Phoslo Recall
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Questions & Answers
Side Effects & Adverse Reactions
Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with PhosLo.
Progressive hypercalcemia due to overdose of PhosLo may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period. The serum calcium times phosphate(CaXP) product should not be allowed to exceed 66. Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft tissue calcification.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PhosLo is indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption.
History
There is currently no drug history available for this drug.
Other Information
Each opaque gelcap with a blue cap and white body is spin printed in blue and white ink with “PhosLo®” printed on the cap and “667 mg” printed on the body. Each gelcap contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and 10 mg of the inert binder, polyethylene glycol 8000 NF. The gelatin cap and body have the following inactive ingredients: FD&C blue #1, D&C red #28, titanium dioxide, USP and gelatin, USP.
PhosLo Gelcaps (calcium acetate) are administered orally for the control of hyperphosphatemia in end stage renal failure.
Sources