Pantoprazole Sodium Delayed Release Tablets USP 40mg Technical Specification:
Product Name: | Pantoprazole Sodium Delayed Release Tablets USP 40mg |
Brand Name: | Pantopap |
Strength: | 20mg, 40mg |
Dosage Form: | Tablets (Delayed Release Enteric Coated) |
Route of Administration: | Via Oral Route |
Packing: | 10s, 30s, 100s, 500s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antacid, Gastroenterological |
Indication: | Pantoprazole reduces the amount of acid your stomach makes. |
Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Pantoprazole Sodium Delayed Release Tablets USP 40mg (Pantopap)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Pantoprazole Sodium Delayed Release Tablets USP 40mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 40mg
Excipients……………………………………….q.s.
Color: Brilliant blue FCF
THERAPEUTIC INDICATIONS:
Pantoprazole reduces the amount of acid your stomach makes. It’s used for heartburn, acid reflux and gastro-oesophageal reflux disease (GORD) – GORD is when you keep getting acid reflux.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician.
Why Taj pharmaceuticals?
Taj Pharmaceuticals stands as a beacon of excellence in gastrointestinal care, offering Pantoprazole Sodium Delayed Release Tablets that prioritize your digestive health. With a steadfast commitment to your well-being, we have crafted these tablets to deliver exceptional relief from acid-related conditions. At the heart of our tablets lies Pantoprazole Sodium, a potent proton pump inhibitor (PPI) renowned for its ability to reduce stomach acid production. Our Delayed Release Tablets are engineered to release this medication gradually in the stomach, ensuring long-lasting relief from ailments like gastroesophageal reflux disease (GERD), ulcers, and heartburn. What truly sets Taj Pharmaceuticals apart is our unwavering dedication to quality, safety, and efficacy. We uphold rigorous manufacturing standards and implement stringent quality control procedures to guarantee that each tablet delivers its intended therapeutic effect. When you choose Taj Pharmaceuticals, you’re not merely selecting a medication; you’re choosing assurance and trust. Our Pantoprazole Sodium Delayed Release Tablets have earned the confidence of healthcare professionals worldwide for their proven effectiveness in managing gastrointestinal conditions. Prioritize your digestive health wisely—opt for Taj Pharmaceuticals.
What is Pantoprazole Sodium Delayed Release Tablets and its uses?
Pantoprazole Sodium Delayed Release Tablets are a pharmaceutical remedy designed to address various gastrointestinal ailments. At the core of these tablets lies Pantoprazole Sodium, a potent proton pump inhibitor (PPI). This class of medication functions by reducing the production of stomach acid, primarily by inhibiting proton pumps within the stomach lining. This reduction in gastric acid production brings valuable relief to a range of gastrointestinal conditions.
Common Uses:
- Gastroesophageal Reflux Disease (GERD): Pantoprazole Sodium Tablets are a frequent prescription for individuals grappling with GERD. This condition entails the backflow of stomach acid into the esophagus, resulting in symptoms like heartburn, acid reflux, and esophageal lining damage. Pantoprazole effectively alleviates these symptoms and supports the healing of the esophagus.
- Peptic Ulcers: Whether they manifest in the stomach (gastric ulcers) or the initial part of the small intestine (duodenal ulcers), Pantoprazole plays a crucial role in their management. By reducing stomach acid production, it facilitates the healing process of these ulcers while working to prevent their recurrence.
- Zollinger-Ellison Syndrome: In rare instances, Pantoprazole Sodium Tablets may be prescribed for those diagnosed with Zollinger-Ellison syndrome. This condition results in excessive stomach acid production. Pantoprazole is deployed to normalize and control acid production in such cases.
- Erosive Esophagitis: When the esophageal lining sustains inflammation and erosion due to stomach acid exposure, Pantoprazole is employed to aid the healing process. It achieves this by mitigating acid production and affording relief from associated symptoms.
- Helicobacter pylori Eradication: Pantoprazole is also employed as part of a combination therapy to eradicate Helicobacter pylori, a bacterium associated with the development of peptic ulcers.
To maximize the benefits and ensure safety, Pantoprazole Sodium Delayed Release Tablets must be used strictly as prescribed by a healthcare professional. The dosage and duration of treatment are tailored to the specific condition under treatment. While Pantoprazole can effectively alleviate gastrointestinal distress, it may come with potential side effects and interactions with other medications, underscoring the importance of its use under medical supervision.
