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Renal
SEVOMAR-400 TAB
SALT COMPOSITION
SEVELAMAR 400MGTYPE
TABLET
STORAGE
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
PRODUCT INTRODUCTION
SEVOMAR-400 TAB, containing Sevelamer 400mg, is a crucial medication for managing hyperphosphatemia in patients with chronic kidney disease (CKD), especially those on dialysis. Hyperphosphatemia, or elevated phosphate levels in the blood, is a common complication of CKD and can lead to serious health issues like bone disease, cardiovascular calcification, and increased mortality. SEVOMAR-400 works by binding to dietary phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream. This helps to maintain healthy phosphate levels, thereby reducing the risk of associated complications and improving the overall quality of life for renal patients. It is an essential part of comprehensive CKD management.
Uses of SEVOMAR-400 TAB
SEVOMAR-400 TAB is primarily prescribed to manage elevated phosphate levels in patients suffering from chronic kidney disease.
- Hyperphosphatemia in Chronic Kidney Disease (CKD)
SEVOMAR-400 TAB is indicated for the control of serum phosphorus in adult and pediatric patients (≥6 years of age) with chronic kidney disease who are on dialysis. It helps prevent the accumulation of phosphate, which can lead to bone and cardiovascular complications.
- End-Stage Renal Disease (ESRD)
Patients with ESRD, particularly those undergoing hemodialysis or peritoneal dialysis, often struggle with hyperphosphatemia. SEVOMAR-400 is vital in these patients to bind dietary phosphate, thereby lowering serum phosphate levels and improving overall mineral and bone disorder management.
- Prevention of Renal Osteodystrophy
By effectively controlling phosphate levels, SEVOMAR-400 helps prevent and manage renal osteodystrophy, a bone disease common in CKD patients. It reduces the risk of bone pain, fractures, and other skeletal abnormalities associated with high phosphate.
Side Effects of SEVOMAR-400 TAB
Like all medicines, SEVOMAR-400 TAB can cause side effects, although not everybody gets them. Most side effects are mild to moderate and related to the gastrointestinal system.
Common side effects
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Abdominal pain
- Indigestion
- Flatulence
While less common, some serious side effects may occur and require immediate medical attention.
- Bowel obstruction
- Dysphagia (difficulty swallowing)
- Peritonitis (in peritoneal dialysis patients)
If any side effect persists or worsens, or if you experience any severe symptoms, contact your doctor immediately. Do not discontinue the medication without consulting your healthcare provider.
How to use SEVOMAR-400 TAB
- Adults:
The usual starting dose for adults is 800 mg to 1600 mg (1-2 tablets of SEVOMAR-400) three times a day with meals. The dose should be titrated based on serum phosphate levels, aiming to maintain them within the target range (typically 3.5 to 5.5 mg/dL). It is crucial to take the tablets with food.
- Children:
For pediatric patients (≥6 years of age), the dosage should be determined by a physician based on body surface area and individual phosphate levels. It is generally initiated at a lower dose and carefully adjusted under medical supervision.
- Elderly:
No specific dose adjustment is required for elderly patients. However, they should be monitored closely for potential side effects, especially gastrointestinal disturbances, and the dose should be adjusted as per serum phosphate levels.
- Missed Dose:
If you miss a dose of SEVOMAR-400, take it with your next meal. Do not take a double dose to make up for a forgotten one. Continue with your regular dosing schedule. Consistent administration with meals is key for efficacy.
How SEVOMAR-400 TAB works
Sevelamer, the active ingredient in SEVOMAR-400 TAB, is a non-absorbed, polymer-based phosphate binder. When taken orally, Sevelamer remains in the gastrointestinal tract and binds to phosphate ions present in ingested food. The positively charged amine groups on the sevelamer polymer interact with the negatively charged phosphate ions, forming an insoluble complex. This complex cannot be absorbed by the body and is subsequently excreted in the feces. By preventing the absorption of dietary phosphate, Sevelamer effectively lowers serum phosphate levels in patients with chronic kidney disease. Unlike calcium-based phosphate binders, Sevelamer does not contribute to calcium load, which is a significant advantage in patients prone to vascular calcification. Its mechanism helps to mitigate the progression of renal osteodystrophy and reduce the cardiovascular risks associated with hyperphosphatemia, making it a vital therapeutic option for long-term management.
Precautions
- Do not take SEVOMAR-400 if you have hypophosphatemia (low phosphate levels).
- Use with caution in patients with dysphagia, severe gastrointestinal motility disorders, or a history of major gastrointestinal surgery.
- Monitor serum calcium, bicarbonate, and chloride levels regularly, as Sevelamer can affect their balance.
- Regular monitoring of fat-soluble vitamins (A, D, E, K) and folic acid is recommended, as Sevelamer may decrease their absorption.
- Inform your doctor about all other medications you are taking, as Sevelamer can interact with certain drugs (e.g., ciprofloxacin, mycophenolate mofetil, levothyroxine).
- Maintain adequate hydration to minimize the risk of constipation.
- This medication should be used under strict medical supervision, especially in patients with existing gastrointestinal conditions.
