VELAMIR 800
Sevelamer carbonate
VELAMIR 800: Each film coated tablet contains Sevelamer carbonate 800 mg
Clinical Pharmacology:
Sevelamer carbonate is a positively charged, non-absorbed polymer that binds to dietary phosphates in the gut, forming an insoluble complex that cannot be absorbed by the body. This reduces the amount of phosphate that is absorbed into the bloodstream, helping to control serum phosphorus levels.
It is indicated in the treatment of hyperphosphataemia in patients with Chronic kidney disease/ESRD on dialysis.
The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. It is taken taken three times per day with meals.
Doses should be adjusted based on serum phosphorum level:
5.5 to <7.5 mg/dL: 800 mg tid
7.5 to <9 mg/dL: 1.2-1.6 g tid
≥9 mg/dL: 1.6 g tid.
Ciprofloxacin - sevelamer carbonate may decrease the bioavailability of ciprofloxacin
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients - sevelamer carbonate may possibly reduce levels of ciclosporin, mycophenolate mofetil and tacrolimus.
Proton pump inhibitors -very rare cases of increased phosphate levels have been reported in patients taking proton pump inhibitors co-administered with sevelamer carbonate. Caution should be exercised when prescribing PPI to patients concomitantly treated with sevelamer carbonate.
Bioavailability
Sevelamer carbonate is not absorbed and may affect the bioavailability of other medicinal products. When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after sevelamer carbonate, or the physician should consider monitoring blood levels.
Some of the most common side effects reported in patients taking sevelamer carbonate:
-vomiting
- upper abdominal pain
- nausea
- diarrhoea
- abdominal pain
- indigestion
- flatulence.
Do not take Sevelamer carbonate if:
• you are allergic to the active substance or to any of the other ingredients of this medicine
• you have bowel obstruction
Warnings and precautions
Talk to your doctor before taking Sevelamer carbonate if any of the following applies to you:
• swallowing problems, dysphagia
• problems with motility (movement) in your stomach and bowel
• active inflammation of the bowel
• have undergone major surgery on your stomach or bowel.
Talk to your doctor while taking Sevelamer carbonate:
• if you experience severe abdominal pain, stomach or intestine disorders, or blood in your stools.