GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Sevelamer Carbonate Tablets 400mg
B) Sevelamer Carbonate Tablets 800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Sevelamer Carbonate Tablets 400mg
Each film coated tablet contains:
Sevelamer Carbonate……………400mg
Excipients…………………………. q.s.
Colour: Red Oxide of Iron

B) Sevelamer Carbonate Tablets 800mg
Each film coated tablet contains:
Sevelamer Carbonate……………...800mg
Excipients………………………………...q.s.
Colour: Tartrazine


THERAPEUTIC INDICATIONS:

Sevelamer is a phosphate binding medication used to treat hyperphosphatemia in patients with chronic kidney disease. When taken with meals, it binds to dietary phosphate and prevents its absorption.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A NEPHROLOGIST.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 25 °C.
Protect from Light and moisture.
Dosage: As directed by the Nephrologist.

Sevelamer Carbonate Tablets 800mg Technical Specification:

Product Name:Sevelamer Carbonate Tablets 800mg
Brand Name:Fos-Control
Strength:400mg, 800mg
Dosage Form:Tablets (Film coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antihyperphosphatemia
Indication: Sevelamer is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis.
Storage:Store below 25 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Sevelamer Carbonate Tablets 800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sevelamer Carbonate Tablets 800mg
    Each film coated tablet contains:
    Sevelamer Carbonate……………800mg
    Excipients…………………………. q.s.
    Colour: Tartrazine

THERAPEUTIC INDICATIONS:

Sevelamer is a phosphate binding medication used to treat hyperphosphatemia in patients with chronic kidney disease. When taken with meals, it binds to dietary phosphate and prevents its absorption.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H prescription drug: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A NEPHROLOGIST.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store below 25 °C.
Protect from Light and moisture.
Dosage:  As directed by the Nephrologist.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a pharmaceutical company known for several qualities that make it a preferred choice for Sevelamer Carbonate Tablets

  • Quality Assurance: Taj Pharmaceuticals is committed to maintaining high-quality standards in pharmaceutical manufacturing. Their dedication to quality ensures the safety and efficacy of Sevelamer Carbonate Tablets, instilling confidence in healthcare providers and patients.
  • Pharmaceutical Expertise: With extensive experience in the pharmaceutical industry, Taj Pharmaceuticals brings valuable expertise to the production and distribution of pharmaceutical products. Their proficiency enhances the reliability and quality of their medications, making them a trusted supplier.
  • Regulatory Compliance: Taj Pharmaceuticals adheres to strict regulatory standards and implements robust quality control procedures. This commitment ensures that Sevelamer Carbonate Tablets comply with essential quality and safety requirements mandated by regulatory authorities, enhancing patient safety.
  • Global Reach and Distribution: Taj Pharmaceuticals has a global presence and a well-established distribution network. This extensive reach ensures the availability of Sevelamer Carbonate Tablets and other pharmaceuticals to healthcare providers and patients in diverse regions. This international accessibility elevates patient care to a global level, guaranteeing that essential medications are readily accessible when needed.
  • Research and Development (R&D): Investment in research and development (R&D) underscores Taj Pharmaceuticals’ commitment to pharmaceutical innovation and improvement. This commitment to R&D may lead to the development of more effective and advanced formulations of medications like Sevelamer Carbonate.
  • Reliable Supply: A consistent and dependable supply of pharmaceuticals is indispensable to ensure that healthcare institutions and patients have uninterrupted access to vital medications. Taj Pharmaceuticals’ dedication to supply chain management contributes to the reliable availability of Sevelamer Carbonate Tablets, ensuring they remain accessible when required.
  • Affordability: Taj Pharmaceuticals may offer competitive pricing options, making Sevelamer Carbonate Tablets more accessible and affordable to healthcare providers and patients. This commitment aligns with the goal of ensuring that essential medications are within reach of all individuals, without imposing financial barriers.
  • Patient-Centric Approach: Taj Pharmaceuticals places a strong emphasis on patient well-being and safety. This aligns seamlessly with the importance of medications like Sevelamer Carbonate, which are used to manage conditions like hyperphosphatemia in patients with chronic kidney disease. 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.

