of systemic effects, such as adrenal suppression or bone density reduction. These risks are generally lower with inhaled corticosteroids than with oral forms.
Frequently Asked Questions About Budesonide Inhalation Powder:
Certainly, here are some frequently asked questions (FAQs) about Budesonide inhalation powder:
- What is Budesonide inhalation powder used for?
Budesonide inhalation powder is used to treat chronic respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). It helps reduce inflammation in the airways and improve lung function.
- How does Budesonide inhalation powder work?
Budesonide is a corticosteroid that works by reducing inflammation in the airways. It suppresses the immune response and decreases the production of inflammatory mediators in the lungs, leading to improved breathing and symptom control.
- Is Budesonide inhalation powder a rescue inhaler?
No, Budesonide inhalation powder is not a rescue inhaler. It is a maintenance medication used to control and prevent symptoms in chronic respiratory conditions. For acute symptom relief during sudden attacks, individuals should use a separate rescue inhaler or bronchodilator as prescribed.
- How often should I use Budesonide inhalation powder?
The dosing frequency will be determined by your healthcare provider based on your specific condition and severity of symptoms. It is typically used once or twice daily as a longterm maintenance medication. Always follow the prescribed dosing instructions.
- Are there any special instructions for using the inhaler device?
Yes, proper inhaler technique is crucial for effective medication delivery. It’s important to follow the instructions provided with the inhaler device and practice proper inhalation technique to ensure the medication reaches your lungs effectively.
- Can Budesonide inhalation powder cause oral thrush?
Yes, one potential side effect of Budesonide inhalation powder is oral thrush, a fungal infection in the mouth. To reduce the risk, rinse your mouth with water and spit it out after each use of the inhaler. Maintaining good oral hygiene can also help prevent this side effect.
- Can I stop using Budesonide inhalation powder if my symptoms improve?
It’s important to follow your healthcare provider’s instructions regarding the use of Budesonide inhalation powder. Even if your symptoms improve, abruptly discontinuing the medication without guidance can lead to symptom relapse. Discuss any changes in your treatment plan with your healthcare provider.
- Are there any interactions with other medications?
Inform your healthcare provider about all medications, including prescription, overthecounter, and herbal products, that you are taking. Some medications may interact with Budesonide, and dosage adjustments or alternative treatments may be necessary.
- Is Budesonide inhalation powder safe for longterm use?
Budesonide inhalation powder is generally safe for longterm use when prescribed by a healthcare provider. It is designed as a maintenance medication for chronic respiratory conditions. The benefits of symptom control and prevention of exacerbations often outweigh the potential risks when used as directed.
Always consult with your healthcare provider for personalized guidance and answers to specific questions or concerns you may have about Budesonide inhalation powder and its use in your particular situation.
As Budesonide inhalation powder Exporters; We can cater to export business queries from the following geographies. We are exporting our Budesonide inhalation powder product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Budesonide inhalation powder Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Budesonide inhalation powder, Taj Pharmaceuticals Limited to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Budesonide Nebuliser Suspension BP 0.5mg/2ml
B) Budesonide Nebuliser Suspension BP 1mg/2ml
B) Budesonide Nebuliser Suspension BP 1mg/2ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Budesonide Nebuliser Suspension BP 0.5mg/2ml
Each 2ml contains:
Budesonide BP………….0.5mg
B) Budesonide Nebuliser Suspension BP 1mg/2ml
Each 2ml contains:
Budesonide BP………….1mg
Each 2ml contains:
Budesonide BP………….0.5mg
B) Budesonide Nebuliser Suspension BP 1mg/2ml
Each 2ml contains:
Budesonide BP………….1mg
THERAPEUTIC INDICATIONS:
Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma.
Direction Of Use:
The product should be used with a nebuliser only, under the direction of a physician. It is not to be injected or administered orally. Remove a pouch of combipack respule from the carton. Use a fresh respule for each dose.
1. Open the sealed aluminum foil envelope and remove one ampoule from the plastic strip. Record the space provided.
2. Gently shake the ampoule using a circular motion. Before if use.
3. Hold the ampoule upright without squeezing and open by twisting off the top.
4. Place the open end of the ampoule into the nebulizer cup, and slowly squeeze out all of the contents. Discard the respules after use.
1. Open the sealed aluminum foil envelope and remove one ampoule from the plastic strip. Record the space provided.
2. Gently shake the ampoule using a circular motion. Before if use.
3. Hold the ampoule upright without squeezing and open by twisting off the top.
4. Place the open end of the ampoule into the nebulizer cup, and slowly squeeze out all of the contents. Discard the respules after use.
CAUTION & WARNING:
CAUTION:
Even invisible damage to respule caused during storage or transit may result in contamination. Do not use, and return for replacement if the solution is discoloured, leak found on squeezing or contains visible black particles.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SHAKE WELL BEFORE USE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Even invisible damage to respule caused during storage or transit may result in contamination. Do not use, and return for replacement if the solution is discoloured, leak found on squeezing or contains visible black particles.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SHAKE WELL BEFORE USE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store the respules in foil pouch at all times. Once the foil pouch is opened the respules should be used within one month.
Store below 25°C.
Protect from light.
Do not freeze. Dosage: As directed by the Physician
Attach dispensing label as per end country.
Store below 25°C.
Protect from light.
Do not freeze. Dosage: As directed by the Physician
Attach dispensing label as per end country.