How does Pantoprazole Sodium Delayed Release Tablets work?
Pantoprazole Sodium Delayed Release Tablets are a medication designed to address various gastrointestinal conditions. These tablets contain Pantoprazole Sodium, a potent proton pump inhibitor (PPI). PPIs work by reducing the production of stomach acid, primarily by inhibiting proton pumps in the stomach lining. This reduction in gastric acid production is beneficial in the treatment of several gastrointestinal issues. One common use of Pantoprazole Sodium Tablets is in the management of Gastroesophageal Reflux Disease (GERD). GERD involves the backflow of stomach acid into the esophagus, causing symptoms like heartburn, acid reflux, and damage to the esophageal lining. Pantoprazole effectively alleviates these symptoms and supports the healing of the esophagus. Another frequent application is in the treatment of Peptic Ulcers, which can occur in the stomach (gastric ulcers) or the initial part of the small intestine (duodenal ulcers). Pantoprazole helps by reducing stomach acid production, facilitating ulcer healing, and preventing their recurrence. In rare cases, Pantoprazole Sodium Tablets may be prescribed for individuals with Zollinger-Ellison Syndrome, a condition characterized by excessive stomach acid production. Pantoprazole plays a crucial role in normalizing and controlling acid production in such cases. Pantoprazole is also used to manage Erosive Esophagitis, a condition where the esophageal lining becomes inflamed and eroded due to prolonged exposure to stomach acid. By mitigating acid production, Pantoprazole aids in the healing process and provides relief from associated symptoms. Additionally, Pantoprazole is sometimes part of a treatment regimen to eradicate Helicobacter pylori, a bacterium associated with the development of peptic ulcers. For safe and effective use, Pantoprazole Sodium Delayed Release Tablets should be taken precisely as prescribed by a healthcare professional. Dosage and treatment duration are tailored to the specific condition, and medical supervision is crucial due to potential side effects and interactions with other medications.
Benefits of Pantoprazole Sodium Delayed Release Tablets:
Pantoprazole Sodium Delayed Release Tablets offer a range of benefits for individuals dealing with various gastrointestinal issues. As a potent proton pump inhibitor (PPI), Pantoprazole is highly effective at reducing stomach acid production. This reduction serves as a key advantage, providing relief from the discomfort and symptoms associated with acid-related conditions, including heartburn, acid reflux, and gastritis.
Additionally, Pantoprazole plays a vital role in the management of peptic ulcers. By curbing stomach acid production, it not only promotes the healing of existing ulcers but also acts as a preventive measure against their recurrence. This makes it a valuable tool in ulcer treatment and prevention.
For those grappling with Gastroesophageal Reflux Disease (GERD), Pantoprazole is an integral part of the treatment plan. By effectively controlling stomach acid, it helps alleviate the symptoms associated with GERD while safeguarding the delicate lining of the esophagus.
Moreover, Pantoprazole is an effective solution for individuals suffering from erosive esophagitis—a condition characterized by inflammation and erosion of the esophageal lining due to prolonged acid exposure. In such cases, Pantoprazole aids in the healing process, providing relief from pain and discomfort.
In instances where Helicobacter pylori infection is linked to peptic ulcers, Pantoprazole may be combined with antibiotics to eradicate the bacterium, effectively preventing ulcer recurrence.
Side Effects of Pantoprazole Sodium Delayed Release Tablets:
While Pantoprazole Sodium Delayed Release Tablets offer substantial benefits, it’s crucial to be aware of potential side effects. Common side effects can include headaches, nausea, abdominal pain, and diarrhea. These effects are generally mild and temporary.
Long-term use of PPIs like Pantoprazole may lead to the reduced absorption of certain vitamins and minerals, such as vitamin B12, magnesium, and calcium. This emphasizes the importance of regular monitoring and dietary adjustments.
There is a slightly increased risk of gastrointestinal infections associated with prolonged PPI use, and older adults may face a slightly elevated risk of fractures.
Though rare, allergic reactions to Pantoprazole can occur, presenting as skin rash, itching, swelling, severe dizziness, or breathing difficulties. Immediate medical attention is crucial if such symptoms arise.
Ultimately, while Pantoprazole’s benefits are significant, its use should be guided by healthcare professionals who can assess its appropriateness and monitor for potential side effects. The medication should be used at the lowest effective dose and for the shortest necessary duration, and any concerns or unusual reactions should be promptly discussed with a healthcare provider.