Safety Advice
Alcohol
CONSULT YOUR DOCTORIt is advisable to consult your doctor regarding alcohol consumption while taking SEVOMAR-400. Alcohol may exacerbate gastrointestinal side effects or interfere with overall health management in CKD patients.
Pregnancy
CONSULT YOUR DOCTORThe safety of SEVOMAR-400 during pregnancy has not been fully established. It should only be used if the potential benefit justifies the potential risk to the fetus. Always consult your doctor before use.
Breastfeeding
CONSULT YOUR DOCTORIt is unknown whether Sevelamer is excreted in human milk. Consult your doctor to weigh the benefits of breastfeeding against the potential risks to the infant while on this medication.
Driving
SAFESEVOMAR-400 TAB is generally not known to impair the ability to drive or operate machinery. However, if you experience any side effects that affect your concentration or vision, avoid driving.
Kidney
CONSULT YOUR DOCTORSEVOMAR-400 is specifically used for kidney patients to manage hyperphosphatemia. However, its use should always be under the guidance and prescription of a nephrologist or healthcare provider specializing in kidney care.
Liver
CONSULT YOUR DOCTORWhile SEVOMAR-400 is primarily processed in the gut and not significantly metabolized by the liver, it's prudent to consult your doctor if you have pre-existing liver conditions to ensure safe and appropriate use.
Fact Box
Frequently asked questions by patients
Q: What is SEVOMAR-400 TAB used for?
A: SEVOMAR-400 TAB is used to control high phosphate levels in the blood (hyperphosphatemia) in patients with chronic kidney disease, especially those on dialysis. High phosphate can lead to bone and heart problems.
Q: How should I take SEVOMAR-400 TAB?
A: You should take SEVOMAR-400 TAB orally with meals, usually three times a day. It's crucial to take it with food to allow it to bind to the phosphate in your diet. Do not crush or chew the tablets.
Q: Can SEVOMAR-400 TAB cause constipation?
A: Yes, constipation is a common side effect of SEVOMAR-400 TAB. To help manage this, ensure you maintain adequate fluid intake and discuss it with your doctor if it becomes bothersome.
Q: Is SEVOMAR-400 TAB safe for long-term use?
A: SEVOMAR-400 TAB is generally considered safe for long-term use in chronic kidney disease patients under medical supervision. Regular monitoring of blood phosphate levels and other parameters is essential to ensure its continued efficacy and safety.
Frequently Asked Questions
Q: What happens if I stop taking SEVOMAR-400 TAB suddenly?
Stopping SEVOMAR-400 TAB suddenly can lead to a rapid increase in your blood phosphate levels, which can worsen hyperphosphatemia and increase the risk of complications like bone disease and cardiovascular problems. Always consult your doctor before discontinuing the medication.
Q: Does SEVOMAR-400 TAB interact with other medications?
Yes, SEVOMAR-400 TAB can interact with certain medications, potentially reducing their absorption. It's important to inform your doctor about all other medicines, including over-the-counter drugs and herbal supplements, you are taking. Specific interactions include ciprofloxacin, mycophenolate mofetil, and levothyroxine, which may require separate dosing times.
Q: What dietary changes should I make while taking SEVOMAR-400 TAB?
While SEVOMAR-400 TAB helps bind dietary phosphate, it's still important to follow a low-phosphate diet as advised by your doctor or dietitian. Limiting foods high in phosphate, such as dairy products, nuts, processed foods, and certain meats, will enhance the effectiveness of the medication.
Q: How long does it take for SEVOMAR-400 TAB to work?
SEVOMAR-400 TAB starts working immediately by binding phosphate in your gut. However, it may take several days to weeks for your blood phosphate levels to stabilize within the target range, depending on your diet and individual response. Regular blood tests will monitor its effectiveness.
Q: Can SEVOMAR-400 TAB affect my vitamin levels?
Yes, SEVOMAR-400 TAB can potentially reduce the absorption of fat-soluble vitamins (A, D, E, K) and folic acid due to its binding properties in the gut. Your doctor may recommend vitamin supplements or regular monitoring of these vitamin levels to prevent deficiencies.
Additional Information
SEVOMAR-400 TAB, containing Sevelamer 400mg, is a vital medication for the effective management of hyperphosphatemia in patients with chronic kidney disease (CKD), particularly those undergoing dialysis. By acting as a non-calcium, non-metal-based phosphate binder, it plays a crucial role in preventing the absorption of dietary phosphate, thereby maintaining healthy serum phosphate levels. This action is instrumental in mitigating the severe complications associated with high phosphate, such as renal osteodystrophy and cardiovascular calcification, which significantly impact the quality of life and survival rates of CKD patients. Patients are advised to take SEVOMAR-400 TAB strictly as prescribed by their healthcare provider, typically with meals, to ensure optimal efficacy. While generally well-tolerated, common gastrointestinal side effects like constipation, nausea, and diarrhea may occur. It is imperative to report any persistent or severe side effects to your doctor. Regular monitoring of phosphate levels, calcium, and vitamin levels is essential during treatment. Adherence to dietary recommendations for phosphate restriction, alongside SEVOMAR-400, forms a comprehensive approach to managing CKD-related mineral and bone disorders, ultimately contributing to better patient outcomes and reduced disease progression.