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RENVELA TABLET 800MG

Product Information

Registration Status: Active

SIN13725P

RENVELA TABLET 800MG is approved to be sold in Singapore with effective from 2009-06-11. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN13725P.

This product contains Sevelamer 800mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by Genzyme Ireland LTD in IRELAND.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Sevelamer is a phosphate binding drug used to prevent hyperphosphataemia in patients with chronic renal failure. When taken with meals, sevelamer binds to dietary phosphate and prevents its absorption. It is marketed by Genzyme under the trade name Renagel.

Indication

For the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis.

Mechanism of Action

Sevelamer prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels.

Pharmacokinetics

Absorption
Not absorbed following oral administration, however no absorption studies have been performed in patients with renal disease.
Distribution
Metabolism
Elimination

Toxicity

Sevelamer has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Sevelamer has been given in average doses up to 13 grams per day to hemodialysis patients. There are no reported overdosages of sevelamer in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.

Active Ingredient/Synonyms

Sevelamer | Sévélamer | Sevelamero | Sevelamerum | Sevelamer |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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