Renal
SEVOMAR-800 TAB
SALT COMPOSITION
SEVELAMAR 800MGTYPE
TABLET
STORAGE
Store SEVOMAR-800 TAB below 30°C in a dry place, away from direct sunlight and moisture. Keep the tablets in their original packaging to protect from humidity. Do not freeze. Keep out of reach of children and pets.
PRODUCT INTRODUCTION
SEVOMAR-800 TAB, containing Sevelamer 800mg, is a vital medication specifically designed for patients suffering from chronic kidney disease (CKD) who develop hyperphosphatemia. This condition, characterized by abnormally high levels of phosphate in the blood, can lead to serious complications like bone disorders, cardiovascular issues, and calcification of soft tissues. SEVOMAR-800 TAB works by binding to dietary phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream. It is a non-calcium, non-aluminum based phosphate binder, making it a preferred choice for many patients to effectively manage their phosphate levels and improve overall health outcomes.
Uses of SEVOMAR-800 TAB
SEVOMAR-800 TAB is primarily used to control serum phosphorus levels in patients with chronic kidney disease (CKD) who are on dialysis.
- Hyperphosphatemia in CKD on Dialysis
SEVOMAR-800 TAB is indicated for the reduction of serum phosphorus in adult and pediatric patients (6 years and older) with chronic kidney disease (CKD) on dialysis. High phosphate levels can lead to secondary hyperparathyroidism, renal osteodystrophy, and increased cardiovascular risk. This medication helps maintain phosphate within the target range, improving patient quality of life and reducing long-term complications associated with elevated phosphorus.
- Hyperphosphatemia in CKD Not on Dialysis
While primarily used in dialysis patients, SEVOMAR-800 TAB may also be prescribed off-label or in specific cases for managing hyperphosphatemia in adult CKD patients who are not yet on dialysis, under strict medical supervision. Controlling phosphate levels early can help slow the progression of mineral and bone disorders and mitigate cardiovascular risks before dialysis initiation becomes necessary. Always consult a nephrologist for appropriate management.
- Prevention of Vascular Calcification
By effectively lowering serum phosphate levels, SEVOMAR-800 TAB indirectly contributes to the prevention or slowing of vascular calcification, a significant complication in CKD patients. Vascular calcification is a strong predictor of cardiovascular morbidity and mortality. Maintaining optimal phosphate balance with medications like Sevelamer is a key strategy in reducing this serious risk and improving overall prognosis for renal patients.
Side Effects of SEVOMAR-800 TAB
Like all medicines, SEVOMAR-800 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
- Diarrhea
- Constipation
- Abdominal pain
Less common or rare side effects may include more serious gastrointestinal issues or other systemic reactions. Seek immediate medical attention if you experience any severe symptoms.
- Intestinal obstruction
- Dysphagia (difficulty swallowing)
- Peritonitis (inflammation of the abdominal lining)
If any of these side effects bother you or do not go away, please consult your doctor. Do not stop taking the medication without speaking to your healthcare provider first.
How to use SEVOMAR-800 TAB
- Adults:
The recommended starting dose for adults is 800 mg to 1600 mg (1-2 tablets) three times a day with meals, based on serum phosphate levels. Dosage should be adjusted in increments of 800 mg per day every 2-4 weeks until the target serum phosphate level is achieved. The maximum daily dose can be up to 13 grams, but typically ranges from 6-9 grams per day. Tablets should be swallowed whole and not crushed, chewed, or broken.
- Children:
For pediatric patients (6 years and older) with CKD on dialysis, the starting dose is based on body surface area (BSA) or weight, typically 400 mg to 800 mg three times a day with meals. Dosage adjustments should be made based on serum phosphate levels and tolerance, under the guidance of a pediatric nephrologist. Tablets should be administered with meals and swallowed whole.
- Elderly:
No specific dose adjustment is required for elderly patients. The dosage should be individualized based on serum phosphate levels and tolerance, similar to adult patients. Close monitoring for potential side effects is advisable, although Sevelamer is generally well-tolerated in this population.
- Missed Dose:
If you miss a dose of SEVOMAR-800 TAB, take it with your next meal. Do not take a double dose to make up for a missed one. Consistent dosing with meals is important for effective phosphate binding. If you frequently miss doses, discuss this with your doctor or pharmacist to find strategies to improve adherence.
How SEVOMAR-800 TAB works
Sevelamer, the active ingredient in SEVOMAR-800 TAB, is a non-absorbed, polymeric phosphate binder. When taken orally, it exchanges chloride ions for phosphate ions in the gastrointestinal lumen. This ionic exchange leads to the formation of an insoluble complex between sevelamer and phosphate, which is then excreted in the feces. By preventing the absorption of dietary phosphate, Sevelamer effectively lowers serum phosphate concentrations in patients with hyperphosphatemia. This mechanism is crucial for CKD patients, as their impaired kidneys are unable to excrete excess phosphate efficiently. The binding capacity of sevelamer is pH-dependent, with optimal binding occurring at the acidic pH found in the stomach and small intestine. Unlike calcium-based binders, sevelamer does not contribute to calcium load, reducing the risk of hypercalcemia, a common concern in CKD management. Its non-metallic nature also avoids the risks associated with aluminum accumulation.
Precautions
- Do not take SEVOMAR-800 TAB if you have hypophosphatemia (low blood phosphate levels) or bowel obstruction.
- Monitor serum calcium, phosphate, bicarbonate, and chloride levels regularly during treatment.
- Patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, or major gastrointestinal surgery should use with caution.
- May decrease the absorption of certain fat-soluble vitamins (A, D, E, K) and folic acid. Supplementation may be required.
