ELIPHOS calcium acetate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
Available from:
KAISER FOUNDATION HOSPITALS
INN (International Name):
CALCIUM ACETATE
Composition:
CALCIUM ACETATE 667 mg
Prescription type:
PRESCRIPTION DRUG
Authorization status:
Abbreviated New Drug Application

ELIPHOS- calcium acetate tablet

KAISER FOUNDATION HOSPITALS

----------

DESCRIPTION

Each white, round tablet (stamped “CYP910”) contains 667 mg calcium acetate, USP (anhydrous;

Ca(CH COO) ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000

NF; sodium lauryl sulfate, NF; and crospovidone, NF. ELIPHOS (Calcium Acetate, USP) are

administered orally for the control of hyperphosphatemia in end stage renal failure.

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 (ELIPHOS ) 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.

ELIPHOS 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.

INDICATIONS AND USAGE

ELIPHOS is indicated for the control of hyperphosphatemia in end stage renal failure and does not

promote aluminum absorption.

CONTRAINDICATIONS

Patients with hypercalcemia.

WARNINGS

Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No

other calcium supplements should be given concurrently with ELIPHOS .

Progressive hypercalcemia due to overdose of ELIPHOS 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.

PRECAUTIONS

General

Excessive dosage of ELIPHOS 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. ELIPHOS should not be given to patients on digitalis, because hypercalcemia may

precipitate cardiac arrhythmias. ELIPHOS therapy should always be started at low dose and should not

be increased without careful monitoring of serum calcium. An estimate of daily dietary 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

ELIPHOS 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 calcium acetate tablets.

Pregnancy

Teratogenic Effects: Category C.

Animal reproduction studies have not been conducted with calcium acetate tablets. It is also not known

whether calcium acetate tablets can cause fetal harm when administered to a pregnant woman or can

affect reproduction capacity. Calcium acetate tablets should be given to a pregnant woman only if

clearly needed.

Pediatric Use

Safety and efficacy of calcium acetate have not been established.

Geriatric Use

Of the total number of subjects in clinical studies of calcium acetate tablets (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 calcium acetate tablet therapy.

Hypercalcemia may occur during treatment with ELIPHOS . 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 ELIPHOS dose or temporarily discontinuing

therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate

tablets therapy.

Decreasing dialysate calcium concentration could reduce the incidence and severity of ELIPHOS

induced hypercalcemia. The long-term effect of calcium acetate tablets on the progression of vascular

or soft-tissue calcification has not been determined.

Isolated cases of pruritus have been reported which may represent allergic reactions.

OVERDOSAGE

Administration of ELIPHOS in excess of the appropriate daily dosage can cause severe

hypercalcemia (See ADVERSE REACTIONS).

DOSAGE AND ADMINISTRATION

The recommended initial dose of ELIPHOS for the adult dialysis patient is 2 tablets 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 tablets with each meal.

HOW SUPPLIED

In tablet form with "CYP910" debossed on one side and plain on the other, for oral administration. Each

white round tablet contains 667 mg calcium acetate (anhydrous Ca(CH COO) ; MW=158.17 grams)

equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000, NF; sodium lauryl sulfate, NF; and

crospovidone, NF.

Tablets NDC 0179-0098-70, Box of 30 Unit Dose Tablets

STORAGE

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room

Temperature].

Rx only

Manufactured for Hawthorn Pharmaceuticals, Inc.

Madison, MS 39110

Repackaged by:

KAISER FOUNDATION HOSPITALS

Livermore, CA 94551

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ELIPHOS

calcium acetate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 179 -0 0 9 8 (NDC:6 3717-9 10 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALCIUM ACETATE (UNII: Y8 8 2YXF34X) (CALCIUM CATION - UNII:2M8 3C4R6 ZB)

CALCIUM ACETATE

6 6 7 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYETHYLENE GLYCO L 8 0 0 0 (UNII: Q6 6 2QK8 M3B)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)

Product Characteristics

Color

WHITE (WHITE)

S core

no sco re

S hap e

ROUND

S iz e

18 mm

KAISER FOUNDATION HOSPITALS

Flavor

Imprint Code

CYP9 10

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 179 -0 0 9 8 -70

30 in 1 BOX, UNIT-DOSE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 50 2

0 8 /24/20 11

Labeler -

KAISER FOUNDAT ION HOSPIT ALS (053052619)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

KAISER FOUNDATION HOSPITALS

0 530 526 19

re pa c k

Revised: 9/2011

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