Presentation
Each tablet contains Sevelamer Hydrochloride INN 400 mg.
Descriptions
Renophos (Sevelamer Hcl) is a new treatment for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Elevated serum phosphorus levels or uncontrolled hyperphosphatemia leads to development of secondary hyperparathyroidism, renal bone disease, calcification of vascular and nonvascular tissues, and cardiovascular disease. Renophos is a calcium-free, metal-free, nonabsorbed phosphate binder.
Renophos (sevelamer hydrochloride) is a nonabsorbed polymer phosphate binder. When taken with meals Renophos inhibits intestinal absorption of ingested phosphate.
Indications
Renophos is indicated for the reduction of serum phosphorus in patients with end-stage renal disease (ESRD).
Dosage & Administration
Patients not taking a Phosphate Binder: The recommended starting dose of Sevelamer is 800 to 1600 mg, which can be administered as two to four 400 mg Sevelamer tablets, with meals based on serum phosphorus level.
Renophos400 Recommendation for the patients with hyperphosphatemia is given below-
Table 1. Starting dose of Renophos for dialysis patients not taking any phosphate binder.
Serum Phosphorus------------Sevelamer 400 mg
> 5.5 and < 7.5 mg/dL ----2 tablets three times daily with meals
≥ 7.5 and < 9.0 mg/dL ----3 tablets three times daily with meals
≥ 9.0 mg/dL-----------------4 tablets three times daily with meals
Table 2. Starting dose for dialysis patients switching from calcium acetate to Sevelamer.
Calcium Acetate 667 mg---------- Sevelamer 400 mg
(Tablets per meal)------------------ (Tablets per meal)
1 tablet--------------------------------2 tablets
2 tablets------------------------------3 tablets
3 tablets-----------------------5 tablets
Dose titration for all patients taking Sevelamer: Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dl or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary.
Table 3. Dose titration guideline
Serum Phosphorus -------------Sevelamer dose
> 5.5 mg/dL ----------------------Increase 1 tablet per meal at 2 week intervals
3.5 - 5.5 mg/dL ------------------Maintain current dose
< 3.5 mg/dL ----------------------Decrease 1 tablet per meal
Side Effects
Sevelamer may cause dyspepsia, peritonitis, diarrhea, nausea, constipation, pruritus, abdominal distension, vomiting, fatigue, anorexia, arthralgia and less commonly ileus, bowel obstruction and bowel perforation.
Precautions
The safety and efficacy of Sevelamer in patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation, or major GI tract surgery have not been established. Caution should be exercised when Sevelamer is used in patients with these GI disorders.
Contraindications
Sevelamer is contraindicated in patients with hypophosphatemia or bowel obstruction and in patients with known hypersensitivity to Sevelamer hydrochloride or any of its constituents.
Use in Pregnancy & Lactation
Pregnancy: Pregnancy Category C.
Lactation: No adequate and controlled studies have been conducted using Sevelamer in nursing mothers. Sevelamer should be used during breastfeeding only if the potential benefit justifies the potential risks.
Drug Interaction
Sevelamer has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.
Overdose
Over dosages of Sevelamer in patients was never reported. Since Sevelamer is not absorbed, the risk of systemic toxicity is low.
Commercial Packaging
Each box contains 5 blister strips of 4 tablets.
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