- Approval Id
- 2c59b812df9979b1
- Drug Name
- SEVELA FILM COATED TABLET 800MG
- Product Name
- SEVELA FILM COATED TABLET 800MG
- Approval Number
- SIN16105P
- Approval Date
- 2021-02-16
- Registrant
- MD PHARMACEUTICALS PTE. LTD.
- Licence Holder
- MD PHARMACEUTICALS PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p>Due to the rapid reaction of the drug with hydrochloric acid in stomach, the dosage of Sevelamer Carbonate tablet is expected to be similar to that of the hydrochloride salt.</p>
<p><strong>2.1 General Dosing Information</strong></p>
<p>The drug should be taken 3 times daily with meals.</p>
<p><em>D</em>ose for Adult Patients Not Taking a Phosphate Binder: The recommended starting dose of Sevelamer Carbonate is 0.8 to 1.6 g with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Sevelamer Carbonate for adult patients not taking a phosphate binder.</p>
<img src="/TGIF/Sevela-Table1.png" alt="Sevela Dosage Table 1" /><br><br>
<p><em>Switching from Sevelamer Hydrochloride Tablets:</em> For adult patients switching from Sevelamer Hydrochloride tablets to Sevelamer Carbonate tablets or powder, use the same dose in grams. To achieve the target phosphate concentration, further adjusting of dose may be necessary. For CKD patients on dialysis treatment, the highest daily dose of Sevelamer Carbonate studied was 14 grams.</p>
<p><em>Switching from Calcium Acetate:</em> A research performed on 84 CKD patients on dialysis indicated that equivalent doses (approximate mg to mg) of Sevelamer Hydrochloride and Calcium Acetate showed similar reductions in serum phosphorus levels. Table 2 gives recommended starting doses of Sevelamer Carbonate based on a patient’s current calcium acetate dose.</p>
<img src="/TGIF/Sevela-Table2.png" alt="Sevela Dosage Table 2" /><br><br>
<p><em>Adjusting doses for all patients using this product:</em> Adjust the Sevelamer Carbonate dose by 0.8 g per meal at two-week intervals as necessary to achieve target serum phosphorus levels (3.5 mg/ dL to 5.5 mg/dL).</p>
<p>Sevelamer Carbonate tablet should be swallowed intact and should not be crushed, chewed or broken into pieces prior to administration.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>Sevelamer Carbonate is indicated for the control of hyperphosphatemia in adult patients receiving haemodialysis or peritoneal dialysis.</p>
<p>Sevela Carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus >= 1.78 mmol/l.</p>
<p>Sevelamer Carbonate should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxyvitamin D3 or one of its analogues to control the development of renal bone disease.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>Sevelamer carbonate is contraindicated in patients with hypophosphatemia and bowel obstruction.</p>
<p>Sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, or to any of the excipients.</p>
- Atc Code
- V03AE02
- Atc Item Name
- sevelamer
- Pharma Manufacturer Name
- MD PHARMACEUTICALS PTE. LTD.
