Fosfamer

Fosfamer

sevelamer

Manufacturer:

Stallion Labs

Distributor:

One Pharma
Concise Prescribing Info
Contents
Sevelamer carbonate
Indications/Uses
Control of serum P in patient w/ CKD on dialysis; hyperphosphatemia in adults receiving hemodialysis or peritoneal dialysis. Adult CKD patients not on dialysis w/ serum P >1.78 mmol/L.
Dosage/Direction for Use
Adult & elderly >65 yr not taking a phosphate binder Initially 800-1,600 mg, which can be administered as one to two 800-mg tab based on serum P level. Serum P >5.5 & <7.5 mg/dL (>1.78 & <2.42 mmol/L) 1 tab tid, ≥7.5 & <9 mg/dL (≥2.42 & <2.91 mmol/L), ≥9 mg/dL (≥2.91 mmol/L) 2 tab tid. Patient switching from Ca acetate Give sevelamer in equiv doses on a mg for mg wt basis compared to the previous Ca based phosphate binder (ie, 1 tab sevelamer carbonate 800 mg = 1 tab Ca acetate 667 mg). Dose may be adjusted accordingly for all patients w/ goal of lowering serum P to ≥1.78 mmol/L (5.5 mg/dL).
Administration
Should be taken with food: Swallow whole, do not chew/crush/divide.
Contraindications
Hypersensitivity. Hypophosphatemia or bowel obstruction.
Special Precautions
Patients w/ dysphagia, swallowing disorders, severe GI motility disorders including severe constipation or major GIT surgery; contributing co-morbid conditions affecting ability to swallow including swallowing disorders or oroesophageal abnormalities. Reevaluate treatment in patients who develop severe constipation or other severe GI symptoms. Consider using powd for oral susp in patients w/ history of difficulty swallowing. Assess serum vit A, D, & E levels & vit K status regularly in patients not taking supplemental vit but on treatment. Pregnancy. Childn <18 yr.
Adverse Reactions
Nausea, vomiting; diarrhea, dyspepsia, abdominal pain, flatulence, constipation.
Drug Interactions
Decreased bioavailability of ciprofloxacin. Reduced conc of cyclosporin, mycophenolate mofetil & tacrolimus in transplant patients w/o any clinical consequences (ie, graft rejection). Very rare cases of increased TSH levels w/ levothyroxine. Very rare cases of increased phosphate levels w/ PPIs.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.
Presentation/Packing
Form
Fosfamer FC tab 800 mg
Packing/Price
30's
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