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Phoslyra® (calcium acetate oral solution)

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]
DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED

(DESCRIPTION) top of page

DESCRIPTION
PHOSLYRA acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17.

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.

CLINICAL PHARMACOLOGY: top of page

CLINICAL PHARMACOLOGY
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.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE
PHOSLYRA is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.

CONTRAINDICATIONS top of page

Hypercalcemia.

PRECAUTIONS top of page

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 maltitol.


DRUG INTERACTIONS
PHOSLYRA may decrease the bioavailability of tetracyclines or fluoroquinolones.
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 drug.

ADVERSE REACTIONS top of page

 The most common (>10%) adverse reactions are hypercalcemia, nausea, and diarrhea.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION  top of page

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.

HOW SUPPLIED top of page

Oral Solution: 667 mg calcium acetate per 5 mL.

HOW SUPPLIED/ STORAGE AND HANDLING

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)

Storage:
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.

REFERENCE

Package Insert data: 
Manufactured for:
Fresenius Medical Care North America
Waltham, MA 02451
1-800-323-5188

Manufactured by:
Lyne Laboratories
Brockton, MA 02301
1-508-583-0943
101087.00 4/2011
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