What is Sevelamer Carbonate Tablets and its uses:

Sevelamer Carbonate Tablets are a medication used in the management of certain kidney-related conditions, particularly in patients with chronic kidney disease (CKD). Here are the key aspects of Sevelamer Carbonate Tablets and their uses:

  • Active Ingredient: Sevelamer Carbonate is the active ingredient in these tablets.
  • Use in Chronic Kidney Disease (CKD): Sevelamer Carbonate is primarily prescribed for patients with CKD, especially those on hemodialysis or peritoneal dialysis. CKD is a condition in which the kidneys gradually lose their ability to filter waste and excess minerals from the blood, leading to a buildup of phosphate in the bloodstream.
  • Phosphate Binder: Sevelamer Carbonate acts as a phosphate binder. In CKD, the kidneys cannot effectively excrete excess phosphate from the body, leading to elevated phosphate levels in the blood. High phosphate levels can contribute to bone and mineral metabolism problems, cardiovascular complications, and other health issues.
  • Mechanism of Action: Sevelamer Carbonate binds to dietary phosphate in the digestive tract, preventing its absorption into the bloodstream. By reducing the absorption of phosphate, it helps control phosphate levels in patients with CKD.
  • Prevention of Complications: Controlling phosphate levels is important in CKD management because it can help prevent complications such as bone disease (renal osteodystrophy), vascular calcifications, and secondary hyperparathyroidism.
  • Part of Comprehensive CKD Treatment: Sevelamer Carbonate is typically prescribed as part of a comprehensive treatment plan for CKD patients. This plan may also include dietary changes, other medications, and regular monitoring of laboratory values, including phosphate levels and markers of kidney function.
  • Types of CKD: Sevelamer Carbonate may be used in CKD patients at various stages, depending on the severity of hyperphosphatemia (elevated phosphate levels). It is often considered when dietary phosphate restriction alone is insufficient to control phosphate levels.
  • Dosage and Administration: The dosage of Sevelamer Carbonate Tablets is determined by a healthcare provider based on the patient’s specific needs. It is typically taken with meals or as directed by the healthcare provider.

It’s important to note that Sevelamer Carbonate Tablets should be used under the guidance and supervision of a healthcare provider. The dosage and frequency of administration may vary depending on the patient’s individual condition and response to treatment. Regular monitoring of phosphate levels and other relevant markers is crucial to ensure the effectiveness of therapy and to make any necessary dosage adjustments. Patients should also follow dietary recommendations provided by their healthcare provider while taking Sevelamer Carbonate Tablets.

How do Sevelamer Carbonate Tablets work?

Sevelamer Carbonate Tablets work as phosphate binders, and their mechanism of action is centered around reducing the absorption of phosphate in the digestive tract. Here’s how Sevelamer Carbonate Tablets work:

  • Phosphate Binding: Sevelamer Carbonate is a polymer-based medication that contains positively charged ions. When taken orally with meals, these tablets dissolve in the stomach and release these positively charged ions.
  • Interaction with Phosphate: Phosphate, a mineral commonly found in various foods and beverages, is negatively charged. The positively charged ions from Sevelamer Carbonate are attracted to the negatively charged phosphate ions.
  • Formation of Insoluble Complexes: When Sevelamer Carbonate comes into contact with dietary phosphate in the digestive tract, it forms insoluble complexes or compounds. These complexes are unable to be absorbed through the intestinal wall into the bloodstream.
  • Reduced Phosphate Absorption: The formation of these insoluble complexes effectively traps dietary phosphate, preventing it from being absorbed into the bloodstream. As a result, less phosphate is absorbed from the gastrointestinal tract into the body.
  • Lowering Phosphate Levels: By reducing the absorption of dietary phosphate, Sevelamer Carbonate helps to lower the concentration of phosphate in the bloodstream. This is particularly important in patients with chronic kidney disease (CKD) who have impaired kidney function and struggle to eliminate excess phosphate from their bodies.
  • Preventing Complications: Elevated phosphate levels in CKD patients can lead to complications such as bone disorders, vascular calcifications, and secondary hyperparathyroidism. Sevelamer Carbonate helps to control phosphate levels, thereby reducing the risk of these complications.
  • Part of Comprehensive CKD Treatment: Sevelamer Carbonate is typically prescribed as part of a comprehensive treatment plan for CKD patients, which may also include dietary phosphate restriction, other medications, and dialysis if necessary.

It’s important to note that Sevelamer Carbonate Tablets should be taken with meals or as directed by a healthcare provider to ensure their optimal binding capacity with dietary phosphate. The medication’s effectiveness is dependent on regular use and compliance with the prescribed regimen. Additionally, patients should have their phosphate levels monitored regularly to assess the medication’s effectiveness and make any necessary adjustments to the treatment plan.

Benefits of Sevelamer Carbonate Tablets:

  • Control of Phosphate Levels: The primary benefit of Sevelamer Carbonate Tablets is their ability to control and reduce elevated phosphate levels in the bloodstream. This is particularly crucial in patients with chronic kidney disease (CKD) who have impaired kidney function and difficulty eliminating excess phosphate from their bodies.
  • Prevention of Complications: By effectively lowering phosphate levels, Sevelamer Carbonate helps prevent complications associated with hyperphosphatemia (elevated phosphate levels). These complications include bone disorders, vascular calcifications, and secondary hyperparathyroidism.
  • Bone Health: Sevelamer Carbonate contributes to better bone health by reducing the risk of renal osteodystrophy, a condition characterized by weakened bones, fractures, and bone pain, often seen in CKD patients with elevated phosphate levels.
  • Reduced Cardiovascular Risk: Lowering phosphate levels can have a positive impact on cardiovascular health, as elevated phosphate is associated with an increased risk of cardiovascular events in CKD patients. Sevelamer Carbonate may help mitigate this risk.
  • Part of Comprehensive CKD Management: Sevelamer Carbonate is typically used as part of a comprehensive treatment plan for CKD patients, which may also include dietary phosphate restriction, other medications, and dialysis if necessary. Its inclusion in this plan helps address one of the critical aspects of CKD management.

