Ambroxol Hydrochloride Respiratory Solution 15mg Technical Specification:
Product Name: | Ambroxol Hydrochloride Respiratory Solution |
Brand Name: | Mucoshield |
Strength: | 15mg/Respule |
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: | Mucolytics, Anticough |
Indication: | Ambroxol works to thin down and break up phlegm (sputum). |
Storage: | Store below 25°C. Protect from light. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ambroxol Hydrochloride Respiratory Solution 15mg/2ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ambroxol Hydrochloride Respiratory Solution 15mg/2ml
Composition:
Each 2ml contains:
Ambroxol Hydrochloride USP………….15mg
In an isotonic solution………………………….Q.S.
THERAPEUTIC INDICATIONS:
Ambroxol works by thinning down the mucus in the airway passages, thus making the mucus less sticky and it also facilitates the removal of the mucus from the airways.
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.
For oral administration.
shake the bottle 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: Adults & Children (Above 5 years of age): One respule(15mg) twice daily.
Children (Below 5 years of age): Half Respule (7.5mg) twice daily.
Mucoshield Respules are inhaled with the aid of a nebulizer. They can also be diluted with distilled water in the ratio of 1:1.
Attach dispensing label as per end country.
Why Taj pharmaceuticals?
Discover why Taj Pharmaceuticals is your trusted choice for Ambroxol Hydrochloride. We provide high-quality pharmaceutical products, including Ambroxol Hydrochloride, known for its effectiveness in respiratory conditions. With our commitment to excellence, stringent quality control, and global distribution, Taj Pharmaceuticals ensures reliable and accessible healthcare solutions. Choose us for your Ambroxol Hydrochloride needs and experience superior pharmaceuticals that prioritize your well-being.
What is Ambroxol Hydrochloride and its uses:
Ambroxol Hydrochloride is a medication primarily utilized as a mucolytic agent and expectorant, with its primary purpose being the relief of respiratory conditions. This medication proves highly effective in this regard by assisting in the thinning and loosening of mucus within the airways, facilitating its easier expulsion and clearance from the lungs. Its principal applications include managing a range of respiratory disorders, such as coughs, bronchitis (both acute and chronic), and chronic obstructive pulmonary disease (COPD). It can also play a supportive role in asthma management by helping control excessive mucus production. Importantly, Ambroxol Hydrochloride is considered safe for use in children and is often prescribed for pediatric respiratory conditions. Furthermore, it may find use in pre- and post-surgical scenarios to minimize postoperative pulmonary complications and is part of the treatment regimen for cystic fibrosis, where thick and sticky mucus production is a hallmark. Always remember that this medication should be administered under the guidance and prescription of a healthcare professional, with the dosage and duration of treatment tailored to the specific respiratory condition and patient’s age. While it proves efficacious, it is typically employed alongside other therapies as part of a comprehensive treatment strategy.
How does Ambroxol Hydrochloride Work:
Ambroxol Hydrochloride functions as a mucolytic agent and expectorant, primarily targeting the properties of mucus within the respiratory system to alleviate respiratory conditions. Its mechanism of action is multifaceted: firstly, it reduces the viscosity or thickness of mucus, transforming it into a more fluid state. This change enables the mucus to move more freely within the airways, minimizing its stickiness. Consequently, the respiratory passages become less congested as mucus can be easily expelled through coughing and natural bodily mechanisms.
Additionally, Ambroxol Hydrochloride enhances the activity of tiny hair-like structures called cilia that line the respiratory tract. These cilia play a vital role in transporting mucus and trapped particles upwards and out of the lungs. Ambroxol’s stimulation of ciliary action promotes more effective mucus movement, preventing stagnation in the airways.
Furthermore, Ambroxol may enhance the efficiency of the cough reflex itself, making it more productive. This means that when a person coughs, it is more likely to effectively clear mucus from the respiratory passages.
In essence, Ambroxol Hydrochloride’s mode of action revolves around improving the clearance of mucus from the respiratory system, providing relief for conditions characterized by excessive mucus production, such as coughs, bronchitis, and chronic obstructive pulmonary disease (COPD). By facilitating the body’s natural mechanisms for maintaining clear airways, it eases breathing for individuals with these respiratory ailments. It is essential to adhere to the prescribed usage of Ambroxol Hydrochloride under the guidance of a healthcare professional to optimize its efficacy in managing respiratory conditions effectively.
Benefits:
Ambroxol Hydrochloride offers several valuable benefits in the management of respiratory conditions. Its primary advantage is its ability to enhance the clearance of excessive mucus from the respiratory tract. By thinning and loosening mucus, it assists individuals with conditions characterized by thick and sticky mucus, such as coughs, bronchitis, and chronic obstructive pulmonary disease (COPD). This action leads to improved respiratory comfort and reduced coughing. Notably, Ambroxol is considered safe for use in children, making it a valuable option for pediatric respiratory ailments.
Side Effects:
While Ambroxol Hydrochloride provides relief for respiratory conditions, it can be associated with some potential side effects. Mild gastrointestinal disturbances like nausea, vomiting, diarrhea, or stomach discomfort may occur in some individuals. These effects are often short-lived and can often be managed by taking the medication with food or water. Rare but severe allergic reactions may manifest as skin rash, itching, swelling, dizziness, or breathing difficulties, requiring immediate medical attention. Headaches, dizziness, and dryness in the mouth or throat are occasional side effects, generally of mild intensity.
