Perfosen Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sevelamer carbonate

Indications/Uses

Control of serum P in patients w/ CKD on dialysis. Control of hyperphosphatemia in adults receiving hemodialysis. Adult CKD patients not on dialysis w/ serum P >1.78 mmol/L (5.5 mg/dL).

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Dosage/Direction for Use

Patient not taking a phosphate binder Initially 0.8-1.6 g based on serum P level. Serum P level >5.5 & <7.5 mg/dL 1 tab tid; ≥7.5 mg/dL 2 tab tid. Titrate dose by 0.8 g tid at 2-wk intervals as necessary. Switching from sevelamer HCl tab to sevelamer carbonate tab/powd Use same dose in g. Max: 14 g in CKD patients on dialysis. Switching between sevelamer carbonate tab & powd, & from Ca Acetate Use same dose in g.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity. Patients w/ bowel obstruction.

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Special Precautions

Monitor bicarbonate & Cl levels; monitor for reduced Vit D, E, K (clotting factors) & folic acid levels. Consider monitoring clinical responses &/ blood levels of concomitant drugs that have a narrow therapeutic range. Patients w/ history of swallowing disorders. Pregnancy & lactation. Childn <6 yr. Elderly >65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dysphagia, esophageal tab retention, bowel obstruction & perforation.

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Drug Interactions

Reduced bioavailability of cyclosporine, tacrolimus & levothyroxine. Decreased bioavailability of ciprofloxacin. Decreased the mean MPA C_max & AUC_{0-12 hr} w/ mycophenolate mofetil. Increased TSH levels w/ levothyroxine. Digoxin, enalapril, Fe, metoprolol, & warfarin.

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Action

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MIMS Class

Antidotes & Detoxifying Agents

ATC Classification

V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Perfosen FC tab 800 mg

Packing/Price

30's (P1,012.5/box)

Perfosen

sevelamer

Manufacturer:

Medisure

Distributor:

Kaufmann