Common Side Effects of Sevelamer Carbonate Tablets:

  • Gastrointestinal Symptoms: Gastrointestinal side effects are among the most common. These can include nausea, vomiting, diarrhea, abdominal pain, and bloating. These symptoms are usually mild to moderate and may improve over time as the body adjusts to the medication.
  • Constipation: Some individuals may experience constipation while taking Sevelamer Carbonate Tablets. Adequate fluid intake and dietary fiber may help alleviate this side effect.
  • Flatulence: Increased gas production or flatulence may occur in some individuals. This is generally not a serious side effect and can often be managed with dietary adjustments.
  • Interference with Absorption: Sevelamer Carbonate may interfere with the absorption of certain vitamins and medications, such as fat-soluble vitamins (e.g., vitamin D) and some oral drugs. Patients should discuss potential interactions with their healthcare provider and follow any recommended supplement or medication adjustments.
  • Other Rare Side Effects: In rare cases, Sevelamer Carbonate may lead to more severe side effects such as gastrointestinal bleeding or intestinal blockage. These are rare but should be promptly reported to a healthcare provider.

It’s important to note that not all patients will experience these side effects, and many people tolerate Sevelamer Carbonate well. Patients should take the medication as prescribed by their healthcare provider, report any unusual or severe side effects promptly, and follow dietary recommendations provided by their healthcare team. The benefits of Sevelamer Carbonate in managing phosphate levels and preventing complications often outweigh the potential side effects when used under medical supervision.

Frequently asked Questions About Sevelamer Carbonate Tablets:

Certainly, here are some frequently asked questions (FAQs) about Sevelamer Carbonate Tablets:

  1. What is Sevelamer Carbonate, and what is it used for?

Sevelamer Carbonate is a medication used to control and reduce elevated phosphate levels in the blood, primarily in patients with chronic kidney disease (CKD). Elevated phosphate levels can lead to complications in CKD patients.

  1. How does Sevelamer Carbonate work?

Sevelamer Carbonate works by binding to dietary phosphate in the digestive tract, preventing its absorption into the bloodstream. This helps lower phosphate levels in CKD patients.

  1. Can Sevelamer Carbonate cure kidney disease?

No, Sevelamer Carbonate cannot cure kidney disease. It is used as a treatment to manage phosphate levels and reduce the risk of complications associated with CKD.

  1. How should Sevelamer Carbonate Tablets be taken?

Sevelamer Carbonate Tablets should be taken with meals or as directed by a healthcare provider. It’s important to follow the prescribed dosage and administration instructions.

  1. Are there dietary restrictions while taking Sevelamer Carbonate?

Yes, patients taking Sevelamer Carbonate should follow dietary recommendations provided by their healthcare provider, which often include limiting the intake of high phosphate foods and phosphorus containing supplements.

  1. What are the common side effects of Sevelamer Carbonate?

Common side effects may include gastrointestinal symptoms like nausea, vomiting, diarrhea, abdominal pain, and bloating. Constipation and flatulence are also possible side effects.

  1. Can Sevelamer Carbonate interact with other medications?

Yes, Sevelamer Carbonate may interfere with the absorption of certain medications and vitamins. Patients should inform their healthcare provider about all medications and supplements they are taking to assess potential interactions.

  1. How often should phosphate levels be monitored while taking Sevelamer Carbonate?

Phosphate levels should be regularly monitored as part of CKD management. The frequency of monitoring may vary based on individual patient needs and healthcare provider recommendations.

  1. Can Sevelamer Carbonate be used during pregnancy or breastfeeding?

Pregnant or breastfeeding individuals should consult their healthcare provider before using Sevelamer Carbonate, as its safety in these situations may need to be evaluated on a case by case basis.

  1. Is Sevelamer Carbonate available over-the-counter (OTC)?

No, Sevelamer Carbonate is a prescription medication and should be used under the guidance of a healthcare provider.

Patients should always consult their healthcare provider or medical professionals for personalized information and guidance regarding the use of Sevelamer Carbonate Tablets, potential side effects, dietary recommendations, and appropriate treatment protocols for chronic kidney disease.

As Sevelamer Carbonate Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Sevelamer Carbonate 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

Sevelamer Carbonate 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 Sevelamer Carbonate 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
Fax No: +91 22 2634 1274