In very rare cases, more serious side effects, including severe skin reactions, liver function changes, or blood disorders, have been reported, necessitating immediate medical intervention. Ambroxol may also interact with certain medications, underscoring the importance of disclosing all medications and supplements to healthcare providers. Special precautions should be observed for individuals with a history of gastric or duodenal ulcers, as Ambroxol may exacerbate these conditions. Additionally, while Ambroxol is generally considered safe during pregnancy and breastfeeding when used as directed, consultation with a healthcare provider is advisable in these circumstances. Overall, Ambroxol Hydrochloride’s benefits in respiratory relief can be substantial, but users should be aware of the potential side effects and consult a healthcare professional if any concerns arise during its use.
Frequently Asked Questions About Ambroxol Hydrochloride:
- What is Ambroxol Hydrochloride used for?
Ambroxol Hydrochloride is primarily used as a mucolytic agent and expectorant to help thin and loosen mucus in the respiratory tract. It is commonly prescribed for respiratory conditions characterized by excessive mucus, such as coughs, bronchitis, and chronic obstructive pulmonary disease (COPD).
- How does Ambroxol Hydrochloride work?
Ambroxol Hydrochloride works by reducing the viscosity of mucus, making it less thick and sticky. This action aids in the clearance of mucus from the airways, making it easier for individuals to cough up and expel mucus.
- Is Ambroxol Hydrochloride safe for children?
Yes, Ambroxol Hydrochloride is generally considered safe for use in children and is often prescribed for pediatric respiratory conditions. However, it should be used under the guidance and prescription of a healthcare professional.
- What are the common side effects of Ambroxol Hydrochloride?
Common side effects may include mild gastrointestinal discomfort (nausea, vomiting, diarrhea), headache, dizziness, dry mouth or throat, and, rarely, allergic reactions. Serious side effects are rare but can include severe skin reactions, liver function changes, and blood disorders.
- Can Ambroxol Hydrochloride be used during pregnancy and breastfeeding?
Ambroxol Hydrochloride is generally considered safe during pregnancy and breastfeeding when used as directed. However, it’s advisable to consult a healthcare provider before using it during these periods.
- How should I take Ambroxol Hydrochloride?
Ambroxol Hydrochloride should be taken exactly as prescribed by a healthcare provider. The dosage and duration of treatment will depend on the specific respiratory condition and the patient’s age. It is typically administered orally and may be taken with or without food.
- Can Ambroxol Hydrochloride interact with other medications?
Yes, Ambroxol Hydrochloride may interact with certain medications. It’s important to inform your healthcare provider about all the drugs and supplements you are taking to avoid potential interactions.
- What should I do if I experience severe side effects or an allergic reaction to Ambroxol Hydrochloride?
If you experience severe side effects or signs of an allergic reaction, such as skin rash, itching, swelling, dizziness, or difficulty breathing, seek immediate medical attention.
- How long does it take for Ambroxol Hydrochloride to work?
The time it takes for Ambroxol Hydrochloride to show its full therapeutic effects can vary from person to person and depends on the severity of the respiratory condition being treated. It may take several days to a week or more to experience noticeable relief.
- Can I use Ambroxol Hydrochloride for a dry cough?
Ambroxol Hydrochloride is more effective for productive or chesty coughs where mucus needs to be thinned and cleared. It may not be as beneficial for dry, non-productive coughs. It’s best to consult a healthcare provider for guidance on the most suitable cough medication for your specific condition.
As Ambroxol Hydrochloride Exporters; We can cater to export business queries from the following geographies. We are exporting our Ambroxol Hydrochloride 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
Ambroxol Hydrochloride 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 Ambroxol Hydrochloride, 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) Ambroxol Hydrochloride Respiratory Solution 15mg/2ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Ambroxol Hydrochloride Respiratory Solution 15mg/2ml
Composition:
Each 2ml contains:
Ambroxol Hydrochloride USP………….15mg
In an isotonic solution………………………….Q.S.
Composition:
Each 2ml contains:
Ambroxol Hydrochloride USP………….15mg
In an isotonic solution………………………….Q.S.
THERAPEUTIC INDICATIONS:
Ambroxol works by thinning down the mucus in the airway passages, thus making the mucus less sticky and it also facilitates the removal of the mucus from the airways.
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.
FOR ORAL ADMINISTRATION.
SHAKE THE BOTTLE 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.
FOR ORAL ADMINISTRATION.
SHAKE THE BOTTLE 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: Adults & Children (Above 5 years of age): One respule(15mg) twice daily.
Children (Below 5 years of age): Half Respule (7.5mg) twice daily.
Mucoshield Respules are inhaled with the aid of a nebulizer. They can also be diluted with distilled water in the ratio of 1:1.
Attach dispensing label as per end country.
Store below 25°C.
Protect from light.
Do not freeze.
Dosage: Adults & Children (Above 5 years of age): One respule(15mg) twice daily.
Children (Below 5 years of age): Half Respule (7.5mg) twice daily.
Mucoshield Respules are inhaled with the aid of a nebulizer. They can also be diluted with distilled water in the ratio of 1:1.
Attach dispensing label as per end country.