Document
DailyMed Label: Phoslo
Title
DailyMed Label: Phoslo
Date
2010
Document type
DailyMed Prescription
Name
Phoslo
Generic name
Calcium Acetate
Manufacturer
Physicians Total Care, Inc.
Product information
NDC: 54868-5691
Product information
NDC: 54868-5691
Product information
NDC: 54868-3460
Product information
NDC: 54868-3460
Description
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(CH 3 COO) 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.
Indications
PhosLo is indicated for the control of hyperphosphatemia in end stage renal
failure and does not promote aluminum absorption.
Dosage
The recommended initial dose of PhosLo for the adult dialysis patient is 2
gelcaps with each meal. The dosage may be increased gradually to bring the serum
phosphate value below 6 mg/dl, as long as hypercalcemia does not develop. Most
patients require 3-4 gelcaps with each meal.
Contraindications
Patients with hypercalcemia.
Precautions
General Excessive dosage of PhosLo induces hypercalcemia; therefore,
early in the treatment during dosage adjustment serum calcium should be
determined twice weekly. Should hypercalcemia develop, the dosage should be
reduced or the treatment discontinued immediately depending on the severity of
hypercalcemia. PhosLo should not be given to patients on digitalis, because
hypercalcemia may precipitate cardiac arrhythmias. PhosLo therapy should always
be started at low dose and should not be increased without careful monitoring of
serum calcium. An estimate of daily calcium intake should be made initially and
the intake adjusted as needed. Serum phosphorus should also be determined
periodically.
Information for the Patient The patient should be informed about compliance with dosage
instructions, adherence to instructions about diet and avoidance of the use of
nonprescription antacids. Patients should be informed about the symptoms of
hypercalcemia (see ADVERSE REACTIONS section).
Drug Interactions PhosLo may decrease the bioavailability of tetracyclines.
Carcinogenesis, Mutagenesis, Impairment of
Fertility Long term animal studies have not been performed to evaluate the
carcinogenic potential, mutagenicity, or effect on fertility of PhosLo.
Pregnancy Teratogenic Effects: Category C. Animal reproduction studies have
not been conducted with PhosLo. It is not known whether PhosLo can cause fetal
harm when administered to a pregnant woman or can affect reproduction capacity.
PhosLo should be given to a pregnant woman only if clearly needed.
Pediatric Use Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use Of the total number of subjects in clinical studies of PhosLo
(n=91), 25 percent were 65 and over, while 7 percent were 75 and over. No
overall differences in safety or effectiveness were observed between these
subjects and younger subjects, and other reported clinical experience has not
identified differences in responses between the elderly and younger patients,
but greater sensitivity of some older individuals cannot be ruled out.
Adverse reactions
In clinical studies, patients have occasionally experienced
nausea during PhosLo therapy. Hypercalcemia may occur during treatment with
PhosLo. Mild hypercalcemia (Ca>10.5mg/dl) may be asymptomatic or manifest
itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia
(Ca>12mg/dl) is associated with confusion, delirium, stupor and coma. Mild
hypercalcemia is easily controlled by reducing the PhosLo dose or temporarily
discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis
and discontinuing PhosLo therapy. Decreasing dialysate calcium concentration
could reduce the incidence and severity of PhosLo induced hypercalcemia. The
long-term effect of PhosLo on the progression of vascular or soft tissue
calcification has not been determined.
How supplied
Gelcap: A white and blue gelcap for oral
administration containing 667 mg calcium acetate (anhydrous Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg
(8.45 mEq) calcium.
Gelcap
NDC 54868-5691-0 Bottles of 200
NDC 54868-5691-1 Bottles of 100
STORAGE Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
See USP “Controlled Room Temperature.”
Rx only
Manufactured for Fresenius Medical Care Waltham, MA 02451
100623.00 01/07
Repackaging and Relabeling by:
Physicians Total Care, Inc.
Tulsa, OK 74146
Clinical pharmacology
Patients with advanced renal insufficiency (creatinine clearance
less than 30 ml/min) exhibit phosphate retention and some degree of
hyperphosphatemia. The retention of phosphate plays a pivotal role in causing
secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue
calcification. The mechanism by which phosphate retention leads to
hyperparathyroidism is not clearly delineated. Therapeutic efforts directed
toward the control of hyperphosphatemia include reduction in the dietary intake
of phosphate, inhibition of absorption of phosphate in the intestine with
phosphate binders, and removal of phosphate from the body by more efficient
methods of dialysis. The rate of removal of phosphate by dietary manipulation or
by dialysis is insufficient. Dialysis patients absorb 40% to 80% of dietary
phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet
needs to be reduced by using phosphate binders in most renal failure patients on
maintenance dialysis. Calcium acetate (PhosLo) when taken with meals, combines
with dietary phosphate to form insoluble calcium phosphate which is excreted in
the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally
considered as a clinically acceptable outcome of treatment with phosphate
binders. PhosLo is highly soluble at neutral pH, making the calcium readily
available for binding to phosphate in the proximal small intestine.
Orally administered calcium acetate from pharmaceutical dosage forms has been
demonstrated to be systemically absorbed up to approximately 40% under fasting
conditions and up to approximately 30% under nonfasting conditions. This range
represents data from both healthy subjects and renal dialysis patients under
various conditions.
Package label
PhosLo Gelcaps (calcium acetate)
NDC 54868-5691
667 mg Gelcap
NDC 54868-3460
image of package label
image of "No Label Available"
1 organization
1 product
Product
Calcium AcetateOrganization
Physicians Total Care, Inc.