- Administer other oral medications at least one hour before or three hours after SEVOMAR-800 TAB to avoid potential binding and reduced absorption.
- Not studied in patients with acute peritonitis or severe active inflammatory bowel disease.
Safety Advice
Alcohol
CAUTIONThere is no known direct interaction between alcohol and Sevelamer. However, excessive alcohol consumption can worsen overall health, especially in patients with chronic kidney disease. It's advisable to limit or avoid alcohol intake.
Pregnancy
CONSULT YOUR DOCTORSEVOMAR-800 TAB should be used during pregnancy only if clearly needed and the potential benefits outweigh the risks. Animal studies have shown no evidence of teratogenicity, but human data is limited. Always discuss with your doctor if you are pregnant or planning to conceive.
Breastfeeding
CONSULT YOUR DOCTORIt is unknown whether Sevelamer is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SEVOMAR-800 TAB is administered to a nursing woman. Consult your doctor to weigh the potential risks and benefits.
Driving
SAFESEVOMAR-800 TAB is not known to impair the ability to drive or operate machinery. It does not typically cause drowsiness or dizziness. You can safely drive unless you experience any unusual side effects that affect your concentration.
Kidney
SAFE IF PRESCRIBEDSEVOMAR-800 TAB is specifically designed for patients with chronic kidney disease to manage hyperphosphatemia. It is safe and effective for kidney patients when used as prescribed by a nephrologist. Regular monitoring of phosphate levels is crucial.
Liver
CONSULT YOUR DOCTORSevelamer is not absorbed systemically and is not metabolized by the liver, so liver impairment is not expected to affect its pharmacokinetics. However, patients with severe liver disease should consult their doctor before starting treatment, as their overall health status may require careful consideration.
Fact Box
Frequently asked questions by patients
Q: How long do I need to take SEVOMAR-800 TAB?
A: SEVOMAR-800 TAB is typically a long-term medication for patients with chronic kidney disease to manage their phosphate levels. You should continue taking it as prescribed by your doctor, usually for as long as you are on dialysis or as long as hyperphosphatemia persists.
Q: Can I crush or chew SEVOMAR-800 TAB?
A: No, SEVOMAR-800 TAB should be swallowed whole. Crushing, chewing, or breaking the tablets can alter their release properties and effectiveness, potentially leading to inadequate phosphate binding. If you have difficulty swallowing, discuss alternative options with your doctor.
Q: What if I forget to take SEVOMAR-800 TAB with a meal?
A: If you forget to take your dose with a meal, you should take it with your next meal. Do not take a double dose to compensate for the missed one. Consistent dosing with meals is crucial for the medication to effectively bind with dietary phosphate.
Q: Will SEVOMAR-800 TAB affect other medications I take?
A: Yes, Sevelamer can interfere with the absorption of certain other oral medications. It is recommended to take other oral medications at least one hour before or three hours after SEVOMAR-800 TAB. Always inform your doctor about all medications, including over-the-counter drugs and supplements, you are currently taking.
Frequently Asked Questions
Q: What is hyperphosphatemia and why is it dangerous in CKD?
Hyperphosphatemia is a condition where there are abnormally high levels of phosphate in the blood. In chronic kidney disease (CKD), damaged kidneys cannot effectively remove excess phosphate. This can lead to serious complications such as bone and mineral disorders (renal osteodystrophy), calcification of blood vessels and soft tissues, and an increased risk of cardiovascular disease, which is a leading cause of death in CKD patients.
Q: How does SEVOMAR-800 TAB differ from calcium-based phosphate binders?
SEVOMAR-800 TAB (Sevelamer) is a non-calcium, non-aluminum based phosphate binder. Unlike calcium-based binders, it does not add to the body's calcium load, which is important for CKD patients who are already at risk of hypercalcemia and vascular calcification. It also avoids the potential toxicity associated with aluminum-containing binders.
Q: Are there any dietary restrictions while taking SEVOMAR-800 TAB?
While SEVOMAR-800 TAB helps manage phosphate levels, it is still crucial to follow a low-phosphate diet as advised by your doctor or dietitian. This includes limiting foods rich in phosphorus, such as dairy products, nuts, processed foods, and certain meats. The medication works best in conjunction with dietary modifications.
Q: Can SEVOMAR-800 TAB cause weight changes?
Weight changes are not a commonly reported side effect of SEVOMAR-800 TAB. However, gastrointestinal side effects like nausea, vomiting, or changes in appetite could indirectly affect food intake and potentially lead to minor weight fluctuations. If you experience significant or concerning weight changes, consult your doctor.
Q: Is SEVOMAR-800 TAB safe for long-term use?
Yes, SEVOMAR-800 TAB is generally considered safe and effective for long-term use in patients with chronic kidney disease to manage hyperphosphatemia. Regular monitoring of blood parameters, including phosphate, calcium, and vitamin levels, is recommended to ensure optimal treatment and address any potential deficiencies or complications over time.
Additional Information
SEVOMAR-800 TAB, containing Sevelamer 800mg, is a cornerstone in the management of hyperphosphatemia for patients with chronic kidney disease, particularly those on dialysis. By effectively binding dietary phosphate in the gut, it helps prevent the accumulation of excess phosphorus in the blood, thereby mitigating the risks of bone disease, cardiovascular complications, and soft tissue calcification. Its non-calcium, non-aluminum formulation offers a significant advantage, reducing concerns about hypercalcemia and metal toxicity. Adherence to the prescribed dosage, along with dietary phosphate restriction, is crucial for achieving optimal therapeutic outcomes and improving the long-term health and quality of life for renal patients. Always consult your healthcare provider for personalized advice and management of your condition.
