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PHOSLYRA acts as a phosphate binder. Its chemical name is calcium
acetate. Its molecular formula is C4H6CaO4, and its molecular weight is
PHOSLYRA for oral administration is provided as pale to light
greenish-yellow clear liquid. Each 5 mL of PHOSLYRA contains 667 mg
calcium acetate, USP equal to 169 mg (8.45 mEq) calcium. PHOSLYRA also
contains the following inactive ingredients: maltitol NF, glycerin USP,
Magnasweet 110, propylene glycol USP, povidone K25 USP, sucralose NF,
methylparaben NF, artificial black cherry flavor, menthol flavor,
purified water USP.
Patients with ESRD retain phosphorus and can develop hyperphosphatemia.
High serum phosphorus can precipitate serum calcium resulting in ectopic
calcification. Hyperphosphatemia also plays a role in the development of
secondary hyperparathyroidism in patients with ESRD.
Mechanism of Action
Calcium acetate, when taken with meals, combines with dietary phosphate
to form an insoluble calcium-phosphate complex, which is excreted in the
feces, resulting in decreased serum phosphorus concentrations.
WARNINGS AND PRECAUTIONS
Treat mild hypercalcemia by reducing or interrupting PHOSLYRA
and Vitamin D. Severe hypercalcemia may require hemodialyis and
discontinuation of PHOSLYRA.
May cause diarrhea with nutritional supplements that contain
PHOSLYRA may decrease the bioavailability of tetracyclines or
When clinically significant drug interactions are expected,
administer the drug at least one hour before or at least three
hours after PHOSLYRA, or consider monitoring blood levels of the
DOSAGE AND ADMINISTRATION
Starting dose is 10 mL with each meal.
Titrate the dose every 2 to 3 weeks until an acceptable serum
phosphorus level is reached. Most patients require 15 to 20 mL
with each meal.
PHOSLYRA for oral administration is a clear solution containing
667 mg calcium acetate per 5 mL. PHOSLYRA is supplied in
amber-colored, multiple-dose bottles, packaged with a marked
dosing cup in the following size:
473 mL (16 fl. oz) bottle (NDC 49230-643-31)
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
[see USP Controlled Room Temperature].
The shelf life is 24 months.
Package Insert data:
Fresenius Medical Care North America
Waltham, MA 02451
Brockton, MA 02301