Renvela Sevelamer Carbonate Tablets

1. Indications and Usage
Hyperphosphatemia in Chronic Kidney Disease (CKD):
Treatment of hyperphosphatemia in adult patients with CKD who are on dialysis.
Note: Also indicated for CKD patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L (≥ 5.5 mg/dL).
2. Dosage and Administration
Route of Administration:
Oral administration.
Recommended Dosage:
Standard Dose: The dosage is titrated based on serum phosphorus levels.
Calculation: Approximately 1.9 g of Sevelamer Carbonate per gram of dietary phosphorus.
Typical Regimen: Usually administered as 800 mg or 1600 mg three times daily with meals.
Critical Administration Instructions:
With Meals: Must be taken with food (during or immediately after a meal) to effectively bind dietary phosphorus.
Swallow Whole: Tablets should be swallowed whole and must not be crushed, chewed, or broken.
3. Mechanism of Action
Polymeric Phosphate Binder:
Sevelamer Carbonate is a cross-linked polymer that contains no calcium or aluminum.
Gastric Acid-Dependent Binding:
In the acidic environment of the stomach, the amine groups of the polymer become protonated (positively charged).
Therapeutic Result: Through ion exchange and hydrogen bonding, it binds to dietary phosphate in the intestine, preventing its absorption into the bloodstream and leading to increased fecal excretion of phosphate.
4. Safety and Warnings
Gastrointestinal Obstruction/Perforation:
Severe gastrointestinal adverse events, including obstruction, strictures, and perforation, have been reported.
Action: Use with caution in patients with severe gastrointestinal motility disorders or recent GI surgery.
Electrolyte Imbalances:
Can cause hypocalcemia (low calcium) and metabolic acidosis. Monitor serum calcium, bicarbonate, and chloride levels regularly.
Fat-Soluble Vitamin Deficiency:
May decrease the absorption of fat-soluble vitamins (A, D, E, and K). Monitoring is recommended.
Contraindications:
Hypophosphatemia.
Bowel obstruction.
5.Adverse Reactions
Most Common:
Nausea, vomiting, diarrhea, abdominal pain, dyspepsia, constipation, and flatulence.
6.Drug Interactions
Absorption Interference:
May reduce the absorption of other concomitantly administered oral medications.
Action: Administer other oral drugs at least 1 hour before or 3 hours after Sevelamer Carbonate.
Specific Drugs:
Ciprofloxacin: Significantly reduces bioavailability.
Immunosuppressants: May reduce levels of cyclosporine, tacrolimus, and mycophenolate mofetil; monitoring is advised.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Sevelamer Carbonate.
Appearance: White to off-white, elliptical film-coated tablets.
Packaging: Bottles or Blister packs (e.g., 800 mg).
Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Protect from moisture and light.