Frequently Asked Questions About Pantoprazole Sodium Delayed Release Tablets:
- What is Pantoprazole Sodium Delayed Release Tablets used for?
Pantoprazole Sodium Delayed Release Tablets are primarily used to reduce the production of stomach acid. They are commonly prescribed to treat conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, erosive esophagitis, and to prevent the recurrence of peptic ulcers.
- How do Pantoprazole Sodium Delayed Release Tablets work?
These tablets are classified as proton pump inhibitors (PPIs) and work by inhibiting proton pumps in the stomach lining. This action reduces the secretion of stomach acid, providing relief from acid-related symptoms and promoting the healing of acid-induced damage.
- What is the recommended dosage for Pantoprazole Sodium Delayed Release Tablets?
The recommended dosage varies depending on the specific condition being treated. It’s crucial to follow the dosage instructions provided by your healthcare provider. Typically, Pantoprazole is taken once daily before a meal.
- Can Pantoprazole Sodium Delayed Release Tablets be taken long-term?
Long-term use of Pantoprazole Sodium Delayed Release Tablets may be necessary for certain medical conditions, such as GERD. However, prolonged use should be carefully monitored by a healthcare provider due to potential risks like reduced vitamin and mineral absorption.
- Are there potential interactions with other medications?
Pantoprazole can interact with certain medications. Inform your healthcare provider about all the drugs and supplements you are taking to avoid potential interactions. This includes mentioning any blood thinners, antifungals, or medications containing iron or calcium.
- Can I take Pantoprazole Sodium Delayed Release Tablets during pregnancy or while breastfeeding?
Before taking Pantoprazole during pregnancy or while breastfeeding, consult your healthcare provider. They can assess the potential risks and benefits and provide guidance on the appropriate use of the medication.
- What are the common side effects of Pantoprazole Sodium Delayed Release Tablets?
Common side effects may include headaches, nausea, abdominal pain, and diarrhea. These effects are usually mild and temporary. However, consult your healthcare provider if they persist or worsen.
- Can Pantoprazole Sodium Delayed Release Tablets be used for immediate relief of heartburn or acid reflux symptoms?
These tablets are not designed for immediate relief of symptoms. They are typically taken before a meal to prevent the production of excess stomach acid over time. For immediate relief of heartburn or acid reflux, other antacid medications may be more suitable.
- Is it safe to discontinue Pantoprazole Sodium Delayed Release Tablets abruptly?
Do not stop taking Pantoprazole suddenly without consulting your healthcare provider, especially if you have been on the medication long-term. Abrupt discontinuation can lead to rebound acid hypersecretion. Your healthcare provider can guide you on how to gradually reduce the dosage if necessary.
- Can Pantoprazole Sodium Delayed Release Tablets be crushed or split for easier administration?
It’s generally recommended not to crush or split these tablets unless specifically advised by your healthcare provider. They are designed for delayed release, and altering the tablet may affect its effectiveness. Consult your healthcare provider for alternative dosing options if you have difficulty swallowing the tablets.
As Pantoprazole Sodium Delayed Release Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Pantoprazole Sodium Delayed Release Tablets 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
Pantoprazole Sodium Delayed Release Tablets 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 Pantoprazole Sodium Delayed Release Tablets, 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
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Pantoprazole Sodium Delayed Release Tablets USP 20mg (Pantopap)
B) Pantoprazole Sodium Delayed Release Tablets USP 40mg (Pantopap)
B) Pantoprazole Sodium Delayed Release Tablets USP 40mg (Pantopap)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Pantoprazole Sodium Delayed Release Tablets USP 20mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 20mg
Excipients……………………………………….q.s.
Color: Ferric oxide yellow
B) Pantoprazole Sodium Delayed Release Tablets USP 40mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 40mg
Excipients……………………………………….q.s.
Color: Brilliant blue FCF
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 20mg
Excipients……………………………………….q.s.
Color: Ferric oxide yellow
B) Pantoprazole Sodium Delayed Release Tablets USP 40mg
Each enteric coated delayed release tablet contains:
Pantoprazole Sodium sesquihydrate USP
Equivalent to Pantoprazole…………… 40mg
Excipients……………………………………….q.s.
Color: Brilliant blue FCF
THERAPEUTIC INDICATIONS:
Pantoprazole reduces the amount of acid your stomach makes. It's used for heartburn, acid reflux and gastro-oesophageal reflux disease (GORD) – GORD is when you keep getting acid reflux.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.